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510(k) Data Aggregation
(200 days)
The Visionbody System is a device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
The Visionbody System is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the training programs or operational parameters are designed or ailing muscles and its use on such muscles is contraindicated.
The Visionbody System's electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the muscle fibers via the motor endplate where they generated 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 Visionbody System is a wireless electrical muscle stimulation device for health and fitness applications. The main components are the Visionbody Box, the Visionbody Software and the choice of a Visionbody garment, whether a Visionbody Powersuit, Visionbody PowerPants or Visionbody Power Vest, dependent on a user's personal choice and needs. The Visionbody Box delivers a safe low to mid frequency electrical current to the electrodes in a Visionbody garment. The Visionbody uses electrical muscle stimulation (EMS) and electrical muscle activation (EMA) technologies to provide a streamlined approach to a user's fitness goals, especially regarding body composition, strength and endurance. Underlying to both these technologies are safe electrical impulses, which stimulate muscle contractions equating to muscle workouts.
The provided text is a 510(k) Summary for the Visionbody system, a powered muscle stimulator. It details a comparison with a predicate device (Katalyst Training System Model 1) and two reference devices (FM-B2403A EMS and R-E1 EMS).
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner as one might find for diagnostic performance (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly demonstrated through compliance with various safety and performance standards and by showing substantial equivalence to a legally marketed predicate device.
The "reported device performance" is primarily the device's compliance with safety standards and its functional characteristics. The comparison table directly addresses this.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Visionbody®) | Comparison to Predicate/Reference |
|---|---|---|---|
| Intended Use | Stimulate healthy muscles to improve/facilitate muscle performance; for adults only; not for therapy/medical conditions. | Same as predicate. | Similar |
| Classification | Class II, Powered muscle stimulator (21 CFR 890.5850), Product Code NGX. | Class II, Powered muscle stimulator (21 CFR 890.5850), Product Code NGX. | Similar |
| Compliance with Voluntary Standards | Compliance with relevant IEC and ISO standards for electrical safety, EMC, and biocompatibility. | Yes (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-1, ISO 10993-5, ISO 10993-10, IEC 62366). | Similar to predicate (both comply with core electrical safety and EMC standards). |
| Software Level of Concern | Moderate (failure leads to delayed medical care). | Moderate level of concern. | Not directly compared, but implies software validation and verification successfully addressed this. |
| Maximum Output Voltage | Within safety limits of IEC 60601-2-10. | 60 V @ 500Ω, 60 V @ 2kΩ, 60 V @ 10kΩ | Lower than predicate (Katalyst: 60 V @ 500 Ω, 100 V @ 2 kΩ, 100 V @ 10 kΩ). Deemed safe as both comply with IEC 60601-2-10 limits. |
| Maximum Output Current | Within safety limits of IEC 60601-2-10. | 120 mA ±10% @ 500Ω, 30 mA ±10% @ 2kΩ, 6 mA ±10% @ 10kΩ | Similar to predicate @ 500Ω (Katalyst: 120 mA @ 500 Ω). Lower than predicate @ 2kΩ and 10kΩ. Deemed safe/effective. |
| Pulse Width | Acceptable range for muscle stimulation. | 150 - 500 µs | Different from predicate (Katalyst: 250 - 375 µs). Both support adjustable pulse width, within acceptable ranges. |
| Frequency Range | Acceptable range for muscle stimulation. | 4 - 100 Hz | Similar to predicate (Katalyst: 5 - 105 Hz) and reference devices (R-E1: 1-110 Hz, FM-B2403A: <199 Hz). |
| Maximum Phase Charge | Within safety limits. | 30 µC @ 500 Ω | Lower than predicate (Katalyst: 45 µC @ 500 Ω). Similar to reference devices (R-E1: 22.8µC@500 Ohm, FM-B2403A: 35uC@500 Ohm). Deemed safe. |
| Maximum Current Density | Within safety limits. | 2.17 mA/cm² @ 500 Ω | Higher than predicate (Katalyst: 1.15 mA/cm² @ 500Ω). Similar to reference device R-E1 (2.4 mA/cm²), and higher than FM-B2403A (0.5645 mA/cm²). Deemed safe as it's comparable to other cleared devices. |
| Maximum Power Density | Within safety limits. | 6.52 mW/cm² @ 500Ω | Lower than predicate (Katalyst: 22.68 mW/cm² @ 500Ω). Deemed safe. |
| Safety Features | Comprehensive safety mechanisms. | Short-circuit, watchdog, no-load, overload trip, output current, connector, battery voltage, hardware error/manipulation monitoring, integrity/authenticity checking of binary code. | More detailed list than predicate (Katalyst only lists no-load trip, overload trip, no more publicly available). Implies enhanced safety. |
| Effectiveness | Performs comparably to predicate. | Demonstrated comparable performance. | No new questions raised regarding effectiveness due to similar intended use, functionality, operating principle, and comparable stimulation parameters to cleared devices. |
Summary of the study that proves the device meets the acceptance criteria:
The study is a non-clinical product evaluation intended to demonstrate safety and effectiveness for substantial equivalence. It is primarily a comparison of technical characteristics and compliance with recognized standards rather than a traditional clinical trial or performance study with a test set of data.
2. Sample size used for the test set and the data provenance
There is no mention of a "test set" in the context of human data or any specific patient or subject data being used for device performance evaluation in this document. The evaluation is based on non-clinical testing of the device itself against established engineering and safety standards, and a comparative analysis against predicate and reference devices' technical specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As there is no human "test set" or diagnostic evaluation mentioned, there is no ground truth established by experts in that context. The "truth" here is compliance with technical specifications and safety standards.
4. Adjudication method 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. This device is a powered muscle stimulator, not an AI-powered diagnostic imaging system that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The term "standalone" typically refers to the performance of an AI algorithm independent of human input or review. While the Visionbody system has software, its purpose is to control electrical muscle stimulation, not to perform diagnostic or interpretative tasks where "standalone" performance metrics for AI would apply. The device's "standalone" performance would be its functional operation in stimulating muscles according to its programmed parameters, which was evaluated through performance testing.
The document states: "Software verification and validation testing were conducted on the Visionbody system and documentation was provided as recommended by FDA's Guidance... The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw in the software would lead to a delayed delivery of appropriate medical care." This confirms standalone software testing was performed to ensure its functionality and safety.
7. The type of ground truth used
The ground truth used for this type of device (a powered muscle stimulator) is primarily:
- Compliance with recognized international standards: Electrical safety (IEC 60601-1, IEC 60601-2-10), Electromagnetic Compatibility (IEC 60601-1-2), Biocompatibility (ISO 10993 series), and Usability/Risk Management (IEC 62366).
- Manufacturer's own requirements and specifications: Performance testing verified the device against its own design requirements.
- Predicate device characteristics: Similarity to a legally marketed predicate device (Katalyst Training System Model 1) serves as a benchmark for substantial equivalence in safety and effectiveness.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a "training set" of data in the typical sense for model development. The software is for device control, not for learning or prediction based on data.
9. How the ground truth for the training set was established
Not applicable.
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(292 days)
The device is intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities. It is also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis. Environments of Use: Clinics, hospital and home environments Patient Population: Adult
The PM710 is a wearable electrotherapy device that is designed to alleviate chronic, acute and arthritic muscle leg pain. It delivers TENS (Transcutaneous Electrical Nerve Stimulation) technology through the simple, convenient control on the main unit. The reusable, self-adhesive contouring pads allow for discreet and convenient placement on the pain locations below the knee. The device contains one main TENS unit which is rechargeable and can be attached to a single sized gel and a medium or large band (model number follow by "-M" / "-L") which helps to attach the device to the leg. The pad with attached TENS unit can then be applied to intact skin at the desired location below the knee for therapy and pain relief. Control of the PM710 TENS system is through the control buttons on the main unit and the intensity of the therapy is displayed by the Intensity Level Indicators during treatment. The PM710 will be packaged with an Instruction Manual which provides details on setting up the device for use, setting and controlling intensity levels, and troubleshooting. The system accessories include one charger, one AC adapter for the charger, and one pad holder and storage case.
Here's a summary of the acceptance criteria and study information for the Omron Focus TENS Therapy, Model PM710-M/-L, based on the provided FDA 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of "acceptance criteria" against which a clinical study's performance metrics are directly compared. Instead, it demonstrates substantial equivalence through extensive non-clinical testing and comparison of technological characteristics with predicate and reference devices. The "performance data" provided refers exclusively to these non-clinical tests.
However, based on the comparison tables, we can infer some "performance criteria" that the device implicitly meets by matching or being within acceptable ranges of the predicate and reference devices.
| Feature/Parameter | Acceptance Criteria (Inferred from Predicate/Reference) | Reported Device Performance (Omron Focus TENS PM710-M/-L) |
|---|---|---|
| Classification Regulation | 21 CFR§882.5890, Transcutaneous electrical nerve stimulator for pain relief | 21 CFR§882.5890, Transcutaneous electrical nerve stimulator for pain relief |
| Product Code | NUH and NYN (Transcutaneous electrical nerve stimulator for pain relief) | Primary: NUH, Secondary: NYN |
| Indications for Use | Relief of pain associated with sore or aching muscles (lower back, arms, legs, shoulders, or feet) due to strain from exercise or normal household work activities; symptomatic relief and management of chronic, intractable pain, and relief of pain associated with arthritis. The Quell reference device also includes temporary relief of pain associated with sore and aching muscles in the lower extremities due to strain from exercise or normal household and work activities, and symptomatic relief and management of chronic intractable pain. | Intended for the relief of pain associated with sore or aching muscles of the lower extremities (leg) due to strain from exercise or normal household work activities. Also intended for the use of symptomatic relief and management of chronic, intractable pain associated with arthritis. (Narrower than Avail but similar to Quell for lower extremities and chronic pain/arthritis). |
| Environments of Use | Clinics, hospital, and home environments (for predicate Avail and implied for other TENS devices) | Clinics, hospital, and home environments |
| Patient Population | Adult | Adult |
| Contraindications | Avoid use with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices. | Same as predicate and reference devices regarding cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices. |
| Electrical Parameters | Output parameters within the range of predicate Avail device, and within IEC60601-2-10:2012 (Clause 201.4.2) limit of <2mA/cm² for current density. Waveforms should achieve similar therapeutic outcomes. | Max current density: 0.97 mA/cm² (well below 2 mA/cm² limit). Max average power density: 7.59x10⁻³ W/cm². Waveform: Biphasic Rectangular. Pulse Duration: 60 µsec. Frequency: 1-250 Hz. Net Charge: 0 µC per pulse. |
| Treatment Duration | Selectable time ranges for TENS therapy, commonly 5-60 minutes, or 30-180 minutes, with reference devices offering 30 or 60 minutes. | Fixed timer duration for 30 minutes. (Matches R-T1 reference, within predicate range). |
| Safety Standards | Compliance with ES 60601-1, IEC60601-1-2, IEC60601-2-10, IEC 60601-1-11. | ES 60601-1, IEC60601-1-2, IEC60601-2-10, IEC 60601-1-11. |
| Biocompatibility | Patient-contacting components must demonstrate biocompatibility. | Tested to demonstrate biocompatibility. |
| Software/Firmware | Verification and validation to ensure the device performs as intended. | Software verification and validation completed. |
2. Sample Size for Test Set and Data Provenance
The submission explicitly states: "Clinical testing was not performed to support this 510(k) submission." Therefore, there is no "test set" in the context of clinical data, no sample size, and no data provenance for a clinical test set. The evaluation relies entirely on non-clinical (bench) testing and comparison to legally marketed predicate devices.
3. Number of Experts and Qualifications for Ground Truth of Test Set
Not applicable, as no clinical test set was used to establish ground truth in this submission.
4. Adjudication Method for Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done, as traditional clinical studies were not performed. The submission does not discuss human reader improvement with or without AI assistance as this is a TENS device, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a medical device, not an AI algorithm. Its performance is evaluated through its physical and electrical characteristics as a TENS unit.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on engineering specifications, adherence to international and national standards (e.g., IEC 60601 series), and the demonstrated performance of legally marketed predicate and reference TENS devices. The "truth" is that the device's electrical outputs and functional characteristics are safe and effective by being substantially equivalent to these established devices.
8. Sample Size for the Training Set
Not applicable, as no AI model or learning algorithm is described, and no clinical "training set" was used. The device is a TENS unit, not a machine learning system.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned in the submission.
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