(80 days)
A. General Indications: The indication for use of the air conduction hearing aids in this submission is to amplify some indicated for individuals with impaired hearing. The devices are indicated for individuals with losses in hearing. The devices are indicated for individuals with losses in hearing. The devices are indicated as and can and
Severity:
X 1. Slight
X 2. Mild
X 3. Moderate
X 4. Severe
5. Profound
Configuration:
X 1. High Frequency - Precipitously Sloping
X 2. Gradually Sloping
X 3. Reverse Slope
X 4. Flat
5. Other
Other
X 1. Low tolerance To Loudness
2.
3.
B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
1.
2.
3.
Not Found
This looks like a 510(k) clearance letter for a hearing aid, not a document describing a clinical study with acceptance criteria and performance data as typically provided for AI/ML-based medical devices.
Therefore, I cannot extract the requested information about acceptance criteria, device performance, study design, expert ground truth, or MRMC studies. This document is a regulatory approval notice, confirming substantial equivalence to a predicate device, and includes general indications for use, but no specific performance study details are present here.
To directly address the prompts based on the lack of this information in the provided text:
- A table of acceptance criteria and the reported device performance: Not provided in this document. This is a 510(k) clearance letter, not a performance study report.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in this document.
- 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 provided in this document.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in this document.
- 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 provided in this document. This device is a hearing aid, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hearing aid, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in this document.
- The sample size for the training set: Not applicable; this is a hardware device, not an AI/ML model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.