(60 days)
The indication for use of the air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following categories : Severity : Slight , Mild , Moderate . . . . . . . Configuration : High Frequency Precipitously Sloping , Gradual Sloping Reverse Slope , Flat
Air Conduction Hearing Aid. To amplify and transmit sound to the ear. Features: Volume Control. On/Off switch built into Volume Control. Assembly: Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical Characteristics: Technical specifications were obtained in accordance with S3.22-1987 ANSI Specifications. Preliminary data sheets for the SP models are enclosed. Fit: The frequency response of this product is dictated by the individual audiogram from each client. Power: Standard hearing aid battery #312.
This document describes a 510(k) premarket notification for the Scientific Plastics Model SP ITC Hearing Aid, which is an air conduction hearing aid. The information provided heavily focuses on regulatory approval based on substantial equivalence, rather than detailed performance studies with acceptance criteria as might be expected for a novel AI/software-based medical device.
Therefore, many of the requested sections (e.g., sample sizes, ground truth establishment, MRMC studies) are not applicable or cannot be extracted from the provided text, as this is a traditional medical device approval based on established standards and substantial equivalence to predicate devices, not a study evaluating an AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Indication | To amplify sound for individuals with impaired hearing, specifically for losses in categories: Slight, Mild, Moderate, and configurations: High Frequency Precipitously Sloping, Gradual Sloping, Reverse Slope, Flat. This is based on the substantial equivalence to predicate devices for these indications. | The device is intended for and described as meeting these indications. The FDA's substantial equivalence determination implies it meets the performance characteristics of predicate devices for these uses. |
| **Technical | ||
| Characteristics** | Compliance with S3.22-1987 ANSI Specifications. | Technical specifications were obtained in accordance with S3.22-1987 ANSI Specifications. Preliminary data sheets for the SP models are enclosed (not provided in this excerpt). |
| **Safety and | ||
| Effectiveness** | Substantial equivalence to devices marketed prior to May 28, 1976, or reclassified devices, under the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). This implies it meets the safety and effectiveness profile of legally marketed predicate devices. Compliance with Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820). | The FDA determined the device is substantially equivalent for the stated indications, subject to general controls and GMP compliance. |
| **Electromagnetic | ||
| Compatibility (EMC)** | No explicit acceptance criteria provided in this document as it was not a requirement at the time of initial approval. However, the FDA notes it may be a future consideration. | The FDA advises that electromagnetic interference from digital cellular telephones and other sources is a concern and encourages labeling modification to inform users. A 510(k) submission would be required for any claims of compatibility. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document pertains to a traditional medical device (hearing aid) and its regulatory clearance based on substantial equivalence to predicate devices, not a performance study of an AI algorithm with a test set. There is no mention of a "test set" in the context of an algorithmic evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. See point 2. The "ground truth" for this device's performance is established by its adherence to ANSI standards and its equivalence to established predicate devices, rather than an expert panel adjudicating results from a test set.
4. Adjudication Method for the Test Set
Not applicable. See point 2 and 3.
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
Not applicable. This device is a hearing aid, not an AI-assisted diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant to this type of device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical hearing aid. It is inherently a "human-in-the-loop" device as it amplifies sound for a human wearer. There is no standalone algorithm in this context.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established performance and safety profiles of legally marketed predicate hearing aids, coupled with compliance to technical specifications (e.g., ANSI S3.22-1987) for the physical device characteristics (e.g., frequency response, amplification). The FDA's determination of "substantial equivalence" is the primary mechanism of "ground truthing" here.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
§ 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.