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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: Slight, Mild, Moderate, Severe
Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat
Other: Low tolerance To Loudness

Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments.
Features: Two programmable memories, 3 choices of signal processing, optional remote control
Assembly: Assembled from components available to hearing instruments manufacturer. Delivered completely assembled to the hearing aid dispenser
Technical Characteristics: Technical specifications comply with ANSI S3.22 - 1987
Audiometric Fit: Frequency response, gain, and output are fitted to the individual audiogram
Controls: Operated with remote control
Power Source: Standard hearing instrument battery, size 312

The provided documents describe a 510(k) premarket notification for the Phonak Epica E 2 hearing instrument. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data to prove novel acceptance criteria.

Therefore, the following information is either not applicable or not explicitly detailed in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance Study:
The document states that the "Technical specifications comply with ANSI S3.22 - 1987." This implies that compliance with this industry standard serves as the acceptance criterion for technical performance. However, specific numerical acceptance criteria (e.g., gain, output, frequency response ranges) and the corresponding reported device performance values against these criteria are not provided within the given text.

A standalone performance study, in the sense of a clinical trial to establish new performance metrics, is not detailed as the submission's goal is substantial equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance:
Not applicable/not specified. The 510(k) summary does not mention a specific test set or data provenance for a clinical study comparing the device against acceptance criteria.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable/not specified. No information regarding experts establishing ground truth is provided, as clinical efficacy data is not the primary focus of this 510(k) submission.

4. Adjudication Method:
Not applicable/not specified. No adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. MRMC studies are typically used in medical imaging to assess the impact of AI on human reader performance. This device is a hearing aid, and this type of study is not relevant to its regulatory pathway.

7. Type of Ground Truth Used:
Not applicable. Since the submission focuses on substantial equivalence to a predicate device and compliance with a technical standard (ANSI S3.22-1987), there's no mention of ground truth established through expert consensus, pathology, or outcomes data for clinical efficacy.

8. Sample Size for the Training Set:
Not applicable/not specified. There is no information about a training set or specific machine learning algorithms for this device.

9. How the Ground Truth for the Training Set was Established:
Not applicable/not specified. As with point 8, no training set or its ground truth establishment is discussed.

Summary based on the provided text:

The information primarily indicates that the device's technical characteristics comply with ANSI S3.22-1987, which serves as a key acceptance criterion for its fundamental performance. The 510(k) process is about demonstrating substantial equivalence, not conducting de novo clinical trials to prove new performance criteria.

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