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510(k) Data Aggregation
(125 days)
The PerforMax Total Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. For multi-use in the hospital/institutional environment or single patient reuse in the home. The mask is to be used on patients 7 years or older (>40 lbs/18.2 kg) for whom CPAP or bi-level therapy has been prescribed.
The PerforMax Total Face Mask is intended to be used with positive airway pressure devices such as CPAP or bi-level systems. The small size mask is intended for use on patients 7 years or older (>40 lbs/20kg) and the large size mask is intended for use on patients (>66 lbs/30 kg) for whom CPAP or bilevel therapy has been prescribed.
The PerforMax Total Face Mask consists of a polycarbonate faceplate and a silicone cushion seal for the face. The PerforMax Total Face Mask can utilize a bronchoscopy elbow. This elbow will allow physicians to perform bronchoscopy procedures on a patient while the patient is receiving non-invasive ventilation. A pressure-pick off port is located on the elbow. A separate exhalation device is required when using the Respironics PerforMax Total Face Mask with bronchoscopy elbow because exhalation is not built into the mask. The mask is available in two sizes: small and large.
The Respironics PerforMax Total Face Mask is intended for use with a patient circuit that is used to connect the therapy device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing and a method of venting exhaled gases.
This document describes a 510(k) submission for the Respironics PerforMax Total Face Mask. The submission focuses on a modification to an existing device, specifically the introduction of a bronchoscopy elbow, and asserts substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Unintentional leak | Completed and passed during extensive performance testing. |
| Pressure drop | Completed and passed during extensive performance testing. |
| CO2 rebreathing | Completed and passed during extensive performance testing. |
| Mask deadspace | Completed and passed during extensive performance testing. |
| Therapy device compatibility | Completed and passed during extensive performance testing. |
| Biocompatibility (new skin-contacting and air path-contacting materials) | Biocompatibility assessment completed in accordance with ISO 10993-1, including irritation, sensitization (ISO 10993-10), and cytotoxicity (ISO 10993-5) tests, and passed. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test (unintentional leak, pressure drop, CO2 rebreathing, mask deadspace, therapy device compatibility, biocompatibility). The testing described appears to be retrospective in the sense that it evaluates a modification to an existing device against established performance benchmarks for that device. The provenance of the data is internal testing conducted by Respironics, Inc. There is no indication of external data sources or specific countries of origin beyond the company's location.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The testing described focuses on engineering and biocompatibility benchmarks, not on clinical interpretation or expert consensus regarding performance.
4. Adjudication method for the test set:
This information is not applicable as the evaluation is based on objective performance metrics and compliance with engineering standards, rather than subjective expert adjudication.
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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical mask for CPAP/bi-level therapy, not an AI-assisted diagnostic tool or imaging system. Therefore, the concept of human readers improving with AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
A standalone algorithm performance study was not done. This device is a physical medical mask, not an algorithm.
7. The type of ground truth used:
The ground truth used for this product is based on engineering performance specifications and biocompatibility standards. Specifically:
- For performance tests (leak, pressure drop, CO2 rebreathing, deadspace, compatibility), the ground truth is established by the pre-defined performance specifications for the device, consistent with the predicate device tests.
- For biocompatibility, the ground truth is established by international standards such as ISO 10993-1, ISO 10993-10, and ISO 10993-5.
8. The sample size for the training set:
There is no training set in the context of this device, as it is a physical medical device and not a machine learning model.
9. How the ground truth for the training set was established:
This question is not applicable as there is no training set for this device.
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