(47 days)
to amplify and transmit sound to the ear.
assembled from standard components that are widely used by other hearing aid manufacturers.
Here's an analysis of the provided text regarding acceptance criteria and supporting study information:
Based on the provided 510(k) summary, there is no information about acceptance criteria and a study proving a device meets acceptance criteria in the way typically expected for an AI/diagnostic device submission.
This document describes a traditional medical device (an FM at-the-ear auditory trainer) and focuses on describing its features, intended use, and comparison to predicate devices, particularly in relation to technical specifications and standards.
Therefore, I will extract and present the available relevant information, and explicitly state where information requested in your prompt is not present.
Device Name: Telex Select 2-40 with Adaptive Compression® (FM at-the-ear Auditory Trainer)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Technical specifications comply with S3.2-1987 ANSI standards. | "technical specifications comply with S3.2-1987 ANSI standards." |
| Frequency response per S3.2-1987 ANSI standard. | "frequency response per S3.2-1987 ANSI standard as shown on specification filed with 510(k)." |
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 document does not describe performance testing against a "test set" in the context of an AI/diagnostic device. The compliance mentioned is against established technical standards for audio devices.
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. There is no "ground truth" establishment described, as this is a device complying with technical performance standards, not interpreting clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication method 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. This is not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device, not an algorithm. Performance is assessed against technical standards rather than human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" for this device's performance is adherence to the S3.2-1987 ANSI standard for hearing aids. This is a technical standard, not clinical ground truth derived from expert consensus, pathology, or outcomes.
8. The sample size for the training set
- Not applicable. This device does not have a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. No training set is described.
Summary of available "study" information:
The "study" or justification for this device primarily relies on its compliance with the S3.2-1987 ANSI standard for hearing aids. This standard defines technical specifications for frequency response and other operational characteristics. The manufacturer states that the device's technical specifications and frequency response comply with this standard, as detailed in a separate specification filed with the 510(k). This is a declaration of adherence to established engineering and performance benchmarks, rather than a clinical trial or AI performance study.
§ 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.