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The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders.

This product, MASTER, like its predicate device, the Navigator Pro, is a diagnostic device intended to be used as part of a set of audiometric test protocols. It is especially indicated for use in defining the configuration of the hearing loss particularly for individuals whose behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. It allows for the estimation of behavioral hearing threshold at various frequencies, through the use of ABR (Auditory Brainstem Response) or ASSR (Auditory Steady-State Response) test protocols. It is designed to be used as a diagnostic test procedure by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies.

Bio-logic EP Systems can be used for patients of all ages, from children to adults, including infants and geriatric patients. The use of the Bio-logic EP family of products is to be performed under the prescription and supervision of a physician or other trained health care professional.

The Bio-logic Evoked Potential family of products is intended to be used for the recording and analysis of human physiological data for the purpose of neurological diagnosis and treatment of sensory disorders. The predicate device referenced above is the latest in a series of diagnostic systems of this type marketed by Bio-logic. Other related diagnostic devices in the Evoked Potential family include:

• 510(k) #K803226 Bio-logic Evoked Response Stimulators. 1.
• 510(k) #K842543 Bio-logic Evoked Potential System. 2.
• 510(k) #K844992 Bio-logic Portable Evoked Response System. 3.
• 510(k) #K862690 -- Bio-logic Traveler LT System. 4.
• 5. 510(k) #K930328 - Navigator and Traveler Evoked Potential Product.

The predicate device, the Bio-logic Evoked Potential system with Navigator Pro hardware, performs Evoked Potential recording and analysis functions, including up to 2 channels of data recording and numerous diagnostic protocols and modalities. This new MASTER Evoked Potential with Navigator Pro device performs many of these same functions in essentially the same ways with a one-channel version of the same hardware, but employs a new software application package with significant new capabilities over those of the predicate device. Through the use of the Auditory Steady State Response (ASSR) modality, which is a variant of the MLR / 40 Hz test modality used in the referenced systems already on the market, hearing threshold levels can quickly and reliably be determined based on physiological rather than behavioral means.

The Auditory Steady State Response test is an alternative to tone burst Auditory Brainstem Response (ABR) testing which is used to predict frequency-specific behavioral hearing thresholds particularly for patients who cannot provide a reliable behavioral response. The ASSR technique avoids one of the inherent pitfalls of the tone burst ABR technique which is the problem of "spectral splatter" (distortions in frequency-specific data due to the start/stop actions of the tone burst) of the short duration acoustic stimulus that is required for ABR measurement. The ASSR technique uses a continuous frequency and/or amplitude modulated tone as the stimulus and can combine several stimuli together simultaneously to assess responses to various frequencies all at the same time. The evoked response recorded from scalp electrodes is reflective of the frequency of the modulation envelope of the stimulus. Thus, assessment of the response spectrum can yield information about the presence of the response to stimuli of varying intensities in order to determine the response threshold. ASSR thresholds have a predictable relationship to behavioral thresholds that is dependent on stimulus frequency and the presence and degree of hearing loss.

The MASTER application software is a modification of software originally designed by and exclusively licensed from researchers at the Rotman Research Institute, Baycrest Centre for Geriatric Care, at The University of Toronto. This software was designed originally for research purposes, and Bio-logic made significant modifications to create double fault conditions for any situation that could impact patient safety (e.g. presentation of prolonged, intense acoustic stimuli), to block the user from making parameter changes that are known to result in poor quality data, and to improve overall reliability, performance and ease of use. Additionally, the user interface has been simplified in terms of operation and information display so that only the relevant operations and data are available. More complex functions that do not have clinical relevance were eliminated from the software.

This system will be used to assist in defining the configuration of the hearing loss particularly in populations that are difficult to test using traditional behavioral audiometry. It is designed to be used as a diagnostic test procedure by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies.

The provided text is a 510(k) summary for the Bio-logic MASTER Evoked Response System. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against those criteria.

The document states that the modification was designed and incorporated "in accordance with the Bio-logic internal Product Development procedures which are intended to meet ISO-9001. EN-46001 and FDA QSR Design Control specifications." It also mentions a "Hazard/Risk analysis ... performed using the Fault Tree analysis (FTA) approach, and a detailed Risk Assessment was written in accordance with EN-1441." An addendum to this hazard/risk file was written for the new MASTER software.

Therefore, based on the provided text, a comprehensive table of acceptance criteria and reported device performance, as well as the detailed study information requested, cannot be fully generated as such a study is not explicitly described.

However, I can extract information related to the device's design control and risk assessment, which are usually components of meeting acceptance criteria for medical devices:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific, quantifiable acceptance criteria (e.g., specific accuracy metrics, threshold determination accuracy) and corresponding reported performance metrics from a clinical study. Instead, it focuses on demonstrating that the new MASTER device has "no significant differences which would adversely affect product safety and effectiveness" compared to its predicate.

The closest to "acceptance criteria" are the statements regarding safety and effectiveness, and the comparison table highlighting similarities and differences with the predicate device.

2. Sample Size for Test Set and Data Provenance:

• The document does not specify a sample size for a test set or discuss any clinical data provenance (e.g., country of origin, retrospective/prospective study). The submission is primarily focused on software modification and substantial equivalence to a predicate device, relying on design controls and risk analysis rather than a new clinical performance study.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• This information is not provided in the document as there is no mention of a clinical test set requiring expert-established ground truth.

4. Adjudication Method (Test Set):

• This information is not provided as there is no mention of a clinical test set requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on the device's standalone capability for diagnostic testing by trained healthcare professionals.

6. Standalone Performance Study:

• No specific standalone performance study with detailed metrics is reported in this summary. The document states that the software was "originally designed for research purposes" and Bio-logic "made significant modifications... to improve overall reliability, performance and ease of use." The claim of performance is inferred from the device's design to estimate behavioral hearing thresholds reliably through ASSR, a variant of an existing modality. The safety and effectiveness are established through adherence to design control procedures, hazard/risk analysis, and comparison with the predicate device.

7. Type of Ground Truth Used (if standalone study was done):

• Since no specific standalone study is described, the type of ground truth is not explicitly stated. However, the product's function is to "estimate behavioral hearing threshold," implying that the ultimate ground truth for auditory devices would typically relate to actual behavioral hearing thresholds or objective physiological measures that correlate strongly with them.

8. Sample Size for the Training Set:

• The document does not provide information on a training set sample size. The software was "originally designed by and exclusively licensed from researchers at the Rotman Research Institute... at The University of Toronto" for "research purposes." This suggests it was developed based on existing research data, but the specific size or nature of this "training" data is not detailed as part of the submission.

9. How Ground Truth for Training Set was Established:

• This information is not provided. Given the software's origin in research for "estimating behavioral hearing threshold," the ground truth in the original research would likely have been established through a combination of psychoacoustic behavioral audiometry and physiological measurements (e.g., ABR) that the ASSR technique is designed to complement or predict. However, the document does not elaborate on this for the software's development.

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