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The Intronix Model 8008 Myoguide System (Myoguide) is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.

Myoguide is a battery powered, handheld, EMG amplifier with audio feedback, LCD EMG signal and device status display, and current stimulation ranging from 0 mA - 20 mA. This device is internally powered and rated for continuous use. The patient input connection is a type BF applied part. Myoguide will automatically power off after 30 minutes of inactivity to conserve battery life.

Myoguide is designed to amplify electrophysiological signals from muscle and provide audio feedback to assist clinicians in locating areas of muscle activity. The Stimulator can be used as an adjunct. Myoguide provides muscle and nerve localization information, to accurately guide and monitor needle electrode insertion, and/or injection of neuromodulator drugs, into a muscle in the human body. Any drug used will be that of the physician.

The large LCD display provides the complete system status at a glance. EMG audio, EMG signal display, EMG RMS Value, Integrated EMG signal strength and stimulation capability, increases efficacy for injection point localization. The simple control panel is intuitive and easy to operate.

Myoguide operates in two modes: "[EMG]" and "[Stimulation]". The default mode, "[EMG]", records electromyographic (EMG) signals from electrodes placed on the subject. The second mode, "[Stimulation]", enables Myoguide's onboard stimulator to stimulate through the needle electrode that was used to record the EMG. This enables the clinician to record and stimulate through the same needle electrode. The switch is used to change the state of operation.

The provided text is a 510(k) Summary for the Myoguide System, seeking substantial equivalence to predicate devices. It does not contain a study demonstrating the device meets specific acceptance criteria in terms of performance metrics. Instead, it relies on demonstrating equivalence in intended use and technological characteristics to previously cleared devices through non-clinical testing.

Here's an analysis based on the information provided and typical FDA 510(k) submission practices:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not define specific quantitative acceptance criteria or report device performance in the manner of a typical performance study with metrics like sensitivity, specificity, accuracy, etc. Instead, it focuses on demonstrating compliance with safety and electrical standards and equivalence in technological characteristics to predicate devices.

The "Comparison Table" provided in the document acts as a de-facto performance comparison, showing that the Myoguide System has similar specifications and features to its predicate devices. The implicit acceptance criteria here are that the Myoguide System's characteristics are within a range comparable to the predicate devices and comply with relevant international standards.

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

• Test Set: Not applicable for this type of submission. There was no "test set" of patient data in the context of a clinical performance study. The testing was non-clinical (hardware, software, electrical safety, EMC).
• Data Provenance: Not applicable. The testing was laboratory-based, focusing on the device itself rather than clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. As no clinical data was used or generated, there was no need for experts to establish ground truth from patient cases. The "ground truth" for non-clinical testing is typically defined by engineering specifications and international standards.

4. Adjudication Method for the Test Set

• Not applicable. There was no test set requiring expert adjudication.

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

• No, an MRMC comparative effectiveness study was not performed.
• The document explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the device is supported by the non-clinical testing."
• Therefore, there's no data on the effect size of AI assistance on human readers. The Myoguide System is a standalone medical device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, in a sense, the entire submission functions as a "standalone" assessment of the device's characteristics and safety. The performance is assessed based on its inherent design, and its compliance with electrical and safety standards.
• However, it's not an "algorithm-only" performance study in the context of diagnostic AI, as the device is hardware-based with embedded software, intended for direct use by a clinician.

7. Type of Ground Truth Used

• For the non-clinical testing (hardware, software, electrical safety, EMC), the "ground truth" was established based on:
  • Software Design Specifications: The device's software was tested against its established specifications.
  • Device Hazard Analysis: Identifying and mitigating risks.
  • International Standards: Compliance with IEC 60601-1 (Safety), IEC 60601-1-2 (EMC), and IEC 60601-2-40 (specific to electrical nerve stimulators).
  • Predicate Device Characteristics: The functional and technological characteristics of the predicate devices (STIMPOD NMS450 and Clavis EMG Device) served as a benchmark for substantial equivalence.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML model that requires a "training set" of data for learning. Its functionality is based on fixed algorithms and hardware design.

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

• Not applicable, as there was no training set.

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