Search Results

The Niveus Medical Muscle Stimulation System 110 is indicated for:

• 1. Maintaining or increasing range of motion of the knee joint
• 2. Prevention or retardation of disuse atrophy in the quadriceps
• 3. Muscle re-education of the quadriceps
• 4. Relaxation of muscle spasms
• 5. Increasing local blood circulation

The Muscle Stimulation System 110 is a portable, externally-powered device which provides electrical stimulation to the quadriceps using constant current pulses. Pulses are delivered via six independently controlled stimulation channels (3 per leg) and are provided to the patient via electrodes integrated into soft Stimulation Array Pads. An Interconnect Cable allows for communication between the System Controller and Stimulation Array Pads.

The major components of the system consist of a Controller, an Interconnect Cable, a pair of disposable Stimulation Array Pads configured for application to the quadriceps of a patient, a Power Cord, and Instructions for Use. An optional accessory to the system is the Niveus Medical StayCool FlexPaks.

The provided text describes a 510(k) summary for the Niveus Medical Muscle Stimulation System 110. This document primarily focuses on demonstrating substantial equivalence to a predicate device and outlines minor modifications to the device.

However, the document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it lacks:

• A table of acceptance criteria with reported device performance: The document states that software verification testing, simulated use testing, and real-time aging data were used, but it does not provide specific acceptance criteria or the results of these tests in a quantifiable manner.
• Sample sizes and data provenance for test sets: There's no mention of the number of participants or data origin for any testing.
• Number and qualifications of experts for ground truth: No expert involvement for establishing ground truth is described.
• Adjudication method for the test set: No adjudication method is mentioned.
• MRMC comparative effectiveness study: No such study is described. This device is a muscle stimulator, not an AI diagnostic tool, so this type of study would not be applicable.
• Standalone algorithm performance: This is not an AI algorithm; it's a physical medical device.
• Type of ground truth used: Not applicable in the context of this device's testing as described.
• Sample size and ground truth for the training set: Not applicable as it's not an AI/ML device with a training set.

Based on the information provided in the document, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance:

• Sample Sizes: Not provided.
• Data Provenance: Not specified. The testing seems to be internal bench and simulated use testing, rather than human subject trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not mentioned. The testing described (software verification, simulated use, real-time aging) does not involve establishing ground truth typically associated with expert review of data (e.g., in diagnostic imaging studies).

4. Adjudication method for the test set:

• Not applicable/Not mentioned.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a muscle stimulation system, not an AI/ML diagnostic or assistive technology for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Not applicable in the conventional sense. The "ground truth" for the performance data would be the established functional requirements for the software, the physical integrity and performance requirements for the array pads, and the stability parameters for the shelf-life testing. These are determined by engineering specifications and standards, not expert consensus or pathology in the context of diagnostic performance.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning or AI that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. This device does not use machine learning or AI that requires a training set.

Summary of the Study:

The document describes a submission for demonstrating substantial equivalence (510(k)) for the Niveus Medical Muscle Stimulation System 110. The study referenced consists of bench performance data to support minor modifications to a previously cleared predicate device. These modifications include:

• Updates to the user interface: Evaluated through software verification testing.
• Minor changes for improved mounting of the touchscreen: Not explicitly stated how this was evaluated, but likely part of general design and manufacturing verification.
• A change to the Stimulation Array Pads affecting a non-functional portion: Evaluated through simulated use testing.
• Extension of the expiration date to 18 months: Supported by real-time aging data.
• Addition of an instructional label to the Interconnect Cable connector: This is a labeling change, not a performance study.

The overall conclusion is that these bench performance data confirm the subject device is as safe and effective and substantially equivalent to the predicate device. Specific quantitative acceptance criteria or detailed results of these tests (e.g., number of test cases for software verification, specific parameters for simulated use, stability data points for aging) are not provided in this summary.

Ask a specific question about this device

The Muscle Stimulation System 110 is indicated for:

• Maintaining or increasing range of motion of the knee joint
• Prevention or retardation of disuse atrophy in the quadriceps
• Muscle re-education of the quadriceps
• Relaxation of muscle spasms
• Increasing local blood circulation

The Muscle Stimulation System 110 is a portable, externallypowered device which provides electrical stimulation to the quadriceps using constant current pulses. The device is a Powered Muscle Stimulator per 21 CFR § 890.5850 (Product Code: IPF). Pulses are delivered via six independently controlled stimulation channels (3 per leg) and are provided to the patient via electrodes integrated into disposable Stimulation Array Pads. An Interconnect Cable allows for communication between the System Controller and Stimulation Array Pads.
The major components of the system consist of a Controller, an Interconnect Cable, a pair of disposable Stimulation Array Pads configured for application to the quadriceps of a patient, a Power Cord, and instructions for use.

The provided text is a 510(k) summary for the Niveus Medical Muscle Stimulation System 110, which is a Powered Muscle Stimulator. The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than conducting a detailed clinical study with specific acceptance criteria and performance metrics.

Therefore, the requested information, such as a table of acceptance criteria and reported device performance, sample sizes for test and training sets, expert qualifications, and specific study types like MRMC or standalone performance, are not explicitly present in this 510(k) summary.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific "acceptance criteria" in the sense of quantitative performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device) and corresponding "reported device performance" are provided for the Muscle Stimulation System 110. The 510(k) relies on demonstrating substantial equivalence to predicate devices through various types of testing and comparisons.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified. The document mentions "usability testing," but does not provide details on the number of participants or cases in this testing.
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as the submission focuses on engineering and regulatory compliance testing rather than clinical expert-driven ground truth establishment.

4. Adjudication method for the test set:

This information is not provided.

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:

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is a muscle stimulator, not an AI-powered diagnostic or interpretive tool that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: No, a standalone algorithm performance study is not applicable as this is a physical medical device (muscle stimulator), not a diagnostic algorithm. Performance is assessed through engineering validations and safety tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The concept of "ground truth" (as understood in the context of diagnostic performance) is not applicable to this submission. The "ground truth" for the device's functionality is its ability to perform its intended electrical stimulation safely and effectively based on engineering specifications and compliance with standards.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device is a hardware system, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

• Ground Truth for Training Set: Not applicable.

Summary of the Study:

The study presented in the 510(k) summary for the Niveus Medical Muscle Stimulation System 110 is primarily a regulatory submission aimed at demonstrating substantial equivalence to previously cleared predicate devices. It is not a clinical efficacy or diagnostic performance study in the traditional sense.

The "study" involved various forms of engineering and compliance testing to show that the device performs as intended and is as safe and effective as the predicate devices. These tests included:

• Usability testing: To ensure the device can be used effectively and safely.
• Electrical safety and compatibility testing: To ensure the device meets safety standards (UL and IEC).
• Software and hardware validations: To confirm proper functionality of the device's components.
• Packaging and transit validation: To ensure the device remains functional after shipping.
• Shelf-life and biocompatibility evaluations: To address material safety and device longevity.

The conclusion is based on these testing data, asserting that the device is "safe and effective and functions in substantially equivalent manner to the predicate devices." The general controls provisions of the Act, Good Manufacturing Practices, Quality System Regulations, and risk management were applied throughout the design and manufacturing process.

Ask a specific question about this device