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Muscle re-education of the quadriceps, Maintaining or increase 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, Increasing local blood circulation.

The Kneehab XP Conductive Garment is a portable, two-channel transcutaneous electrical muscle stimulator incorporating multipath®, a patented technology developed by neurotech®. This technology enables the Kneehab XP Conductive Garment to deliver highly focused and accurate quadriceps contractions and operates by using constant current pulses to stimulate the nerves in the quadriceps area of the body. These pulses are designed to cause muscular contractions through the application of electrical stimulation to the peripheral nervous system. The Kneehab XP pack consists of a rechargeable control unit, a left or right universally sized garment, a pack of custom adhesive electrodes, a battery charger and instructions for use. The garment is fastened around the thigh and above the kneecap and contains a connector socket into which the control unit is plugged. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. A battery charger is included with the device. This device cannot be used while being charged. All internal connections of the unit are over molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path. There are three treatment programs in total with duration of 20 minutes each. Program details are included in the instructions for use. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.

The provided text is a 510(k) premarket notification for the Kneehab XP Conductive Garment, Type 411. This document primarily focuses on establishing substantial equivalence to previously marketed devices and does not contain detailed information about a study that describes acceptance criteria and device performance in the format requested.

Specifically, the document does not provide the following information:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or its data provenance.
• The number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Details of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Standalone (algorithm-only) performance results.
• Specific ground truth types used for evaluation (beyond the general indication that a clinical study was submitted).
• Sample size for a training set.
• How ground truth for a training set was established.

The document does mention:

• A clinical study: "A clinical study, 'The effectiveness of the Kneehab™ in strengthening the quadriceps of patients in rehabilitation after anterior cruciate ligament reconstruction'', has been submitted as part of this 510k premarket notification." (Page 2, Section 7)

This indicates that a clinical study was performed and submitted, but the detailed results, methodology, and performance metrics are not included in this summary. The 510(k) summary is designed to demonstrate substantial equivalence, often by referencing conformance to standards and the content of such studies, rather than providing the full study report itself.

Therefore, I cannot populate the requested table and answer the questions based on the provided text alone. The document confirms that a clinical study exists and was submitted, but it does not detail its findings in the manner you've asked for.

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