(161 days)
The CEFAR REHAB 2 and CEFAR REHAB 2 PRO are symmetrical biphasic neuromuscular electronic stimulators indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. Intended uses include:
- 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
The CEFAR REHAB 2 and CEFAR REHAB 2 PRO are battery powered handheld Neuro-Muscular Electrical Stimulation (NMES) devices only to be used under medical supervision for adjunctive therapy of medical diseases and conditions. The devices operate with two channels and 22 preset stimulation programs. On the CEFAR REHAB 2 PRO the user also can set parameters to create user defined stimulation programs.
Program information and amplitude is displayed on a LCD. The user can set the amplitude in the range 0-100 mA for all programs.
The provided document, a 510(k) summary for the CEFAR REHAB 2 and CEFAR REHAB 2 PRO devices, does not contain information regarding specific acceptance criteria, a detailed study proving device performance against such criteria, or any of the specific points requested (sample sizes, ground truth establishment, expert qualifications, MRMC studies, or standalone algorithm performance).
The document focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and general safety/EMC testing, rather than a clinical performance study with defined acceptance criteria.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Missing. The document does not provide a table with specific acceptance criteria or quantitative performance metrics for the device's intended uses (e.g., a specific percentage of muscle spasm reduction or improvement in range of motion).
The comparison table provided focuses on technical specifications to demonstrate equivalence:
| Characteristic | Ortho DX (Predicate device) | CEFAR REHAB 2 and CEFAR REHAB 2 PRO |
|---|---|---|
| Indications for use statement | Identical | See Section 1 B Indications for Use Statement |
| Prescription device | Yes | Yes |
| Number of channels | 2 | 2 |
| Output | 0-100 mA | 0-100 mA |
| Wave form | Symmetrical biphasic rectangle with zero net DC | Symmetrical biphasic rectangle with zero net DC |
| Pulse width | 0-300 $ \mu $ s | 50-300 $ \mu $ s |
| Maximum charge per pulse | 30 $ \mu $ C | 30 $ \mu $ C |
| Pulse rate | 33.3 Hz, fixed | 2-120 Hz, fixed in each preset program |
| Transcutaneous current delivery | Yes, through electrodes placed on patients body | Yes, through electrodes placed on patients body |
| User control of output | Yes, knobs | Yes, pushbuttons |
| Power supply | Yes, battery operated 4xAA batteries (rechargeable or alkaline) | Yes, battery operated 2xAA batteries (rechargeable or alkaline) |
Note: This table compares features, not performance against clinical acceptance criteria.
2. Sample size used for the test set and the data provenance
Missing. The document states "An extensive collection of tests has been conducted and successfully completed, including system validation in-house and external testing to show compliance with IEC EN 60 601-1-2 regarding EMC, IEC EN 60601-1 regarding general safety for medical equipment." However, these are general safety and electromagnetic compatibility standards, not clinical performance studies. There is no mention of a clinical test set, sample size, or data provenance (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing. Since no clinical test set or ground truth establishment is described, this information is not present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing. This information pertains to a clinical study with ground truth established by experts, which is not described.
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. The CEFAR REHAB 2 and REHAB 2 PRO are Neuro-Muscular Electrical Stimulation (NMES) devices, not AI-powered diagnostic or assistive tools. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an NMES device with no described AI algorithm component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Missing. As no clinical performance study is detailed, no ground truth type is specified. The assessment focuses on the device's technical specifications and compliance with general medical device safety standards.
8. The sample size for the training set
Not applicable. This device does not use an AI algorithm that would require a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a training set for an AI algorithm.
In summary: The provided 510(k) summary demonstrates substantial equivalence based on a comparison of device characteristics and compliance with general safety and EMC standards. It does not include details of a clinical performance study with specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement as would be typical for a device requiring such evidence for performance claims. This is common for predicate pathway 510(k) submissions where the new device is functionally very similar to an already cleared device and does not raise new questions of safety or effectiveness.
§ 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).