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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 multipatient re-use in the hospital/institutional environment.

The headgear colour of the modified device has changed. The color of the outer layer of the fabric is being changed from dark blue to tan. All other aspects of the device remain unchanged.

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

The modified Mirage Micro is a prescription device supplied nonsterile.

Both the masks incorporate vent holes to provide continuous air leak to flush out the dead space within the mask and minimize the amount of CO2 rebreathed by the patient. The design of the mask components is such that the incorporation of these vent-holes does not interfere with the intended performance of the masks. Both masks connect to a conventional air delivery hose between the mask and the positive airway-pressure source via standard conical connectors (ref: ISO 5356-1:2004)

Both masks have provisions for connecting oxygen and pressure sensing tubing via luer ports.

Both masks are constructed using molded plastic components and fabric headgear. All the components of both the masks are fabricated using materials deemed safe. (ref: ISO 10993-1).

Both the modified device and the previously cleared device can be reused in the hospital / institution environment.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. This document is for a Special 510(k) for a minor device modification (headgear color change). No new clinical or performance test data was generated with a specific test set. The submission relies on a comparison to the predicate device and the assertion that the change is cosmetic and does not impact performance.
• Data Provenance: Not applicable for a new test set. The basis for substantial equivalence is the prior clearance of the predicate device (Mirage Micro Mask K072940) and the established safety and effectiveness of vented nasal masks with CPAP/Bilevel therapy.

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

• Not applicable. No new ground truth was established for a test set as part of this Special 510(k) submission.

4. Adjudication method for the test set:

• Not applicable. No test set requiring adjudication was used.

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 device is a passive medical device (a mask); it does not involve AI or human readers for interpretation. Therefore, an MRMC study is not relevant.

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

• No. This device is a passive medical device and does not involve any algorithms or software-driven performance that would require standalone testing.

7. The type of ground truth used:

• The ground truth for the safety and effectiveness of the device is based on the prior clearance and established performance of the predicate device (Mirage Micro Mask K072940). The current submission argues that the modified device is substantially equivalent because the change is purely cosmetic (headgear color) and does not alter the fundamental design, materials, or intended use that were proven safe and effective by the predicate.

8. The sample size for the training set:

• Not applicable. This device is a passive medical device, and this submission is for a minor modification. It does not involve machine learning or AI, and therefore no training set.

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

• Not applicable. As there is no training set involved, no ground truth needed to be established for it.

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The Mirage Micro channels airflow noninvasively 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. - to be used for single-patient re-use in the home environment and multi-patient reuse in the hospital/institutional environment.

Not Found

This appears to be a 510(k) clearance letter from the FDA for a medical device (Mirage Micro™). It does not contain the information required to answer your prompt.

The document is a regulatory approval, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance, labeling, and reporting requirements.

Specifically, the document does NOT include any of the following:

• A table of acceptance criteria or reported device performance.
• Information on sample sizes for test sets, data provenance, or training sets.
• Details about expert involvement, ground truth establishment, or adjudication methods.
• Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot provide the requested information based on the provided text.

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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 text is a 510(k) summary for the ResMed Mirage Micro, a vented nasal mask. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study with acceptance criteria and a comprehensive study report. Therefore, much of the requested information regarding specific acceptance criteria, test sets, experts, and detailed study methodologies is not present in the provided text.

Here is the information that can be extracted or reasonably inferred from the document:

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

2. Sample size used for the test set and the data provenance

The document explicitly states: "Bench testing is sufficient to demonstrate safety and efficacy of the Mirage Micro, as was the case with the predicate devices."

• Sample Size for Test Set: Not specified. Since it refers to "bench testing," it would involve testing physical prototypes or samples rather than human subjects. The number of masks tested is not provided.
• Data Provenance: Bench testing results. Country of origin is not specified, but the applicant (ResMed) is a global company. Based on the submission being to the FDA, it's likely the testing was conducted in a manner consistent with US regulatory requirements, potentially in the US or by a facility accredited for such testing. The testing is prospective in the sense that it was performed to support this specific submission.

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

Not applicable. This was a bench testing study comparing the modified device to a predicate device based on physical characteristics and performance measurements (CO2, pressure-flow). There was no "ground truth" derived from expert interpretation of images or clinical outcomes in the traditional sense that would require a panel of experts.

4. Adjudication method for the test set

Not applicable, as no expert review or adjudication of clinical data was performed. The evaluation relied on objective measurements from 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

Not applicable. This device is a medical mask for respiratory support, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

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

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used

For the performance data (CO2, pressure-flow, flow impedance), the "ground truth" would be established by the objective measurements obtained from the bench testing against predefined engineering specifications and comparison to the predicate device's performance. For biocompatibility, the ground truth refers to compliance with ISO 10993-1 standards using validated material testing methods.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no training set.

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

Not applicable, as there is no training set for this device.

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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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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 and 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 text describes the 510(k) summary for the ResMed Mirage Micro™ nasal mask. This document outlines the device's characteristics and its substantial equivalence to predicate devices, rather than a clinical study demonstrating the device meets specific acceptance criteria through comprehensive performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, and ground truth establishment are not present in this regulatory submission for a nasal mask. The submission emphasizes "bench testing" and "proven technology" for substantial equivalence.

Here's an analysis based on the information available and not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific numerical targets. Instead, it relies on a comparison to predicate devices, asserting "substantial equivalence" in key performance characteristics relevant to its function as a nasal mask for PAP therapy.

2. Sample size used for the test set and the data provenance

The document explicitly states: "Bench testing is sufficient to demonstrate safety and efficacy of the Mirage Micro, as was the case with the predicate devices." This indicates that the primary performance evaluation was conducted via bench testing, meaning in a laboratory setting, rather than with human subjects in a clinical trial.

• Sample size: Not specified for bench tests. For physical component characteristics, it would likely involve a sample of manufactured masks.
• Data provenance: Bench test data, not explicitly described as from a specific country, but linked to internal testing by ResMed Ltd (Australia). The data provenance is retrospective in the sense that it's based on internal validation for product development.

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

Not applicable. As the evaluation was based on bench testing and comparison to predicate devices, there was no "ground truth" derived from expert interpretation of clinical data in the traditional sense. The "ground truth" for performance would be the specifications and validated behavior of the predicate devices and general knowledge of CPAP mask function.

4. Adjudication method for the test set

Not applicable. No expert adjudication method is described, as it was 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

Not applicable. This device is a medical mask, not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This device is a medical mask, not an algorithm. Its "standalone" performance refers to its physical and functional characteristics on a bench.

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

The ground truth for this device's performance is based on engineering specifications, material safety standards (ISO 10993-1), recognized international standards for connectors (ISO 5356-1:2004), and the established performance characteristics of the predicate devices. It’s not clinical ground truth like pathology or expert consensus on patient data.

8. The sample size for the training set

Not applicable. This is a physical device, not an algorithm that requires a training set.

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

Not applicable. No training set is involved for this device.

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