(368 days)
E-Fit EP-1280 is a machine with electronic muscle stimulation based on EMS technology. Regarding is use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy museles and clients, not for rehabilitation purposes.
The E-Fit EF-1280 intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The E-Fit EF-1280 is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the E-Fit EF-1280 training programs is designed for injured or alling muscles and its use on such muscles is contraindicated.
The E-Fit EF-1280 electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and fotal session duration), different types of muscle work can be imposed on the stimulated muscles.
The various types of muscle work that the E-Fit E-Fit E-1280 can impose on the stimulated muscles are able to improve or facilitate muscle performance. The E-Fit EF-1280 may therefore be considered a technique of muscle training.
E-fit EF-1280 is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.
The provided document is a 510(k) summary for the E-Fit EF-1280, a powered muscle stimulator. In these types of FDA submissions, acceptance criteria and detailed study results as commonly found in clinical trials for new drugs or high-risk devices are typically not presented in this format. Instead, the submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This means showing that the new device is as safe and effective as a device already on the market, rather than proving its absolute safety and effectiveness through extensive clinical trials.
Therefore, the specific information requested in your prompt regarding acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets is not available in the provided text.
Here's a breakdown of what can be extracted and what is missing, based on the nature of a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria for specific performance metrics in a table. The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device, meaning the new device performs at least as well and is as safe as the predicate.
- Reported Device Performance: Instead of performance criteria, the document provides a comparative table of technological characteristics between the E-Fit EF-1280 and its predicate device, Compex Sport (K011880). This comparison serves as the "performance" demonstration in a substantial equivalence context.
| Parameter/Application | E-Fit EF-1280 | Compex Sport (K011880) |
|---|---|---|
| Powered Muscle Stimulator | YES | YES |
| Regulated | YES | YES |
| Max Output Voltage @500Ω | 36 V | 48 V |
| Max Output Current @500Ω | 72 mA | 96.1 mA |
| Max Phase Charge @500Ω | 36 µC | 32.3 µC |
| Max Current Density @500Ω | 0.85 mA/cm² | 3.84 mA/cm² |
| Max Power Density @500Ω | 6.3 mW/cm² | 10.2 mW/cm² |
| Maximum Output Current | 72 mA | 120 mA |
| Maximum Output Voltage | 0-36 V | 0-135 V |
| Number of channels | 1 output channel can shift in time to 12 outputs; current regulated individually on every output | 4 independent channels; current regulated individually |
| Waveform | Symmetric biphasic | Symmetric biphasic |
| Output frequency | 5-120 Hz | 5-120 Hz |
| Positive pulse width | 100-500 µsec | 50-400 µsec |
| Negative pulse width | 100-500 µsec | 50-400 µsec |
| Number of programs | 5+5 | 4+5 |
| Program duration | Maximum 30 min | Maximum 60 min |
| Power source - Battery | 12V (3.4Ah) lead Acid | 7.2V (1.2Ah) NIMH battery |
| Size of the electrodes | Pre-defined (supplied with device) size and correct position | Choice of size, connection, and positioning by user |
| User interface | Rotary encoder, push button capability, large START/STOP and POWER off buttons, pictographs, fixed electrodes in clothing | Complex menu, slow integrated buttons, one button for multiple functions |
| Safety circuits | Short-circuit monitoring, watchdog monitoring, no load trip, onload trip, battery monitoring, battery voltage monitoring, output current monitoring (emergency STOP option), option for self test, hardware error monitoring | No load trip, onload trip, battery monitoring |
| Portability/Mobile Use | Portable with difficulty, no mobile device, requires qualified and trained operator | Small, portable device (pocket size) |
| Material of the enclosure | Stainless steel | Plastic |
| Intended use | Stimulate healthy muscles to improve/facilitate muscle performance | Stimulate healthy muscles to improve/facilitate muscle performance |
| Operator | Certified persons (training required by seller) | Anyone can purchase and use |
| Menu / Settings | Simple one-level menu system | More levels/sub-menus, complex menu system |
| Plugs | Cables connect to electrodes with snap fastener, to machine with plastic 12-pin waterproof ip68 connector | Cables connect to electrodes with snap fastener, to machine with 4 similar plastic 2-pin connectors (risk of undefined channel control) |
| Lead wires - cables | SIFF 1-1.5mm2 (1x375 unique filaments) ultra flexible - Compliant with protected lead wire and patient cable safety requirements | CU 0.2mm2 (1x50 unique filaments) partly flexible - Compliant with protected lead wire and patient cable safety requirements |
| Conductivity of the electrodes | 100% hygroscopic cotton underwear soaked with tap water, in contact with electrodes. Small conductive pads are washable and disinfectable. | Limited usage, gel-covered electrodes. Quality depends on user's skin type. |
| Soldering of the Printed Circuit Boards | According to ROHS directive (no lead solder) | Lead soldering solutions |
| Placement of the electrodes | Appropriately pre-placed in specific areas according to muscle anatomy | Self-Adhesive on any area of body |
| Reusable pads | YES | YES |
| Display | LCD 2x40 character LCD display with LED backlight | LCD graphical display |
| Statistical functions | Counting hours of operation | NO |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: The document does not describe a clinical performance test set or data provenance in the way a clinical study would. The submission relies on a comparison of technical specifications and adherence to recognized standards to demonstrate safety and effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: No expert-established ground truth is mentioned, as there isn't a performance study evaluating diagnostic accuracy or similar metrics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No adjudication method is mentioned, as there isn't a performance study involving human interpretation that would require such a process.
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 / Not Provided: This device is a muscle stimulator, not an AI-assisted diagnostic imaging device for human readers. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: This device is a physical muscle stimulator, not an algorithm, so a standalone algorithmic performance study is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: Ground truth for training or testing is not applicable due to the nature of the device and the substantial equivalence submission process.
8. The sample size for the training set
- Not Applicable / Not Provided: There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: See point 8.
Summary of the Study per the Document:
The "study" presented is a 510(k) Premarket Notification, which is a regulatory submission, not a research study in the traditional sense. It aims to demonstrate substantial equivalence to an existing legally marketed device (the predicate device: Compex Sport, K011880).
The demonstration of substantial equivalence is based on:
- Comparison of Intended Use: Both devices are intended to stimulate healthy muscles to improve/facilitate muscle performance.
- Comparison of Technological Characteristics: A detailed table comparing various parameters (output voltage/current, pulse characteristics, programs, safety features, operator requirements, etc.) is provided. The submitter argues that differences do not raise new issues of safety or effectiveness.
- Adherence to Recognized Standards: The E-Fit EF-1280 is designed and manufactured in accordance with several international standards (EN ISO 14971:2012, EN ISO 13485:2003 /AC2009, IEC 60601-1:2005 3rd edition, IEC 60601-1-2:2007, IEC 60601-1-11:2010, IEC 60601-2-10:2012). Software verification was done according to FDA guidance.
The conclusion is that based on the comparison of intended use, design, materials, and performance, the new device is substantially equivalent to the predicate in all aspects impacting safety and effectiveness, and the differences do not raise new issues 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).