(191 days)
The OxiMAX Pulse Oximetry System with N-595 Pulse Oximeter and OxiMAX Sensors and Cables is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The OxiMAX Pulse Oximetry System is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments. These devices are for prescription use only.
The OxiMAX Pulse Oximetry System is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by use of one of a range of compatible Nellcor OxiMAX oxygen transducers (sensors). The N-595 Pulse Oximeter displays digital values of SpO2 and Pulse Rate. Pulse Amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The N-595 can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (manually switchable from 115V to 230V) or alternatively by an integral sealed 6V rechargeable lead-acid battery. The OxiMAX Pulse Oximetry System is intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, intra-hospital transport, and home environments.
The provided text is a 510(k) summary for the OxiMAX Pulse Oximetry System. It declares that clinical and non-clinical tests were performed to support the determination of substantial equivalence, but it does not provide details about specific acceptance criteria or the results of these tests.
Therefore, I cannot populate the table or answer most of your detailed questions regarding acceptance criteria, specific device performance, sample sizes, ground truth, or expert involvement. The document states that the system "uses similar SpO2 and Pulse Rate software algorithm, motion-filtering software, and SatSeconds alarm management software as the legally marketed predicate device, N-395," implying that the performance is expected to be similar, but no direct comparative data is presented.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided: The document states that "clinical and non-clinical tests were performed" but does not detail the acceptance criteria or reported device performance metrics (e.g., accuracy, precision) for SpO2 or pulse rate under specific conditions.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided: The document mentions "Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards," but does not specify sample sizes, data provenance, or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot be provided: The document makes no mention of experts, ground truth establishment methods, or their qualifications for the test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided: The document does not describe any adjudication methods.
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
- Cannot be provided: Pulse oximetry is a direct measurement device, not an AI-assisted diagnostic tool that involves human "readers" in the way an MRMC study would typically assess. Therefore, this type of study is not applicable and not mentioned. The device provides numerical outputs for SpO2 and pulse rate.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Likely yes, but not explicitly detailed: Pulse oximeters inherently operate in a "standalone" mode, continuously measuring and displaying physiological parameters. The document focuses on the system's ability to process signals and provide real-time values. However, it does not explicitly describe a "standalone study" in terms of specific performance metrics or comparisons.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided: The document does not describe how ground truth was established for any clinical evaluations. For pulse oximeters, ground truth for SpO2 is typically established through arterial blood gas analysis (co-oximetry) but this is not stated in the provided text.
8. The sample size for the training set
- Not applicable / Cannot be provided: This document describes a medical device (pulse oximeter) that uses a "software algorithm, motion-filtering software, and SatSeconds alarm management software." While these algorithms would have been developed and "trained," the document does not refer to a distinct "training set" in the context of machine learning, nor does it provide a sample size for such a set. It focuses on the device's substantial equivalence to a predicate device.
9. How the ground truth for the training set was established
- Not applicable / Cannot be provided: As above, the concept of a separate "training set" with established ground truth as in AI/machine learning contexts is not explicitly discussed for the development of the device's algorithms in this 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).