(60 days)
To amplify and transmit sound to the ear.
The Rexton Long Life Rx-12 is a full shell hearing aid utilizing a 675 battery and a low drain class D circuit. The combination of these to unique features gives the Rexton Long Life the ease of battery handling (a large 675 battery) and the benifits of extended battery life. These two features should make for a special product with-in the industry. Assembled from standard components which are widely utilized by other hearing aid manufacturers.
This document describes a hearing aid device and focuses on its features and technical characteristics rather than providing details on a study proving its acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted.
However, based on the provided text, we can infer some information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner or present reported device performance against such criteria. It highlights features and technical characteristics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated | Not explicitly stated |
| Inferred: Easy battery handling (due to large 675 battery) | Rexton Long Life Rx-12 utilizes a large 675 battery for ease of battery handling. |
| Inferred: Extended battery life (due to low drain class D circuit) | Rexton Long Life Rx-12 uses a low drain class D circuit for extended battery life. |
| Inferred: Sound amplification and transmission | Intended Use: To amplify and transmit sound to the ear. |
| Inferred: Compliance with sound specifications | Technical specifications were obtained in accordance with S3.22-1987 ANSI Specifications. |
Missing Information: Quantitative acceptance criteria (e.g., specific battery life duration, sound amplification levels, distortion limits) and numerical performance data are not provided in the text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document describes the device's features and technical characteristics, but no details about a test set or its provenance are mentioned.
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)
This information is not available in the provided text. The document does not describe any study involving experts to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. No details about a test set or its adjudication are mentioned.
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
This information is not available in the provided text. The device is a hearing aid, not an AI-assisted diagnostic tool, so an MRMC study in this context is unlikely to be relevant to this specific product description.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available in the provided text. The device is a hearing aid, which by its nature is a human-in-the-loop device. No standalone algorithm performance is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not available in the provided text. No ground truth is discussed as there is no description of a study for verifying performance against a criterion.
8. The sample size for the training set
This information is not available in the provided text. The document does not describe any training or machine learning component.
9. How the ground truth for the training set was established
This information is not available in the provided text. No ground truth or training set is mentioned.
§ 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.