(24 days)
To amplify and transmit sound to the ear.
Dahlberg K-AMP BTE
This document is a Summary of Safety and Effectiveness for the Dahlberg K-AMP BTE hearing aid, submitted as part of a 510(k) premarket notification (K964794). This type of document is filed with the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
Based on the provided text, the available information is insufficient to address most of your specific questions regarding acceptance criteria and studies proving device performance. The document is a high-level summary and does not contain the detailed study information you are requesting.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets performance standards based on ANSI S3.22-1987 methodology | Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids. |
| Substantial Equivalence to Predicate Device (K954941) | Substantially Equivalent to Miracle-Ear K-AMP Circuits which was cleared for distribution under document control number K954941. |
| Materials commonly used in the industry | The hearing aid cases will be manufactured from materials that are commonly used in the industry. |
| Similar assembly practices to current products | The hearing aid will be assembled utilizing similar assembly practices as Dahlberg's current products. |
Explanation: The document explicitly states that Dahlberg uses the ANSI S3.22-1987 methodology for testing. For a hearing aid, this standard defines methods for measuring acoustic performance characteristics such as gain, frequency response, distortion, equivalent input noise, etc. The "acceptance criteria" would be compliance with certain thresholds or ranges within this standard, or demonstrating performance comparable to the predicate device according to these measurements. However, the specific numerical acceptance criteria (e.g., "THD must be less than X%") and the actual measured performance data (e.g., "THD was Y%") are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The summary does not mention any specific clinical or performance studies with test sets, sample sizes, or data provenance. The focus is on demonstrating substantial equivalence through technical characteristics and a comparison to a predicate device.
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. This type of information is typically relevant for diagnostic devices or AI algorithms where expert consensus establishes a "ground truth" for a specific condition. For a hearing aid like this, performance is measured objectively against acoustic standards (like ANSI S3.22-1987) rather than by expert interpretation of images or patient data to establish a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. See explanation for #3.
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/Not provided. This is a hearing aid, not a diagnostic AI system intended to assist human readers. Therefore, an MRMC study is not relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not provided. This is a hardware device (hearing aid), not a standalone algorithm. Its performance is measured directly by how it amplifies sound.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Objective Acoustic Measurements / Compliance with ANSI S3.22-1987. For a hearing aid, the "ground truth" would be the objective physical characteristics and acoustic performance measurements (e.g., frequency response, maximum output, distortion levels) as defined by the ANSI standard. This is not "expert consensus" in the diagnostic sense, but rather adherence to engineering and performance specifications.
8. The sample size for the training set
- Not applicable/Not provided. Hearing aids are traditionally designed and manufactured based on acoustic engineering principles, not "trained" on data sets in the way AI algorithms are.
9. How the ground truth for the training set was established
- Not applicable/Not provided. See explanation for #8.
In summary, the provided document explicitly states that the device's performance data is obtained through the ANSI S3.22-1987 methodology and that it is substantially equivalent to a predicate device (K954941). However, the specific numerical results of these tests and detailed clinical study information are not within this high-level "Summary of Safety and Effectiveness." To find that level of detail, one would typically need to review the full 510(k) submission or associated technical reports, which are not included here.
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.