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to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to severe.

This air-conduction behind-the-ear hearing instrument with body-worn processor is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses from mild to severe. The device is powered by a standard hearing aid battery (type 13) and 2 standard alkaline type AAA batteries. The device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices. The intended use, performance specifications, functions and operations of the Audallion® II Hearing System are essentially identical to that described in the 510(k) Premarket Notification for the ReSound® BT4 Personal Hearing System™. The ability to program digitally the fitting parameters of the hearing device is the same as in the ReSound® BT4 Personal Hearing System™, as is the ability to change the characteristics of the sound processing and adjust the volume. The Audallion® II Hearing System has the ability to retain up to four programs in memory, whereas the predicate device has the ability to retain two.

The provided text is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for the Audallion® II Hearing System, submitted as a 510(k) premarket notification. This document focuses on demonstrating substantial equivalence to a predicate device, the ReSound® BT4 Personal Hearing System™.

The concept of substantial equivalence in 510(k) submissions means demonstrating that a new device is as safe and effective as a legally marketed predicate device. This is achieved by showing that the new device has the same intended use as the predicate and either the same technological characteristics or, if different technological characteristics, that they do not raise different questions of safety and effectiveness and the information submitted demonstrates that the device is as safe and effective as the legally marketed device.

Critically, this document describes a regulatory submission for substantial equivalence based on technological characteristics and intended use similarity, not on clinical performance studies with specific acceptance criteria that one would typically use to "prove the device meets acceptance criteria" in the way clinical diagnostic or AI-driven devices are evaluated today.

Therefore, I cannot populate most of the requested fields because the provided text does not contain information about:

• Specific performance acceptance criteria in terms of metrics like sensitivity, specificity, accuracy, or other quantitative measures.
• A "study" designed to prove the device meets such criteria using a test set of data.
• Sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods for performance evaluation.
• MRMC or standalone comparative effectiveness studies.
• Training set details for an algorithm (as this device is a hearing aid, not an AI algorithm in the modern sense).

Here's how I can address the prompts based only on the provided text, highlighting what is and isn't available:

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

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

• Not applicable / Not provided. The document does not describe a performance study with a test set. The basis for substantial equivalence is a comparison of technological characteristics and intended use, not statistical performance on a dataset.

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)

• Not applicable / Not provided. There was no test set requiring expert ground truth establishment for performance evaluation in the context of this 510(k) summary.

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

• Not applicable / Not provided. No test set or expert 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

• No. This is a hearing aid, not an AI-driven diagnostic device or one that involves human "readers" interacting with an AI. No MRMC study or AI assistance is mentioned.

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

• No. This device is a hearing aid, which is a standalone device in its operation (it amplifies sound for the user). However, it's not an "algorithm only" in the sense of a software-based diagnostic tool, nor is "standalone performance" evaluated in the context of an algorithm's output vs. ground truth. Its "performance" is inherent to its function as a hearing aid.

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

• Not applicable / Not provided. No external "ground truth" for performance evaluation was used beyond the comparison to the existing predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not applicable / Not provided. This document is not describing an algorithm that requires a training set.

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

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

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