(298 days)
The pulse oximeter (YK-81C ) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult and pediatric in clinic environment. This medical device can be reused. Not for continuously monitoring,
The proposed device, fingertip pulse oximeter, YK-81C, can display SpO2%, pulse rate value, and vertical bar graph pulse amplitude;
The pulse oximeter, YK-81C, is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a clinic environment. This medical device can be reused. Not for continuously monitoring.
The proposed device is NOT for life-supporting or life-sustaining, not for implant. The proposed device is NOT provided sterile and is NOT a reprocessed single-use device.
The provided document is a 510(k) premarket notification for a medical device, specifically a Fingertip Pulse Oximeter (Model YK-81C). While it describes the device, its intended use, and a clinical study for SpO2 accuracy, it does not present a formal table of "acceptance criteria" for the device's performance in the typical sense of a pre-defined set of metrics that must be met. Instead, it describes compliance with recognized standards and presents the results of a specific performance test.
Here's an attempt to extract and synthesize the information based on your request, with an understanding that the document isn't structured around explicit "acceptance criteria" in a table format but rather demonstrates compliance and performance results.
I. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by compliance with the relevant ISO standard for pulse oximeters regarding SpO2 accuracy.
| Metric (Implicit Acceptance Criteria) | Reported Device Performance (YK-81C) |
|---|---|
| SpO2 Accuracy (Arms) for 70-100% SaO2 | 2.53% |
| (Implicit acceptance criteria based on ISO 80601-2-61:2011 Appendix EE.2) | (This value indicates the accuracy of the device based on the study) |
| SpO2 Measurement Range | 0-100% |
| SpO2 Accuracy (stated specification) | 70%~100%, ±3% |
| SpO2 Resolution | ±1% |
| PR Measurement Range | 30-254 bpm |
| PR Accuracy | ±2 bpm |
| PR Resolution | ±1 bpm |
| Electrical Safety | Complies with IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 |
| Biocompatibility | Complies with ISO 10993-1 |
| Labeling | Conforms to FDA Regulatory Requirements |
Note on Acceptance Criteria: The document does not explicitly state an "acceptance criteria" value for the SpO2 accuracy (Arms) that the device must be less than or equal to. However, the study was performed according to Clause 201.12.1.101.2 and Annex EE.2 of ISO 80601-2-61:2011 "Procedure for invasive laboratory testing on healthy volunteers." This standard outlines the methodology for evaluating pulse oximeter accuracy, and the resulting Arms value is used to demonstrate performance. Typically, a lower Arms value indicates better accuracy, and regulatory bodies often have an expectation around this value based on the standard. For many pulse oximeters, an Arms value of 3.0% or less in the 70-100% range is often considered acceptable for regulatory clearance. The reported 2.53% falls within typical acceptable ranges.
II. Study Details
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Sample Size used for the Test Set and Data Provenance:
- Sample Size: 12 healthy adult volunteer subjects.
- Data Provenance: The study was conducted in a laboratory setting (likely in China, given the manufacturer's location, though not explicitly stated for the study site). It was a prospective study involving induced hypoxia.
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Number of Experts used to establish the Ground Truth for the Test Set and the Qualifications of those Experts:
- The document does not specify the number of experts used to establish ground truth or their qualifications.
- The ground truth was established by arterial blood CO-Oximetry, a laboratory analytical method, not by human expert assessment.
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Adjudication Method for the Test Set:
- Not applicable / None directly stated. The ground truth (SaO2) was determined by an objective lab measurement (CO-Oximetry) of arterial blood samples, not by expert consensus or adjudication. The device's SpO2 readings were compared to these objective measurements.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was NOT done. This type of study is more common for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. For a pulse oximeter, the primary evaluation is device accuracy against a physiological reference.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The clinical trial evaluated the device's SpO2 accuracy performance by comparing its readings directly to arterial blood CO-Oximetry. While a human applies the device, the performance metric (Arms) is a direct measure of the device's algorithmic output against the physiological reference.
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The Type of Ground Truth Used:
- Outcomes Data / Physiological Standard (Arterial Blood CO-Oximetry): The ground truth for SpO2 accuracy was established by analyzing arterial blood samples using a reference CO-Oximeter, which provides functional SaO2. This is considered the gold standard for SpO2 accuracy assessment in pulse oximetry.
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The Sample Size for the Training Set:
- Not applicable / Not stated in the context of this document. This document describes a 510(k) submission for a finished medical device. The clinical study described is a validation study (test set) for the device's accuracy, not a study for training an AI model. Pulse oximeters typically rely on well-established physiological principles and calibrations, not 'training data' in the machine learning sense, although their internal algorithms are developed and refined using extensive data. The document focuses on proving the device's performance against a standard after its design and internal algorithms are finalized.
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How the Ground Truth for the Training Set was Established:
- Not applicable. As mentioned in point 7, there's no "training set" described in the context of this 510(k) document. The device's internal algorithms would have been developed and calibrated by the manufacturer, likely using proprietary methods and data, but this information is not part of the regulatory submission's clinical performance evaluation.
§ 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).