(371 days)
The FD EMS is a symmetrical biphasic neuromuscular electronic stimulator intended for medical purposes, which repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following:
- Prevention or retardation of muscle disuse atrophy; -
- Relaxation of muscle spasm; .
- Muscle reeducation; ・
- Maintaining and increasing the range of motion; -
- Increasing local blood circulation; -
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. .
The FD EMS is a handheld battery powered EMS device, which is used for muscle stimulation. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the skin of patient. Consequently, the electrical pulses would then pass through the skin to nerves of the muscle and cause the muscle to expand and contract. FD EMS has two output channels and seven stimulation programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 15 steps.
The provided text is a 510(k) summary for the FD EMS device, which is a powered muscle stimulator. It focuses on establishing substantial equivalence to a predicate device rather than detailing specific clinical studies to prove device performance against acceptance criteria in the manner requested.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria or reported device performance in terms of clinical outcomes or specific quantitative metrics. The basis for clearance is substantial equivalence to a predicate device, BMLS03-1 (K031427), not new performance data against pre-defined clinical acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
No clinical test set or data provenance is mentioned because "Clinical Testing 10.8: Not Applicable as there are no new or innovative aspects that have been introduced." The submission relies on non-clinical testing for compliance with voluntary standards and software verification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no clinical test set was used to establish ground truth because no clinical testing was performed for this 510(k) submission.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. No MRMC study was conducted or mentioned. The submission states that clinical testing is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This device is a physical muscle stimulator, not an AI/algorithm-based diagnostic or therapeutic device that would typically involve "standalone" performance evaluation in the context of an algorithm.
7. Type of Ground Truth Used:
Not applicable. No clinical ground truth was established for this submission. The "ground truth" for demonstrating substantial equivalence relied on engineering specifications, adherence to voluntary standards (EN 60601-1 and EN 60601-1-1), software verification, and comparison of intended use and technological characteristics to the predicate device.
8. Sample Size for the Training Set:
Not applicable. No training set is mentioned as part of this 510(k) submission, as it's not for an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set and therefore no ground truth for a training set was established.
Summary of what the document does provide:
- Non-clinical Testing: Compliance to EN 60601-1 and EN 60601-1-1 requirements, and software verification according to FDA software guidance. These are considered sufficient to demonstrate safety and effectiveness for a device of this type when substantially equivalent to a predicate.
- Technological Comparison: The FD EMS has similar basic technological characteristics, is battery-powered, has adjustable output amplitudes, and is a two-channel device, just like the predicate (BMLS03-1, K031427).
- Key Technological Difference: The FD EMS possesses an "open-circuit detection feature" to check continuity and avoid output increment in the absence of a load, which is presented as an added safety feature, not a new innovative aspect requiring clinical validation.
- Intended Use: Identical indications for use as expected for a powered muscle stimulator to treat conditions like muscle disuse atrophy, muscle spasm, etc.
In conclusion, the 510(k) summary for the FD EMS explicitly states that clinical testing was "Not Applicable" because there were no new or innovative aspects introduced. Therefore, the detailed information requested regarding clinical acceptance criteria, sample sizes, expert ground truth, and study designs is not present in this document. The device's clearance is based on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing and comparison of technical characteristics and intended use.
§ 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).