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The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients during no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

The Masimo SET Reusable Soft Oximetry Sensors (DBI/P Sensors) have been cleared under K090662 for use with Masimo SET and Masimo SET -compatible pulse oximeter monitors as well as Nellcor and Nellcor compatible pulse oximeter monitors. This submission presents data demonstrating that the DBI/P Sensors also are compatible for use with pulse oximeter monitors incorporating Philips FAST SpO2 Technology. Two additional M-LNCS sensors with M-15 connectors are included in this notification.

The provided text describes a 510(k) submission for Masimo SET® Reusable Soft Oximetry Sensors. However, it explicitly states that "There are no changes to the design of the device cleared in K090662. Specifically, the principles of operation performance and materials of the device remain unchanged from the existing Masimo SET Reusable Soft Oximetry Sensors."

This indicates that the current submission (K113596) is for demonstrating compatibility of the existing device with Philips FAST SpO2 Technology, rather than presenting new performance data for the device itself. Therefore, the document does not contain specific acceptance criteria or a dedicated study proving performance against new criteria for this particular submission. Instead, it refers to prior performance data.

Given this, I cannot extract the detailed information requested in the prompt based on the provided text, as the focus is on demonstrating equivalence rather than a new performance study.

However, I can extract the information that is implicitly available or explicitly stated regarding the nature of the submission and the validation that was performed to support the substantial equivalence claim.

Here's an analysis based on the available text:

Acceptance Criteria and Device Performance (Implicit, as this is mainly an equivalence claim):

Study Details:

The provided text does not contain the specific details about the original design validation study (K090662) that would provide explicit numbers for the acceptance criteria, sample sizes, ground truth establishment, etc. This submission (K113596) is a supplemental filing based on prior clearance.

However, based on the information provided for K113596:

• 2. Sample size used for the test set and the data provenance:

  • Test Set Size: Not explicitly stated for this submission's validation. The text mentions "Bench and clinical testing," but no numbers are provided for participants or data points.
  • Data Provenance: Not specified. likely internal to Masimo or a contracted lab. The type of testing ("Bench and clinical") suggests a combination of lab and human subject data, though no specifics are given.
  • Retrospective/Prospective: Not specified.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

  • Not applicable/Not specified in this document, as this submission primarily focuses on demonstrating compatibility with a new monitor technology rather than re-evaluating core device performance. The original K090662 submission would contain such details if they were needed for that clearance.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

  • Not applicable/Not specified.

• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

  • No. This device is a pulse oximetry sensor, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

  • While the device itself operates "standalone" in its measurement function, the "standalone" assessment usually refers to performance of a diagnostic algorithm without human input. This submission primarily relates to hardware compatibility. The "Bench and clinical testing" implicitly involves the device operating in a standalone capacity to measure SpO2 and pulse rate. No explicit standalone algorithm performance report as typically seen in AI/CAD submissions is provided.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

  • Not specified in this document. For pulse oximeters, the typical "ground truth" for SpO2 accuracy studies is co-oximetry (blood gas analysis) from arterial blood samples. The original K090662 submission would likely detail this.

• 8. The sample size for the training set:

  • Not applicable. This is a hardware sensor, not a machine learning model that requires a training set.

• 9. How the ground truth for the training set was established:

  • Not applicable. This is a hardware sensor, not a machine learning model.

Summary of what can be determined from the provided text:

This 510(k) submission (K113596) is for Masimo SET® Reusable Soft Oximetry Sensors to demonstrate "substantial equivalence" when used with pulse oximeter monitors incorporating Philips FAST SpO2 Technology. The core device design and performance principles remain unchanged from a previously cleared device (K090662).

The key "study" or validation performed for K113596 found that "Bench and clinical testing... demonstrate that the SpO2 and pulse rate accuracy is equivalent to the performance data submitted for the previously cleared Masimo sensors" when used with Philips FAST SpO2 Technology. The "acceptance criteria" for this submission was effectively demonstrating equivalence to the previously established performance. No specific quantitative criteria or detailed study results are provided within this document.

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