(87 days)
The Classic NMS is recommended for use for the following conditions:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical simulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
A portable NMS device for pain control.
The provided text is a 510(k) summary for a neuromotor stimulator (NMS) device. It states that clinical testing was "Not applicable" because the device demonstrated substantial equivalence to a predicate device through bench testing of electrical output characteristics. Therefore, a study demonstrating the device meets specific acceptance criteria as you've requested was not performed, nor was it required for this 510(k) clearance.
This means I cannot provide the detailed information you've asked for regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth, as these elements were not part of the submission or FDA's review for this particular device based on the provided document.
Here's a summary based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable - Clinical testing was not performed based on substantial equivalence to a predicate device. | The CLASSIC NMS™ is substantially equivalent in electrical output to the predicate device, as determined by bench testing. |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not applicable, as no clinical test set was used. Bench testing was performed on the device itself.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no clinical test set requiring expert ground truth was used.
4. Adjudication method for the test set
- Not applicable, as no clinical test set requiring adjudication was used.
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 MRMC comparative effectiveness study was done. This device is a neuromotor stimulator, not an AI-assisted diagnostic or imaging device, so "human readers" and "AI assistance" are not relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical neuromotor stimulator, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable, as no clinical ground truth was established or used. The basis for clearance was substantial equivalence in electrical output characteristics to a predicate device.
8. The sample size for the training set
- Not applicable, as no clinical training set was used.
9. How the ground truth for the training set was established
- Not applicable, as no clinical training set was used.
§ 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).