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The Mirage Echo channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel system. The Mirage Echo is: to be used by adult patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed intended for single-patient re-use in the home environment and multipatient re-use in the hospital/institutional environment.

The Mirage Echo provides an interface 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 Echo is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. Mirage Echo is a prescription device supplied non-sterile.

Here's an analysis of the Mirage Echo Traditional 510k, based on the provided text, focusing on acceptance criteria and supporting studies.

Based on the provided information, the 510(k) submission for the Mirage™ Echo nasal mask describes a comparative study against predicate devices (Mirage Micro and Ultra Mirage II Mask) to demonstrate substantial equivalence, rather than a study with explicit, quantitative acceptance criteria for device performance as one might see for an AI algorithm.

The core of the "study" is a set of comparisons and assertions of substantial equivalence, relying on bench testing and the existing clinical acceptance of similar technology.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional 510(k) for a medical device (nasal mask), the "acceptance criteria" are primarily established implicitly by demonstrating substantial equivalence to predicate devices, focusing on safety, performance characteristics, and intended use. The performance is reported as "substantially equivalent" to the predicates.

2. Sample Size for the Test Set and Data Provenance

The provided text does not mention a "test set" in the context of clinical data or patient-specific evaluation. The performance data refers to bench testing. Therefore, information regarding:

• Sample size for the test set
• Data provenance (e.g., country of origin, retrospective/prospective)
  is not applicable as no clinical test set data is described. The submission relies on "bench testing" and comparison of technical specifications.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable. Since no clinical test set data is described, there's no mention of experts establishing a ground truth for such a set. The "ground truth" for this type of submission is typically derived from established engineering principles, international standards (e.g., ISO), and the performance of legally marketed predicate devices.

4. Adjudication Method for the Test Set

This information is not applicable. No clinical test set data is described that would require an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, potentially with AI assistance. The Mirage Echo is a medical device (nasal mask) for therapy delivery, not a diagnostic tool requiring interpretation.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done, nor would it be relevant for this type of device. The Mirage Echo is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context is established through bench testing results, adherence to international standards (e.g., ISO 10993-1 for biocompatibility, ISO 5356-1:2004 for connectors), engineering specifications, and the established performance and safety profile of legally marketed predicate devices. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this submission, as it focuses on demonstrating substantial equivalence in physical and functional characteristics.

8. Sample Size for the Training Set

This information is not applicable. The Mirage Echo is a physical medical device, not an AI algorithm that undergoes a "training set" process.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As it's not an AI algorithm, there is no "training set" or ground truth for such a set.

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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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