(254 days)
The Papillon® Mask Set is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure), operating at or above 4 cm H,O for the treatment of adult obstructive sleep apnea. The mask is single patient reusable.
The Papillon® Mask Set is a patient interface accessory for use with nasal Continuous Positive Airway Pressure (CPAP) and bi-level systems used in the treatment of Obstructive Sleep Apnea (OSA).
One mask set consists of a mask cushion, forehead pad, mask frame, hose connector system and the AeroFix headgear with the AeroFix plus hose clip. The mask cushion is available in two different sizes.
The mask fame integrates the standard mask frame and the forehead frame into one piece with an adjustable hinge design, which forms the central and supporting part of the Papillon nasal mask cushion and forehead pad are fixed to the mask frame prior to use. The mask cushion and forehead pad are both made of a hypoallergenic silicone material. The mask cushion and outer shell are comprised of a single, soft, silicone piece that covers the entire nasal area. The cushion includes an exhalation system consisting of six exhalation vents. The hose connection system allows a standard respiratory hose to be connected to the Papillon nasal mask. The hose connection system includes two connectors for external pressure measurement and for administering O.. The Aerofix headgear and Aerofix plus hose clip are easily connected to the mask frame and the respiratory hose using fasteners. The Aerofix headgear secures the nasal mask to the head of the patient.
The provided text does not contain detailed information about specific acceptance criteria for performance metrics or a study designed to prove the device meets such criteria. This document is a 510(k) summary for a medical device (a nasal mask for CPAP therapy) and generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.
However, based on the available information, here's what can be extracted and inferred regarding the study that demonstrated substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Summary) |
|---|---|
| Equivalency in preventing CO2 re-breathing | Demonstrated through verification testing to perform equivalently to the predicate mask system. |
| Biocompatibility | Compliant with ISO 10993-1 "Biological Evaluation of Medical Devices". |
| Mask performance for sleep apnea therapy | Compliant with prEN ISO 17510-2 "Sleep apnoea breathing therapy -- Part 2: Masks and application accessories". |
| Intended use, environment, and patient population similarity | Confirmed to be the same as the predicate device. |
| Safety and effectiveness despite design differences | Differences (e.g., design of mask cushion, mask frame, forehead pads, adaptation to respiratory hose) do not affect safety and effectiveness. |
Explanation:
The document states that "Verification testing has been performed and demonstrates that the exhalation vents perform equivalently in preventing CO2 re-breathing as compared to the predicate mask system." This implies that the acceptance criterion was "equivalent performance in CO2 re-breathing prevention" compared to the predicate device. The other criteria are inferred from the statements about compliance with standards and the claim of substantial equivalence, meaning the new device performs similarly to the predicate for its intended purpose.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "verification testing," but the number of subjects or samples included in this testing is not provided.
- Data Provenance: Not explicitly stated. Given that the submitter is a German company (MAP Medizin-Technologie GmbH), it's plausible the testing was conducted in Germany or a European context. It's also not specified if the data was retrospective or prospective, though "verification testing" generally implies prospective testing specifically for the device approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method for the Test Set
- Not mentioned. The focus of this 510(k) is on the physical device and its performance against standards and a predicate, not on subjective assessments requiring adjudication.
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, an MRMC comparative effectiveness study was not done. This device is a physical medical device (nasal mask), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As stated above, this device is a physical medical device and does not involve an algorithm. Performance testing was likely focused on mechanical and physiological parameters (e.g., CO2 re-breathing, fit, biocompatibility).
7. The Type of Ground Truth Used
- The "ground truth" for the device's performance appears to be established through:
- Direct measurement and comparison: For CO2 re-breathing, the performance was compared directly to a legally marketed predicate device (Sullivan® Mirage™ Mask System) through verification testing.
- Compliance with established standards: The mask was tested and found compliant with ISO 10993-1 (biocompatibility) and prEN ISO 17510-2 (mask performance for sleep apnea therapy). These standards themselves define the "ground truth" or acceptable benchmarks for these aspects.
8. The Sample Size for the Training Set
- Not applicable. This device does not use machine learning or AI, 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, this question is not relevant.
§ 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).