(140 days)
The Moore Park mask is intended to be used by patients weighing more than 66 lb (30 kg) who have been prescribed noninvasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. The mask is intended for single patient re-use in the home and multi-patient re-use in the hospital/institutional environment.
The Moore Park mask is an externally placed vented respiratory mask. Positive air pressure (PAP) is directed to the patient's airway non-invasively, via the nose and/or mouth. The mask connects to the positive pressure flow source through conventional air tubing via an industry standard conical connector. The mask is held in place with adjustable headgear straps.
The Moore Park mask comprises 4 assemblies: headgear, frame, cushion and elbow. The exhaust ports are incorporated into the elbow and cushion assemblies. The anti-asphyxia valve is incorporated in the frame assembly. The cushion is available in various sizes to fit a wide patient population. The Moore Park mask is a prescription device supplied non-sterile.
Acceptance Criteria and Device Performance Study for Moore Park Mask
Based on the provided FDA 510(k) summary, here's a description of the acceptance criteria and the study conducted to prove the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on non-clinical verification and validation testing, confirming compliance with relevant standards rather than stating specific quantitative performance metrics as acceptance criteria. However, the types of tests performed indicate the implicit acceptance criteria for safety and performance.
| Acceptance Criteria Category | Implicit Acceptance Criteria / Standard Compliance | Reported Device Performance |
|---|---|---|
| Performance (per ISO 17510:2015) | - CO2 rebreathing: (Compliance with ISO 17510:2015 limits) | Met all intended performance requirements. (Detailed rebreathing values not provided, but compliance with standard is asserted). |
| - Pressure-Flow characteristics: (Compliance with ISO 17510:2015, similar to predicate) | Met all intended performance requirements. (Detailed characteristics not provided, but compliance with standard and similarity to predicate acknowledged). | |
| - Resistance to flow: (Compliance with ISO 17510:2015 limits) | Met all intended performance requirements. | |
| - Anti-Asphyxia valve operating pressures: (Compliance with ISO 17510:2015 specifications) | Met all intended performance requirements. | |
| - Breathing resistance: (Compliance with ISO 17510:2015 limits) | Met all intended performance requirements. | |
| Other Bench Tests | - Pressure performance testing: (Met predetermined acceptance criteria) | Met all intended performance requirements. |
| - Mechanical Integrity (before/after environmental tests: Home cleaning, Transportation & Storage, Operation environment): (Maintained integrity and functionality) | Met all intended performance requirements. | |
| Biocompatibility | - Compliance with ISO 18562 series (Parts 1, 2, 3) and ISO 10993 series (Parts 1, 3, 5, 10, 11, 17, 18) for materials with patient exposure (e.g., cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, VOCs, particulate matter, leachables). | Biocompatibility evaluation conducted and concluded to meet all intended performance requirements. (Specific test results not provided, but compliance with listed standards is asserted). |
| Validation of Reprocessing Claims | - Cleaning efficacy: (Demonstrated effective cleaning) | Validation confirmed that the new device met the predetermined acceptance criteria. |
| - Disinfection efficacy: (Demonstrated effective disinfection) | Validation confirmed that the new device met the predetermined acceptance criteria. | |
| - Residual toxicity: (No unacceptable residual toxicity post-reprocessing) | Validation confirmed that the new device met the predetermined acceptance criteria. | |
| - Mechanical integrity post-reprocessing: (Maintained mechanical integrity after reprocessing) | Validation confirmed that the new device met the predetermined acceptance criteria. | |
| Overall Substantial Equivalence | - Performance is substantially equivalent to the predicate Mirage Liberty Full Face Mask (K063011). | Verification confirmed that the new device met the predetermined acceptance criteria and the performance is substantially equivalent to the previously cleared predicate Mirage Liberty Full Face Mask (K063011). |
2. Sample Size for the Test Set and Data Provenance
The provided document describes non-clinical verification and validation testing (bench testing). Therefore, the concept of "test set" in the context of patient data (as might be applicable for an AI/diagnostic device) does not directly apply.
- Sample Size: Not applicable in the context of patient data for this device. The testing involved physical units of the mask and its components. The document does not specify the number of mask units or components used for each bench test.
- Data Provenance: Not applicable in the context of patient data. The data is generated from laboratory (bench) testing of the physical device components and assembled products. The company (ResMed Ltd) is based in Australia, suggesting the testing activities likely took place there or at affiliated test facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the described studies are non-clinical, bench-top engineering and biocompatibility tests for a medical device (mask), not a diagnostic algorithm that requires expert-established ground truth.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable as the described studies are non-clinical, bench-top engineering and biocompatibility tests for a medical device (mask), not a diagnostic algorithm requiring an adjudication method for ground truth.
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 information is not applicable. The device is a PAP mask, not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a PAP mask, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable in the sense of clinical "ground truth" for a diagnostic device. For the non-clinical tests described:
- Performance Tests: "Ground truth" is established by the specifications in the referenced ISO standards (e.g., ISO 17510:2015 for CO2 rebreathing limits, pressure-flow characteristics) or internal design specifications that ensure equivalence to the predicate device.
- Biocompatibility Tests: "Ground truth" is defined by the acceptance criteria within the referenced ISO 18562 and ISO 10993 series standards, which specify acceptable levels of biological response, emissions, or leachable substances.
- Reprocessing Validation: "Ground truth" is established by predetermined efficacy criteria for cleaning, disinfection, and maintenance of material properties.
8. The sample size for the training set
This information is not applicable. The device is a PAP mask, not an AI-powered device, and therefore does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this type of medical device.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).