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The Kneehab XP Controller is indicated for muscle re-education of the quadriceps, maintaining or increasing range of motion of the knee joint, prevention or retardation of disuse atrophy in the quadriceps, early post-surgical quadriceps strengthening and improved post-surgical knee stability secondary to quadriceps strengthening and increasing local blood circulation.

The Kneehab XP Controller is a portable, two-channel transcutaneous electrical muscle stimulator incorporating multipath®, a patented technology developed by neurotech®. It is designed to work in conjunction with the Kneehab XP. Conductive Garment and electrodes to deliver highly focused and accurate quadriceps contractions by using constant current pulses to stimulate the nerves in the quadriceps area of the body. The Kneehab XP controller is supplied with a rechargeable control unit, battery charger and instructions for use. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. The controller may be only be connected to the garment/electrodes or the charger due to the utilisation of a single custom connector. All the internal connections of the unit are over-molded to prevent moisture ingress. There are three treatment programs in total with duration of 20 minutes each and details of these are included in the instructions for use.

The provided document describes a 510(k) premarket notification for the Kneehab XP Controller (Type 411), a powered muscle stimulator. This type of submission is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials. Therefore, the document does not contain information about specific acceptance criteria, device performance metrics, or a study designed to explicitly meet such criteria in the way a clinical trial would.

Instead, the "study" described is a demonstration of compliance with established electrical safety and electromagnetic compatibility (EMC) international standards, and an assertion of substantial equivalence to a previously cleared device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, this document does not present "acceptance criteria" in the typical sense of a clinical trial (e.g., target diagnostic accuracy, sensitivity, specificity) nor does it report performance against such metrics. Instead, the device's "performance" and "acceptance" are demonstrated by its compliance with relevant safety standards and its technological equivalence to a predicate device.

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

This document does not describe a test set or data provenance in the context of a clinical performance study. The "test" involved demonstrating compliance with technical standards through engineering evaluations and documentation, not through patient data.

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

Not applicable. There was no "test set" requiring ground truth established by experts as part of a clinical evaluation. Compliance with standards is verified by testing laboratories and regulatory bodies.

4. Adjudication Method for the Test Set

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

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 a muscle stimulator, not an AI-powered diagnostic or assistive technology. No MRMC study was performed.

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

Not applicable. This device is a physical muscle stimulator, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the existence of established international safety and EMC standards (e.g., IEC 60601 series). Compliance with these standards serves as the benchmark against which the device's technical specifications and test results are evaluated.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of device and regulatory submission.

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

Not applicable. There is no concept of a "training set" or "ground truth" for it in this context.

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