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The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors models MAXAL, MAXP, and MAXI are indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients in the sizes indicated in the respective sensor directions for use. These devices are for prescription use only.

Device Description

The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors, models MAXA, MAXAL, MAXP, and MAXI are designed for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with a Nellcor Pulse Oximeter. The Reprocessed Nellcor OxiMax SpO2 Sensors, models MAXA, MAXAL, MAXP, and MAXI are intended for prescription use with adult, pediatric and infant patients in hospitals, hospital-type facilities, and intra-hospital transport. The proposed device is not provided sterile.

AI/ML Overview

This document describes the validation of Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors (models MAXA, MAXAL, MAXP, and MAXI), which are reprocessed pulse oximetry sensors. The study aims to demonstrate that the reprocessed devices are substantially equivalent to the original, legally marketed predicate device (Nellcor OxiMax Pulse Oximeter Sensors, K052186) and a reference device (Hygia Health Services Reprocessed OxiMax Sensors, K041867).

Due to the nature of this medical device (a reprocessed pulse oximetry sensor that measures physiological parameters, not an AI/ML powered device), many of the requested criteria related to AI/ML software validation (e.g., sample size for test set/training set, number of experts for ground truth, adjudication method, MRMC studies) are not applicable (N/A) in this context. The study focuses on demonstrating physical and performance equivalence through non-clinical and clinical testing, rather than evaluating the accuracy of a machine learning algorithm against a human expert's interpretation of images or other complex data.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on achieving performance comparable to the predicate device, particularly in terms of SpO2 and pulse rate accuracy, and satisfying relevant standards and guidance documents.

Acceptance Criteria Category	Specific Criteria (Target)	Reported Device Performance (Achieved)
SpO2 Accuracy	SpO2 accuracy of 70% - 100% ± 2 digits (as per predicate device, under steady state and non-motion conditions)	Achieved "an accuracy of 2% for 70% - 100% SpO2." "The study concluded that the SpO2 accuracy performance of the proposed devices passed the Arms specification of 3% under steady state and non-motion conditions for the range of 70% to 100%." (Note: The predicate device listed 2 digits, while the study concludes it passed 3% Arms, which is generally acceptable for pulse oximeters within the 70-100% range, often assessed using Arms and bias. The 2% claimed for 70-100% SpO2 seems to match the predicate's ±2 digits.)
Pulse Rate Accuracy	20 - 250 bpm ± 3 digits (as per predicate device)	20 - 250 bpm ± 3 digits (explicitly stated in the comparison table as "Medline ReNewal is same as predicate")
Biocompatibility	No cytotoxicity, sensitization, irritation; acceptable acute systemic toxicity.	Tested and deemed acceptable: "Biocompatibility: cytotoxicity, sensitization, irritation; acute systemic toxicity"
Disinfection	Effective disinfection.	Tested and deemed acceptable.
Shelf Life	Appropriate shelf life validation.	Tested and deemed acceptable.
Electrical Safety	Compliance with electrical safety standards.	Tested and deemed acceptable.
Performance Testing	Acceptable tissue heating, pulse rate accuracy, active element assessment, adhesive peel, and environmental (extreme heat and operating conditions) performance.	Tested and deemed acceptable: "tissue heating," "pulse rate accuracy," "active element assessment," "adhesive peel," and "environment (extreme heat and operating conditions)."
Cleaning Efficacy	Effective cleaning with minimal residual protein and hemoglobin.	Tested and deemed acceptable: "Cleaning: visual inspection; cleaning efficacy (residual protein and residual hemoglobin)."
Intended Use Equivalence	Medline ReNewal will not make claims for neonatal use or for motion or low perfusion performance. Otherwise, same as predicate.	Conformed to this restriction. "Medline ReNewal will only reprocess pulse oximeter sensors. Medline ReNewal will not make claims for neonatal use or for motion or low perfusion performance; otherwise same as written." The patient population for the proposed device is "Adult, Pediatric, Infant," excluding neonates compared to the predicate/reference which included neonates.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Clinical Test Set: 10 healthy adult volunteer subjects.
Data Provenance: The clinical study was conducted from May 9 to May 10, 2018. While the specific country of origin is not explicitly stated, the FDA 510(k) submission format suggests it's likely a study conducted in the U.S. or in accordance with U.S. regulatory standards (CFR for Non-significant Risk Investigational Studies, ISO 14155:2011, and ISO 80601-2-61:2011 are referenced). It was a prospective clinical study specifically designed to evaluate the reprocessed device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

N/A. For this type of device (pulse oximetry sensor), "ground truth" for SpO2 accuracy is not typically established by human expert consensus or radiologists' interpretations. Instead, it's established by a recognized clinical methodology, such as arterial blood gas (ABG) analysis (co-oximetry), which provides a direct and objective measurement of arterial oxygen saturation (SaO2) and is considered the gold standard for validating SpO2 accuracy. The study mentions it followed "ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteers," which describes how to perform such comparisons using co-oximetry. There are no "experts" in the sense of image readers or diagnosticians determining a "ground truth" for each measurement.

4. Adjudication Method for the Test Set

N/A. As the ground truth is established by objective, invasive laboratory testing (e.g., co-oximetry), there is no need for human adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is relevant for evaluating diagnostic imaging systems where human readers interpret cases with and without AI assistance. This study pertains to a reprocessed medical sensor for physiological measurement, not an imaging or AI diagnostic device. Therefore, no MRMC study was performed, and no effect size regarding human reader improvement with AI assistance is applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

Yes, in essence. The clinical study evaluates the reprocessed sensor's performance (SpO2 accuracy) on subjects by comparing its readings to a recognized gold standard (invasive laboratory testing). While the device outputs a reading for a human to interpret, its fundamental performance (accuracy of the SpO2 measurement) is assessed as a standalone measurement, irrespective of specific human interpretation biases. There isn't an "algorithm" in the AI/ML sense, but the device's sensing and processing of physiological signals are evaluated directly.

7. Type of Ground Truth Used

Clinical Gold Standard / Objective Measurement: The ground truth for SpO2 accuracy was established through invasive laboratory testing, specifically by comparing the device's SpO2 readings to reference SaO2 values obtained from arterial blood samples (co-oximetry), as per the procedures outlined in ISO 80601-2-61:2011. This method is considered the gold standard for pulse oximeter accuracy validation.

8. Sample Size for the Training Set

N/A. This device is a reprocessed sensor, not a machine learning or AI-powered system that requires a "training set." Its performance is based on its physical and functional characteristics after reprocessing, which are validated against established standards and the predicate device, not by training an algorithm on a dataset.

9. How the Ground Truth for the Training Set Was Established

N/A. As there is no training set for an AI/ML algorithm, this question is not applicable.

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