(252 days)
The Nasal Interface is intended for use with nasal CPAP and bilevel devices for the treatment of adult patients with Obstructive Sleep Apnea. The Nasal Interface may be used in the home, hospital, nursing home, sub-acute care center or other location where nasal CPAP or bilevel therapy is applied. The Nasal Interface will facilitate nasal CPAP or bilevel therapy via a silicone seal which makes contact solely with the patient's nose on the external aspects of the nares. This device is further supported by padded protuberances, which rest on the patient's cheeks below the zygomatic processes. The device is held in place with headgear, which extends back from the nasal interface around the back and top of the patient's head.
Nasal Interface
The provided document is a 510(k) clearance letter from the FDA for a medical device called "Nasal Interface Model 7910." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.
It is critical to understand that this type of FDA clearance letter (510(k)) generally does not include detailed device performance acceptance criteria or the study data that "proves" the device meets these criteria.
Instead, a 510(k) submission demonstrates that a new device is as safe and effective as a legally marketed predicate device. This typically involves comparing technological characteristics, intended use, and performance data if necessary, to show substantial equivalence. The actual performance data and acceptance criteria would be contained within the 510(k) submission itself, which is not publicly released in this format.
Therefore, based solely on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Not available in the provided document. The document describes the device's intended use and design, but does not list specific quantitative acceptance criteria or performance metrics (e.g., leakage rate, pressure stability, comfort scores, etc.) for the Nasal Interface.
2. Sample size used for the test set and the data provenance:
- Not available in the provided document. The letter does not mention any specific test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not available in the provided document. No information regarding ground truth establishment or expert involvement in a test set is provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not available in the provided document. No information about test set adjudication is provided.
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 Nasal Interface (likely for CPAP/Bilevel therapy), not an AI-powered diagnostic imaging or interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As above, this device is a physical medical device, not an algorithm. Standalone performance for an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not available in the provided document. Information on ground truth for any potential studies is not mentioned.
8. The sample size for the training set:
- Not available in the provided document. Information on any training set is not mentioned.
9. How the ground truth for the training set was established:
- Not available in the provided document. Information on how ground truth for any training set was established is not mentioned.
In summary: The provided FDA 510(k) clearance letter confirms the regulatory status of the device but does not contain the detailed technical performance data, study designs, or acceptance criteria that would typically be found within the full 510(k) submission itself. Without access to the actual submission, these details cannot be extracted.
§ 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).