(114 days)
The Nellcor Portable SpO2 Patient Monitoring System is indicated for prescription use only for spot check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.
The Nellcor Portable SpO2 Patient Monitoring System is a modification of the OxiMax NPB-40 and N-600X Pulse Oximetry Systems. It is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using Nellcor pulse oximetry sensors with OxiMAX technology, and the oximetry sensor cable. The monitor displays digital values of SpO2 and Pulse Rate. Pulse Amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The Nellcor Portable Sp02 Patient Monitoring System is powered by four AA batteries.
This document is a 510(k) summary for the Nellcor Portable SpO2 Patient Monitoring System (K141542). It claims substantial equivalence to two predicate devices: OxiMAX NPB-40 Pulse Oximeter (K051352) and N-600X Pulse Oximeter (K123581).
Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics for the Nellcor Portable SpO2 Patient Monitoring System itself. Instead, it relies on the established performance of its predicate devices and states that its performance is equivalent.
However, it does mention adherence to standards, which imply certain performance expectations:
| Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|
| Oximetry performance verification in accordance with FDA Guidance document: "Pulse Oximeters - Premarket Notification Submissions [510(k)s] Guidance for Industry and Food and Drug Administration Staff" | Verified by non-clinical testing. |
| Compliance with ISO 80601-2-61:2011 | Test reports available. |
| Compliance with IEC 60601-1:2005 | Test reports available. |
| Human Factors Summative Usability validation | Validation performed. |
| Pulse rate accuracy in the range of 20-250 beats per minute during motion | Verified using a functional tester and simulated motion. |
| SpO2 and Pulse Rate performance across neonatal, pediatric, and adult patients during both no motion and motion, well-perfused and poorly-perfused conditions | Stated to be the same as the N-600X pulse oximeter, established in K060576 and K123581. |
2. Sample Size Used for the Test Set and Data Provenance:
The document leverages clinical data from the predicate devices (K060576 and K123581). Since these studies are not detailed within this document, the specific sample sizes for their test sets and data provenance (e.g., country of origin, retrospective/prospective) are not directly provided in this K141542 summary.
The current device (K141542) underwent non-clinical/bench testing. For the pulse rate accuracy test during motion, it refers to using a "functional tester" and "simulated motion," which implies a test set of situations/scenarios rather than human subjects. The details of this test set are not specified (e.g., number of different motion patterns, duration).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the K141542 summary. As the device relies on clinical data from predicate devices, details about how ground truth was established in those earlier studies (K060576 and K123581) would be necessary for a full answer. For the non-clinical testing of K141542, ground truth would likely be based on calibrated equipment for measurements like pulse rate.
4. Adjudication Method for the Test Set:
This information is not provided in the K141542 summary.
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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done, nor is it applicable in this context. This device is a pulse oximeter, which directly measures physiological parameters (SpO2 and pulse rate) and presents them to a user. It is not an AI-assisted diagnostic imaging or interpretation tool where human readers would improve with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The performance discussed is inherently "standalone" in the sense that it refers to the device's ability to accurately measure SpO2 and pulse rate. The "oximetry performance verification" and "pulse rate accuracy during motion" tests evaluate the device's technical capabilities directly, without requiring human interpretation as part of the core measurement process.
7. The Type of Ground Truth Used:
For the clinical data referenced from K060576 and K123581, the ground truth for SpO2 measurements in pulse oximetry studies typically involves arterial blood gas analysis (co-oximetry) as the gold standard for measuring actual arterial oxygen saturation. For pulse rate, an ECG often serves as the reference.
For the non-clinical testing of K141542, particularly for pulse rate accuracy during motion, the "functional tester" would likely have a precisely controlled and known output for pulse rate, serving as the instrument-based ground truth.
8. The Sample Size for the Training Set:
This document is for a medical device (pulse oximeter) that performs direct physiological measurements, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device would refer to its design, engineering, and calibration processes. Therefore, the concept of a "training set sample size" as typically understood for AI is not applicable.
9. How the Ground Truth for the Training Set Was Established:
As mentioned above, the concept of a "training set" as it applies to AI/ML is not relevant for this specific device. The device's performance is based on its underlying technology and algorithms, which are developed and validated against established physiological principles and measurement standards.
§ 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).