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Independent device testing for the Open Oximetry Project follows <a href="https://docs.google.com/document/d/1bpVzZg9M0StLoyB_iF07V8at0h8lQhDyYnNCoSMVZQU/edit" target="_blank" rel="noopener">our protocol consistent with ISO and FDA</a>. Only devices labeled as ‘verified’ or ‘failed’ have been independently tested by the Open Oximetry Project.<br /> All other devices listed show data from manufacturers or published literature and have not been confirmed by the Open Oximetry team. Scoring criteria will be modified based on evolving data on this topic. See the table below for scoring criteria for this category:</p> </div> <div class="content__table"> <div class="table__grid table__grid--col-0-heading" style="grid-template-columns: repeat( 4, minmax(160px, 1fr) );"> <div class="grid__cell grid__cell--header grid__cell--col-0">Score</div> <div class="grid__cell grid__cell--header grid__cell--col-1">Root mean square error (Arms) composite all skin colors & all perfusions tested 2022 FDA/ISO <span>(manufacturer* or independent testing)</span></div> <div class="grid__cell grid__cell--header grid__cell--col-2">Skin color</div> <div class="grid__cell grid__cell--header grid__cell--col-3">Perfusion</div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-0" >No Data</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-0" >No Data</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-0" ></div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-0" ></div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-1" >1 (red)</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-1" >>4%</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-1" ></div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-1" ></div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-2" >2 (red)</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-2" ><4%</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-2" >AND/OR Data suggesting Arms for dark skin color of >4%</div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-2" >AND/OR Data suggesting Arms for PI<1 in dark or light skin color of >4%</div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-3" >3 (yellow)</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-3" ><4%</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-3" >AND/OR Data suggesting Arms for dark skin color of 3-4%</div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-3" >AND/OR Data suggesting Arms for PI<1 in dark or light skin color of 3-4%</div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-4" >4 (green)</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-4" ><3%</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-4" >AND No data for or against performance problems in darker skin colors</div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-4" >AND No data for or against performance problems in low perfusion</div> <div class="grid__cell grid__cell--content grid__cell--col-0 grid__cell--row-5" >5 (green)</div> <div class="grid__cell grid__cell--content grid__cell--col-1 grid__cell--row-5" ><3%</div> <div class="grid__cell grid__cell--content grid__cell--col-2 grid__cell--row-5" >AND Extended testing beyond ISO/FDA recommendations Criteria TBD April 2023</div> <div class="grid__cell grid__cell--content grid__cell--col-3 grid__cell--row-5" >AND Extended testing beyond ISO/FDA recommendations Criteria TBD April 2023</div> </div> <span class="table__caption">* only independently tested devices by OpenOximetry (Hypoxia Lab and Clinimark Lab) get labeled as ‘verified’</span> </div> </div> </section> <script src="https://openoximetry.org/wp-content/themes/oximetry/build/Homepage.js?f0cff159"></script> </body> </html>