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The MyoTrac Infiniti system is indicated for the ongoing treatment of the following conditions: Relaxation of Muscle Spasms, Prevention of disuse atrophy, increasing local blood circulation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion and Stroke Rehab by Muscle re-education. It is also used for Relaxation & Muscle Re-Education purposes.

The MyoTrac Infiniti device is an electrical muscle stimulator for contraction of muscles as indicated below. The MyoTrac Infiniti is also an electromyography device. It is intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves and to monitor and display the electrical activity produced by nerves. The indications for use are muscle re-education, relaxation and biofeedback.

Here's an analysis of the provided text regarding the MyoTrac Infiniti System, focusing on acceptance criteria and supporting studies:

This 510(k) premarket notification (K053266) for the MyoTrac Infiniti System does not contain specific acceptance criteria or a dedicated study designed to prove the device meets such criteria in the conventional sense of a clinical trial demonstrating performance metrics against quantitative thresholds.

Instead, the submission focuses on substantial equivalence to predicate devices. The "performance data" section primarily refers to non-clinical tests verifying product specifications, system validation, safety, and EMC testing, along with biocompatibility assessments of electrodes. The core argument for equivalence is a direct comparison of functional and hardware specifications with legally marketed predicate devices.

Therefore, many of the requested categories within your prompt cannot be directly answered from the provided text. I will address what is available and indicate when information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit "acceptance criteria" (e.g., "sensitivity > X%", "accuracy > Y%") are not presented in this 510(k) summary. The "performance" is demonstrated through substantial equivalence to predicate devices based on technical specifications and safety testing.

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

• Sample Size for Test Set: Not applicable. This document describes a 510(k) submission for substantial equivalence based on technical comparisons and non-clinical testing, not a clinical study with a "test set" of patient data.
• Data Provenance: Not applicable for a patient data test set. The data provenance for component testing (e.g., biocompatibility) would be laboratory testing reports.

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

• Not applicable. There is no clinical "test set" with ground truth established by experts discussed in this submission.

4. Adjudication Method for the Test Set

• Not applicable. There is no clinical "test set" requiring 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

• No. This device is a biofeedback and muscle stimulation system, not an AI-assisted diagnostic tool that would typically undergo an MRMC study with human readers interpreting results.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This device is not an algorithm-only medical device. It is a physical medical device (stimulator and biofeedback unit) used with human-in-the-loop operation.
• The "standalone performance" is addressed by the comparison of its technical specifications to predicate devices and verification of its own product specifications.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For the purpose of this 510(k) submission, the "ground truth" for proving substantial equivalence is the technical specifications and established safety/effectiveness profiles of the predicate devices, along with the results of internal non-clinical tests (verification, validation, safety, EMC). There is no patient-reported outcomes, pathology, or expert consensus used to establish ground truth for a novel performance claim in this documentation.

8. The Sample Size for the Training Set

• Not applicable. This device does not employ an AI algorithm requiring a "training set" of data.

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

• Not applicable, as there is no training set for an AI algorithm.

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