(219 days)
The Pulse Oximeter FS10A and FS20A are portable, non-invasive devices intended for spot check monitoring of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult patients (weighing ≥ 30 kg) in hospitals.
The proposed devices of Pulse Oximeter FS10A, FS20A are fingertip devices, which can display SpO2 and pulse rate value. The proposed devices consist of detector and emitter LED, CPU, display unit and power unit. The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The wavelength of one light source is 660 nm, which is red light; the other is 906nm, which is infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light overtime. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The power sources of the proposed devices are 2 AAA alkaline batteries. All of the proposed devices have low battery voltage indicator function and all of the proposed devices will automatically power off when there is no signal for longer than 8 seconds. The proposed devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization. The devices are for prescription. The devices do not contain drug or biological products. The Pulse Oximeters FS10A,FS20A share the same measurement principle and oximeter sensor and oxygen saturation module and power supply. The indented target population and use environment of the Pulse Oximeters FS10A, FS20A are the same. The devices are software-driven and the software validation is provided in Section of Software.
The provided document is a 510(k) premarket notification for the Pulse Oximeter, Model FS10A and FS20A. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of a device's specific acceptance criteria and a study proving it. Therefore, much of the requested information, particularly regarding detailed study methodologies, sample sizes for training/test sets, expert qualifications, and adjudication methods, is not explicitly available in this document.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for SpO2 accuracy are implicitly defined by the stated accuracy specifications related to the predicate device and the clinical trial conclusion. The reported performance is also explicitly stated.
| Metric | Acceptance Criteria (from predicate/comparison) | Reported Device Performance (FS10A/FS20A) |
|---|---|---|
| SpO2 Accuracy (70-99%) | ±2% (for predicate MD300C1) | FS10A: 70-99%: ±2% |
| SpO2 Accuracy (70-100%) | ±2% (for predicate MD300C2) | FS20A: 70-100%: ±2% |
| SpO2 Accuracy (0-69%) | No definition | FS10A/FS20A: No definition |
| Pulse Rate (PR) Accuracy | ±2bpm (30-99bpm) and 2% (100-235bpm) (for predicate) | FS10A/FS20A: ±3bpm |
| SpO2 Resolution | 1% | FS10A/FS20A: 1% |
| PR Resolution | 1 bpm | FS10A/FS20A: 1 bpm |
| SpO2 Display Range | 0-99% (MD300C1), 0-100% (MD300C2) | FS10A: 0-99%, FS20A: 0-100% |
| PR Display Range | 0-254 bpm (predicate) | FS10A/FS20A: 0-250 bpm |
Study Proving Device Meets Acceptance Criteria:
A clinical trial was conducted for the FS20A model, following ISO80601-2-61:2011, Annex EE.2 Procedure for invasive laboratory testing. The conclusion states that "the accuracy Arms of the proposed device is smaller than 2%," which indicates it meets the standard for SpO2 accuracy within the specified range (70-100% for FS20A).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document only mentions "a clinical test for one of the proposed devices, and the model is FS20A." The specific number of subjects or data points is not provided.
- Data Provenance: The clinical test was conducted by the "Guangzhou Huangpu Traditional Chinese Medicine Hospital." This indicates the data is from China. It is implied to be prospective as it's a clinical trial related to the device's submission.
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 document. The clinical trial described in the document is an "invasive laboratory testing" which likely involves direct measurement of arterial blood gas (ABG) for ground truth, rather than expert consensus on subjective data.
4. Adjudication Method for the Test Set
- This information is not provided in the document. Given the nature of a pulse oximeter clinical trial involving direct physiological measurements (ABG), "adjudication" in the sense of resolving conflicting expert opinions for ground truth is unlikely to be applicable. The ground truth would typically come from a reference standard instrument.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This document describes a clinical trial for a standalone device (pulse oximeter) to determine its accuracy against a reference standard, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone study was done. The clinical trial described for the FS20A pulse oximeter is a standalone performance study. The device (algorithm and hardware) directly measures and displays SpO2 and pulse rate without human interpretation or intervention as part of the core measurement process.
7. The Type of Ground Truth Used
- The clinical trial followed "Annex EE.2 Procedure for invasive laboratory testing of ISO80601-2-61:2011," which for pulse oximeters, typically refers to invasive arterial blood gas (ABG) measurements as the reference standard for oxygen saturation. This is the gold standard for SpO2 ground truth.
8. The Sample Size for the Training Set
- This information is not provided in the document. The document describes a "clinical trial" which is usually a validation step for a device already developed, implying an algorithm may have been developed and "trained" prior to this validation. However, no details on a "training set" for the oximeter's algorithm are given.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided in the document, as no details on a training set or its ground truth establishment are mentioned. If the device uses a machine learning algorithm, the ground truth for training would typically involve similar methods to the test set (e.g., ABG 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).