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The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing.

The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing.

The provided text is a 510(k) Pre-market Notification for the Danavox 163 / 162 BTE hearing aids. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving safety and effectiveness through a clinical trial with specific performance criteria.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria in the same way a de novo or PMA submission would.

Here's why and what information can be gleaned:

• Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is achieved by demonstrating that the new device has the same intended use and similar technological characteristics, or, if there are differences, that those differences do not raise new questions of safety or effectiveness.
• Performance Specifications: The document states that "The intended use, performance specifications, functions and operations of the Danavox 163 / 162 BTE are essentially identical to that described in the 510(k) Premarket Notification for the Danavox Aura." This implies the Danavox Aura's performance specifications serve as the de facto acceptance criteria. However, those specific criteria are not detailed in this document.

Information NOT present in the document:

• A table of acceptance criteria and reported device performance (for the 163/162 BTE specifically).
• Sample size for a test set or data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance (as this is a hardware device, not an AI/algorithm).
• Type of ground truth used (as there's no clinical study described).
• Sample size for a training set (as there's no machine learning/AI component).
• How ground truth for a training set was established.

Information that can be inferred or extracted (but not in the format requested):

While there are no explicit acceptance criteria or a study detailed in the document, the basis for market clearance is "substantial equivalence." The predicate device's performance specifications are implicitly the target.

Intended Use/Performance Description (from the document):

Summary of "Acceptance Criteria" and "Study" based on a 510(k) Submission:

Since this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating "substantial equivalence" to the predicate device, the Danavox Aura (K905692). The "study" proving this is effectively the comparison provided in the summary of safety and effectiveness, which highlights similarities in intended use, technological characteristics, and performance.

1. Table of Acceptance Criteria and Reported Device Performance: Such a table is not provided. The document states the performance specifications, functions, and operations are "essentially identical" to the predicate device. The only noted difference is memory capacity (3 programs vs. 4 for the predicate), which was deemed acceptable.
2. Sample Size and Data Provenance: Not applicable, as this is a comparison to a predicate device, not a new clinical study.
3. Number of Experts and Qualifications: Not applicable.
4. Adjudication Method: Not applicable.
5. MRMC Comparative Effectiveness Study: Not applicable (not an AI device).
6. Standalone Performance: The "standalone" performance is understood to be the inherent functionality of the hearing aid, which is asserted to be "essentially identical" to the predicate device. No new standalone performance study is detailed.
7. Type of Ground Truth: Not applicable. The "ground truth" for a 510(k) is the established safety and effectiveness of the legally marketed predicate device.
8. Sample Size for Training Set: Not applicable (not an AI device).
9. How Ground Truth for Training Set Was Established: Not applicable (not an AI device).

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The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):

Severity:
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

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® III Hearing System are essentially identical to that described in the 510(k) Premarket Notification for the Danavox Aura.
The ability to program digitally the fitting parameters of the hearing device is the same as in the Danavox Aura as is the ability to change the characteristics of the sound processing and adjust the volume.
The Audallion® III Hearing System has the ability to retain up to four programs in memory, iust as the predicate device.

The provided document is a 510(k) premarket notification for the Audallion® III Hearing System. It is a declaration of substantial equivalence to a predicate device, the Danavox Aura 510(k) No. K905692. This type of submission does not typically include a standalone study proving the device meets specific acceptance criteria in the way a clinical trial for a novel device would.

Instead, the submission relies on demonstrating that the Audallion® III Hearing System is substantially equivalent to a device that has already been cleared by the FDA. Therefore, the "acceptance criteria" here are met by showing that the new device shares the same intended use, performance specifications, functions, and operations as the predicate device.

Here's an analysis based on your request, highlighting what's present and what's absent due to the nature of a 510(k) substantial equivalence submission:

Acceptance Criteria and Device Performance for Audallion® III Hearing System

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the 510(k) summary. A substantial equivalence submission typically does not require new clinical or performance studies if the device is sufficiently similar to a predicate device. The "test set" in this context is the comparison against the specifications and features of the predicate device, not necessarily a new test set for the Audallion III.

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

This information is not provided. As explained above, the "ground truth" for a 510(k) is the established performance and safety of the predicate device, which has been previously cleared by the FDA. No new expert panel for establishing ground truth for the Audallion III is mentioned.

4. Adjudication method for the test set

This information is not provided. The comparison is a regulatory review process conducted by the FDA, assessing whether the new device falls within the scope of the predicate device's cleared status.

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

An MRMC study is not applicable and not mentioned. The Audallion® III Hearing System is an air-conduction hearing aid, not an AI-assisted diagnostic or interpretative system that would involve "human readers" in the context of an MRMC study.

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

This information is not applicable and not provided. The device is a hearing aid, which is a physical device that continuously processes sound for the wearer, not a standalone algorithm.

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

For a 510(k) submission, the "ground truth" is established by the prior FDA clearance and historical safety and effectiveness data of the predicate device, the Danavox Aura. The Audallion III is deemed safe and effective because it is substantially equivalent to a device already deemed safe and effective.

8. The sample size for the training set

This information is not applicable and not provided. As a hardware medical device submitting for 510(k) clearance based on substantial equivalence, there is no "training set" in the context of machine learning or AI algorithms used in the device's development as described in the document.

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

This information is not applicable and not provided. See point 8.

In summary: The provided document is a 510(k) premarket notification of intent to market based on substantial equivalence. It is not a clinical study report. Therefore, it focuses on demonstrating that the new device (Audallion® III) is essentially the same as a previously cleared device (Danavox Aura) in terms of intended use, technology, and performance specifications. The "acceptance criteria" are the features and performance of the predicate device, which the Audallion® III is claimed to match. This type of submission generally does not require new de novo clinical studies or detailed data analysis as would be expected for a novel device or an AI-powered diagnostic.

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