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510(k) Data Aggregation
(105 days)
The Quattro LT 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 Quattro LT 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 Quattro LT provides an interface such that airflow from a positive pressure source is directed to the patient's nose and mouth. The mask is held in place with adjustable headgear that straps the mask to the face.
The Quattro LT is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.
The Quattro LT is a prescription device supplied non-sterile.
The provided text is a 510(k) summary for a medical device called the Quattro™ LT, a full face mask designed for use with positive airway pressure (PAP) devices. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a clinical study with detailed acceptance criteria and performance data in the way a typical AI/ML device study would.
Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this document. The document states that "Bench testing is sufficient to demonstrate safety and efficacy of the Quattro LT, as was the case with the predicate devices."
However, I can extract information related to the performance claims and the basis for substantial equivalence.
Here's a breakdown of what can be inferred or extracted based on the provided text, while acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" for a clinical study with numerical metrics. Instead, it defines performance equivalence to predicate devices based on functional characteristics.
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (vs. Predicate Devices) |
|---|---|
| Intended Use: Device channels airflow noninvasively from a PAP device to an adult patient (>66lb / >30kg) for prescribed positive airway pressure, for single-patient re-use in home, and multi-patient re-use in hospital/institutional environments. | The Quattro LT's intended use is identical to the predicate devices. |
| Technological Characteristics: | |
| - Sealing mechanism | Both the Quattro LT and predicate Mirage Quattro provide a seal via a silicone interface. |
| - Fit for extended patient population | Both masks are offered in various sizes to ensure adequate fit over the extended patient population. |
| - CO2 Rebreathing (vent holes) | Both masks incorporate vent holes to provide continuous air leak to flush out and minimize CO2 rebreathed. The design ensures vents do not interfere with performance. The CO2 performance of the new device and the predicate device are substantially equivalent. |
| - Antiasphyxia valve (AAV) functionality | Both masks contain an AAV to enable patient to breathe fresh air if airflow from generator is impeded. |
| - Connection to air delivery hose | Both masks connect to a conventional air delivery hose via standard conical connectors (ISO 5356-1:2004). |
| - Material Biocompatibility | All components in both masks are fabricated using materials deemed safe (ISO 10993-1). |
| - Compatibility with flow generators | Both the new device and the predicate are designed to operate on the same ResMed flow generator settings. |
| - Pressure-flow characteristics and flow impedance | The pressure-flow characteristics and flow impedance of both devices are substantially equivalent. |
| - Reusability (home/hospital) | Both the new device and the predicate device can be reused in the home and hospital/institution environment. |
| Safety and Effectiveness: Does not raise new questions of safety and effectiveness, and is at least as safe and effective as predicate devices. | The document explicitly states this as part of the substantial equivalence conclusion. It relies on the substantial equivalence of intended use and technological characteristics, and that "Bench testing is sufficient to demonstrate safety and efficacy of the Quattro LT, as was the case with the predicate devices." |
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: Not applicable. No clinical "test set" (patient data) was used. The document mentions "bench testing."
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No expert-evaluated test set was used. The basis for safety and efficacy was "bench testing" and comparison of technical characteristics to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical 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
- Not applicable. The device is a physical medical mask, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical medical mask.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of an AI/ML study. For this device, the "truth" or benchmark was established by demonstrated performance of predicate devices and through "bench testing" (e.g., CO2 rebreathing tests, pressure-flow characteristics, material safety).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
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