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The SleepNet Mojo and Veraseal masks are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H2O. The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. Veraseal - Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional) Mojo - Single patient, multi-use (home or hospital/institutional)

The SleepNet Mojo and Veraseal Full Face mask are modifications of the SleepNet Mojo Full Face mask cleared under K060273. The modifications to the cleared Mojo Full Face mask are: - different durations of use - o single use, disposable (Hospital/Institutional) Veraseal - o single patient, multi-use up to 7 days (Hospital/Institutional) Veraseal - o single patient, multi-use (Home or Hospital/Institutional) MoJo - a change in materials . - updated design of the exhaust elbow used with the mask As a result of these modifications we have established two (2) product tradenames to help distinguish them. Veraseal model has 2 durations of use - single use, disposable or single patient, multi-use up to 7 days in the hospital. Mojo model is single patient, multi-use (typically more than 7 days) for use in the home or hospital.

Here's a breakdown of the acceptance criteria and study information for the SleepNet Mojo and Veraseal Full Face Mask, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to predicate devices using comparative performance testing, rather than explicit acceptance criteria with numerical targets for each attribute. However, the "Comparative Performance" section and the "Table of Comparison to Predicates" implicitly serve this purpose by showing that the modified devices perform similarly to or better than the predicates.

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The Mirage Micro channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bilevel system.

The Mirage Micro is:

• to be used by adult patients (>66lb / >30kg) for whom positive airway pressure has been prescribed.
• intended for single patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment.

The Mirage Micro provides seal such that airflow from a positive pressure source is directed to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face.

Mirage Micro is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.

Mirage Micro is a prescription device supplied nonsterile.

The provided document is a 510(k) summary for the ResMed Mirage Micro Traditional, a vented nasal mask, seeking substantial equivalence to predicate devices. It is not a study that proves the device meets acceptance criteria in the way typically seen for AI/ML-based medical devices or diagnostics. Instead, it demonstrates substantial equivalence through comparisons of technological characteristics and performance data via bench testing.

Therefore, many of the requested fields (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of submission.

Here's a breakdown of the available information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state formal "acceptance criteria" with numerical thresholds in the sense of a diagnostic device. Instead, it relies on demonstrating substantial equivalence to predicate devices through comparative performance and technological characteristics. The "reported device performance" is essentially a statement of equivalence.

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

• Sample size for the test set: Not applicable. The submission refers to "bench testing" and "comparison with predicate" rather than a clinical trial or a test set of data points in the context of an AI/ML device.
• Data provenance: Not applicable. Bench testing is typically performed in a laboratory setting. No country of origin for clinical data is mentioned as none was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of experts: Not applicable. Ground truth establishment by experts is not described as part of this bench testing for a mechanical device.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable. This concept is relevant for expert disagreement resolution in diagnostic studies, not for mechanical device bench testing.

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

• MRMC study: No. This is a medical device, not an AI/ML diagnostic.
• Effect size: Not applicable.

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

• Standalone performance: Not applicable. This is a medical device, not an AI/ML diagnostic.

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

• Type of ground truth: Not explicitly stated as "ground truth" in the AI/ML sense. The performance of the new device was compared against the performance of the predicate devices (Mirage Micro K071808 and Mirage Quattro K063122) through bench testing parameters like CO2 performance, pressure-flow characteristics, and flow impedance. The "truth" is based on the established safety and efficacy of the predicate devices.

8. The sample size for the training set

• Sample size for training set: Not applicable. This is a medical device, not an AI/ML system.

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

• Ground truth for training set establishment: Not applicable. This is a medical device, not an AI/ML system.

Summary of the Study (as described in the 510(k) Summary):

The submission for the Mirage Micro Traditional nasal mask relies on a bench testing study to demonstrate substantial equivalence to its predicate devices (Mirage Micro Mask K071808 and Mirage Quattro Mask K063122).

The core of the "study" involved:

• Comparison of Technological Characteristics: Detail how the new device's design, materials, and features are similar to the predicates. This includes aspects like the dual-wall silicone interface, vent hole design, standard connectors, luer ports, and biocompatible materials.
• Performance Data Comparison (Bench Testing): Direct comparison of the new device's performance against the predicate Mirage Micro regarding:
  • CO2 performance: Stated as "substantially equivalent."
  • Pressure-flow characteristics: Stated as "substantially equivalent."
  • Flow impedance: Stated as "substantially equivalent."
  • Operation on standard flow generator settings: Stated as designed to operate on the same settings.

The conclusion drawn from this comparison and bench testing is that the new Mirage Micro is substantially equivalent because it shares the same intended use, similar technological characteristics, does not raise new questions of safety and effectiveness, and is at least as safe and effective as the predicate devices. Clinical data was deemed unnecessary as "Use of vented nasal masks with CPAP or Bilevel therapy is proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy..."

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