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General Indications: A. 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: 1. Slight, X 2. Mild, X 3. Moderate, X 4. Severe, 5. Profound. Configuration: X 1. High Frequency - Precipitously Sloping, X 2. Gradually Sloping, X 3. Reverse Slope, X 4. Flat, 5. Other. Other: X 1. Low tolerance To Loudness, 2., 3. B. Specific Indications (only if appropriate.): (Most psychoacuustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) - l. 2. - 3.

Programmable behind-the-ear hearing instrument. Substantially equivalent to other programmable behind-the-ear hearing instruments

The provided text does not contain information about acceptance criteria or a study proving the device meets these criteria in the typical format of a medical device performance study (e.g., diagnostic accuracy, sensitivity, specificity).

Instead, the documents are a 510(k) Premarket Notification Summary for a hearing aid, the Phonak Novo Forte E3. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against specific, quantifiable acceptance criteria through a clinical study.

Here's a breakdown of what the document does provide, and why it doesn't fit the requested format for acceptance criteria and study details:

• Device Description and Intended Use: The documents clearly describe the Phonak Novo Forte E3 as a "Programmable behind-the-ear hearing instrument" intended "To amplify and transmit sound to the ear."
• Technical Characteristics: It states that "Technical specifications comply with ANSI S3.22 - 1987." This is the closest thing to a performance standard or criterion mentioned, but it's a general compliance statement rather than specific device performance metrics.
• Substantial Equivalence: The FDA letter explicitly states, "we have determined the device is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976." This is the core of a 510(k) submission.
• Indications for Use: Page 4 details the specific types and severities of hearing loss for which the device is indicated (Slight, Mild, Moderate, Severe; High Frequency, Gradually Sloping, Reverse Slope, Flat; Low tolerance to Loudness).

Answer based on the provided text:

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

Explanation: The document does not specify quantitative performance acceptance criteria (e.g., a required signal-to-noise ratio, hearing gain at specific frequencies, or distortion levels) or present performance data from a specific study against such criteria. The primary "acceptance" was the FDA's determination of substantial equivalence to a predicate device and compliance with ANSI S3.22 - 1987.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable/Not provided. The 510(k) summary does not describe a clinical performance study with a test set of patients or data.
• Data Provenance: Not applicable/Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. No test set or ground truth establishment process is described.

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

• Not applicable/Not provided. No test set or adjudication process is described.

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. This device is a hearing aid, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a hearing aid; it does not involve algorithms for standalone diagnostic performance.

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

• Not applicable/Not provided. No ground truth is established as no clinical performance study is described. The "ground truth" for the 510(k) application is the established safety and effectiveness of the predicate device to which the Novo Forte E3 is compared for substantial equivalence.

8. The sample size for the training set:

• Not applicable/Not provided. No training set is mentioned as this is not an AI/machine learning device.

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

• Not applicable/Not provided. No training set is mentioned.

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