(126 days)
Gnesis EMS Plus is intended to stimulate healthy muscles in order to improve or facilitate muscle performance, is not intended to be used in coniunction with therapy or treatment of medical diseases or medical conditions of any kind.
None of Gnesis EMS Plus training programs is designed for injured or ailing muscles and its use on such cases is contraindicated.
Each of Gnesis EMS Plus training programs, depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), is designed for a specific type of exercise.
Gnesis EMS Plus is a device for electronic muscle stimulation based on EMS technology. Gnesis EMS Plus is specifically designed as an addition to other sports and for training muscles. It must be used only on healthy muscles, not for rehabilitation purposes.
Gnesis EMS Plus is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training.
None of Gnesis EMS Plus training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. It must be used only on healthy muscles and patients, it is not designed for rehabilitation purposes.
The device must be worn over the underwear provided by the system manufacturer, ensuring that the electrodes do not come into direct contact with the patient's skin.
Gnesis EMS Plus System cannot be used while the user is performing demanding tasks, such as jumping or lifting weights, any exercise must be approved by a qualified trainer.
Genesis EMS Plus System includes the stimulator device, EMS suit with integrated electrodes, electrode wiring, specific underwear, stimulator charger (Off-the-shelf USB-C PD 3.0) and control device (Off-the-shelf Android Tablet with custom application)
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text.
The Gnesis EMS Plus device is a Powered Muscle Stimulator. The provided FDA 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance and safety testing against recognized electrical and medical device standards. There is no information about an AI component or a study involving human readers or comparative effectiveness in the traditional sense of AI system evaluation. The "acceptance criteria" here relate to meeting established safety and performance standards for powered muscle stimulators and demonstrating similar technological characteristics and intended use as predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Standards Adhered to) | Reported Device Performance / Compliance |
|---|---|---|
| General Characteristics | Classified as "Powered muscle stimulator" (NGX) | Same as Predicates |
| Regulation Number: 21 CFR 890.5850 | Same as Predicates | |
| Regulatory Class: Class II | Same as Predicates | |
| Panel: Physical Medicine | Same as Predicates | |
| Intended Use | Must be used for healthy muscles; not for therapy or treatment of medical diseases/conditions. Not for injured/ailing muscles. Designed for improving/facilitating muscle performance. | Same as Predicates, all devices designed for improving healthy muscle training. |
| Use Environment | Use in athletic training facilities; not outdoors. | Same as Predicates |
| Anatomical Sites | Electrodes can be applied to multiple anatomical sites. | Same as Predicates |
| Power Source | Battery operated (Lithium) | Battery operated (Lithium). Higher input voltage than one predicate (WIEMPro) and similar to another (I-Motion). Deemed similar and does not affect safety/performance. |
| Method of Line Current Isolation | N/A (battery operated device) | N/A (battery operated device) |
| Patient Leakage Current | N/A (battery operated device) | N/A (battery operated device) |
| Number of Output Modes | One output mode with varying stimulation frequency and duty cycle ranges. | Same as Predicates |
| Number of Output Channels | 1 Channel, Alternating | Same as Predicates |
| Independent Channels with Possibility to Regulate Current | All channels conforming to regulations | 12 Channels (Predicates have 10). Two extra channels are identical and conform to regulations. |
| Regulated Current and/or Voltage | Regulated current | Same as Predicates |
| Software/Firmware/Microprocessor Control | Yes | Same as Predicates |
| Automatic Overload Trip | Yes | Same as Predicates |
| Automatic No-load Trip | Yes | Same as Predicates |
| Automatic Shut Off | On/Off switch, Power-save timer | Adds power-save timer when device is not connected to control App and not delivering treatment. |
| Patient Override Control | Yes, push on On/Off button directly pauses program. | Same as Predicates |
| Indicator Display | Yes | Same as Predicates |
| Housing Material | Safety tested for leakage currents and impact resistance. | Aluminum (Predicates are plastic). Safety tested according to IEC 60601-2-10. |
| Device Weight | Not a specific criterion, but compared. | 500g (Predicates 300g). Heavier due to aluminum construction. |
| Dimensions | Not a specific criterion, but compared. | Similar to Predicates |
| Waveform | Symmetrical bi-phasic (all programs) | Same as Predicates |
| Current/Voltage | Higher current than one predicate (I-Motion), similar to another (WIEMPro). | Higher current than i-motion, similar to WIEMSPRO. |
| Maximum Power Density | Included in risk management file according to IEC 60601-2-10 clause 201.4.2. | Higher than Predicates. Included in risk management, due to higher frequencies/duty cycle, not used in practice. |
| Maximum Current Density | Not a specific criterion, but compared. | Similar to Predicates (2 mA/cm2 vs 1.92/1.87 mA/cm2). |
| Pulse Duration (Width) | Allows for lower pulse durations, lower energy density, complies with IEC 60601-2-10 accuracy limits. | 25-400 µs (Predicates 150-450 µs). |
| Frequency | Allows for higher frequencies, complies with IEC 60601-2-10 limits. | 1-150 Hz (Predicates 1-100 Hz). |
| Time Range (Minutes) | Maximum program: 90 minutes | More restrictive than Predicates (unlimited). |
| Reusable Pads | Yes | Same as Predicates |
| Compliance with Voluntary Standards / LAB tests performed | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10, IEC 62304, ISO 14971. | Full compliance with these standards by accredited laboratory. |
2. Sample Size for the Test Set and Data Provenance
The provided document describes non-clinical testing in a laboratory setting. There is no "test set" in terms of patient data or clinical imaging. The "test set" for this device would refer to the physical device and its components undergoing engineering and electrical testing.
- Sample Size: Not applicable in the context of clinical or AI performance data. The device itself (Gnesis EMS Plus) was the "sample" for the non-clinical tests.
- Data Provenance: The tests were conducted by an accredited laboratory (SGS Tecnos Spain) in accordance with international and European standards (e.g., IEC, ISO, UNE-EN). This is engineering and safety testing, not human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable as the device is not an AI system being evaluated for diagnostic performance against a medical ground truth. The "ground truth" here is adherence to engineering and safety standards, verified by testing laboratories and the technical specifications of the device.
4. Adjudication Method for the Test Set
This is not applicable. There was no need for adjudication as the testing involved objective measurements against established technical standards, not subjective interpretations requiring expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done, and is not applicable to this device. This device is a powered muscle stimulator, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm-only performance study was not done, and is not applicable to this device. This device is a physical medical device, not a software algorithm or AI. The "performance" assessment was through non-clinical testing of its electrical and safety characteristics against recognized standards.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on compliance with established international and European consensus standards for electrical medical equipment and powered muscle stimulators (e.g., IEC 60601 series, IEC 62304, ISO 14971). These standards define acceptable limits for electrical output, safety, EMC, software lifecycle, and risk management.
8. Sample Size for the Training Set
Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for an AI model, there is no ground truth established for one. The device's design and parameters were developed based on engineering principles and compliance with existing standards.
§ 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).