(197 days)
The intended use of these models is to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for impaired hearing.
Descriptions of the device functions, scientific concepts, and physical and performance characteristics of the above-mentioned Intrastar models are set forth in Attachments 1 and 2.
The provided text is a 510(k) summary for a pre-wired faceplate for in-the-ear hearing aids. It describes the device, its intended use, and compares its technical characteristics to two predicate devices. However, this document does not contain information about:
- Acceptance criteria in the context of a clinical study or performance evaluation.
- A specific study designed to prove the device meets acceptance criteria.
- Sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are typically associated with studies evaluating diagnostic or AI-driven devices.
- Training set details.
The document primarily focuses on establishing substantial equivalence to predicate devices based on technical specifications. Therefore, I cannot extract the requested information.
§ 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.