(186 days)
The Maskmedic Concept Nasal Mask is indicated for use as an accessory nasal mask with standard Continuous Positive Airway Pressure (CPAP) and bi-level positive air treatment devices and other non continuous ventilators. The mask is suitable for use in medical facilities or for patient home use. It is intended for single patient/multi-use
The device is a silicone elastomer nasal mask composed of a moulded, form fitting face mask, connected to standard 16 mm ventilator tubing via a standard 22 mm terminal fitting and fitted with a neoprene harness.
I am sorry, but the provided text does not contain the detailed information required to fill out all the sections of your request regarding acceptance criteria and a study proving device performance. The document is a 510(k) summary for a medical device (Maskmedic Concept Nasal Mask) that focuses on demonstrating substantial equivalence to a predicate device, rather than a detailed report of a performance study with acceptance criteria.
Here's what I can extract and what is explicitly not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative criteria or benchmarks. The comparison is against the predicate device. | "Comparative performance testing has demonstrated performance equivalent to the predicate device, and the performance of the device is not compromised by storage in extreme environmental conditions or after cleaning." |
| "A risk assessment concluded that there were no significant new safety concerns raised by the design of the Maskmedic Concept Nasal Mask." |
Explanation: The 510(k) summary asserts "performance equivalent to the predicate device." However, it does not provide specific numerical acceptance criteria (e.g., leakage rates, pressure drop) or detailed results from the comparative performance testing.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). While "Comparative performance testing" is mentioned, no details about participant numbers or study design are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical medical device (nasal mask), not an AI/diagnostic device where expert ground truth would typically be established. The "testing" referred to is likely engineering/bench testing, not clinical evaluation with expert interpretation as ground truth.
4. Adjudication method for the test set:
- Not applicable for the same reasons as #3.
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 is a physical device (nasal mask), not an AI/diagnostic algorithm that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical device, not an algorithm.
7. The type of ground truth used:
- For the physical performance testing mentioned ("Comparative performance testing"), the "ground truth" would likely be established through engineering specifications, validated test methods, and comparison against the predicate device's known performance characteristics (e.g., manufacturing specifications, regulatory clearances). It's not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic study.
8. The sample size for the training set:
- Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI algorithm that requires a training set.
In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device (a nasal mask). It mentions "comparative performance testing" but does not contain the detailed study results, acceptance criteria, or methodological specifics that would be required for a comprehensive answer to your questions, especially those related to AI or diagnostic studies.
§ 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).