(90 days)
The Pulse Oximeter is a non-invasive device intended for the spot-check or continuously monitor of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through finger in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The device is not intended for single use and out-of-hospital transport use.
The Fingertip Pulse Oximeter is tiny, and with low power consumption, convenient to use and carry. You just need to put the fingertip into the sensor of the device, the SpO2 value will appear on the screen immediately.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, beyond general statements about testing. The document is primarily a 510(k) summary for a Pulse Oximeter (CMS-50E), focusing on its substantial equivalence to a predicate device and its intended use.
Therefore, much of the requested information regarding detailed acceptance criteria, specific study design, sample sizes, expert qualifications, and ground truth establishment is not present in the provided excerpt.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in detail beyond general compliance. | Not specified in detail beyond general compliance. |
| Electrical safety | Met design specifications (stated in "Test Conclusion") |
| EMC | Met design specifications (stated in "Test Conclusion") |
| Other specifications | Met all design specifications (stated in "Test Conclusion") |
Missing Information: Specific numerical acceptance criteria for SpO2 accuracy, pulse rate accuracy, resolution, measurement range, alarm limits, etc., as well as the exact performance metrics achieved by the device against these criteria.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. It's implied that "Laboratory testing was conducted" to validate performance, but details about the origin of data (e.g., country, retrospective/prospective) are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For a pulse oximeter, ground truth for SpO2 and pulse rate is typically established using a reference device (e.g., co-oximeter for SpO2) and not by expert human interpretation of images or signals. The text does not mention any expert involvement in establishing ground truth.
4. Adjudication method for the test set:
- Not applicable/Not specified. Adjudication methods are typically used in studies involving human interpretation (e.g., radiology studies). For a pulse oximeter, the comparison would be against a reference standard.
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:
- Not applicable. This device is a pulse oximeter, which directly measures physiological parameters. It is not an AI-assisted diagnostic tool that would involve human readers or image interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "Test Conclusion" states "Laboratory testing was conducted to validate and verify that the proposed devices met all design specifications," which implies direct testing of the device's performance (standalone) against its specifications. The device itself operates autonomously to measure SpO2 and pulse rate.
7. The type of ground truth used:
- Not explicitly stated, but for a pulse oximeter, ground truth for SpO2 and pulse rate is typically established using reference medical devices. For SpO2, this often involves a co-oximeter (a device that measures the actual ratio of oxygenated hemoglobin to total hemoglobin in a blood sample). For pulse rate, an ECG or an accurate reference pulse oximeter would commonly be used.
8. The sample size for the training set:
- Not applicable. This is a measurement device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. (As above, no training set for this type of device.)
Summary of what is present in the document:
- The device is a non-invasive pulse oximeter for spot-check or continuous monitoring of SpO2 and pulse rate.
- It's intended for adult patients, used through the finger, in home and hospital environments.
- Laboratory testing was conducted to validate and verify that the device met all design specifications, including electrical safety and EMC.
- The FDA determined the device to be substantially equivalent to the predicate device (Pm-60 Pulse Oximeter, K072581).
§ 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).