(123 days)
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.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Technological Characteristics | Substantially equivalent to predicate devices for: output waveforms, basic unit characteristics, output specifications, accessories, and software/firmware/microprocessor control, as per FDA's June 1999 guidance for powered muscle stimulators. |
| Usability | Device performs as intended. |
| Electrical Safety and Compatibility | Device performs as intended. Conforms to UL and IEC electrical safety and performance standards. |
| Software and Hardware Validations | Device performs as intended. |
| Packaging and Transit Validation | Device performs as intended. |
| Shelf-life and Biocompatibility Evaluations | Device performs as intended. |
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.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).