(237 days)
The Fingertip Pulse Oximeter is intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult, child and adolescent patients in hospital, hospital type facilities, as well as in the home care environment. The oximeter is not suitable to monitor patient continuously for long term.
The proposed devices, Fingertip Pulse Oximeters M70, M70A, M70C and M70D are fingertip devices, which can display %SpO3, pulse rate value, waveform pulse amplitude bar indication. The five models share the same configuration, intended use, safety and performance, the only difference is extrinsic feature. The proposed devices, Fingertip Pulse Oximeters M70, M70A, M70C and M70D are modified versions of the predicate device, M70, cleared under K081712. The oximetry technology including the sensor was unchanged.
The provided text describes a 510(k) premarket notification for Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D by Guangdong Biolight Meditech Co., Ltd. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
While the document outlines performance specifications and compliance with standards, it does not contain a detailed study report that proves the device meets specific acceptance criteria in the format typically required for an AI/ML medical device submission. This document focuses on the substantial equivalence argument based on performance specifications and compliance with general medical device standards, rather than a dedicated clinical study with a defined test set, ground truth experts, or MRMC analysis often seen for novel AI/ML device evaluations.
However, I can extract the relevant information from the document to construct an answer based on the provided text, interpreting "acceptance criteria" as the claimed performance specifications and "study" as the non-clinical tests and substantial equivalence comparison.
Here's an analysis based on the information provided:
Acceptance Criteria and Device Performance for Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
The device, Fingertip Pulse Oximeter, is intended to measure functional arterial oxygen saturation (SpO2) and pulse rate. The "acceptance criteria" can be inferred from the device's claimed performance specifications that are stated to be compliant with ISO 80601-2-61.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Proposed Device Specifications) | Reported Device Performance (from Proposed Device Specifications) |
|---|---|---|
| SpO2 Measuring Range | 0%-100% | 0%-100% |
| SpO2 Accuracy | 70~100%, ±2% | 70~100%, ±2% |
| PR Measuring Range | 25~250 bpm | 25~250 bpm |
| PR Accuracy | ±1% or ± 1 bpm, whichever is greater | ±1% or ± 1 bpm, whichever is greater |
Note: The document states that the subject device models have more accurate pulse rate and SpO2 specifications than the predicate device K141128. This implies the listed specifications are the target "acceptance criteria" for the new devices.
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ... ISO 80601-2-6: 2011, Medical Electrical Equipment - Part 2-61: Particular Requirements For Basic Safety And Essential Performance Of Pulse Oximeter Equipment."
- Sample Size for Test Set: The exact sample size for the non-clinical tests is not specified in the provided text. The document refers to compliance with ISO 80601-2-61, which would dictate the methodology and sample sizes for testing SpO2 accuracy (e.g., typically requires human subject studies with induced hypoxia). However, the specific study details are not presented.
- Data Provenance: The document does not specify the country of origin of data or whether the tests were retrospective or prospective. It only mentions "Non clinical tests were conducted." Given the nature of a 510(k) for a pulse oximeter, human subject testing would typically be prospective to determine SaO2 accuracy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For pulse oximeters, the 'ground truth' for oxygen saturation (SaO2) is typically established by co-oximetry of arterial blood samples, performed by trained medical personnel. It is not typically established by 'experts' in the sense of radiologists or other clinicians interpreting outputs for AI/ML devices.
4. Adjudication Method for the Test Set
This information is not provided in the document. It's not applicable in the context of typical pulse oximetry accuracy testing, where the reference method itself (co-oximetry) serves as the ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There was no MRMC comparative effectiveness study performed or reported. This type of study is typically relevant for AI/ML devices that aim to assist human readers in diagnostic tasks, demonstrating how AI impacts human performance. A pulse oximeter is a standalone measurement device.
6. Standalone (Algorithm Only) Performance
The document describes the performance of the device itself (algorithm + hardware), which is inherently "standalone" in mechanical terms, as it provides direct SpO2 and pulse rate readings. However, it's not an "algorithm-only" performance as typically evaluated for AI/ML, but rather the performance of the integrated medical device. The "non-clinical tests" and compliance with ISO 80601-2-61 essentially represent the standalone performance evaluation.
7. Type of Ground Truth Used
For pulse oximeter accuracy, the ground truth for arterial oxygen saturation (SaO2) is typically established by co-oximetry of arterial blood samples. This is implied by compliance with ISO 80601-2-61, which sets out requirements for determining SpO2 accuracy through human subject testing with induced hypoxia and comparison against arterial blood gas analysis. The document does not explicitly state this, but it is the standard method for establishing ground truth for oximeters.
8. Sample Size for the Training Set
The document is for a traditional pulse oximeter and does not describe an AI/ML algorithm or a "training set." Therefore, this information is not applicable and not provided.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of an AI/ML algorithm or a "training set," this information is not applicable and not provided.
§ 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).