(232 days)
The pulse oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatic (≥10Kg) patients during both no motion and for patients who are well or poorly perfused.
Pulse Oximeter is intended for hospitals, hospital-type facilities, home environments.
The Pulse Oximeter is a small, lightweight, portable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO₂), pulse rate (PR) and perfusion index (PI) by measuring the absorption of red and infrared light passing through perfused tissue. It indicated for adult and pediatric (≥10Kg) patients during both no motion and motion conditions, and for patients who are well or poorly perfused.
The device consists of probe, electronic circuits, OLED/LED display (differentiated by models) and plastic housing which powered by two alkaline AAA batteries.
The provided text describes the regulatory clearance of a pulse oximeter and includes information about its performance testing. However, it does not contain the specific details required to answer all parts of your request, especially regarding a clinical study with a human-in-the-loop or standalone AI performance evaluation, expert qualifications, or ground truth establishment relevant to AI. This document is a 510(k) summary for a pulse oximeter, and as such, it focuses on demonstrating substantial equivalence to a predicate device, primarily through engineering and bench testing, and standard clinical trials for SpO2 accuracy.
Here's an attempt to answer your questions based only on the provided text, with clear indications where information is not available:
Acceptance Criteria and Device Performance for Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104)
This device is a pulse oximeter, and its performance is evaluated against the accuracy specifications defined by the ISO 80601-2-61 standard for pulse oximeter equipment.
1. Table of Acceptance Criteria and the Reported Device Performance
| Parameter | Acceptance Criteria (ISO 80601-2-61 Standard) | Reported Device Performance (ARMS) |
|---|---|---|
| SpO2, No Motion | 70 – 100%, ≤ 2% ARMS* | 70 – 100%, 2% ARMS (adults/pediatrics) |
| SpO2, Motion | 70 – 100%, ≤ 3% ARMS* | 70 – 100%, 3% ARMS (adults/pediatrics) |
| SpO2, Low Perfusion | 70 – 100%, ≤ 2% ARMS* | 70 – 100%, 2% ARMS (adults/pediatrics) |
| Pulse Rate, No Motion | 25 – 250 BPM, ≤ 2 BPM ARMS* | 25 – 250 BPM, 2 BPM ARMS (adults/pediatrics) |
| Pulse Rate, Motion | 25 – 250 BPM, ≤ 4 BPM ARMS* | 25 – 250 BPM, 4 BPM ARMS (adults/pediatrics) |
| Pulse Rate, Low Perfusion | 25 – 250 BPM, ≤ 2 BPM ARMS* | 25 – 250 BPM, 2 BPM ARMS (adults/pediatrics) |
*Note: The acceptance criteria are inferred from the reported performance, as they typically match the standard's requirements for a device to be compliant. The standard ISO 80601-2-61 is explicitly mentioned as the compliance standard for performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states that "Narigmed provided the results of clinical testing to demonstrate that pulse oximeter meets relevant consensus standards. ISO 80601-2-61:2017 Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment."
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective). This type of clinical data for pulse oximeters typically involves healthy volunteers undergoing induced hypoxemia in a controlled lab setting, which is a prospective study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Available: For pulse oximeters, the "ground truth" for oxygen saturation is typically established using a co-oximeter directly measuring arterial blood samples, not by human experts. The concept of "experts" to establish ground truth is usually relevant for image-based diagnostic AI systems.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Available: As mentioned above, ground truth for pulse oximetry is usually based on direct physiological measurements (co-oximetry blood gas analysis), not expert consensus requiring adjudication.
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
- Not Applicable / Not Available: This device is a standalone pulse oximeter and does not involve AI assistance for human readers or interpretation of medical images. Therefore, an MRMC study related to AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in essence. The performance metrics listed (SpO2 and Pulse Rate accuracy) are measures of the device's (algorithm's) ability to accurately measure these physiological parameters independently. The "clinical data" mentioned refers to this standalone performance against reference measurements. The device itself is "algorithm only" in terms of its core measurement function; it doesn't provide interpreted results that then go through a human for validation, but rather directly displays the measured values.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for pulse oximetry accuracy studies, as per ISO 80601-2-61, is established through concurrent direct measurements of arterial oxygen saturation using a co-oximeter from arterial blood samples. This is considered the gold standard for SpO2.
8. The sample size for the training set
- Not Applicable / Not Available: The document does not describe "training" or "test" sets in the context of an AI model's development. For a pulse oximeter, its measurement algorithms are typically developed and refined through engineering, physics principles, and then validated in clinical studies against reference methods. There isn't a "training set" for a machine learning model, as would be the case for AI-driven diagnostic tools.
9. How the ground truth for the training set was established
- Not Applicable / Not Available: As above, the concept of a training set with established ground truth is not elaborated upon as this is not an AI diagnostic device. The device's underlying algorithms are validated through performance against established physiological standards and clinical reference measurements.
§ 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).