(37 days)
To amplify and transmit sound to the ear.
Dahlberg Hearing Aid with multi-channel compression circuit
This document focuses on the Dahlberg Hearing Aid with multi-channel compression circuit and appears to be a summary of safety and effectiveness, likely for regulatory submission (e.g., to the FDA for a 510(k) clearance, given the "K960804" and "K954941" document control numbers).
Based on the provided information, it's clear this is not a study describing the performance of an AI/ML-driven device or an imaging diagnostic tool. Instead, it describes a conventional medical device (a hearing aid) and its technical specifications and regulatory classification.
Therefore, many of the requested categories for AI/ML performance studies are not applicable to this document. I will fill in the applicable information and indicate "N/A" (Not Applicable) for the others.
1. A table of acceptance criteria and the reported device performance
Based on the provided document, explicit "acceptance criteria" related to specific performance metrics (like sensitivity, specificity, or accuracy for an AI system) and corresponding "reported device performance" are not detailed in this summary. The document states: "Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids." This implies that the device's performance is measured against the standards outlined in ANSI S3.22-1987, but the specific values of that performance or the acceptance thresholds are not present in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Adherence to ANSI S3.22-1987 methodology for performance testing | Performance data collected via ANSI S3.22-1987 methodology |
| Safe and Effective (implied by regulatory submission) | Not explicitly quantified in this summary |
| Substantially equivalent to predicate device K954941 | Claimed substantial equivalence |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
N/A. This document describes a hearing aid, not a data-driven device tested on a dataset. Performance testing likely involves laboratory measurements against standards rather than a "test set" of patient data in the AI/ML sense.
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)
N/A. This is not an AI/ML diagnostic device requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. This is not an AI/ML diagnostic device requiring adjudication.
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
N/A. This is a standalone medical device (hearing aid), not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone device, but not in the context of an "algorithm only" performance. The device itself is designed to function independently of human intervention during its operation (once fitted), amplifying and transmitting sound. Performance would be assessed through audiological and technical measurements as per ANSI standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
N/A. For a hearing aid, "ground truth" would relate to its physical and acoustic performance characteristics measured against established engineering and audiological standards (e.g., ANSI S3.22-1987). It's not about diagnostic accuracy against an independent clinical truth.
8. The sample size for the training set
N/A. Hearing aids are designed and manufactured using established engineering principles. There isn't a "training set" in the machine learning sense for such a device. Initial design and development would involve testing prototypes, but this isn't data-driven training.
9. How the ground truth for the training set was established
N/A. As there is no "training set" in the AI/ML context, this question is not applicable.
§ 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.