(183 days)
The Finger Clip Pulse Oximeter is a handheld non-invasive and multi-use device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate in hospital-type facilities, and homecare.
This device is not recommended for use during exercise or low perfusion scenarios.
This device is not intended for use on infants and newborns. (Recommended for people over 3 years and the thickness of finger greater than or equal to 7mm).
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The provided text is an FDA 510(k) clearance letter for a Finger Clip Pulse Oximeter. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this type of document does not contain the detailed information required to answer your specific questions about acceptance criteria and the comprehensive study that proves the device meets those criteria.
The information you're asking for (acceptance criteria table, study sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in the summary of safety and effectiveness (SSE) or clinical study reports that are part of the original 510(k) submission. These documents are generally not made public in their entirety by the FDA in the clearance letter itself.
The clearance letter only states the following relevant points:
- Device Name: Finger Clip Pulse Oximeter
- Regulation Number: 21 CFR 870.2700 (Oximeter)
- Regulatory Class: Class II
- Product Code: DQA
- Indications for Use: Handheld non-invasive and multi-use device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate in hospital-type facilities, and homecare. Not recommended for use during exercise or low perfusion scenarios. Not intended for use on infants and newborns (recommended for people over 3 years and finger thickness >= 7mm).
To answer your request, I would need access to the actual 510(k) submission's technical documentation, specifically the performance testing and clinical data sections, which are not included in the provided text.
Therefore, I cannot populate the table or provide details on the study as requested, as the necessary information is not present in the given document.
§ 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).