(50 days)
To amplify and deliver sound to the ear
DigiFocus Compact (DFC) is a seven band, two channel fully automatic hearing instrument which utilizes true digital signal processing (DSP). True DSP allows for precise, seven band frequency shaping and a unique and complex compression system utilizing syllabic compression in the lower frequency channel (below 1500Hz) and nonsyllabic compression in the higher frequency channel (above 1500Hz). 54 dB HFA gain. Assembled from standard electronic hearing aid components mounted together with custom microchips on flexfilm. Technical specifications are in accordance with ANSI Standards S3.22-1987. Frequency response, compression threshold and ratio, gain and SSPL 90 is dictated by individual audiometric and patient history data. All parameters are digitally programmed via software. The hearing aid has a manual OTM switch. Standard type 13 battery.
This document is a 510(k) summary for a hearing aid, not a study describing the acceptance criteria and performance of an AI/ML device. Therefore, much of the requested information regarding AI/ML study specifics (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or cannot be extracted from the provided text.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technical specifications in accordance with ANSI Standards S3.22-1987 | Technical specifications are in accordance with ANSI Standards S3.22-1987 |
| Amplifies and delivers sound to the ear | Intended Use: To amplify and deliver sound to the ear |
| Features: Seven band, two channel fully automatic hearing instrument utilizing true digital signal processing (DSP); precise, seven-band frequency shaping; unique and complex compression system (syllabic below 1500Hz, non-syllabic above 1500Hz); 54 dB HFA gain. |
Study that proves the device meets the acceptance criteria:
The document states: "Technical specifications are in accordance with ANSI Standards S3.22-1987." This implies that the device was tested against these industry standards. However, no specific study details are provided within this summary for how this compliance was proven. It can be inferred that standard audiological testing and measurements were performed to verify performance against ANSI S3.22-1987, as this is typical for hearing aid clearance.
Regarding the AI/ML specific questions:
- 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. This is a traditional medical device (hearing aid), not an AI/ML device in the context of diagnostic or prognostic algorithms.
- 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. Ground truth for a hearing aid's technical specifications is typically based on objective measurements and established standards (like ANSI).
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
- 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.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device would be its objective technical performance as measured against established audiological standards (ANSI S3.22-1987).
- 8. The sample size for the training set
- Not applicable.
- 9. How the ground truth for the training set was established
- Not applicable.
In summary, the provided document is a 510(k) summary for a conventional hearing aid, not an AI/ML powered device. Therefore, most of the detailed questions pertaining to AI/ML study design are not applicable to this submission. The "study" proving the device meets acceptance criteria is an implicit reference to testing against ANSI Standards S3.22-1987, but no details of such a study are provided.
§ 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.