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510(k) Data Aggregation
(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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