(126 days)
To amplify and transmit sound to the ear.
CIC, ITC and ITE Hearing Aids
The provided document is a Summary of Safety and Effectiveness for a 1997 Dahlberg hearing aid device. This type of document for a Class I device from 1997 does not contain the detailed clinical study information requested in your prompt.
Here's why and what information can be extracted:
- Class I Devices: Class I devices are typically low-risk and often exempt from extensive premarket clinical studies. The regulatory pathway (510(k)) focuses more on demonstrating substantial equivalence to a legally marketed predicate device rather than providing new clinical performance data from human trials.
- 1997 Document: Regulatory expectations and the level of detail required in 510(k) submissions were significantly different in 1997 compared to today, especially concerning clinical study design and performance metrics for AI/software devices.
- Device Type: This is a physical hearing aid, not an AI software or diagnostic device. The concepts of "ground truth," "expert consensus," "training set," "test set," "MRMC studies," and "AI assistance" are not applicable to this type of device described in this kind of document. The "performance data" mentioned in the document refers to acoustic performance standards (like ANSI S3.22-1987) rather than clinical accuracy for a diagnostic task.
Therefore, I cannot fulfill your request for: Acceptance Criteria Table, Sample Sizes, Expert Information, Adjudication, MRMC studies, Standalone Studies, Ground Truth Types for Test/Training, and Training Set Size/Ground Truth Establishment.
The provided document simply does not contain this information. It focuses on:
- Substantial Equivalence: The primary "acceptance criteria" here is demonstrating that the new device is substantially equivalent to a previously cleared predicate device (Miracle-Ear Sharp Plus, K935265).
- Technical Characteristics: Performance is assessed against industry standards for acoustic output, not diagnostic accuracy.
Here's what little can be inferred from the provided text, but it doesn't align with your prompt's specific requests about AI/diagnostic device evaluation:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implicit): Substantial equivalence to predicate device K935265. Meeting ANSI S3.22-1987 methodology for acoustic performance.
- Reported Device Performance: "Dahlberg utilizes the ANSI S3.22-1987 methodology to test and obtain performance data for hearing aids." (Specific performance values like gain, frequency response, output are not provided in this summary, but would have been in the full submission).
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. This document does not describe a clinical "test set" in the context of diagnostic accuracy. Performance "testing" refers to acoustic measurements in a lab, not human trials.
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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 / Not provided. There is no "ground truth" established by experts for this type of device in this context.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
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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 / Not provided. This device is a hearing aid, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided.
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The sample size for the training set
- Not applicable / Not provided.
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How the ground truth for the training set was established
- Not applicable / Not provided.
§ 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.