(330 days)
PULSE OXIMETER SHO-3002,SHO-3006 and SHO-3008 is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult at hospital (including clinical use internist/surgery, Anesthesia etc ).It is not for continuously monitoring.
The devices consist of detector and emitter LED, CPU, display unit and power unit. The Pulse oximeter is a kind of innovated medical detection device with non-invasive and continuous features for arterial SPO2 and PR detection. The proposed device consists of photo detector and emitter, LED, CPU, data display unit and power unit. It is portable and easy to measure the SPO2 and PR value quickly and precisely. The series of pulse oximeter detect the body's oxygen saturation and pulse rate through the fingers. The device does not contain drug or biological products. The power sources of the proposed devices are 2 AAA alkaline batteries. All the proposed devices have low battery voltage indicator function, and all the proposed devices will automatically power off when there is no signal for longer than 5 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 oximeter SHO-3002, SHO-3006 and SHO-3008 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 oximeter SHO-3002, SHO-3006 and SHO-3008 are the same. The devices are software-driven and the software validation is provided in Section of Software.
Here's an analysis of the acceptance criteria and study detailed in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate or Standard) | Reported Device Performance (SHO-3002, SHO-3006, SHO-3008) |
|---|---|---|
| SpO2 Accuracy | 70% | 70%~100%: ±2%, 0~69%: unspecified. Clinical study results: Accuracy Arms is smaller than 2%. |
| Pulse Rate Accuracy | ±2bpm (Predicate device MD300C1/MD300C2: ±2bpm (30 | ±2bpm. |
| SpO2 Display Range | Predicate device MD300C1: 0 | 35%~100%. (Slightly different from predicate but compliant with clinical application, ES60601-1 and ISO80601-2-61 requirements, and 0~69% is no definition for accuracy). |
| PR Display Range | Predicate device: 0~254 bpm. Clinical application, ES60601-1 and ISO80601-2-61 requirements. Clinical experience shows 30bpm range is sufficient. | 30bpm~250bpm. (Slightly different from predicate but compliant with clinical application, ES60601-1 and ISO80601-2-61 requirements, and clinical experience indicates this range meets application needs). |
| Measurement Wavelength (IR) | Predicate device: 940nm. Infrared spectrum area (800nm ~ 1000nm), ES 60601-1 and ISO80601-2-61 requirements. | 905nm. (A different wavelength than predicate, but within acceptable infrared spectrum area (800nm ~ 1000mm) and complies with standards). |
| Electromagnetic Compatibility (EMC) | Conformed to IEC60601-1-2. | Conformed to IEC60601-1-2. |
| Electrical Safety | Conformed to IEC60601-1. | Conformed to IEC60601-1. |
| Biocompatibility | No cytotoxic potential (In Vitro Cytotoxicity), No evidence of causing sensitization (Skin Sensitization Test), No evidence of significant irritation (Skin Irritation Test). | Results confirmed: No cytotoxic potential, No evidence of causing sensitization, No evidence of significant irritation from the test extract to rabbits. |
| Software Validation | Compliance with FDA Guidance for the content of Premarket Submissions for Software Contained in Medical Devices, Moderate Level of Concern. | Compliance with FDA Guidance for the content of Premarket Submissions for Software Contained in Medical Devices, Moderate Level of Concern. Software Validation and Verification Test performed. |
| General performance/functionality | FFC bending test, drop test, function test, Use Life Test, Storage Condition Test. | All bench tests conducted (including FFC bending test, drop test, function test) and results are provided in the performance testing section. Use Life Test and Storage Condition Test performed. Met requirements of FDA Guidance. |
Study Details:
This submission primarily refers to internal validation and clinical testing against established standards and a predicate device, rather than a large-scale, multi-center pivotal trial.
2. Sample size used for the test set and the data provenance
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Test Set (Clinical Study for SpO2 and PR Accuracy): The document states that the clinical trial was performed "according to Annex EE.2 Procedure for invasive laboratory testing of ISO80601-2-61:2011". This annex details the use of healthy adult volunteers and a protocol for creating various SpO2 levels by controlled hypoxia.
- The exact number of subjects for the clinical test set is not explicitly stated in the provided text, but such studies as per ISO 80601-2-61 typically involve a minimum of 10 healthy subjects to obtain a sufficient number of SpO2 data points across the specified range.
- Data Provenance: The nature of the clinical test described (controlled hypoxia on healthy subjects) implies prospective clinical data. The country of origin is not explicitly stated, but given the manufacturer's location (Beijing, P. R. China), it is highly probable the study was conducted in China.
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Bench Tests: The specific sample sizes for bench tests (e.g., number of devices tested for drop, bending, etc.) are not provided. These are generally internal quality and engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- For the SpO2 Accuracy clinical study, the ground truth for arterial oxygen saturation (SaO2) is established using a laboratory CO-oximeter measurement of arterial blood samples. This is considered the gold standard for SpO2 accuracy studies.
- The ground truth is not established by "experts" in the sense of clinicians making subjective assessments, but by the objective measurements from a calibrated clinical laboratory instrument. Therefore, the concept of "number of experts" and their "qualifications" for ground truth determination in this context is not directly applicable, beyond the qualified laboratory personnel operating the CO-oximeter and the clinical staff monitoring the subjects.
4. Adjudication method for the test set
- Not applicable in the traditional sense for subjective assessments. The ground truth for SpO2 accuracy is determined by the invasive and objective method of CO-oximetry. Differences or discrepancies might be resolved through standard laboratory protocols and instrument calibration checks, rather than an expert adjudication process.
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
- No MRMC comparative effectiveness study was done or reported. This device is a Pulse Oximeter, which provides direct numerical readings (SpO2 and Pulse Rate). It is not an AI-assisted diagnostic imaging device or a system requiring human "readers" or interpretations that would typically be subject to MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance evaluation was conducted. The clinical study to determine SpO2 and Pulse Rate accuracy (Arms) in comparison to invasive CO-oximetry is a standalone performance evaluation of the device's algorithm and sensor. The device provides "spot-check" readings, meaning it operates autonomously to produce these measurements without human interpretation or adjustment influencing the output itself. The results, particularly the Arms value "smaller than 2%", refer to this standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the SpO2 accuracy clinical study, the ground truth used is invasive CO-oximetry of arterial blood samples. This is the established gold standard for determining oxygen saturation in such studies.
8. The sample size for the training set
- The document does not explicitly state a sample size for a training set. Pulse oximeters, especially those based on the Lambert-Beer Law and photoelectric principles, typically rely on established physics and pre-defined algorithms rather than machine learning models that require distinct 'training sets' in the AI sense. While there would have been internal R&D data used for algorithm development and calibration, it is not described as a formal "training set" like in typical AI/ML submissions.
9. How the ground truth for the training set was established
- Since a formal "training set" in the context of machine learning is not explicitly mentioned or implied for this device, the method for establishing its ground truth is not detailed. The device's operation is based on known physical principles and established calibration processes, rather than learning from a dataset with pre-established ground truths. Internal calibration would use reference values from other gold-standard oximetry methods or gas mixtures to ensure accuracy.
§ 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).