Search Results

A. General Indications: The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: ✓ 1. Slight ✓ 2. Mild ✓ 3. Moderate ✓ 4. Severe Configuration: ✓ 1. High Frequency - Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope ✓ 4. Flat
B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)

ITE Hearing Aid - substantially equivalent to other in-the-ear (ITE) hearing aids. Features: 675 Long Life battery using a 675 size battery pill in an ITE Hearing Aid, with Class D battery size gives the benefit of extended battery life for this style of hearing instrument. 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 Vista V-12 Long Life models are enclosed Fit: The frequency response of this product is dictated by the individual audiogram from each client. Power: Standard 675 size hearing aid battery. A user's manual and other information is supplied with each hearing aid.

This document is a 510(k) premarket notification for a hearing aid, not a study report. It states that the device is "substantially equivalent" to previously marketed devices and does not contain detailed information about acceptance criteria or a study proving that the device meets those criteria.

Therefore, most of the requested information cannot be extracted from the provided text. The document is primarily focused on regulatory approval based on demonstrating equivalence to existing devices, rather than presenting a novel clinical study with acceptance criteria and a test set.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document does not define specific "acceptance criteria" for performance that would be typically found in a clinical study. Instead, it relies on substantiating equivalence to existing hearing aids.
• Reported Device Performance: The technical characteristics section mentions "Technical specifications were obtained in accordance with S3.22-1987 ANSI Specifications" and "Preliminary data sheets for the Vista V-12 Long Life models are enclosed." However, the actual performance data from these specifications/data sheets are not provided in the text. The primary performance claim is "extended battery life for this style of hearing instrument."

2. Sample size used for the test set and the data provenance

• Cannot be provided. There is no mention of a "test set" or clinical study with a specific sample size. The approval is based on substantial equivalence, not a new clinical trial dataset for this specific device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Cannot be provided. This information is relevant for studies that establish ground truth, which is not the case here.

4. Adjudication method for the test set

• Cannot be provided. This information is relevant for studies that involve expert review and adjudication, which is not described.

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

• Cannot be provided. This device is a hearing aid, not an AI-powered diagnostic tool, and no MRMC study or AI component is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be provided. This device is a hearing aid, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be provided. The concept of "ground truth" as it pertains to diagnostic accuracy studies is not applicable here. The "truth" in this regulatory context is the established safety and effectiveness of predicate devices, to which this device is deemed equivalent.

8. The sample size for the training set

• Cannot be provided. This information is relevant for machine learning algorithms, which are not described here.

9. How the ground truth for the training set was established

• Cannot be provided. This information is relevant for machine learning algorithms, which are not described here.

Summary based on the provided text:

The provided document is a 510(k) Premarket Notification for a hearing aid. The device, "Vista V-12 Long Life 675 Class D," is deemed "substantially equivalent" to other in-the-ear (ITE) hearing aids marketed prior to May 28, 1976. The basis for this equivalence is outlined in the "Summary of Safety and Effectiveness Information" and refers to:

• Intended Use: To amplify and transmit sound to the ear.
• Features: 675 Long Life battery, 675 size battery pill, Class D battery size for extended battery life.
• Assembly: Standard components widely utilized by other manufacturers.
• Technical Characteristics: Obtained in accordance with S3.22-1987 ANSI Specifications. Preliminary data sheets were enclosed, but their contents are not provided.
• Indications for Use: To amplify sound for individuals with impaired hearing across various severities (Slight, Mild, Moderate, Severe) and configurations (High Frequency, Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat).

The FDA's review concludes that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. The document does not describe a new clinical study to establish performance against specific acceptance criteria for a novel device, but rather a regulatory pathway demonstrating similarity to existing, approved devices.

Ask a specific question about this device