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The Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2 Adhesive Sensors are indicated for single patient use for continuous noninvasive monitoring 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 perfused in hospitals and hospital-type facilities.

Medline ReNewal Reprocessed Masimo LNCS Adult and Pediatric SpO2 Adhesive Sensors, models LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, and LNCS Pdtx-3 are designed for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with instruments containing Masimo SET oximetry or licensed to use LNCS sensors. The Medline ReNewal Reprocessed Masimo LNCS sensor models LNCS Adtx, LNCS Pdtx, LNCS Adtx-3, and LNCS Pdtx-3 are intended for prescription use with adult and pediatric patients in hospitals, hospital-type facilities, and intra-hospital transport. The proposed device is not provided sterile.

The provided text describes a 510(k) summary for the Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors. This document is a premarket notification to the FDA, demonstrating that the reprocessed device is substantially equivalent to legally marketed predicate devices.

The study described is a clinical trial conducted to evaluate the SpO2 accuracy of the reprocessed sensors, specifically focusing on the acceptance criteria for SpO2 accuracy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size: 10 healthy adult volunteer subjects.
• Data Provenance: The study was conducted from May 9 to May 10, 2018. The location of the study (e.g., country of origin) is not explicitly stated but is implied to be within the jurisdiction of the U.S. FDA, given it's part of a 510(k) submission. The study involved prospective data collection as it was a clinical trial performed specifically to evaluate the device.

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

The document does not specify the number or qualifications of experts (e.g., medical professionals, technicians) used to establish the ground truth for SpO2 measurements. The ground truth for SpO2 accuracy in pulse oximetry studies typically relies on co-oximetry measurements from arterial blood samples. While the study followed ISO standards that dictate such procedures, the explicit mention of experts establishing ground truth is absent.

4. Adjudication method for the test set

The document does not describe an adjudication method. For a study evaluating SpO2 accuracy against a reference method (like co-oximetry), adjudication in the sense of multiple expert reviews of a single interpretation is not typically applicable. The comparison is between the device's measurement and the objective reference measurement.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study solely focused on the accuracy of the device itself (standalone performance) in measuring SpO2 in comparison to a reference method, not on how human readers (if this were an AI diagnostic tool) might improve with AI assistance.

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

Yes, a standalone study was done. The clinical trial specifically evaluated the SpO2 accuracy of the proposed devices (the reprocessed sensors) themselves. The performance assessed was the sensor's ability to accurately measure SpO2, which is an inherent function of the device's technology.

7. The type of ground truth used

The ground truth used for SpO2 accuracy in this type of study is typically invasive laboratory testing on healthy volunteers where arterial blood samples are taken and analyzed by a co-oximeter. This is implied by the reference to "ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteers applicable sections" in the "Performance Testing Clinical Tests" section. This forms an objective, physiological ground truth.

8. The sample size for the training set

The document describes a clinical trial for performance evaluation, not the training of an AI algorithm. Therefore, there is no mention of a training set sample size. The device is a reprocessed medical sensor, not an AI model that requires a training dataset.

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

As the device is a reprocessed sensor and not an AI algorithm, there is no training set or associated ground truth establishment for a training phase. The clinical study tested the device's performance directly against established physiological measurements.

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