(84 days)
M800 Handheld Pulse Oximeter is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital, hospital type facilities as well as in the home care environment.
The proposed device is a handheld device, which can display %SpO2, waveform, pulse rate value, pulse amplitude bar indication. It consists of detector and emitter LED, OLED display module, CPU, driving circuit, power supply circuit and battery. In addition, it has alarming function including physical parameter alarming and technical alarming. The physical alarming limit can be set by user. The modifications to M700 Handheld Pulse Oximeter are presented in Table 3-1 Modifications List on the next page.
The provided document is a 510(k) summary for the M800 Handheld Pulse Oximeter, which is a modification of the M700 Handheld Pulse Oximeter. The document focuses on demonstrating substantial equivalence to the predicate device and does not contain detailed information about a study to prove acceptance criteria for a new AI or diagnostic device.
Pulse oximeters are typically evaluated based on specific performance criteria related to the accuracy of SpO2 and pulse rate measurements. However, the provided text does not contain the detailed results of such a study. It only states: "Per the risk management during the design change control, the verification tests performed demonstrated that risks of each hazard are reduced to acceptable region."
Therefore, based on the provided text, I cannot complete the requested tables and sections as they pertain to a detailed study proving device meets acceptance criteria related to performance metrics like sensitivity, specificity, or reader improvement with AI. The document primarily highlights design modifications and claims substantial equivalence.
Information NOT present in the provided text:
- A table of specific acceptance criteria for SpO2 and pulse rate accuracy (e.g., A_rms values, bias, precision) and the reported device performance against these criteria.
- Sample size used for a test set to evaluate accuracy.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human reader improvement with AI.
- If a standalone (algorithm only) performance study was done.
- Type of ground truth used (e.g., arterial blood gas analysis for SpO2 accuracy).
- Sample size for a training set (as this is not an AI/ML device in the context of typical training sets).
- How ground truth for a training set was established.
The document is a 510(k) summary for a pulse oximeter, and these types of devices traditionally undergo verification and validation testing to ensure accuracy and compliance with standards (e.g., ISO 80601-2-61 for pulse oximeter basic safety and essential performance). However, the specific details of these tests and their results against quantitative acceptance criteria are not presented in this summary.
§ 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).