(67 days)
To amplify and transmit sound to the ear.
Dahlberg Hearing Aid with multi-channel compression circuit
This document is a 510(k) summary for a Dahlberg Hearing Aid. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K964530) rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics typically seen for AI/ML or new clinical diagnostic devices.
Therefore, many of the requested categories are not applicable or cannot be extracted from the provided text. I will provide what information is available and indicate where information is missing or not relevant to this type of submission.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the "acceptance criteria" for a 510(k) submission like this are generally demonstrating substantial equivalence to a predicate device. The performance data is primarily technical and measured against industry standards rather than clinical outcomes.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Technical Equivalence to Predicate Device: | |
| - Identical intended use | Met: "To amplify and transmit sound to the ear." |
| - Similar technological characteristics | Met: "Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids." |
| - Similar materials | Met: "The hearing aid shells will be manufactured from materials that are commonly used in the industry." |
| - Similar assembly methods | Met: "The hearing aid will be assembled utilizing similar assembly practices as Dahlberg's current products." |
| Any differences do not raise new questions of safety and effectiveness. | (Implied by FDA clearance) |
Note: The document does not provide specific numerical performance data (e.g., gain, frequency response curves) but states that the methodology used is ANSI S3.22-1987, which is a standard for hearing aid measurement.
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. This 510(k) summary does not describe a clinical study with a "test set" of patient data. The evaluation for this type of device is primarily based on technical specifications and 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. No clinical ground truth establishment is described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided. No clinical test set or 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
- Not Applicable/Not Provided. This device is a hearing aid, not an AI/ML diagnostic tool, so an MRMC study related to human reader performance with AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable/Not Provided. This is a physical medical device (hearing aid), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Not Provided (for clinical ground truth). The "ground truth" equivalent in this context is the adherence to ANSI S3.22-1987 standards for electroacoustic performance and the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not Applicable/Not Provided. No "training set" in the context of AI/ML is relevant to this submission.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided. No training set or associated ground truth establishment is relevant to this submission.
§ 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.