(67 days)
The MEDSTAR 150 should only be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions to relive pain. When used for pain relief, the standard indications for use are:
- symptomatic relief and management of chronic pain and/or .
- an adjunctive treatment in the management of post surgical and posttraumatic acute ● pain.
When used for neuromuscular stimulation, the standard indications for use are:
- Relaxation of muscle spasms .
- Prevention or retardation of disuse atrophy .
- Increasing local blood circulation ●
- Muscle re-education ●
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; ● and
- Maintaining or increasing rang of motion .
The MEDSTAR 150 is a DC battery powered device that generates small pulses of electrical current. These small pulses of electrical current are delivered through lead cables to electrodes placed on the skin. These electrical pulses pass through the skin and activate underlying nerves and muscle.
The provided text describes a 510(k) summary for the MEDSTAR™ 150 Powered Muscle Stimulator. It focuses on establishing substantial equivalence to a predicate device rather than detailing extensive clinical trials with acceptance criteria, sample sizes, or ground truth methodologies common in AI/software device submissions.
Therefore, many of the requested categories (such as acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, adjudication, MRMC studies, and standalone performance) are not applicable or extractable from this specific document.
This document is from 2001 and concerns a hardware medical device (a powered muscle stimulator), not an AI/software device. The regulatory requirements and testing methodologies for hardware stimulators are vastly different from those for AI/ML-based diagnostic or therapeutic software, especially concerning clinical study design as you've outlined in your request.
Here's what can be extracted based on the provided text, with clarifications for the non-applicable sections:
Acceptance Criteria and Device Performance Study for MEDSTAR™ 150
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria (Not explicitly stated as numerical targets) | Reported Device Performance (Summary of functional testing) |
|---|---|---|
| Functional Safety | Not explicitly defined as pass/fail numerical thresholds in this document, but implied to meet general operational safety standards. | "Was performed with a signal generator voltmeter, 20 ohm resistor, and alligator clip wires. The signal generator was set to 1000 Hz and V¡ was set at approximately 2 volts. The voltage drop across the electrodes (V2) was measured and the impedance of the electrodes calculation is as follows: Impedance (Z) = V7/V1 x R" |
| Substantial Equivalence | The device should be "substantially equivalent to 4000+ Interferential Powered Muscle Stimulator in intended use, design and performance." | The FDA granted 510(k) clearance, indicating that the device was determined to be substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document describes functional safety testing, which typically involves device-level electrical and performance measurements, not human subject testing with a "test set" in the context of clinical data. It's a hardware device, not an AI model.
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 / Not provided. Ground truth, in the context of expert consensus, is not relevant for this type of device and its functional safety testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication is not relevant for this type of device and its functional safety testing.
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 hardware muscle stimulator, not an AI-assisted diagnostic or therapeutic software. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device; the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For the functional safety testing described, the "ground truth" would be the expected electrical and physical properties/outputs of the device as measured by standard laboratory equipment. There is no biological or diagnostic "ground truth" in the sense of pathology or expert consensus.
8. The sample size for the training set
- Not applicable / Not provided. This device is not an AI/ML model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this is not relevant.
§ 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).