(57 days)
To obtain accurate imprint of an individual on ear Canal.
Not Found
This is a 510(k) summary document from the FDA, which focuses on regulatory clearance for a device (Hyunjae Corporation Nusil Earmold Impression Material) as substantially equivalent to a predicate device. It does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the format requested.
Specifically, the document primarily addresses:
- Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed devices.
- Regulatory Class: The device is classified as Class I (21 CFR 874.3300/Procode: 77 ESD).
- Indications For Use: "To obtain accurate imprint of an individual on ear Canal."
- General Controls: Mentions general controls provisions of the Act (annual registration, listing, GMP, labeling, etc.).
The information requested in your numbered list (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is part of a performance study report or clinical trial summary, which is not provided in this 510(k) clearance letter. This type of FDA letter typically refers to the fact that the applicant submitted data to support substantial equivalence, but it does not detail the performance study results, acceptance criteria, or ground truth methodology.
§ 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.