(156 days)
The Stim-8 is used for stimulation of muscles for the purposes of 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 and maintaining or increasing range of motion.
The Stim-8 is a compact, battery powered muscle stimulator. It is used to repetitively contract skeletal muscles by providing transcutaneous electrical pulses to areas of the body that require therapy for the indicated medical conditions. The parameters of the Stim-8 cannot be set by the user. Four channels are available on the Stim-8. Each channel operates independently and if desired one, two, three or four channels may be used simultaneously. The only controllable parameters are the amplitude intensity controls of the stimulation.
The provided text includes a 510(k) summary for the Stim-8 muscle stimulator. However, it explicitly states that no clinical testing was performed.
Therefore, without clinical testing, there is no study to prove the device meets acceptance criteria related to clinical performance. The information requested regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be provided from the given text as these typically relate to clinical evaluations.
Here's what can be extracted regarding non-clinical aspects:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Suitable for muscle stimulation (output characteristics) | Comparisons of stimulation outputs for the Stim-8 and the predicate NeuroTech-16 Program System Controller show similar results that are suitable for muscle stimulation. |
| Minimise potential electrical hazards | BMR adheres to recognised and established industry practice and all devices are subject to final performance testing. The Stim-8 is designed and tested to EN 60601-1-2 (IEC 601-1-2). |
| Minimise potential mechanical hazards | BMR adheres to recognised and established industry practice and all devices are subject to final performance testing. |
2. Sample sized used for the test set and the data provenance: Not applicable as no clinical testing was performed.
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 testing was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical testing was performed.
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 as no clinical testing was performed and this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as no clinical testing was performed and this is not an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no clinical testing was performed.
8. The sample size for the training set: Not applicable as no clinical testing was performed and this is not an AI device.
9. How the ground truth for the training set was established: Not applicable as no clinical testing was performed and this is not an AI device.
Summary from the provided text:
The Stim-8 device's safety and effectiveness claims are based on non-clinical tests comparing its stimulation outputs to a predicate device and adherence to industry standards for electrical and mechanical safety (EN 60601-1-2). The document explicitly states: "No clinical testing was performed." Therefore, there is no study described in this submission that proves the device meets clinical acceptance criteria.
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510(k) Notification for Stim-8: Appendix IX
510(k) Summary of Safety and Effectiveness
This summary is submitted in compliance with the FDA interim rule 21 CFR 807.92.
(1) Submitted by: (a)
BMR Ltd., Research & Development, 16 22 Merchants Road, Galway. Republic of Ireland
- 353 91 566911 Telephone: + 353 91 566907 Fax ::
Contact Person:
Position/ Title:
Date of preparation:
Trade name of device:
A
t
(2)
Common name:
Classification name:
Identification of predicate (3) or legally marketed device: Stim-8
Muscle Stimulator
12 December, 1995
Isaac Finnegan
Powered muscle stimulator; $890.5850
Design Engineer - Regulatory Affairs
NeuroTech-16 Program System Controller Model 280 (NeuroTech Inc., 510(k) # K860315)
116
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Description of device: (4)
The Stim-8 is a compact, battery powered muscle stimulator. It is used to repetitively contract skeletal muscles by providing transcutaneous electrical pulses to areas of the body that require therapy for the indicated medical conditions. The parameters of the Stim-8 cannot be set by the user. Four channels are available on the Stim-8. Each channel operates independently and if desired one, two, three or four channels may be used simultaneously. The only controllable parameters are the amplitude intensity controls of the stimulation.
Intended uses: (5)
The Stim-8 is used for stimulation of muscles for the purposes of 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 and maintaining or increasing range of motion.
These uses are similar to the predicate marketed device identified in section (3) of this summary.
(6) Technological comparison
is similar the NeuroTech-16 Program System The Stim-8 Controller in that both utilize microprocessor controlled stimulation parameters. Output for either device is suitable for muscle stimulation using standard skin surface electrodes. Both devices are similar in basic operational design and use the impedance of the output transformer to achieve a near net zero charge into the skin. The Stim-8 is effectively a more limited, portable version of the NeuroTech-16 Program System Controller with a replaceable battery.
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Non-clinical tests: (b) (1)
Comparisons of stimulation outputs for the Stim-8 and the predicate NeuroTech-16 Program System Controller show similar results that are suitable for muscle stimulation. To minimize potential electrical and mechanical hazards, BMR adheres to recognised and established industry practice and all devices are subject to final performance testing. The Stim-8 is designed and tested to EN 60601-1-2 (IEC 601-1-2).
(2) Clinical tests:
No clinical testing was performed.
- (3) Test conclusions:
Testing of the stimulation output parameters of the Stim-8 indicate that the device is safe, that it provides appropriate stimulation output for effective muscle stimulation and that it performs as well as or better than the legally marketed predicate device identified in section (3) of this Summary.
§ 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).