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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.
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(260 days)
The Classic Stim 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 muscle re-education.
This document describes the 510(k) summary for the CARE STIM™ muscle stimulator, and it declares non-clinical testing was sufficient to show substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate) | Reported Device Performance (CARE STIM™) |
|---|---|
| Output characteristics of the predicate device (Ortho Dx muscle stimulator). | Output characteristics are substantially equivalent. |
| Intended Use of the predicate device. | Intended Use is substantially equivalent. |
| Labeling of the predicate device. | Labeling is substantially equivalent. |
| No new questions of safety and effectiveness compared to the predicate device. | No new questions of safety and effectiveness are posed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The study relies on bench testing comparisons to a predicate device, not a human test set.
- Data Provenance: Bench testing data comparing the output characteristics of the CARE STIM™ to the Ortho Dx. The country of origin and whether it's retrospective or prospective are not specified, but it would inherently be a prospective bench test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth for device characteristics was established via engineering bench testing, not expert clinical assessment.
4. Adjudication Method for the Test Set
- Not applicable. This was a technical comparison, not a clinical study requiring adjudication of expert opinions.
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 device is a muscle stimulator, not an AI-powered diagnostic tool. No MRMC study was conducted.
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. Bench testing was done on the device's electrical output.
7. The Type of Ground Truth Used
- Bench Test Comparison Records: The "ground truth" for the CARE STIM™ was the established output characteristics, intended use, and labeling of the predicate device (Ortho Dx). This was determined through non-clinical (bench) testing.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning device and therefore does not have a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
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(90 days)
The Select Stim 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 describes a 510(k) summary for the SELECT STIM™ neuromuscular stimulator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for a novel AI/software device.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Bench Testing) |
|---|---|
| Output characteristics substantially equivalent to predicate device (Ortho Dx K971542) | Output characteristics of SELECT STIM™ are substantially equivalent to the predicate device. |
| Compliance with FDA's Final Rule "Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables." | The SELECT STIM™ uses jacks and cables which comply with FDA's Final Rule. |
2. Sample Size for Test Set and Data Provenance
This is not applicable as no clinical or performance study involving a "test set" in the context of device performance metrics (e.g., accuracy, sensitivity, specificity) was conducted or reported. The assessment was based on bench testing for "technological comparison" and "labeling comparison."
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
This is not applicable for the same reasons as above. No ground truth for a test set was established as no such study was performed.
4. Adjudication Method for the Test Set
This is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Testing: Not applicable." The review is based on substantial equivalence through bench testing.
6. Standalone (Algorithm Only) Performance Study
This is not applicable. The device is a physical neuromuscular stimulator, not an algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" for the device's performance was established via bench testing to compare its electrical output characteristics and cable/jack compliance to the predicate device (Ortho Dx K971542) and relevant FDA regulations.
8. Sample Size for the Training Set
This is not applicable as the device is not an AI/software device that undergoes training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
Summary of the Study:
The "study" described in the 510(k) summary is a premarket notification process for a medical device (SELECT STIM™ Neuromuscular Stimulator). The primary objective was to demonstrate substantial equivalence to a previously cleared predicate device (Ortho Dx, K971542).
- Study Type: This was a nonclinical study focused on bench testing and labeling comparison.
- Methodology:
- Technological Comparison: The SELECT STIM™'s technological characteristics, specifically its output characteristics, were compared to those of the predicate device through bench testing. Additionally, its jacks and cables were verified for compliance with FDA's Final Rule on electrode lead wires and patient cables.
- Labeling Comparison: The labeling of the SELECT STIM™ was compared to that of the predicate device.
- Acceptance Criteria for Substantial Equivalence: The primary acceptance criterion was that the device's electrical output and technological characteristics, as demonstrated by bench testing, are substantially equivalent to the predicate device, and any differences do not raise new questions of safety or effectiveness. Additionally, compliance with the FDA's Final Rule for cables/jacks was an acceptance point.
- Results: The bench testing demonstrated that the output characteristics of the SELECT STIM™ are substantially equivalent to the predicate device. The jacks and cables comply with the relevant FDA rule. The labeling was also found to be substantially equivalent.
- Conclusion: The SELECT STIM™ was deemed substantially equivalent in electrical output to the predicate device, and its differences do not pose new questions of safety and effectiveness. Clinical testing was not deemed applicable for this submission.
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