(119 days)
The Fingertip Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults or children over three years old in 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. The differences between different models only includes the color of the non-patient contacting shell part and the size. And the color display screen of BSX221/BSX223/BSX261/BSX263/BSX281/BSX283 is OLED, while that of BSX231/BSX233/BSX251/BSX253 is TFT.
The provided document describes the K202324 submission for "Fingertip Pulse Oximeter, Models BSX221, BSX223, BSX261, BSX263, BSX281, BSX283, BSX231, BSX233, BSX251, BSX253." The acceptance criteria and the study proving the device meets these criteria are detailed in the "510(k) Summary" section, particularly under "7. Predicate Device Comparison" and "8. Performance Testing."
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The regulatory document outlines the performance specifications, which serve as the acceptance criteria, and the reported performance of the proposed device.
| ITEM | Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) | Comparison Result |
|---|---|---|---|
| SpO2 Range | 0%~100% | 35%~100% | Different (Proposed device has a narrower specified range) |
| SpO2 Accuracy | 70%~100%: ±2% | ||
| 0% to 69%: unspecified | 70% ~79%: ±3%; | ||
| 80%~100%:±2%; | |||
| 0% to 69%: unspecified | Different (Proposed device has slightly wider acceptable accuracy for 70-79%, but the same for 80-100%) | ||
| SpO2 Resolution | 1% | 1% | Same |
| Pulse Rate Range | 25 bpm ~ 250 bpm | 30 bpm ~ 250 bpm | Different (Proposed device has a slightly higher minimum pulse rate) |
| Pulse Rate Accuracy | ±2 bpm | ±3 bpm | Different (Proposed device has slightly wider acceptable accuracy) |
| Pulse Rate Resolution | 1 bpm | 1 bpm | Same |
| Biocompatibility | ISO 10993-1, -5, -10 | Compliance with ISO 10993-1, -5, -10 (Cytotoxicity, Skin Sensitization, Skin Irritation tests passed) | Same |
| Electrical Safety | IEC 60601-1, IEC 60601-1-11 | Compliance with ANSI AAMI ES60601-1 and IEC 60601-1-11 | Same |
| EMC | IEC 60601-1-2 | Compliance with IEC 60601-1-2 | Same |
| Performance (Bench) | ISO 80601-2-61 (Pulse Oximeter Equipment) | Compliance with ISO 80601-2-61:2017. Pulse Rate Accuracy meets ISO 80601-2-61, Clause 201.12.1.104. | Same |
| Software Verification and Validation | N/A (General Guidance) | Provided in accordance with FDA Guidance for software with moderate level of concern. | N/A |
| Cleaning Validation | N/A (General Guidance) | Conducted per FDA guidance, device showed no degradation after repeated cleaning/disinfection. | N/A |
| Clinical Accuracy (SpO2) | N/A (Specific guideline mentioned for evaluation) | Evaluated per Annex EE Guideline of ISO 80601-2-61:2011 | N/A |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states that "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."
However, the specific sample size (number of subjects/patients) used for this clinical test set, or the data provenance (country of origin, retrospective/prospective nature), is not explicitly mentioned in the provided 510(k) summary. ISO 80601-2-61:2011 Annex EE typically outlines requirements for such studies, including participant numbers, but the summary does not detail the results of the specific study performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For pulse oximetry, the ground truth for SpO2 accuracy is typically established using a co-oximeter and arterial blood samples in a controlled desaturation study. This process usually does not involve "experts" establishing a subjective ground truth in the same way as, for example, image interpretation. Instead, it relies on objective laboratory measurements.
The document does not explicitly state the number or qualifications of "experts" involved in establishing the ground truth for the clinical accuracy testing, as the ground truth itself is derived from reference measurements (co-oximetry).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for studies where subjective interpretation is involved, such as reading medical images, and disagreements between multiple human readers need to be resolved to establish ground truth.
For a pulse oximeter's clinical accuracy study (desaturation study), the ground truth for SpO2 values is established by a reference co-oximeter and arterial blood gas analysis, which is an objective measurement without subjective interpretation or the need for adjudication among multiple human experts. Therefore, adjudication methods are not applicable in this context and are not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This device is a Fingertip Pulse Oximeter, a standalone measurement device, not an AI-assisted diagnostic tool that would involve human readers interpreting results. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not relevant to this type of device and was not performed. The submission does not mention AI assistance or human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the primary performance evaluation for a pulse oximeter is based on its standalone (algorithm only) performance. The device directly measures and displays SpO2 and pulse rate. The "Clinical data" section explicitly states that "Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011," which refers to a desaturation study where the device's readings are compared against a co-oximeter, without human intervention in the device's measurement process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical accuracy testing mentioned, the ground truth for oxygen saturation (SpO2) and pulse rate would be established using reference medical devices and laboratory analyses. Specifically, for SpO2 accuracy, this involves:
- Co-oximetry: Measuring arterial oxygen saturation (SaO2) from arterial blood samples using a laboratory co-oximeter.
- Arterial blood gas analysis: Providing other relevant blood gas parameters.
This is considered the gold standard for determining SpO2 accuracy in human subjects.
8. The sample size for the training set
The document does not mention the use of machine learning or AI models that would require a "training set" in the context of device development. The pulse oximeter operates based on established physical principles of light absorption by hemoglobin. Therefore, there is no mention of a training set in this 510(k) summary.
9. How the ground truth for the training set was established
As there is no mention of a training set for this device, the question of how its ground truth was established is not applicable.
§ 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).