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510(k) Data Aggregation
(287 days)
Shenzhen Yimi Life Technology Co., Ltd.
The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients 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 provided document is a 510(k) summary for the Shenzhen Yimi Life Technology Co., Ltd. Pulse Oximeter (various models). It details the device's characteristics and its substantial equivalence to a predicate device. Here's an analysis of the acceptance criteria and the study information as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly refers to acceptance criteria for SpO2 accuracy and Pulse Rate accuracy based on the ISO 80601-2-61 standard.
| Acceptance Criteria (from ISO 80601-2-61) | Reported Device Performance |
|---|---|
| SpO2 Accuracy | |
| 70-100%: ±2% | 70-100%: ±2% |
| 0-69%: Undefined | 0-69%: Undefined |
| Pulse Rate Accuracy | |
| Not explicitly stated in the document, but the device "meets the requirements defined in ISO 80601-2-61, Clause 201.12.1.104" | ±3 bpm (This is the predicate's declared accuracy, and the subject device's declared accuracy is ±2 bpm, which is better and thus meets or exceeds the predicate's and implied standard.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the clinical test set. It only 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". Annex EE of ISO 80601-2-61 generally recommends a minimum of 10 healthy subjects for SpO2 accuracy testing, though more may be required depending on the specific design of the study and the range of SpO2 values assessed.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a Chinese manufacturer, the clinical testing was likely conducted in China or a similar jurisdiction following international standards. The nature of SpO2 accuracy testing typically involves prospective studies where subjects are intentionally desaturated under controlled conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical test set. For pulse oximetry, the ground truth for SpO2 accuracy is typically established by co-oximetry measurements from arterial blood samples, which does not directly involve "experts" in the sense of clinical reviewers for image analysis. The "ground truth" (reference standard) in this context is the quantitative co-oximetry reading.
4. Adjudication Method for the Test Set
Not applicable in the context of pulse oximetry SpO2 accuracy testing. Ground truth is established by objective co-oximetry measurements, not through expert consensus or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is evaluated. Pulse oximeters provide a direct numerical output (SpO2 and pulse rate), so MRMC studies are not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was done. The entire premise of the SpO2 accuracy testing described (clinical data per ISO 80601-2-61 Annex EE) is to evaluate the device's ability to accurately measure oxygen saturation and pulse rate independently, without human interpretation influencing the measurement. The device's output is compared directly against the reference standard (co-oximetry).
7. Type of Ground Truth Used
The ground truth used for SpO2 accuracy testing is co-oximetry measurements from arterial blood samples. This is the gold standard for determining actual arterial oxygen saturation. For pulse rate, the ground truth would typically be from an ECG monitor or a reference pulse rate measurement device.
8. Sample Size for the Training Set
The document does not provide information about a "training set" or its sample size. Pulse oximeters traditionally rely on established physiological principles and algorithms (e.g., Beer-Lambert law and pulsatile blood flow), rather than machine learning models that require extensive training data in the same way an AI image analysis algorithm would. Therefore, a distinct "training set" as understood in AI/ML development is not typically applicable for this type of device.
9. How the Ground Truth for the Training Set was Established
As no training set is described, this question is not applicable. The device's underlying principles are physics-based, and its performance is validated against physiological standards with direct measurements.
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(142 days)
Shenzhen Yimi Life-Technology Co.,Ltd.
The pulse oximeter is a reusable device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients 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. YM101 display the measuring results on 1.5' LED screen, and the backlight of the three models are red, white and green respectively. And the screen of YM201 and YM301 are 0.96' OLED and 1.3' OLED. Additionally, battery indicator and pulse waveform can be displayed on YM201 and YM301.
The provided document describes the FDA 510(k) clearance for Shenzhen Yimi Life Technology Co., Ltd.'s Pulse Oximeter, models YM101, YM201, YM301. The submission includes information on the device's acceptance criteria and the studies conducted to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Measured Value) | Reported Device Performance (Target Value) |
|---|---|
| SpO2 Accuracy (70-100%) | ±2% |
| SpO2 Resolution | 1% |
| Pulse Rate Accuracy | ±2 bpm |
| Pulse Rate Range | 25 bpm ~ 250 bpm |
| Pulse Rate Resolution | 1 bpm |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10 (pass tests for Cytotoxicity, Skin Sensitization, Skin Irritation) |
| Electrical Safety | Complies with IEC 60601-1:2005+CORR.1(2006)+CORR.2(2007)+AM1(2012) |
| EMC | Complies with IEC 60601-1-2:2007 (test results show compliance) |
| Pulse Oximeter Performance | Complies with ISO 80601-2-61:2011 |
| Cleaning/Disinfection Validation | No degradation after repeated cleaning and disinfection |
| Software Verification & Validation | Complies with FDA Guidance for software with moderate level of concern |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Clinical testing is conducted per Annex EE Guideline for evaluating and documenting SpO2 ACCURACY in human subjects of ISO 80601-2-61:2011". However, it does not explicitly state the sample size used for the clinical test set (human subjects study). The data provenance is described as being from "human subjects," implying prospective data collection for the SpO2 accuracy study. The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth, particularly in relation to the clinical testing mentioned in Annex EE. For pulse oximetry, the "ground truth" (reference SpO2) in such studies is typically obtained from co-oximetry of arterial blood samples.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method for the clinical test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, the document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, the testing described for the Pulse Oximeter's performance, particularly the "Clinical data" section for SpO2 accuracy, refers to the device's standalone performance in measuring oxygen saturation in human subjects. The device itself is an algorithm-driven measurement tool, operating without a human-in-the-loop for its direct measurement function.
7. The Type of Ground Truth Used:
For the "Clinical data" section relating to SpO2 accuracy, the ground truth is established by measuring arterial oxygen saturation directly from blood samples using a co-oximeter, which is the standard reference method for SpO2 accuracy studies as outlined in ISO 80601-2-61.
8. The Sample Size for the Training Set:
The document does not refer to a "training set" in the context of machine learning or AI. For a pulse oximeter, the core technology relies on established physiological principles and signal processing, rather than a machine learning model that requires a dedicated training set. The clinical data mentioned is for validation/performance testing, not training.
9. How the Ground Truth for the Training Set was Established:
As there is no mention of a training set in the context of typical machine learning, this information is not applicable and therefore not provided in the document.
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