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510(k) Data Aggregation
(126 days)
The ComfortGel Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for multi-patient use in the home or hospital/institutional environment. The mask is to be used on patients (>66 Ibs/30 kg) for whom CPAP or bi-level therapy has been prescribed using a CPAP or bi-level system.
The Respironics ComfortGel Full Face Mask consists of a polycarbonate faceplate with a gel cushion encapsulated in a urethane seal for the face. The mask includes exhalation ports and an entrainment valve that allows the patient to breath room air if positive pressure is discontinued. The integrated entrainment valve elbow is polycarbonate with a silicone flapper. The function of the entrainment valve is unchanged from K002465 and K954207, based on performance data. The mask with the integrated entrainment valve has integrated exhalation features that are located on the top of the valve. A separate exhalation device is not required for the integrated entrainment valve design. The mask faceplate contains a socket for attachment of the headgear via use of a mushroom-shaped "quick clip" mechanism. The mask is available in three sizes - small, medium and large.
The Respironics ComfortGel Full Face Mask is intended for use with a patient circuit that is used to connect a therapy device to the patient interface device (mask). A typical patient circuit consists of a sixfoot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases.
This document describes the Respironics ComfortGel Full Face Mask. It is a 510(k) submission which demonstrates substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria for a new and novel clinical claim. Therefore, much of the requested information regarding clinical studies, ground truth, expert adjudication, and statistical measures like effect size is not applicable in this context.
However, based on the provided text, we can infer some details related to the "acceptance criteria" in the context of substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are not quantitative performance metrics in a clinical study but rather a demonstration that the new device shares fundamental characteristics with predicate devices and that design modifications do not negatively affect safety or effectiveness. The reported "device performance" relies on demonstrating these similarities and the safety of the modifications.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (as demonstrated by the submission) |
|---|---|
| Intended Use: Same as predicate devices. | The ComfortGel Full Face Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients, for multi-patient use in home or hospital/institutional environment, on patients (>66 lbs./30 kg) for whom CPAP or bi-level therapy has been prescribed. This is stated to be the same intended use as the predicate device. |
| Operating Principle: Same as predicate devices. | Stated as same operating principle. |
| Technology: Same as predicate devices. | Stated as same technology. |
| Manufacturing Process: Same as predicate devices. | Stated as same manufacturing process. |
| Safety and Effectiveness: Design modifications do not affect these. | "Based on the testing performed, none of the design modification affect the safety or effectiveness of the device." (Specific test results are not detailed in this excerpt but would have been part of the full 510(k) submission). The document mentions functional equivalence of the entrainment valve to predicate devices based on "performance data." |
| Functional equivalence of specific components (e.g., entrainment valve). | "The function of the entrainment valve is unchanged from K002465 and K954207, based on performance data." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "testing performed" for design modifications and "performance data" for the entrainment valve, but the number of devices or subjects tested is not provided.
- Data Provenance: The context implies internal testing by Respironics, Inc. The data would be specific to their new device and its components, likely performed in a controlled laboratory setting or in a limited user study, rather than a large-scale clinical trial. It is an internal report prepared for regulatory submission. The document does not specify country of origin for test data, but the company is US-based. It is retrospective for the purpose of this submission, meaning the tests were completed before the submission date.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of submission. Ground truth, in a clinical diagnostic sense, is not being established here. The "truth" is whether the device functions as intended and is safe and effective compared to predicates, which is determined through engineering and performance testing.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring expert adjudication of clinical outcomes or interpretations.
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 device is a medical mask for CPAP/bi-level therapy, not an AI diagnostic tool or imaging device that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this substantial equivalence submission is based on engineering performance specifications and comparison to the established safety and effectiveness of predicate devices. This means that test data (e.g., pressure measurements, material properties, airflow characteristics, sealing properties, dead space, intentional leak rates) would be compared against predetermined specifications derived from regulatory standards, internal design requirements, and the characteristics of the predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning study that would involve a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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