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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.

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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: Slight, Mild, Moderate, Severe
Configuration: High Frequency Precipitously Sloping, Flat
Other: Low tolerance to loudness

The Vista completely in the canal (CIC) is a small instrument designed to fit competely in the ear canal. The volume control is a standard screw-set control and uses a #10A or 5A battery. The CIC fit reduces residual ear canal volume and results in the need for less gain, decreased chance of feedback, improvement of high frequency gain, decreased occlusion effect, and lesser self-masking. The CIC's circuits are assembled into a variety of different configurations including Class D, K-amp, and RGA Class A. Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical specifications comply with S3.22-1987 ANSI Specifications. Dispenser controlled Volume Control. The frequency response of this product is dictated by the individual audiogram from each client. Standard hearing aid battery.

The provided document is a 510(k) premarket notification for a hearing aid, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims.

As such, the document does not contain the acceptance criteria or a study demonstrating the device meets performance criteria in the way a typical clinical trial for a new medical device would. Instead, the criteria outlined are related to technical specifications and intended use, and the "study" is a demonstration of compliance with existing standards and substantial equivalence.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: It's crucial to note that for a hearing aid, typical performance metrics would include aspects like gain, output, frequency response accuracy, distortion, battery life, and possibly specific psychoacoustic measures (e.g., speech intelligibility for specific scenarios if specific claims were made). The document only states compliance with ANSI S3.22-1987, which would cover many of these. The exact numerical performance values against specific ANSI tolerances are not presented in this document.

2. Sample Size Used for the Test Set and Data Provenance

This document describes a 510(k) submission, which relies on substantial equivalence to a predicate device, rather than a de novo clinical study with a "test set" in the traditional sense of evaluating device performance on patients.

• Sample Size: Not applicable in the context of a prospective clinical "test set" with patient data. The "sample" here refers to the device itself and its technical specifications compared against established standards and a predicate device.
• Data Provenance: The data provenance is primarily the technical specifications of the Vista V-38 CIC Hearing Aid itself, which are affirmed to comply with ANSI S3.22-1987. No patient-specific or clinical trial data is presented in this excerpt. The submission is based on the device's design, components, and stated compliance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not directly applicable to this type of submission. The "ground truth" for a 510(k) is often established by the predicate device's existing market acceptance and regulatory clearance, as well as by industry standards (like ANSI S3.22-1987) that expert committees have developed and approved.
• Qualifications of Experts: The experts involved in establishing the ANSI standards would be acousticians, audiologists, engineers, and other specialists in hearing aid technology. The FDA reviewers (e.g., Lillian Yin, Ph.D., Director of the relevant division) are the regulatory experts who determine if the submission adequately demonstrates substantial equivalence.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no "test set" of patient data that requires expert adjudication. The process is a regulatory review by the FDA based on the submitted technical documentation and comparison to a predicate device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This type of study assesses how human performance (e.g., diagnostic accuracy) changes with or without AI assistance. The Vista V-38 CIC is a medical device (hearing aid), not an AI-powered diagnostic or assistive technology in the modern sense that would require such a study for its 510(k) clearance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No, a standalone performance study was not done. This concept primarily applies to AI/ML algorithms. The Vista V-38 CIC is a hardware device with specific electronic circuits ("Class D, K-amp, and RGA Class A"); its performance is inherent to its design and manufacturing, not an algorithm that operates independently.

7. The Type of Ground Truth Used

• The "ground truth" for this 510(k) submission is primarily:
  • Predicate Device Performance: The demonstrated safety and effectiveness of the legally marketed predicate device(s) that the Vista V-38 CIC claims substantial equivalence to.
  • Industry Standards: Compliance with recognized consensus standards, specifically ANSI S3.22-1987 for hearing aid specifications.
  • General Medical Understanding: The accepted medical understanding of hearing loss and the function of hearing aids (e.g., "to amplify sound for individuals with impaired hearing").

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an AI/ML algorithm development. This is a traditional medical device (hearing aid). The "training" for such a device would be the engineering and design validation process using standard components and established manufacturing practices.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no "training set" for an AI/ML algorithm, there's no ground truth established for it. The "ground truth" (or basis of performance and safety) for a traditional medical device like a hearing aid is established through adherence to engineering principles, relevant national/international standards, and manufacturing quality controls.

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