(30 days)
The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR is indicated for single patient use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required for adult patients as indicated in the sensor directions for use. This device is for prescription use only.
The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR is 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 Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR, is intended for prescription use with adult patients in hospitals, hospital-type facilities, and intra-hospital transport. The proposed device is not provided sterile
The provided document describes a 510(k) premarket notification for a reprocessed medical device, the Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, Model MAXNAR. This is not an AI/ML device, but a reprocessed physical sensor. Therefore, many of the typical acceptance criteria and study components for an AI/ML device (like an algorithm's performance, human reader improvement, expert consensus for ground truth on images, training sets, etc.) are not applicable here.
Instead, the study focuses on demonstrating substantial equivalence to an existing predicate device by showing that the reprocessed sensor meets performance specifications and safety standards similar to a new device. The "ground truth" here is the actual arterial oxygen saturation measured by a co-oximeter, and the "device performance" refers to the accuracy of the SpO2 sensor against this gold standard.
Here's an attempt to extract and reframe the information based on the prompt's requirements, noting where AI/ML specific criteria do not apply:
Device: Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, Model MAXNAR
Device Type: Reprocessed pulse oximeter sensor (physical hardware, not an AI/ML algorithm)
Acceptance Criteria and Reported Device Performance
The core acceptance criterion for this device, as a pulse oximeter, is its accuracy in measuring SpO2. This is evaluated against an established standard (ISO 80601-2-61:2011).
| Acceptance Criteria (SpO2 Accuracy) | Reported Device Performance (Medline ReNewal MAXNAR) |
|---|---|
| Accuracy (Arms) for 70% - 100% SpO2 (per ISO 80601-2-61:2011 and FDA guidance) | Passed the Arms specification of 3% |
| Target Accuracy: ±3 digits in adults for 70-100% SpO2 range | Achieved an accuracy of 2% for 70% - 100% SpO2 |
| Pulse Rate Accuracy: 20-250 bpm ±3 digits | 20-250 bpm ±3 digits (Same as predicate) |
Note: "Arms" refers to the "Accuracy Root Mean Square" deviation, which is a statistical measure of accuracy for pulse oximeters.
Study Details
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Sample Size and Data Provenance:
- Test Set Sample Size: 10 healthy adult volunteer subjects.
- Data Provenance: The study was conducted in a laboratory setting on healthy volunteers. The exact country of origin is not specified, but the context implies it's within the US, given the FDA submission. It was a prospective clinical trial.
- Subject Demographics: Ages 25 to 36 years; weight 105 - 220 lb.; height 60 – 72 in.; BMI of 20.0 – 33.4.
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Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable in the typical AI/ML sense where human experts label images.
- The ground truth for SpO2 was established invasively using a co-oximeter (arterial blood gas analysis), which is the gold standard for measuring arterial oxygen saturation. This does not involve human expert interpretation of images. The study followed "ISO 80601-2-61:2011 Procedure for invasive laboratory testing on healthy volunteers applicable sections."
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Adjudication Method for the Test Set:
- Not applicable. This study is a direct comparison of the device reading against an objective, invasive gold standard (co-oximetry), not an interpretation that requires adjudication by multiple experts.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study is relevant for AI/ML systems that assist human interpretation of medical images. This device is a sensor that directly measures a physiological parameter. The study focuses on the sensor's accuracy, not its impact on human reader performance.
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Standalone (Algorithm Only) Performance:
- Yes, but framed differently. This is a hardware device, not an algorithm. The "standalone performance" is the accuracy of the reprocessed sensor itself (Model MAXNAR) in measuring SpO2 and pulse rate against the co-oximeter standard, without further human interpretation other than reading the display. The reported performance of 2% SpO2 accuracy is this standalone performance.
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Type of Ground Truth Used:
- Outcomes Data/Physiological Measurement (Invasive Gold Standard): Arterial oxygen saturation (SpO2) measurements obtained via co-oximetry on arterial blood samples from healthy volunteers. This is considered the true physiological value.
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Sample Size for the Training Set:
- Not applicable. This isn't an AI/ML algorithm that requires a training set. The "training" for a reprocessed device involves the manufacturing and reprocessing procedures themselves, ensuring they meet the original equipment manufacturer's specifications and performance.
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How Ground Truth for the Training Set Was Established:
- Not applicable. As above, no training set in the AI/ML context. The closest analogy would be the validation of the reprocessing methods to ensure the sensor performs "as new." This involves non-clinical tests (biocompatibility, disinfection, shelf life, electrical, tissue heating, pulse rate accuracy, active element assessment, adhesive peel, environmental testing, visual inspection, cleaning efficacy) to establish that the reprocessed device meets specifications. The clinical study mentioned verifies the final performance.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).