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510(k) Data Aggregation
(119 days)
A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. Single patient, multi-use and Multi-patient, multi-use
The proposed nasal patient interface incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.
- . Three (3) sizes of nasal inserts to assure a good fit
- . Integral fixed leak port
- . Headgear for attachment
The provided text is a 510(k) Pre-market Notification for a CPAP nasal mask. It details the device's description, indications for use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically found in clinical trials or performance studies involving specific metrics and statistical analysis.
The 510(k) process is primarily about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving specific performance metrics through a dedicated clinical study with acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria and a study to prove them cannot be extracted from this document.
Here's a breakdown of what can be inferred from the document regarding comparative features, which serves as the basis for the 510(k) submission:
1. A table of acceptance criteria and the reported device performance
This document does not specify formal "acceptance criteria" in terms of performance metrics (e.g., leakage rates, pressure stability, comfort scores) with corresponding reported device performance, as would be expected from a dedicated performance study. The "performance" in this context is demonstrated by showing substantial equivalence to the predicate device based on features and indications for use.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Comparative Features) |
|---|---|
| Indications for Use: Comparable to predicate | "A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support." - Same as predicate. |
| Environment of Use: Comparable to predicate | "Home, Hospital, Sub-acute Institutions, Sleep labs" - Same as predicate. |
| Patient Population: Comparable to predicate | "Adult" - Same as predicate. |
| Contraindications: Comparable to predicate | "None" - Same as predicate. |
| Usage: Single patient, multi-use / Multi-patient, multi-use | "Yes" - Same as predicate. |
| Number of Sizes: Sufficient for good fit | "Yes - three" (Predicate had five, but three are deemed sufficient for a good fit as stated in Device Description) |
| Components: Similar to predicate | "Headgear, Nasal prongs, Tubing, Connectors" - Same as predicate. |
| Dead Space: Within acceptable limits | "Nasal piece - largest 23 ml" (Predicate: 5 to 18 ml; 23ml is presented without further justification as acceptable) |
| Fixed Leak Port: Present | "Yes" - Same as predicate. |
| Materials: Similar to predicate | "Polypropylene, PVC tubing, Silicone" - Same as predicate. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document does not describe a "test set" in the context of a performance study with a specific sample size. The 510(k) relies on comparison to a predicate device using readily available specifications and general knowledge, not new clinical data from a "test set."
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 / Not provided. There is no mention of "experts" establishing a "ground truth" for a test set, as this is not a clinical study assessing a diagnostic or predictive device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or adjudication method is described.
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 / Not provided. This device is a physical medical device (CPAP nasal mask), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. The "ground truth" for this 510(k) submission is the established performance and safety profile of the legally marketed predicate device (InnoMed - Nasal Aire K022465), against which the new device is compared for substantial equivalence. No new "ground truth" data for the new device is presented through a clinical study.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/machine learning device that would involve a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As above, no training set is relevant.
In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence of a new CPAP nasal mask to an existing predicate device. It primarily does this by comparing design features and indications for use, rather than presenting a performance study with detailed acceptance criteria, clinical data, or expert-adjudicated ground truth.
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