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The NeuroEPG System is an evoked response testing and diagnostic device that is capable of eliciting, acquiring and measuring auditory and somatosensory evoked potentials.

The intended use of the NeuroEPG System is to objectively record evoked responses from patients 18 years of age and older, upon the presentation of sensory stimuli. The product is indicated for use as a diagnostic aid and adjunctive tool in sensory related disorders (i.e., auditory, somatosensory) and in surgical procedures for intraoperative monitoring.

The NeuroEPG System is intended to be used by trained personnel in a hospital, clinic, EEG/EP technologist's, surgeon's, or physician's office, operating room, or other appropriate setting.

The anatomical sites of contact for auditory evoked potential (AEP) testing are the patient's ear canal (with the contact object being a sound delivery ear bud), and the patient's head and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).

The anatomical sites of contact for somatosensory evoked potential (SEP) testing are the patient's upper/lower limbs (with the contact object being skin-surface electrodes) and the patient's head and possibly other body sites (with the contact object being electrodes that are capable of measuring bio-potentials).

The NeuroEPG System is an evoked response testing and diagnostic device that is capable of eliciting, acquiring, and measuring auditory and somatosensory evoked potentials.

The provided K123843 document, concerning the Strohl Medical NeuroEPG, does not include a detailed study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity or specificity for diagnostic accuracy.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Intelligent Hearing System SmartEP K070608) primarily through comparison of technological characteristics and safety standards. There is no mention of a clinical performance study involving human subjects to assess the device's diagnostic or monitoring accuracy against a defined ground truth.

Here's an analysis based on the information provided, highlighting the absence of certain requested details:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) or quantitative outcomes are provided in the document. The NeuroEPG System demonstrates equivalence through shared design principles, circuit designs, operating principles, and compliance with safety standards as outlined in the "Comparative Performance and Specifications" section.

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

• The document does not describe a specific test set or study with human subjects to evaluate the device's diagnostic performance. Therefore, there is no sample size for a test set, nor is there information on data provenance (e.g., country of origin, retrospective/prospective).
• The comparison is primarily against the specifications and previous clearance of the predicate device (K070608).

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

• Not applicable, as no human subject test set or ground truth establishment for diagnostic performance is described in this submission.

4. Adjudication method for the test set

• Not applicable, as no human subject test set or adjudication process for diagnostic performance 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. The NeuroEPG System is an evoked response testing and diagnostic device, not an AI-assisted diagnostic tool that aids human readers in interpreting images or other data. This submission does not describe an MRMC study.

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

• The NeuroEPG System is presented as a device for eliciting, acquiring, and measuring evoked potentials. While it performs objective measurements, the ultimate diagnostic interpretation is still expected to be performed by trained personnel (physicians, technologists). The submission does not describe a "standalone" algorithmic performance study in the context of AI or automated diagnostic decisions, but rather the performance of the measurement system itself against its specifications and the predicate.

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

• Not applicable in the context of diagnostic accuracy. The "ground truth" for the substantial equivalence claim relies on the established safety and performance characteristics of the predicate device and compliance with relevant industry standards (e.g., IEC 60601-1).

8. The sample size for the training set

• Not applicable, as this submission does not describe a machine learning or AI-based device that requires a training set.

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

• Not applicable, as this submission does not describe a machine learning or AI-based device.

In summary, this 510(k) submission for the NeuroEPG System establishes substantial equivalence by demonstrating that its technological characteristics, intended use, indications for use, and safety comply with relevant standards and are either identical or insignificantly different from a legally marketed predicate device. It does not contain a clinical performance study with defined acceptance criteria for diagnostic accuracy, nor does it address AI-specific evaluation metrics.

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