(387 days)
The Wrist Pulse Oximeter is intended for spot checking in measuring and displaying oxygen saturation of functional arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospital facilities and home healthcare environments.
This device is a small, lightweight, portable device intended for use in measuring and displaying oxygen saturation of functional arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senror and displays on the OLED after certain further processing. The device is mainly composed of the motherboard, SpO2 transducer and built-in battery. The power supply is 4.2V Li-battery and also the subject device can be powered by adapter. The subject device has a detachable sensor as an accessory to measure the SpO2 and pulse rate (PR). The subject device is not for life-supporting or life-sustaining and it is not an implantable device. The subject device owns software which has been validated by the manufacturer.
Here's a breakdown of the acceptance criteria and study findings for the Wrist Pulse Oximeter, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The relevant acceptance criteria and performance data for the Wrist Pulse Oximeter primarily come from the "Substantial Equivalence" section and the "Clinical Test" section.
| Feature | Acceptance Criteria (Predicate or Standard) | Reported Device Performance (SONOSAT-W01T) |
|---|---|---|
| SpO2 Accuracy | 70 to 100% ±3% (Predicate MD300W4) | ±2% in the range of 70% to 100% |
| SpO2 Measurement Range | 70%-100% (Predicate MD300W4) | 0%-100% (Subject Device) |
| Pulse Rate Accuracy | 25bpm~250bpm, ±3bpm (Predicate MD300W4) | 25bpm~250bpm, ±3bpm (Subject Device) |
| SpO2 Resolution | 1% (Predicate MD300W4) | 1% (Subject Device) |
| Pulse Rate Resolution | 1 bpm (Predicate MD300W4) | 1 bpm (Subject Device) |
| General Requirement | Compliance with IEC60601-1 (Predicate & Subject) | Compliance with IEC60601-1 |
| Special Requirement | Compliance with ISO 80601-2-61, IEC 60601-1-11 | Compliance with ISO 80601-2-61, IEC 60601-1-11 |
| EMC | Compliance with IEC60601-1-2 (Predicate & Subject) | Compliance with IEC60601-1-2 |
| Biocompatibility | Compliance with ISO10993-1 (Predicate & Subject) | Compliance with ISO10993-1 |
| Biocompatibility Test Results | No toxicity, no delayed contact sensitization, no irritation to skin (Predicate) | No toxicity to cells, No delayed contact sensitization, No irritation to skin (Subject Device) |
| Software Validation | Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices | In compliance with FDA Guidance |
| Clinical Study Compliance | Compliance with ISO 80601-2-61:2011 and FDA guidance - "Pulse Oximeter Premarket Notification Submissions" | In compliance with standards and guidance |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The clinical evaluation was conducted on a total of 24 healthy adult male and female volunteers.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study participants beyond mentioning "2 white people, and 15 yellow-skin people." It is implied to be a prospective study as it describes a clinical evaluation conducted to generate data for the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. For pulse oximetry, the ground truth is typically established by arterial blood gas (ABG) analysis, which is a laboratory measurement, not directly by "experts" in the sense of human readers. The clinical study compares the device's readings against these reference measurements.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method in the context of human expert review for the test set. For a pulse oximeter, the "ground truth" is typically objective physiological measurements (ABG), not subjective expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. A MRMC study is typically performed for image-based diagnostic aids where the AI assists human readers. This document describes a medical device (pulse oximeter) that provides a direct physiological measurement, and its accuracy is validated against a gold standard (ABG), not via a comparative effectiveness study with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes. The primary study detailed is a standalone performance validation of the Wrist Pulse Oximeter where its measurements (SpO2 and pulse rate) are compared directly against a reference method (likely arterial blood gas measurements, though not explicitly stated for SpO2, it's the standard for oximeter validation). The reported SpO2 accuracy of ±2% is an algorithm-only performance metric.
7. The Type of Ground Truth Used
The ground truth for the SpO2 accuracy validation was established using a physiological reference standard. While not explicitly named for SpO2 in the clinical test section, the widely accepted and regulatory-mandated method for validating pulse oximeter accuracy (specifically the Arms value) involves inducing various levels of hypoxemia and comparing the oximeter readings to co-oximeter measurements of arterial blood samples (Arterial Blood Gas - ABG).
8. The Sample Size for the Training Set
The document does not provide information regarding a separate training set or its sample size. The description of validation usually pertains to the final, locked algorithm or device. For devices like pulse oximeters, the core algorithm is often developed based on photometric principles and extensive internal testing, rather than a "training set" in the machine learning sense. The clinical test described is a validation test, not a training activity.
9. How the Ground Truth for the Training Set was Established
As no training set is described in the document, there is no information provided on how ground truth for such a set (if it existed) was established. Device development often involves internal calibration and verification, but these details are not typically part of a 510(k) summary focused on regulatory validation.
§ 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).