(258 days)
The iQ 2 and Phantom 2 Nasal Mask is intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O to 30 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital or institutional environment.
The Sleepnet iQ 2 and Phantom 2 Nasal masks are patient interfaces for use with positive pressure equipment, i.e., CPAP and bi-level. They incorporate an exhaust port in the shell. The 2 styles are similar: Same patient population and Indications for Use, Same headgear, Same headgear connector components, Same tubing assembly, Same materials and manufacturing processes. They differ only in: Mask shell shape, Gel cushion shape.
This is a 510(k) summary for the iQ 2 and Phantom 2 Nasal Mask, which is a medical device and not an AI/ML product. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and studies for an AI/ML device.
The document discusses the substantial equivalence of the iQ 2 and Phantom 2 Nasal Mask to a predicate device (iQ Nasal Mask) based on non-clinical testing for biocompatibility and performance bench testing against standards like ISO 17510-2 and ISO 5356-1.
Here's a breakdown of what the document does provide, and why it doesn't fit your AI/ML criteria:
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A table of acceptance criteria and the reported device performance:
- The document provides a "Table of Comparison to Predicate" (page 5) which lists various attributes like product classification, indications for use, patient population, technical characteristics, and performance characteristics (Exhaust flow, Dead space, Resistance to flow, Sound pressure and Sound power level).
- However, these are comparison points to a predicate device, not pre-defined acceptance criteria for an AI/ML model's performance metrics (like accuracy, sensitivity, specificity, AUC). For performance characteristics like "Exhaust flow" there's a comparison to the predicate, and for "Resistance to flow" and "Sound pressure/power level" it states there are "no acceptance criteria" in the relevant ISO standard but notes similarities or differences to the predicate.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document describes physical device testing, not data-driven model testing.
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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): Not applicable. "Ground truth" in the context of AI/ML diagnostic performance is not relevant here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 is not an AI-assisted device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for the physical device performance would be the results of the bench tests against established standards.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the regulatory clearance of a physical medical device (nasal mask) based on substantial equivalence to a predicate device and adherence to relevant performance standards through bench testing, not a study of an AI/ML device.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).