(255 days)
Ion Magnum Genius is intended for muscle conditioning to stimulate healthy muscles. The Ion Magnum Genius is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Ion Magnum Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Ion Magnum Genius is only offered under prescription given by a physician licensed in the state in which he or she practices.
Ion Magnum Genius is a muscle stimulator with six ports and one output that is the same for all ports. The unit is designed for healthy men & women to provide muscle conditioning. Ion Magnum Genius stimulator provides selections of different programs through manual adjustment of the three different frequencies of the device, 90 Hz, 100 Hz which are within the same range as the predicate that offer a range from 1-120 Hz. The setting that the frequency button is turned shows which frequency the device is set on. The device delivers a voltage of 50 volts at 500 Ohms load and 100ma just like the predicate. It delivers a voltage of 200 volts at 10K Ohms just like the predicate. The Ion Magnum maximum output current is 100 ma which is equivalent to the maximum output current of the predicate. The Ion Magnum has a maximum output current of 200 volts which is equivalent to the maximum output current of the predicate. The device primarily treats abdominal muscles (ABS). LCD shows the balance treatment time. The output signal is biphasic, rectangular and based on a voltage and current regulated technology. The unit is easy and simple to use. Ion Magnum is suitable for use by all healthy adults. However as with other muscle stimulators some care is needed when using the Ion Magnum Genius [see contraindications and warnings in manual]
The provided text describes a 510(k) premarket notification for the "Ion Magnum Genius" muscle stimulator, asserting substantial equivalence to a predicate device, the "Compex Sport" (K01180). This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than conducting new clinical trials to prove efficacy from scratch. Therefore, the document does not describe a study that proves the device meets specific acceptance criteria in the way a clinical trial would. Instead, it focuses on demonstrating equivalence to a known device.
However, I can extract the relevant information from the document that functions as acceptance criteria for demonstrating that the device is "substantially equivalent" and the "reported device performance" to meet those criteria.
Here's a breakdown of the information requested, based on the provided document:
Acceptance Criteria and Device Performance (Demonstration of Substantial Equivalence)
Since this is a 510(k) submission, the "acceptance criteria" are effectively the characteristics of the predicate device, and the "reported device performance" is how the Ion Magnum Genius compares to these characteristics to establish substantial equivalence.
1. Table of acceptance criteria and the reported device performance:
| Feature/Criterion (Based on Predicate Device: Compex Sport K01180) | Ion Magnum Genius Performance/Characteristic |
|---|---|
| Indications for Use: Muscle conditioning to stimulate healthy muscles; not for therapy/treatment of medical conditions; not for injured/ailing muscles. | Identical: Muscle conditioning to stimulate healthy muscles; not for therapy/treatment of medical conditions; not for injured/ailing muscles. Prescription use only, administered by a trained physician. |
| Waveform: Biphasic synchronous | Biphasic synchronous |
| Synchronous or alternating channels: Synchronous | Synchronous |
| Max Output Voltage: 50V @ 500 Ω, 200V @ 10k Ω | 50V @ 500 Ω, 200V @ 10k Ω |
| Max Output Current: 100 mA at 500 Ohms | 100 mA at 500 Ohms |
| Frequency (Hz) for Muscle Conditioning: 1-120 Hz | 90 Hz, 100 Hz, 120 Hz (within range) |
| Pulse Duration: 200 to 400 µsec | 416 - 500 µsec |
| Pulse Width: 200 to 400 µsec | 416 - 500 µsec |
| Maximum Phase Charge: 40 µC | 50 µC @ 500 Ω (90/100 Hz); 40 µC @ 500 Ω (120 Hz) |
| Maximum Current Density: 4 mA/cm2 | 4 mA/cm2 |
| Maximum Power Density: 0.038 W/cm^2 | 0.0012 W/cm^2 |
| Current or Voltage Driven: Current Driven / Voltage | Current Driven / Voltage |
| Symmetrical Phases of Waveform: Yes | Yes |
| Regulated Current/Voltage: Constant Current Regulator / Regulated Current | Regulated Voltage and Regulated Current |
| Method of Channel Isolation: Channels isolated by separated transformers | Channels isolated by separated transformers |
| Self-Adhesive Electrodes: Identical | Identical (Axelgaard type, K970426) |
| Current Leakage: >100 microamps (implied predicate limit) | 0.07 µA (demonstrates improved safety here) |
| Software/Microcomputer Control: Yes | No (different, but argued not to affect safety/effectiveness) |
| Number of Channels: 4 | 6 (different, but argued equally safe via risk assessment) |
| Safety Features: Automatic overload trip, automatic shut-off, patient override control, wire insulation/gap design. | Automatic overload trip, automatic shut-off, patient override control, increased wire insulation/gap (9mm). |
| ISO Certification for Manufacturing: Not explicitly stated for predicate in comparison table. | ISO 13485:2003 for muscle stimulators (2011-2014) |
| Bench Tests prior to release: Not explicitly stated for predicate. | Extensive bench tests prior to each unit release. |
Missing Information (Not provided in the document for this type of submission):
The following information is typically associated with clinical trials or specific performance studies, which are generally not required for a 510(k) submission when substantial equivalence is established through comparison to a predicate device. The document does not describe such studies.
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 as no clinical test set is described. The comparison is primarily based on technical specifications and claims of physical characteristics.
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. Ground truth, in the context of clinical studies, is not established for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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, as this device is a muscle stimulator, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this device is a physical muscle stimulator and does not involve "algorithm only" performance separate from its physical application. The entire device performance is akin to "standalone" in that it performs its function. Some technical bench tests are mentioned (e.g., current leakage, electrical outputs) but these are for device specification verification, not a clinical efficacy trial.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the clinical sense. The "ground truth" here is the technical specifications and established safety/efficacy profile of the predicate device. The Ion Magnum Genius demonstrates "truth" by having equivalent (or improved, i.e., current leakage, safety design changes) technical specifications.
8. The sample size for the training set
- Not applicable, as no machine learning/AI training set is described.
9. How the ground truth for the training set was established
- Not applicable.
Summary of "Proof" in a 510(k) Context:
The "study that proves the device meets the acceptance criteria" in this 510(k) submission is the comprehensive comparison table and discussion of technological characteristics and intended use against the predicate legally marketed device. The manufacturer (Ion Genius, Inc.) asserts and demonstrates through specification comparison, and in some cases, risk assessment (e.g., for 6 channels vs. 4), that the Ion Magnum Genius is substantially equivalent to the Compex Sport, which is legally marketed and presumed safe and effective for its intended use. The FDA's issuance of the 510(k) clearance (K123158) confirms this finding of substantial equivalence based on the provided information.
§ 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).