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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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The subject monitor detects bioelectrical signals from muscles for the purpose of guiding injections into the muscles identified. Although the monitor is indicated for guidance of any muscle-specific injection, it is typically used for injections into muscles of the head and neck. This includes botulinum toxin injections of facial and laryngeal muscles.

The subject monitor is intended to detect bioelectrical signals from muscles for the subject monitor in intentions into the muscles identified, including botulinum toxin injections of eye muscles.

The proposed EMG monitoring system is composed of a small, handheld monitor, a reusable patient interface cable and a disposable injector needle electrode. Commercially available surface electrodes, to act as references, may elcotrode. Onlinerally aranabitropoposed system as these are readily available or may not be provided with the proposed keys on the front console -- ON/OFF, at the politic of the of Check, Volume Down, and Mute. The software of the proposed EMG monitoring system interprets console key presses from the user and performs the action associated with that key.

The provided text is a 510(k) summary for the XOMED® AccuGuide Muscle Injection Monitor. As a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device, not necessarily to prove absolute performance against predefined acceptance criteria from novel studies. Therefore, the information provided focuses on comparing the new device to existing, legally marketed devices.

Based on the document, here's a breakdown of the requested information, with specific answers where available and explanations where information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) submission does not present specific quantitative acceptance criteria or a dedicated performance study with a table of results. Instead, it relies on demonstrating that the proposed device, the AccuGuide, is substantially equivalent to a predicate device (Allergan BOTOX® Injection Amplifier) in terms of intended use, technology, and safety/effectiveness. This means it's assumed to meet the same unstated performance benchmarks as the predicate.

For the purpose of this request, we can infer the "acceptance criteria" and "reported performance" are met if the device is deemed substantially equivalent to the predicate.

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

The provided 510(k) summary does not describe a specific "test set" or a performance study with a defined sample size for the AccuGuide device. The submission relies on a comparison to a predicate device and existing knowledge of EMG technology. Therefore:

• Sample Size for Test Set: Not applicable / Not provided.
• Data Provenance: Not applicable, as no specific test data set is described for the new device. The comparison is based on the known performance and characteristics of the predicate device (Allergan BOTOX® Injection Amplifier), which is a "currently marketed" device. This implies its performance is established from its prior marketing and regulatory clearance, which would have involved some form of testing, but details are not provided here for the predicate either.

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

This information is not provided in the 510(k) summary. Given that no specific test set or performance study is detailed for the AccuGuide, there is no mention of experts establishing a ground truth for such a study. The substantial equivalence argument relies on the established use and safety/effectiveness of the predicate device.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. As there's no described test set or performance study, there's no mention of an adjudication method.

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

• MRMC Study Done: No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) submission.
• AI Assistance: The device described is an EMG monitor, a hardware medical device that provides bioelectrical signal detection. It does not incorporate Artificial Intelligence (AI) for interpretation or assistance in the way current AI-driven diagnostic tools do. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• Standalone Performance: Not applicable. The AccuGuide is a hardware device (EMG monitor) designed to provide real-time feedback (audible and visible through LCD bargraph) to a human user (clinician) to guide injections. It does not operate as a standalone "algorithm" generating diagnoses or interpretations without human involvement in the clinical context. Its function is to assist in real-time muscle localization during a procedure.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Since no specific performance study is detailed, the type of ground truth for the AccuGuide's performance is not explicitly stated. However, the basis for its perceived "truth" or effectiveness stems from the functionality of its predicate device, the Allergan BOTOX® Injection Amplifier. The fundamental "ground truth" for these types of EMG monitors is the accurate detection of muscle electrical activity (bioelectrical signals) in the target muscle, confirmed by clinical observation (e.g., specific muscle movement in conjunction with the EMG response) and the subsequent successful and safe injection into that muscle, leading to the desired therapeutic outcome. This is a clinically established method for guiding precise injections.

8. The Sample Size for the Training Set

The provided 510(k) summary does not describe a "training set" for the AccuGuide. This device is a traditional hardware medical device, not a machine learning model that requires a training set in the conventional sense. The design and validation would have followed standard engineering and quality system processes, rather than machine learning training.

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

Not applicable, as no training set for a machine learning model is described for this device.

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