(19 days)
To amplify and transmit sound via air conduction to the ear.
Behind-The-Ear Hearing Aid. Substantially equivalent to other behind-the-ear hearing aids.
The provided document "K964511" is a 510(k) Premarket Notification for a hearing aid, dated November 27, 1996. This type of document is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device.
Critically, this document is a summary of safety and effectiveness information, not a detailed study report with specific acceptance criteria and performance data in the format requested. It focuses on demonstrating substantial equivalence to existing devices rather than presenting the results of a comprehensive study with quantitative performance metrics against predefined acceptance criteria for a novel AI/software-as-a-medical-device (SaMD) product.
Therefore, for the given input, most of the requested information cannot be extracted because it describes a hearing aid and not a software device that typically undergoes the kind of performance evaluation outlined in your request (e.g., AI performance metrics, ground truth establishment, expert adjudication, MRMC studies).
Here's an analysis of what can be inferred or stated about the provided document in relation to your request:
Analysis of K964511 within the context of your request:
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A table of acceptance criteria and the reported device performance:
- Cannot be created. The document lists "Technical Characteristics" that "comply with ANSI Standard S 3.22-1987," but it does not provide specific numerical acceptance criteria (e.g., minimum gain, maximum distortion) and then report actual measured device performance against those criteria. It's a statement of compliance, not a detailed performance report.
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Sample size used for the test set and the data provenance:
- Not applicable/Not mentioned. This document does not describe a "test set" in the context of evaluating an algorithm or AI. It's about a physical hearing aid.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. Ground truth establishment is typically for diagnostic/screening algorithms. This document doesn't involve that.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned.
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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. This device is a hearing aid, not an AI-powered diagnostic tool requiring human reader studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. This concept does not apply to a hearing aid's safety and effectiveness demonstration in this context. The "ground truth" for a hearing aid's basic function might be its physical performance characteristics measured against standards, but this is not the "ground truth" concept you're asking about.
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The sample size for the training set:
- Not applicable/Not mentioned. This information pertains to machine learning model development, which is not relevant to this 1996 hearing aid submission.
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How the ground truth for the training set was established:
- Not applicable/Not mentioned.
Summary specific to K964511:
The document K964511 for the Unitron Industries Sound F/XD hearing aid is a 510(k) Premarket Notification submitted in 1996. It aims to demonstrate substantial equivalence to existing, legally marketed Behind-The-Ear (BTE) hearing aids, rather than presenting a performance study against specific acceptance criteria for a novel device or AI.
The "acceptance criteria" for a 510(k) submission like this are generally satisfied by:
- Intended Use: Being the same as predicate devices ("To amplify and transmit sound via air conduction to the ear.").
- Technological Characteristics: Being "substantially equivalent" to predicate devices and complying with recognized standards (e.g., "Technical specifications comply with ANSI Standard S 3.22-1987"). The document states features like two-channel compression, Class D circuitry, telecoil, and directional microphone, implying these features are standard or comparable to devices on the market at the time.
- Safety and Effectiveness: Inferring from substantial equivalence that the device is as safe and effective as predicate devices.
No specific study with performance metrics against numerical acceptance criteria, as requested in your prompt, is described in this summary. The document's purpose is to summarize safety and effectiveness through equivalence, not to detail a novel performance study.
§ 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.