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The Mirage Activa™ mask is an accessory to a non-continuous ventilator (respirator), intended for multiple-patient use for adult patients prescribed continuous positive airway pressure (CPAP) or bi-level therapy in hospital, clinic and home environments.

Mirage Activa™ is a respiratory nasal mask using a dual cushion design with built-in bellows. It is a multiple-patient, multiple-use interface accessory for use with CPAP or bi-level devices.

The provided text describes a 510(k) premarket notification for the ResMed Mirage Activa™ Mask, seeking clearance for its use as a multiple-patient, multiple-use device. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly regarding disinfection and reuse protocols.

Here's an analysis of the acceptance criteria and study data, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Crucially, the document does not provide quantitative performance metrics (e.g., specific disinfection efficacy logs, number of cycles tested, or mechanical integrity after x cycles) for the Mirage Activa™ mask itself. Instead, it relies on the validation of the protocols against predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document refers to "specific protocols for validating multiple-patient use" developed by ResMed and validated for the Full Face Mask Series 2. It does not mention a specific number of masks or test cycles performed for the Mirage Activa™ mask in this summary.
• Data Provenance: The document does not specify the country of origin for the validation data. It refers to ResMed, which has a US address as the submitter, so it could be assumed the validation was conducted or overseen in the US, following AAMI standards. The data is retrospective in the sense that the protocols were developed and validated for previous devices (Full Face Mask Series 2) and are now being applied to the Mirage Activa™ mask. The text does not describe a new, prospective study specifically for the Mirage Activa™ mask involving human patients or extensive lab testing.

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

Not applicable. This type of submission (device reprocessing validation) does not typically involve expert review of clinical images or patient data to establish "ground truth" in the way a diagnostic AI device would. The "ground truth" here is the efficacy of the disinfection protocols as per AAMI standards. The document mentions that the protocols were "reviewed and validated" but does not specify who performed this review and validation (e.g., internal ResMed experts, external lab personnel, regulatory body representatives).

4. Adjudication Method for the Test Set

Not applicable for this type of device validation study.

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 is not a diagnostic AI device.

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

Not applicable. This is an accessory device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the validation of disinfection protocols against recognized standards (AAMI TIF No. 12-1994) for achieving a specified level of microbial inactivation and material compatibility. This is generally established through laboratory testing (e.g., inoculated samples, residue analysis, material degradation studies) on devices subjected to the reprocessing cycles. The document implies that this ground truth was established for the predicate devices, and the Mirage Activa™ mask is expected to perform similarly due to substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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The Mirage Activa™ mask is an accessory to a non-continuous ventilator (respirator) intended for single-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and home environments.

Mirage ActivaTM is a respiratory nasal mask using dual cushion design with built-in bellows. It is a single-patient-use interface accessory for use with CPAP and bi-level devices.

Here's a breakdown of the acceptance criteria and study information for the Mirage Activa™ Mask, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a sample size for a test set. This report focuses on comparing engineering characteristics of the new device to a predicate device, rather than a clinical study with patient data.

The data provenance is not explicitly stated. The tests conducted were likely prospective engineering tests performed by ResMed Ltd. in a lab setting to assess the physical properties of the mask.

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

This type of information is not applicable to this submission. The "ground truth" here is established through engineering and material testing standards (e.g., ISO 10993 for biocompatibility) and direct comparison of functional parameters to a known predicate device. There is no mention of human expert consensus for interpreting test results in the context of clinical "ground truth."

4. Adjudication Method for the Test Set

This is not applicable here as there is no mention of a human expert panel or adjudication process for the engineering test results.

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

This is not applicable. The Mirage Activa™ Mask is a physical medical device (a nasal mask) and does not involve AI or human readers in the context of image interpretation or diagnostic tasks.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable as the device is a physical nasal mask, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the functional performance criteria (pressure-flow, dead space, flow impedance), the "ground truth" is established by engineering measurements against pre-defined specifications and direct comparison to the physical characteristics of the predicate device.

For biocompatibility, the "ground truth" is established by compliance with ISO 10993 standards and the use of previously cleared materials.

8. The Sample Size for the Training Set

This is not applicable. The Mirage Activa™ Mask is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This is not applicable as there is no training set for this device.

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