(195 days)
The Fingertip Pulse Oximeter is a reusable non-invasive device intended for the spot checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients in hospital and other healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.
The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery. M230, M230A, M230B and M230C display the measuring results on 1.3" LED screen, and the screen of M130, M130A, M130B, M130C, M160A, M160C, M170A and M170C are 0.96" OLED.
Here’s a breakdown of the acceptance criteria and the study proving the device meets these criteria, based on the provided FDA 510(k) summary for the Fingertip Pulse Oximeter models:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary directly compares the proposed device to a predicate device, and indicates that the proposed device complies with specific standards. While it doesn't provide a direct "acceptance criteria" table in the format of a typical requirement specification with Pass/Fail, we can infer the acceptance criteria from the specified performance standards and comparisons.
| Acceptance Criteria (Inferred from Standard/Predicate Comparison) | Reported Device Performance (from "Proposed Device" column or compliance statements) |
|---|---|
| SpO2 Measurement Range: 0%~100% (from Predicate) | 0%~100% (Same as Predicate) |
| SpO2 Resolution: 1% (from Predicate) | 1% (Same as Predicate) |
| SpO2 Accuracy: | 80 to 100%: ±2% (Per ISO 80601-2-61, likely the maximum deviation from reference in this range) |
| 70 to 80%: ±3% (Per ISO 80601-2-61, likely the maximum deviation from reference in this range) | |
| 0% to 69%: unspecified (Same as Predicate) | |
| Pulse Rate Range: (Predicate: 25 bpm ~ 250 bpm) | 25 bpm ~ 254 bpm (Slight difference from Predicate, but within acceptable medical ranges) |
| Pulse Rate Accuracy: (Predicate: ±2 bpm) | ±3 bpm (Slight difference from Predicate, but deemed substantially equivalent) |
| Pulse Rate Resolution: 1% (from Predicate) | 1 bpm (Same as Predicate) |
| Biocompatibility: Complies with ISO 10993-1 | Cytotoxicity, Skin Sensitization, Skin Irritation tests passed, demonstrating compliance. |
| Electrical Safety: Complies with IEC 60601-1 | Complies with IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) |
| EMC: Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2: 2007 |
| Performance Standard: Complies with ISO 80601-2-61 | Complies with ISO 80601-2-61: 2011 |
| Software V&V: Complies with FDA Guidance | Software documentation including verification & validation provided, in accordance with FDA Guidance for moderate level of concern. |
| Cleaning Validation: Meets FDA guidance | Cleaning and disinfection validation testing conducted and device shows no degradation after repeated cleaning. |
2. Sample Size Used for the Test Set and Data Provenance
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Clinical Data (Human Subjects for SpO2 Accuracy): The document states: "Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment."
- Sample Size: The exact number of human subjects is not specified in this document. Annex EE of ISO 80601-2-61 typically requires a sufficient number of subjects (e.g., at least 10) to cover the specified SpO2 range.
- Data Provenance: The document does not explicitly state the country of origin. However, the manufacturer is Shenzhen Raysintone Technology CO., Ltd, China, so it's highly probable the clinical study was conducted in China. It's a prospective study as it involves active testing on human subjects to determine accuracy.
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Non-Clinical Data (Biocompatibility, Electrical Safety, EMC, Bench Testing, Software V&V, Cleaning Validation): These tests are typically performed on samples of the device and its components in a lab setting. The specific "sample size" for these physical or software tests is generally defined by the testing standards and protocols, rather than a "patient" sample size. The provenance for these tests is the manufacturer's testing facilities or contracted labs.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is primarily relevant for studies involving human interpretation (e.g., radiology for diagnostic AI). For a pulse oximeter, the ground truth for SpO2 accuracy is not established by human experts but by a co-oximeter (a laboratory device considered the gold standard for measuring fractional oxygen saturation in blood).
Therefore, this section is not applicable in the traditional sense for this device.
4. Adjudication Method for the Test Set
Not applicable. Ground truth for pulse oximetry involves direct measurement of blood oxygen saturation, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for evaluating how AI assists human readers in diagnostic tasks, typically in imaging. This is a standalone medical device measuring physiological parameters, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, implicitly. The "Clinical data" section refers to testing the accuracy of the SpO2 measurement in human subjects according to ISO 80601-2-61. This standard outlines procedures for testing the accuracy of the pulse oximeter's algorithm/device output compared to a reference standard (co-oximeter), which is a "standalone" performance assessment of the device's core function.
7. The Type of Ground Truth Used
The ground truth used for the SpO2 accuracy assessment is co-oximetry (laboratory or arterial blood gas analysis), which directly measures arterial oxygen saturation (SaO2). This is considered the physiological gold standard for oxygen saturation. The document explicitly references ISO 80601-2-61, Annex EE, which details the methodology for this, involving inducing stable levels of desaturation in human subjects and comparing the device's SpO2 readings to co-oximeter SaO2 readings taken from arterial blood samples.
8. The Sample Size for the Training Set
Not applicable. This device is a traditional medical device (hardware with embedded firmware/algorithm) and not an AI/ML model that undergoes a discrete "training set" process in the context of deep learning. Its internal algorithms for calculating SpO2 and pulse rate are based on established physiological principles and signal processing, not on iterative learning from a large training dataset like a neural network.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no traditional "training set" for an AI/ML model in this context. The core algorithms would have been developed and validated against known physiological models, engineering principles, and potentially smaller datasets from research and development, but not in the sense of a large, labeled training dataset for an AI algorithm seeking regulatory clearance.
§ 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).