(122 days)
The Niveus Medical Muscle Stimulation System 110 is indicated for:
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- Maintaining or increasing range of motion of the knee joint
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- Prevention or retardation of disuse atrophy in the quadriceps
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- Muscle re-education of the quadriceps
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- Relaxation of muscle spasms
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- 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:
| Acceptance Criteria Category (Inferred) | Reported Device Performance (as stated in document) |
|---|---|
| User Interface Functionality | Evaluated through software verification testing |
| Stimulation Array Pad Integrity | Evaluated through simulated use testing |
| Shelf-Life | Supported by real-time aging data |
| Overall Safety & Effectiveness | Bench performance data confirmed the device is as safe and effective and substantially equivalent to the predicate device |
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.
§ 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).