(135 days)
The PARI Vios is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The PARI Vios is intended for adult and pediatric patients for use in hospital, clinic, or home environments.
The PARI Vios nebulizer compressor is a small, lightweight AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The device is non-sterile and prescriptionuse only.
The provided documentation describes the PARI Vios nebulizer compressor, but it does not contain information related to acceptance criteria for an AI/ML powered device or a study involving such a device.
Instead, it's a 510(k) summary for a medical device (a nebulizer compressor) that compares its performance to predicate devices. The "performance" mentioned refers to physical characteristics of the nebulizer compressor itself, not the performance of an algorithm or AI.
Therefore, I cannot provide answers to the requested categories (acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC, standalone, ground truth, training set) as they are relevant to AI/ML device studies, which are not detailed in this submission.
Here's a breakdown of what is provided, as it relates to the general concept of device performance:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" with numerical targets. Instead, it states that the PARI Vios's performance is "comparable to the predicate devices" for the following metrics:
| Acceptance Criteria (Implied: Comparable to Predicate) | Reported Device Performance (PARI Vios) |
|---|---|
| Total Output Rate (TOR) | Comparable to the predicate devices |
| MMD (Mass Median Diameter) | Comparable to the predicate devices |
| Volume % |
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).