(83 days)
The Zest™ Nasal Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-level ventilator treatment. The Zest™ Nasal Mask is intended for Single Patient Adult Use in the home and Multiple Patient Adult Use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
The Zest™ Nasal Mask is a respiratory mask which is non invasive, the Silicone Seal is positioned over the nose, and it seals on the area around the nose, and the upper lip. The mask is held on the face with headgear straps. It connects to a single breathing tube via a swivel adaptor, to receive pressurized gases. On the mask base are exhalation vents (bias holes) that allow exhaled gases to be continually flushed and removed to room air. The silicone seal is contoured for comfort and to reduce leakage.
The provided text is a 510(k) summary for a medical device called the Zest™ Nasal Mask. This document is related to regulatory approval based on demonstrating substantial equivalence to existing devices, not a study evaluating acceptance criteria of a novel AI (Artificial Intelligence) or advanced medical device.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/algorithm performance is not applicable to this type of regulatory submission.
The document states that the Zest™ Nasal Mask is identical to a predicate device (K080209 Fisher & Paykel Healthcare Zest™ Nask Mask) in terms of features, performance, and biocompatibility. Its intended use (Single Patient Adult Use and Multiple Patient Adult Use) is also identical to another predicate device (K063036 Fisher & Paykel Healthcare HC482 Direct Nasal Mask).
Essentially, the "acceptance criteria" here is demonstrating that the new device is the same as an already approved device for relevant characteristics and intended use. There is no independent "study" with performance metrics in the way one would evaluate an AI system.
Here's how to interpret the available information concerning your request:
1. Table of Acceptance Criteria and Reported Device Performance
This concept doesn't directly apply as the submission is for substantial equivalence. The "acceptance criteria" is that the device is identical to the predicate.
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance |
|---|---|
| Technological Characteristics: Identical to Predicate Device K080209 (F&P Healthcare Zest™ Nasal Mask) | Confirmed to be identical in features, performance, and biocompatibility to K080209. |
| Intended Use: Identical to Predicate Device K063036 (F&P Healthcare HC482 Direct Nasal Mask) | Confirmed to be identical to K063036 for Single Patient Adult Use and Multiple Patient Adult Use (in home/clinical settings with proper disinfection). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. A "test set" in the context of an AI/algorithm evaluation doesn't exist for this submission. The device is being compared to an existing device, not undergoing a performance test against a dataset.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. There's no ground truth establishment in the context of an AI/algorithm test set here. The comparison is against established predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No "test set" or adjudication method defined.
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
Not applicable. This is a submission for a physical medical device (nasal mask), not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. No algorithm is involved.
7. The Type of Ground Truth Used
The "ground truth" for this submission is the features, performance, biocompatibility, and intended use of the legally marketed predicate devices. The new device is considered acceptable if it is substantially equivalent to these established devices.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved.
In summary, the provided document is a regulatory submission for a physical medical device based on substantial equivalence to predicate devices, not an evaluation of an AI or algorithm's performance. Therefore, the questions tailored for AI/algorithm performance studies are not relevant to this specific document.
§ 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).