(296 days)
I-MOTION intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The I-MOTION is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the I-MOTION training programs is designed for injured or ailing muscles and its use on such muscles is contra indicated.
I-MOTION 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.
I-MOTION electrical impulses allow the triggering o faction potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the motor end plate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
The device described in this submission is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training performances. None of I-MOTION training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.
I-MOTION is a device for electronic muscle stimulation based on EMS technology. As for its use, the device is specifically designed as a complement to other sports and to train muscles. It must be used only for healthy muscles and clients, not for rehabilitation purposes. The device must be worn over the user's cotton underwear, the electrodes do not come into direct contact with the client. The I-MOTION System cannot be used while the user is moving or lifting weights.
This document describes the I-Motion and I-Motion Fit powered muscle stimulators and their substantial equivalence to a predicate device (WIEMSpro, K181955). However, the provided text does not contain any information about a clinical study or performance data that would directly address acceptance criteria for a new AI/medical device, as typically seen in submissions requiring clinical validation (e.g., for diagnostic AI).
Instead, this is a 510(k) Premarket Notification summary for a Class II medical device (Powered Muscle Stimulator). For this type of device and submission, the primary method of demonstrating safety and effectiveness is through a comparison to a legally marketed predicate device and non-clinical testing (e.g., electrical safety, electromagnetic compatibility, functional tests). It explicitly states: "Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence." and "We did not use any new technology in this system...".
Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of typical AI/diagnostic device validation (e.g., performance metrics, sample sizes, expert ground truth, MRMC studies) is largely not applicable to this specific submission as described.
However, I can extract and present the information that is available in the provided text, reinterpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence based on the comparison to the predicate device and the non-clinical testing.
Device Acceptance Criteria and Performance (Based on Substantial Equivalence to Predicate Device)
Given that this is a 510(k) summary for a powered muscle stimulator demonstrating substantial equivalence to a predicate device, the "acceptance criteria" are implicitly met by showing the new device is as safe and effective as the predicate. This is primarily established through a comparison of technological characteristics and non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details a comprehensive comparison between the I-Motion device and its predicate, the WIEMSpro (K181955). The "acceptance criteria" in this context are the demonstrable similarities or non-significant differences in design, intended use, and performance parameters, alongside compliance with relevant safety standards.
| Characteristic / Feature | Predicate Device (WIEMSpro) | Proposed Device (I-Motion) | Comparison and Performance against "Criteria" (Substantial Equivalence) |
|---|---|---|---|
| General Classification | Powered muscle stimulator (NGX, 21 CFR 890.5850, Class II) | Powered muscle stimulator (NGX, 21 CFR 890.5850, Class II) | Same: Meets the same regulatory classification, indicating similar fundamental characteristics and regulatory pathway. |
| Intended Use & Indications for Use | Stimulate healthy muscles to improve/facilitate muscle performance; not for therapy/treatment of medical conditions/ailing muscles. EMS technology, addition to other sports, training muscles. | Stimulate healthy muscles to improve/facilitate muscle performance; not for therapy/treatment of medical conditions/ailing muscles. EMS technology, addition to other sports, training muscles. | Same/Similar: The core intended use and indications are identical. Minor differences in software application are noted but deemed not to affect safety, efficiency, or functionality. |
| Prescription Use | Prescription only | Prescription only | Same: Both devices are prescription-only. |
| Use Environment | Use in athletic training facilities. Not for use outdoors. | Use in athletic training facilities. Not for use outdoors. | Same: Designed for the same operational environment. |
| Anatomical Sites | Electrodes can be applied to multiple anatomical sites. | Electrodes can be applied to multiple anatomical sites. | Same: Offers the same flexibility in application. |
| Power Source | Battery: 3.7V - 2.4AH (LiPo) | Battery: 2 x 3.7V = 7.4V - 3.4AH (Lithium) | Similar: Minimal differences in battery technical characteristics/performance, not affecting safety, efficiency, or functionality. Both are battery operated. |
| Current / Voltage | 125mA / 62.5V | 90mA / 45V | Similar: Minimal differences in technical characteristics/performance, not affecting safety, efficiency, or functionality. |
| Pulse Duration (Width) | 100-400 µsec | 150-450 µsec | Same: The specified ranges are overlapping or within an acceptable variation for similar function. |
| Frequency | 1-100 Hz | 1-100 Hz | Same: Identical frequency range. |
| Maximum Output Voltage | 170V | 110V | Similar: Minimal differences in technical characteristics/performance, not affecting safety, efficiency, or functionality. |
| Maximum Output Current | 125mA | 90mA | Similar: Minimal differences in technical characteristics/performance, not affecting safety, efficiency, or functionality. |
| Maximum Power Density | 9.61mW/cm² @ 500ohm | 9 mW/cm² @ 500ohm | Similar: Minimal differences in technical characteristics/performance, not affecting safety, efficiency, or functionality. |
| Electrode Type/Application | Silicone conductive electrodes; reusable. Never in direct contact with skin (cotton underwear used). 9 pairs, single muscle group. Sizes: 65 cm², 83 cm². | Conductive fabric, reusable electrodes (not in direct contact with skin). Cotton covers/garments used. 9 pairs, single muscle group. Sizes: 96 cm², 48 cm². | Same/Similar: Both use reusable electrodes not in direct skin contact, utilizing hygroscopic cotton underwear. Differences in exact electrode size are detailed but imply similar functional principle. |
| Connectivity | Lead wires, Stainless steel snap fastener | PIN 2 mm | Similar: Minimal differences in the technical characteristic/performance, not affecting the safety, efficiency, or functionality of the device. |
| Conductivity Medium | 100% hygroscopic cotton underwear soaked/irrigated with normal tap water. | 100% hygroscopic cotton underwear soaked/irrigated with normal tap water. | Same: Identical method for achieving conductivity, ensuring consistent and established safety/efficacy. |
| Software/Firmware/Microprocessor | Yes | Yes | Similar: Minimal differences in technical characteristics/performance, not affecting safety, efficiency, or functionality. The difference is the software application controlling the device, which is stated to not affect safety, efficiency, or functionality. |
| Safety Features | Automatic Overload Trip (Yes), Automatic No-Load Trip (Yes), Automatic Shut Off (On/Off switch), Patient Override Control (Yes, push on On/Off button). Indicator displays (On/Off status, Low Battery, Voltage/Current level). | Automatic Overload Trip (Yes), Automatic No-Load Trip (Yes), Automatic Shut Off (On/Off switch), Patient Override Control (Yes, push on On/Off button). Indicator displays (On/Off status, Low Battery, Voltage/Current level). | Same: All critical safety features and indicators are identical. |
| Compliance with Standards / LAB tests performed | IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-6:2010, IEC 60601-2-10:2012, FCC 47 CFR Part 15, IEC 62304:2006, ISO 14971:2007. | IEC 60601-1:2005 (ed. 3.0) + corrigendum 2006+ corrigendum 2007 + interpretation sheet 2008 + interpretation sheet 2009 + A1:2012, IEC 60601-1-6:2010 (ed.3.0) + A1:2013, IEC 60601-1-2-10:2010 (ed.2.0) + A1:2016, IEC 62304:2006, ISO 14971:2019. | Similar: All corresponding standard norms are complied with. Differences are due to updated versions of the norms, implying continued compliance with current safety and performance requirements. |
Conclusion on "Performance": The document concludes that "None of the differences presented above impact the equivalence of the subject device when compared to the predicate devices." and "There are minimum differences in the technological characteristic/performance... nevertheless, all of them comply with IEC60601-1-2, IEC60601-2-10. Thus, the SE is not affected." This statement serves as the proof that the device "meets the acceptance criteria" for substantial equivalence.
Details on the "Study" (Non-Clinical Testing & Predicate Comparison)
This submission relies on non-clinical data and comparison to a predicate, not a clinical study in the sense of a trial with human subjects for performance evaluation.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (for Non-Clinical Testing): Not explicitly stated as a "sample size" in terms of number of data points or cases. It refers to "Functional laboratory tests conducted under foreseeable operating conditions." These tests would typically be performed on a sample of the manufactured device(s) to verify compliance with standards and functional requirements.
- Data Provenance: The company is I-MOTION GROUP GLOBAL IBERICA S.L., located in Alcorcon, Madrid, Spain. The non-clinical testing was conducted in a laboratory context, and the results were submitted to the FDA (U.S. Food & Drug Administration). The exact location where these lab tests were performed is not specified, but it's presumed to be within a controlled, recognized testing facility. The nature of this submission (510(k)) means it's inherently retrospective in terms of comparing to an already cleared predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable in the typical sense of AI/diagnostic device ground truth. For a powered muscle stimulator 510(k) submission, "ground truth" is established through engineering and safety standards (e.g., IEC 60601 series, ISO 14971, FCC regulations) and verified through robust non-clinical testing conducted by qualified test engineers and laboratories. There isn't a "ground truth" established by human experts reviewing stimulation data or clinical outcomes in this type of submission.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or expert labeling tasks for AI models to resolve discrepancies in human interpretations. Non-clinical engineering tests rely on objective measurements against defined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not performed/Not applicable. This type of study assesses how AI assistance impacts human reader performance (e.g., radiologists interpreting images). The I-Motion device is a muscle stimulator, not an AI-driven diagnostic tool that would typically involve human readers or AI assistance in interpretation. The submission's focus is on direct comparison to a predicate device's established safety and effectiveness.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable in the context of AI performance. The device itself is a "standalone" system in terms of its direct function as a muscle stimulator. Its performance is assessed through its physical characteristics and electrical outputs compared to established standards and the predicate device, not in terms of an algorithm's diagnostic or predictive accuracy. The "software/firmware/microprocessor control" component is acknowledged, and its impact is deemed not to affect safety/effectiveness based on non-clinical tests.
7. Type of Ground Truth Used
- Engineering/Safety Standards and Predicate Device Characteristics: The "ground truth" for this submission is implicitly defined by:
- Compliance with recognized international and national standards for medical electrical equipment (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-10) and risk management (ISO 14971).
- The established safety and effectiveness profile of the legally marketed predicate device (WIEMSpro, K181955).
- Functional requirements and performance specifications derived from the device's intended use as a powered muscle stimulator.
8. Sample Size for the Training Set
- Not applicable. This device is hardware for muscle stimulation. It is not an AI model that requires a "training set" of data for machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI training set, this question is not relevant to the described device.
§ 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).