(32 days)
The Nonin Bluetooth® - enabled Model 4100 Patient Oximeter Module is indicated for use in measuring and transmitting functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and plethysmographic data to a compatible Bluetooth - enabled device.
Nonin's Model 4100 Bluetooth® - enabled wrist-worn Patient Oximeter Module measures and transmits SpO2, pulse rate, and plethysmographic data to a compatible Bluetooth - enabled device. The patient module includes a class II Bluetooth radio with a range of approximately 30 feet (spherical range). The 4100 Patient Oximeter Module is powered with two AA batteries, which last for approximately 120 hours when used continuously.
The provided text is a 510(k) summary for the Nonin Model 4100 Patient Oximeter Module. It states that the device has undergone "both bench and clinical testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate device." However, the document does not provide specific details about the acceptance criteria or the specific study results proving the device meets those criteria.
Therefore, many of the requested details cannot be extracted from this document.
Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify any quantitative acceptance criteria for device performance, nor does it present reported device performance in a table. It only states that functional and safety testing was performed and that the device is "substantially equivalent" to a predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. It only mentions "clinical testing."
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)
This information is not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This is not applicable as the device is an oximeter, not an AI-powered diagnostic tool requiring human reader interpretation improvements. The document describes a traditional medical device (pulse oximeter).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is an oximeter, not an AI algorithm. Its performance is inherent to its function of measuring SpO2 and pulse rate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly provided. For pulse oximeters, the ground truth for SpO2 measurements typically involves co-oximetry blood gas analysis, but the document does not confirm this.
8. The sample size for the training set
This is not applicable as the device is a hardware medical device (pulse oximeter) and does not inherently involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
§ 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).