Search Results
Found 1 results
510(k) Data Aggregation
(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.
Ask a specific question about this device
Page 1 of 1