Search Results

The indication for use of the air conduction hearing aids in this submission is to amplify sound far individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: X 1. Slight X 2. Mild X 3. Moderate X 4. Severe Configuration: X 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat Other X 1. Low tolerance To Loudness

Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments

The provided document is a 510(k) premarket notification for the Phonak "MicroZoom P 2" hearing instrument. This type of submission focuses on establishing substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria and detailed performance metrics as might be seen for novel, higher-risk devices.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific device performance against such criteria, information on test sets, ground truth establishment, or multi-reader multi-case studies.

However, I can extract the relevant information that is present in the document.

1. A table of acceptance criteria and the reported device performance:

The document states: "Technical specifications comply with ANSI S3.22 - 1987". This implies that the acceptance criteria for the device's technical characteristics are adherence to this engineering standard. The reported device performance is that it "comply[ies] with ANSI S3.22 - 1987".

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device, and typically does not include detailed independent test set data in this manner.

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):

This information is not provided in the document. There is no mention of a test set where experts establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not 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:

This information is not provided. This device is a hearing aid, not an AI-assisted diagnostic tool, so such a study would not be applicable or expected for this submission type.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not provided. This device is a hearing aid; it is inherently a human-in-the-loop device for its function (wearing it).

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

The primary "ground truth" for this 510(k) submission is the technical specifications conforming to ANSI S3.22 - 1987 and the established safety and effectiveness of the legally marketed predicate devices to which it is substantially equivalent. No specific "ground truth" in the context of clinical study data is discussed.

8. The sample size for the training set:

This information is not provided. If any "training" occurred, it would be in the context of the device's design and manufacturing processes to meet the ANSI standard, not in the sense of an AI model's training data.

9. How the ground truth for the training set was established:

This information is not provided. As above, the concept of a "training set" and associated "ground truth" in the AI/clinical study sense is not applicable to this 510(k) submission for a hearing aid.

Ask a specific question about this device