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The Kneehab XP, Type 412/421, Indications for use are as follows:

In NMES mode (Programs 1-6) the Kneehab XP is intended to:

• Maintain or increase the range of motion.
• Prevention or retardation of disuse atrophy
• Re-educate muscles
• Early post-surgical quadriceps strengthening and improved post surgical knee stability secondary to quadriceps strengthening
• Relax muscle spasms
• Increase blood circulation

In TENS Mode (Programs 7 - 9) the Kneehab XP is intended to:

• Provide symptomatic relief and management of chronic, intractable pain
• Provide an adjunctive treatment in the management of acute, post-surgical or post-traumatic pain
• Provide symptomatic relief and management of intractable pain and relief of pain associated with arthritis
• Provide an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee

The Kneehab XP, Type 412/421 is a portable, battery operated, combination device which can provide both neuromuscular electronic stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). The device incorporates multipath®, a patented technology developed by neurotech® which enables the Kneehab XP Conductive Garment to deliver highly focused and accurate NMES muscle contractions. This device also provides a method of pain management and relief through the use of TENS technology.

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 and the device cannot be used while being charged. The adhesive electrodes have an estimated usage capability of 20 sessions when used under the recommended conditions of use.

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 nine treatment programs in total (six NMES and three TENS) with a 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 document is a 510(k) Summary for the Kneehab XP, Type 412/421. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than providing clinical study data to meet specific performance acceptance criteria. Therefore, the document does not describe a study that proves the device meets specific acceptance criteria.

Instead, it focuses on comparing the technological characteristics and intended uses of the Kneehab XP to existing predicate devices to argue for substantial equivalence. The document primarily highlights technical and functional comparisons rather than performance metrics from a clinical trial.

Based on the provided document, I cannot fulfill all sections of your request as it does not contain the information regarding an acceptance criteria study.

However, I can extract the following relevant information regarding the device and its intended use, which would typically form the basis for performance evaluation in a clinical study:

1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or reported device performance from a study. It only provides electrical output specifications.

Device Electrical Output Parameters (Technical Characteristics, not performance data):

Intended Use and Indications:

NMES Mode (Programs 1-6):

• Maintain or increase the range of motion.
• Prevention or retardation of disuse atrophy.
• Re-educate muscles.
• Early post-surgical quadriceps strengthening and improved post-surgical knee stability secondary to quadriceps strengthening.
• Relax muscle spasms.
• Increase blood circulation.
  TENS Mode (Programs 7-9):
• Provide symptomatic relief and management of chronic, intractable pain.
• Provide an adjunctive treatment in the management of acute, post-surgical or post-traumatic pain.
• Provide symptomatic relief and management of intractable pain and relief of pain associated with arthritis.
• Provide an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no performance study data is presented in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no performance study data is presented in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no performance study data is presented in this 510(k) summary.

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 is a medical device application for a physical device (electrical stimulator), not an AI/imaging diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device application for a physical device (electrical stimulator), not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no performance study data is presented in this 510(k) summary.

8. The sample size for the training set
Not applicable, as no performance study data is presented in this 510(k) summary.

9. How the ground truth for the training set was established
Not applicable, as no performance study data is presented in this 510(k) summary.

Summary of Device and 510(k) Submission:

The Kneehab XP is a portable, battery-operated combination device that provides both Neuromuscular Electrical Stimulation (NMES) and Transcutaneous Electrical Nerve Stimulation (TENS). Its primary purpose within this 510(k) submission is to demonstrate substantial equivalence to previously cleared predicate devices (Kneehab XP Conductive Garment, MediStim XP, MediTens XP, Staodyn Max Preset, 300 PV Complete Electrotherapy System, Bioncicare® Stimulator System). The submission details the technological characteristics, intended use, and indications for use of the Kneehab XP and compares them to these predicate devices, ensuring that there are "no new technological characteristics that could affect safety or effectiveness." The focus is on meeting international safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) and demonstrating similarity in electrical parameters and functionality to the predicate devices.

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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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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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