(118 days)
The Flexifit™ HC432 Full Face Mask is intended for multiple patient or single patient adult use by individuals who have been diagnosed by a physician as requiring CPAP or Bilevel ventilator treatment in the home, hospital or other clinical setting.
The Flexifit™ HC432 Full Face Mask is a non invasive patient interface that covers the patient's mouth and nose. The mask is held on the face with headgear straps and a quick release clip. It connects to a single breathing tube by a non-rebreathing valve and a swivel adaptor, to receive pressurized gases. The non-rebreathing valve is designed to prevent carbon dioxide build up in the mask in the event of cessation of airflow from the breathing circuit. On the body, or base, of the mask are exhalation vents (bias holes) located above the bridge of the nose that allows exhaled gases to be continually flushed and removed to room air. The base is contoured and has a soft facial seal, which is fitted with a foam cushion for comfort and to reduce leakage.
This 510(k) submission is for a medical device that does not rely on AI/ML. The provided document details the substantial equivalence of the Flexifit™ HC432 Full Face Mask to a predicate device based on non-clinical performance and biocompatibility testing. Therefore, many of the requested categories related to AI/ML specific studies, such as MRMC studies, ground truth establishment for training sets, and expert consensus for test sets, are not applicable.
Here's the information parsed from the document based on the device type:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Performance (compared to predicate device HC431) | Demonstrated substantial equivalence through non-clinical tests |
| Biocompatibility (compared to predicate device Oracle Oral Mask) | Demonstrated substantial equivalence through non-clinical tests |
| Design difference: Exhalation vents | Differs from predicate (holes vs. slots, position above nasal bridge vs. above/below mouth) |
| Design difference: Foam cushion | Present in HC432, absent in predicate. Designed for comfort and sealing, minimizing air leaks. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of data for AI/ML evaluation. The assessment was based on non-clinical tests (performance and biocompatibility testing) comparing the new device to predicate devices. No human subject data (retrospective or prospective) is mentioned for evaluating the device's performance in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is not an AI/ML device requiring expert-established ground truth from a test set. The evaluation relied on non-clinical engineering and material tests.
4. Adjudication Method for the Test Set
Not applicable. No "test set" in the context of data requiring expert adjudication is mentioned.
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 not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation was based on non-clinical test results demonstrating performance and biocompatibility equivalence to legally marketed predicate devices, as well as the design principles for improvements (e.g., foam cushion for comfort/sealing, exhalation vent design).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not 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).