(280 days)
Statement of Indication of Use (in EMG Mode):
- Biofeedback
- Relaxation Training
- Muscle Re-education
Statement of Ladication of Use (in NMS Mode):
The Care ETS 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 stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion.
- Stroke Rehabilitation, using muscle re-education techniques
A portable NMS device for muscle re-education.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CARE ETS™ device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria in a numerical or measurable format for the CARE ETS™ device itself. Instead, it relies on a comparison to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence in technological characteristics | "The CARE ETS™ has technological characteristics that are substantially equivalent to those of the predicate device, as determined by bench testing." |
| Substantial equivalence in labeling | "The labeling of the CARE ETS™ is substantially equivalent to that of the predicate device." |
| Substantial equivalence in output characteristics (nonclinical) | "Bench testing demonstrated that the output characteristics or CARE ETS™ are substantially equivalent to that of the predicate device." |
| No new questions of safety and effectiveness due to differences | "The CARE ETS™ is substantially equivalent in electrical output to the predicate device and any differences between the devices do not pose new questions of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document states "Clinical Testing: Not applicable." This indicates that no clinical studies with human participants were conducted as part of this 510(k) submission to demonstrate the device's performance or safety.
- Data Provenance: Not applicable. As no clinical testing was performed, there is no clinical data provenance to report. The evaluation was based on bench testing comparison to a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. No clinical testing or expert-adjudicated ground truth was established for the device itself.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no test set involving human data or expert review that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document explicitly states "Clinical Testing: Not applicable," which means no human studies were conducted, including comparative effectiveness studies.
- Effect size of human readers improvement with AI vs without AI assistance: Not applicable, as no such study was performed and the device is a neuromuscular stimulator, not an AI diagnostic tool for image interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? No, not in the context of an "algorithm only" performance study typically seen with AI/ML devices. The device is a physical neuromuscular stimulator. The "standalone" performance shown was through bench testing, demonstrating its electrical output characteristics are equivalent to a predicate device.
7. Type of Ground Truth Used
- Type of Ground Truth: For the purpose of the 510(k) submission, the "ground truth" was the performance and characteristics of the legally marketed predicate device (Automove AM800 K972997). The CARE ETS™ was deemed substantially equivalent based on its ability to match these characteristics through bench testing.
8. Sample Size for the Training Set
- Sample Size: Not applicable. There is no mention of a training set as this is not an AI/ML device that requires data for model training.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. As there was no training set, no ground truth needed to be established for it.
§ 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).