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SmartEP is an evoked response testing and diagnostic device, that is capable of eliciting, acquiring, and measuring auditory, somatosensory, and visual evoked potential data, as well as providing nerve stimulation and monitoring.

The intended use of the SmartEP device is to objectively record evoked responses from patients of all ages 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, visual) and in surgical procedures for inter-operative nerve monitoring.

SmartEP is an evoked response system that is capable of eliciting, acquiring, and measuring auditory, somatosensory, and visual evoked potential data, as well as providing nerve stimulation/monitoring.
The feature modifications described in this 510(k) are to incorporate additional/expanded indications to the SmartEP device for somatosensory evoked potential, visual evoked potential, and nerve stimulation testing to the previously FDA cleared indications for auditory evoked potential testing. Specifically, additional hardware and software features have been added to the original SmartEP device system to objectively acquire somatosensory/visual evoked potentials upon the presentation of a somatosensory/visual stimulus, and to provide nerve stimulation/monitoring functionality.

The provided text describes a 510(k) premarket notification for the SmartEP device, seeking expanded indications for Somatosensory Evoked Potential (SEP), Visual Evoked Potential (VEP), and Nerve Stimulation/Monitoring. The core of the information regarding acceptance criteria and supporting studies is based on demonstrating substantial equivalence to predicate devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the equivalence of key specifications and intended use to legally marketed predicate devices. The "reported device performance" is a demonstration that the SmartEP's characteristics meet or are comparable to those of the predicate devices. The tables provided (Table E-1 and Table E-2) serve as the primary evidence for this.

Table 1: Acceptance Criteria and Reported Device Performance for SEP & VEP (Summarized from Table E-1)

Table 2: Acceptance Criteria and Reported Device Performance for Nerve Stimulation/Monitoring (Summarized from Table E-2)

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

The document does not report primary clinical data or a specific test set formed from human subjects for evaluating the performance of the SmartEP device with its expanded indications. Instead, the study relies on a comparative analysis of technical specifications and safety standards against legally marketed predicate devices.

Therefore:

• Sample size for test set: Not applicable, as performance was not demonstrated through a traditional clinical study with a test set of patient data.
• Data provenance: Not applicable. The "data" used for comparison are the technical specifications and regulatory compliance of the predicate devices and the modified SmartEP.

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

Not applicable. The ground truth, in this context, is the established safety and effectiveness profile of the predicate devices. This was determined by FDA clearance processes for those devices, not by new expert consensus for this 510(k). The current submission relies on the regulatory acceptance of the predicate devices as the benchmark for "ground truth" regarding safety and performance.

4. Adjudication Method for the Test Set

Not applicable, as no human subject test set or associated ground truth adjudication was performed as part of this 510(k) submission.

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 an evoked response testing and diagnostic system, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers or MRMC studies. Its function is to elicit, acquire, and measure physiological data, rather than interpret complex images or provide AI-driven assistance to human readers.

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

Not applicable. This device is a measurement instrument; its "performance" is assessed by its ability to accurately measure physiological responses within specified technical parameters, not by an algorithm's standalone diagnostic accuracy in the absence of human operation or interpretation.

7. The Type of Ground Truth Used

The ground truth used is the established safety, performance, and regulatory compliance of legally marketed predicate devices. The SmartEP device demonstrates substantial equivalence by comparing its technical characteristics, intended use, indications for use, and safety features directly against those of the Nicolet Viking II (for SEP and VEP) and the Medtronic XOMED NIM-Response (for Nerve Stimulation/Monitoring).

8. The Sample Size for the Training Set

Not applicable. The device is not a machine learning or AI algorithm that requires a training set of data. Its development and modification process involved engineering design, verification, and validation against specified requirements and safety standards, rather than data-driven machine learning.

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

Not applicable, as there is no training set for this device.

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