(19 days)
To amplify and transmit sound via air conduction to the ear.
Behind-The-Ear Hearing Aids. Four fitter controls Power, Compression Limiting, active low cut tone, high cut tone. Class D circuitry for excellent battery life. Powerful telecoil with preamplifier. Assembled from standard components that are used by Unitron and other hearing aid manufacturers. Technical specifications comply with ANSI Standard S 3.22-1987. Volume control, similar to other devices. Switch for selecting microphone, telecoil and off. Standard hearing aid battery size 13.
The provided document "K9644504" is a 510(k) summary for a Unitron Industries ICON AoHPL +4 Behind-The-Ear Hearing Aid, dated November 27, 1996. This document is a premarket notification to the FDA, demonstrating that the device is "substantially equivalent" to legally marketed predicate devices.
Crucially, this document does not describe a study with acceptance criteria and reported device performance in the way a modern AI/ML device submission would. In 1996, and for this type of medical device (a hearing aid), the regulatory pathway focused on demonstrating substantial equivalence to existing devices, primarily through descriptive technical characteristics and compliance with established industry standards, rather than robust clinical trials with detailed performance metrics against acceptance criteria.
Therefore, I cannot provide the information requested in your numbered list directly from this document, as those types of studies and performance metrics were not required or reported in this format for this specific device at that time.
Here's an explanation of why the requested information cannot be extracted and what can be inferred from the document:
Why the requested information cannot be directly extracted from K9644504:
This document is focused on establishing substantial equivalence to predicate devices. For a hearing aid in 1996, this typically involved:
- Description of Intended Use: Matched that of predicate devices.
- Technological Characteristics: Showed that the device was similar in design, materials, and operation to predicate devices, or that any differences did not raise new questions of safety and effectiveness.
- Compliance with Recognized Standards: Meeting industry standards like ANSI S3.22-1987 was a key part of demonstrating safety and effectiveness.
It did not require or report:
- Clinical Performance Studies: No trials with human subjects to measure sensitivity, specificity, accuracy, or other performance metrics against specific acceptance criteria.
- AI/ML Specifics: No algorithms, training sets, test sets, or ground truth establishment as this is not an AI/ML device.
- Expert Consensus or Adjudication: These methods are used for establishing ground truth, typically in image analysis or diagnostic AI, which is not relevant here.
- Multi-Reader Multi-Case (MRMC) Studies: These are for evaluating human reader performance, usually with diagnostic tools, not for basic amplification devices.
What can be extracted or inferred from the document regarding "acceptance" in its historical context:
The "acceptance criteria" in the context of this 1996 510(k) are implicitly:
- Safety and Effectiveness: Demonstrate that the device is as safe and effective as a legally marketed predicate device.
- Compliance with Standards: Meet the specifications of recognized industry standards.
- No New Questions of Safety and Effectiveness: Any technological differences compared to predicate devices do not raise new concerns.
The "study that proves the device meets the acceptance criteria" is the entirety of the 510(k) submission itself, where the manufacturer presents evidence (primarily descriptive comparison and standards compliance) that these implicit criteria are met.
Here's a breakdown of the requested points, with "N/A" for elements not present in the document and explanations where applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by 510(k) process in 1996) | Reported Device Performance (as per document inferenced) |
|---|---|
| Substantial Equivalence to Predicate Device | Stated: "Substantially equivalent to other behind-the-ear hearing aids." (Implies similar intended use, technology, and performance profile as predicate devices). |
| Intended Use Match | Stated: "To amplify and transmit sound via air conduction to the ear." (Matches standard hearing aid intended use). |
| Technical Characteristics Compliance with Standards | Stated: "Technical specifications comply with ANSI Technical Standard S 3.22-1987." (This is the primary "performance" metric reported in this context). |
| Safety and Effectiveness Similar to Predicates | Implied by "substantial equivalence" claim; no new safety/effectiveness concerns raised by features/design. |
| Standard Components/Assembly | Stated: "Assembled from standard components that are used by Unitron and other hearing aid manufacturers." (Contributes to presumed safety and reliability). |
| Fitter Controls/Features | Listed: "Four fitter controls Power, Compression Limiting, active low cut tone, high cut tone. Class D circuitry... Powerful telecoil with preamplifier." |
| User Controls | Listed: "Volume control... Switch for selecting microphone, telecoil and off." |
| Power Source | Stated: "Standard hearing aid battery size 13." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This document does not describe a test set or any clinical data. It is a technical description and comparison.
3. 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)
- N/A. No ground truth was established for a test set described in this document. The "ground truth" for regulatory clearance was conformance to industry standards and similarity to existing devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set or human adjudication was involved or described for this device's clearance.
5. 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
- N/A. This device is a hearing aid, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an algorithm-based device. Its "performance" is its ability to amplify sound according to its design specifications (which includes features like compression limiting, tone controls), and this was largely demonstrated by compliance with ANSI standards, not standalone algorithmic evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A (in the modern sense). The "ground truth" for this submission was implicitly:
- ANSI S 3.22-1987 Standard: The device's technical specifications met or conformed to this recognized industry standard for hearing aid characteristics.
- Predicate Device Characteristics: The device's features, intended use, and general technology were demonstrably equivalent to legally marketed hearing aids.
8. The sample size for the training set
- N/A. There is no training set for this type of device.
9. How the ground truth for the training set was established
- N/A. There is no training set for this type of device.
In summary, the provided document reflects a regulatory submission from a different era and for a different type of medical device than what your questions implicitly assume (i.e., a modern AI/ML diagnostic tool). The "acceptance criteria" and "proof" were centered around substantial equivalence and compliance with established engineering standards.
§ 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.