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The Lyric Hearing Aid is a disposable, extended-wear, air conduction hearing aid, designed to be used and worn by hearing-impaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an appropriately trained ENT Physician, Audiologist or Hearing Aid Dispenser and can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal the hearing aid is discarded.

The Lyric Hearing Aid amplifies and delivers sounds via air conduction to the external ear of persons with hearing loss. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. The amplification characteristics are contained in digitally programmable memory and adjustment of device parameters is achieved through the proprietary HandFit™ Fitting System and Software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Lyric Hearing Aid:

The provided document, a 510(k) summary for the Lyric Hearing Aid, is quite limited in the type of information typically found in a detailed performance study report. It primarily focuses on establishing substantial equivalence to predicate devices and states that the device meets internal specifications.

Here's an attempt to extract the requested information, with notes on what is not available in the given text:

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)

• Sample Size: Not specified. The document states "The devices met all applicable specifications," but does not provide details on how many devices were tested or how many users were involved in any performance evaluations.
• Data Provenance: Not specified. It's unclear if the testing was done internally at Insound Medical, by a third party, or if it involved human subjects. The type of study (retrospective or prospective) is also not mentioned.

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)

• Number of Experts: Not applicable or not specified. This type of information is typically relevant for studies using expert assessment as a ground truth, often clinical trials or image interpretation studies. For a hearing aid, performance is often measured objectively against standards.
• Qualifications of Experts: Not applicable or not specified.

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

• Adjudication Method: Not applicable or not specified. Adjudication methods are typically used when multiple experts are determining a ground truth for qualitative assessments. The performance evaluation here appears to refer to objective measurements against a standard.

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

• MRMC Study: No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant to this submission. The device is a hearing aid.
• Effect Size: Not applicable.

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

• Standalone Performance: Yes, implicitly. The performance evaluation against ANSI S3.22-2003 and Insound Medical's design specifications would be considered standalone performance testing of the device itself, separate from its use by an individual. However, the exact methodology is not detailed.

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

• Type of Ground Truth: The "ground truth" for this device's performance is based on objective measurements against established engineering standards (ANSI S3.22-2003) and the manufacturer's own design input specifications. It is not based on expert consensus, pathology, or patient outcomes in the sense of a clinical trial proving efficacy for a disease. The efficacy of hearing aids in general for hearing loss is well-established, and this submission focuses on the device meeting performance requirements.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a hardware product that amplifies sound; it does not involve machine learning algorithms that require a training set.

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

• Ground Truth for Training Set: Not applicable. As there is no training set for an AI/ML algorithm.

Summary of Limitations in the Provided Document:

The provided 510(k) summary is very concise and primarily aims to establish substantial equivalence. It does not contain the detailed performance study information (e.g., number of subjects, detailed methodology, specific quantitative results) that would typically be found in a full study report or a more comprehensive technical summary for a device with complex clinical endpoints or AI components. The performance data section is brief, stating compliance with an industry standard and internal specifications, without elaborating on the specific tests, results, or conditions.

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The InSound XT Hearing Aid is a disposable, extendedwear, air conduction hearing aid, designed to be used and worn by hearingimpaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an ENT physician and it can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal, the hearing aid is discarded.

The InSound XT Series Hearing Device amplifies and delivers sounds via air conduction to the external ear of persons with hearing loss. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. The hearing device is extendedwear (up to 4 months) and disposable. It is placed deep in the ear canal by an ENT physician. The amplification characteristics are contained in digitally programmable memory and adjustment of device parameters is achieved through the proprietary HandFit™ Fitting System and Software.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size for the clinical trials or "test set." It only mentions "human subjects." The data provenance is described as "clinical trials" which are typically prospective studies. The country of origin of the data is not explicitly stated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical trials. It does mention that the device is "placed deep in the ear canal by an ENT physician," suggesting that ENT physicians would be involved in the clinical setting and potentially in evaluating the device's performance and comfort.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set or clinical trials.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text, nor is there any discussion of an effect size for human readers improving with AI vs. without AI assistance. This is a hearing aid device, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm only) performance study was done as this is a physical medical device (hearing aid), not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth for the clinical trials appears to be based on:

• Clinical observations and subject feedback: Assessed comfort, safety, and efficacy during extended wear.
• Hearing aid verification battery: Demonstrated user benefit during extended wear.
• Compliance with ANSI standards: Performance characteristics were evaluated against established engineering specifications.

8. Sample Size for the Training Set

The document does not mention a separate "training set" or its sample size. The clinical trials described appear to serve as the evidence for efficacy and safety.

9. How the Ground Truth for the Training Set was Established

As no separate training set is explicitly mentioned, the establishment of ground truth would refer to how the clinical trial outcomes were determined, as described in point 7.

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