Search Results

The Respironics® Total™ Face Mask is intended to provide an interface for application of Respironics CPAP or BiPAP therapy to patients.

The Total Face Mask is intended to provide a single-patient-use interface for adult patients (>30 kg) receiving Respironics CPAP or BiPAP therapy. The mask (Figure 1) fits over the entire face, with the rim of the mask framing the face along the hairline and jawline. The mask consists of a polycarbonate faceplate and a thin silicone cushion that folds inward, creating a flap on the inner perimeter of the mask to improve seal. The faceplate has four Velcro® hooks to which the headgear tabs attach.

The modified faceplate (Figure 2) is smaller, rounder, and has a streamlined profile. (Predicate mask is larger, primarily round, with the exception of the eye area, which is squared off.) Modified mask volume is smaller at 1550 ml. (Predicate volume is 2300 ml.) Modified mask cushion material is silicone. (Predicate cushion is urethane.)

Modified faceplate (Figure 2) has a nosepiece with 22-mm entrainment valve, whose accessory swivel connects to patient circuit. (Predicate faceplate has a 22-mm elbow, to which patient circuit is connected.) Entrainment valve opens to ambient air if pressure should cease. (Predicate requires use of a non-rebreathing valve (NRV).) Two built-in exhalation ports are located on the nosepiece. (Predicate's ports are located on the mask.) Nosepiece has one pressure pickoff port. (Predicate elbow has two.) The headgear consists of Velcro® straps. (Predicate headgear is a cap with Velcro straps.)

The provided text describes a 510(k) premarket notification for a modified Respironics® Total™ Face Mask. While it mentions that "Design verification tests were performed... and acceptance criteria were met," it does not provide any specific details about the acceptance criteria themselves or the results of these tests.

Therefore, I cannot populate the table with acceptance criteria and reported device performance, nor can I answer many of the other questions regarding the study design, sample sizes, ground truth, or expert involvement. The document primarily focuses on demonstrating substantial equivalence to a predicate device based on similar intended use, operating principle, technology, and manufacturing process.

Here's what information can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document states "Design verification tests were performed" but provides no details on the number of units tested or patients involved.
• Data Provenance: Not specified. It's likely the tests were conducted by Respironics, Inc. in Murrysville, PA, USA, given the contact information, but this is an inference, not explicitly stated. The nature (retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. The document does not describe the establishment of a "ground truth" using human experts in the context of diagnostic performance, but rather design verification tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No expert adjudication process is described for design verification tests.

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

• No. This is a medical device for respiratory support, not an AI-powered diagnostic tool. An MRMC study is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device (mask), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not explicitly stated. For "design verification tests," the ground truth would typically be engineering specifications, performance standards (e.g., seal integrity, pressure drop, material biocompatibility, volume), or functional requirements. The document mentions compliance with "applicable standards referenced in the 'Draft FDA Reviewer Guidance for Premarket Notifications,' November 1993," which would presumably define some of these criteria.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/machine learning device.

In summary, the provided text is a 510(k) summary for a modified medical device, not a detailed scientific study report on performance metrics as would be expected for a diagnostic AI device. It confirms that design verification tests were performed and met acceptance criteria, but does not elaborate on what those criteria or results were.

Ask a specific question about this device