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The Evok series is designed for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists.

The target population for this product is primarily the adult population 18 vears of age and older. The target group for this product includes individuals reporting tinnitus who can also benefit from an air conduction hearing aid.

Our devices are a combination of a hearing aid and a tinnitus masker in the same instrument. They are prescribed for those people with hearing loss who do not have significant relief with a hearing aid alone.

Dispenser or user adjustments permit selection of broad band or high or low frequency emphasis noise and aid response. It is essentially a tinnitus masker with a hearing aid added. Programmable volume controls are provided: one for noise level and the other for hearing aid gain. The dispenser, audiologist or user can mix the amount of noise and amplification as required.

The provided document does not contain a study or data proving the device meets specific acceptance criteria. Instead, it is a 510(k) summary, which is a premarket notification to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the provided information in the context of your request:

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

• Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria (e.g., specific auditory thresholds, SNR, or masking effectiveness levels) based on which the device's performance was evaluated. The primary "acceptance criterion" for a 510(k) submission is showing substantial equivalence to predicate devices.
• Reported Device Performance:
  • The document states, "The non-clinical tests submitted in this 510(k) demonstrate the electroacoustic properties of our devices and how similar in test results parameters they are." However, specific electroacoustic parameters or numerical results are not provided in this summary.
  • The document emphasizes the device's function: "The Evok 900 series are designed to provide tinnitus masking and amplification for hearing loss in the same device." Its effectiveness is inferred from its similarity to predicate devices that perform these functions.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• No specific test set or clinical study data is described. The submission relies on "non-clinical tests" demonstrating electroacoustic properties and the established safety record of Class I hearing aids. There is no mention of a human subject test set.

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)

• Not applicable. No human subject test set or ground truth establishment by experts is described in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No human subject test set or adjudication method is 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

• Not applicable. This device is a hearing aid/tinnitus masker, not an AI diagnostic tool that would typically involve human readers. No MRMC study is mentioned.

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

• Not applicable in the AI sense. The device is a physical medical device. While it functions independently, it requires fitting and recommendations by a qualified hearing healthcare professional. Its "performance" refers to its acoustical output and masking capabilities, not an algorithmic assessment.

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

• No explicit ground truth established for a test set. The basis for substantial equivalence is the similarity in "materials, construction and internal circuits" and "electroacoustic properties" to predicate devices, and the established safety of Class I hearing aids. The "truth" here is essentially compliance with engineering specifications and demonstrated functional equivalence to existing, approved devices.

8. The sample size for the training set

• Not applicable. This document describes a medical device, not a machine learning model, so there is no "training set."

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

• Not applicable. (See point 8)

Summary of Device and Evidence:

The Persona Medical Evok series (Evok 900, 913r, 923, 928, 933) is a combination hearing aid and tinnitus masker. The submission is a 510(k) premarket notification asserting substantial equivalence to existing predicate devices (General Hearing Instruments Tranquil Combo Devices and GN Resound TSG Module/Live TS series).

The "study that proves the device meets acceptance criteria" is primarily the non-clinical testing demonstrating the electroacoustic properties of the Evok devices and their similarity to the predicate devices. The document explicitly states:

• "The non-clinical tests submitted in this 510(k) demonstrate the electroacoustic properties of our devices and how similar in test results parameters they are."
• "Since these devices are basically Class I device Hearing Aids, the years these devices have been in market have established a safety track record that substantiates they are safe to market."
• "The technological similarities to the predicate are based on the materials, construction and internal circuits used by Class I Hearing aids..."
• "The testing performed on the Evok 900 series are evidence that these devices are safe when used in accordance with the guidance of a qualified audiologist or other hearing healthcare professional..."

The FDA's decision to clear the device (K093715) indicates that they agreed the device was substantially equivalent to the predicate devices based on this non-clinical data and the established safety records.

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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).

Magna-PWR, Magna-B, Integra 70-74, Futura 67M-68M, MP97, Supra 51-52, Supra 56-59 and Suprema 45-48 Hearing Aids

I am sorry, but the provided text does not contain the detailed information necessary to answer your request. The document is a 510(k) premarket notification approval letter for various hearing aid models from 1997. It confirms substantial equivalence to previously marketed devices and outlines general regulatory compliance and concerns about electromagnetic interference.

Specifically, the text does not include:

• Acceptance criteria tables for device performance.
• Details of any specific studies (e.g., sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance studies).
• Information on how ground truth was established for any training or test sets.

The included "Indications For Use" pages describe the types and severity of hearing loss these hearing aids are intended to address, but this is not a performance study or a set of acceptance criteria.

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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): Severity: Slight, Mild, Moderate, Severe. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat. Other: Low Tolerance To Loudness.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for several hearing aid models (DB, DB2000, PH, ST, CI) manufactured by Magnatone Hearing Aid Corporation. It primarily states that the devices are substantially equivalent to legally marketed predicate devices and can proceed to market. It also includes "Indications For Use" forms for each model.

Based on the provided text, the acceptance criteria and study information are quite limited because this is a regulatory clearance document, not a detailed scientific study publication. The 510(k) pathway demonstrates substantial equivalence rather than requiring a full clinical trial meeting specific performance criteria in the way a PMA (Premarket Approval) would.

Here's an analysis based on the information provided, with an understanding of the limitations inherent in this type of document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or detailed performance metrics in the way a clinical study report would. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The "performance" described relates to the indications for use.

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

The document does not provide information on a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). As a 510(k) submission, the primary evidence is typically technical specifications and comparison to a predicate device, not a new clinical study with a "test set" in the traditional sense of a clinical trial. The "clinical data" mentioned for specific psychoacoustic indications (if made) would typically be provided elsewhere, if at all.

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

This information is not provided in the document. The concept of "ground truth" established by experts for a test set is usually associated with clinical studies involving diagnostic or prognostic devices, where human expert labels are compared to device outputs. For hearing aids seeking 510(k) clearance, the "ground truth" for their substantial equivalence is the predicate device's established safety and effectiveness.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant when multiple experts are interpreting data, and consensus is needed to establish ground truth for a clinical study. This document does not describe such a study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned or implied in this document. These types of studies are used to assess the performance of a device with human readers, often comparing human performance with and without AI assistance. This document is a regulatory clearance for a physical medical device (hearing aids), not an AI-powered diagnostic tool.

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

Not applicable. This device is a hearing aid, which is a physical device used by a human, not a standalone algorithm. Its performance is directly tied to a human wearer.

7. The Type of Ground Truth Used

For the purpose of this 510(k) clearance, the "ground truth" essentially refers to:

• Predicate Device Performance: The safety and effectiveness of the legally marketed predicate device(s) to which the Magnatone hearing aids are compared. This is the cornerstone of substantial equivalence.
• Established Medical Understanding: The classifications of hearing loss severity and configuration (Slight, Mild, High Frequency, Flat, etc.) are based on established audiological standards and medical understanding.

There is no mention of pathology, expert consensus (beyond the regulatory review process), or outcomes data being used to establish ground truth for a novel study of these specific devices within this document.

8. The Sample Size for the Training Set

This information is not applicable/not provided. These are physical hearing aid devices, not AI/machine learning algorithms that require a "training set" of data.

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

This information is not applicable/not provided for the same reasons as point 8.

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