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For VMS-(Pulsed Mode, Burst Mode or FR Mode), Russian, Monophasic Hi-Volt (NMES) & Interferential and Premodulated (IFS)
Relaxation of Muscle Spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Maintaining or increasing range of motion
Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
Additionally for Microcurrent, Interferential, Premodulated (IFS), VMS-(Pulsed Mode, Burst Mode or FR Mode), Asymmetrical Biphasic (TENS), and Symmetrical Biphasic (TENS)
Symptomatic relief or management of chronic, intractable pain
Post-traumatic acute pain
Post-surgical acute pain
For FES
Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait
For DC Continuous Mode
Relaxation of muscle spasm
For EMG
To determination the activation timing of muscles for:
a) retraining of muscle activation
b) coordination of muscle activation
An indication of the force produced by muscle for control and maintenance of muscle contractions
Relaxation muscle training
Muscle re-education
For EMG triggered Stim
Stroke rehab by muscle re-education
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increase local blood circulation
Muscle re-education
Maintaining or increasing range of motion
For Ultrasound
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

1. Relief of pain, muscle spasms and joint contractures
2. Relief of pain, muscle spasms and joint contractures that may be associated with:
   a) Adhesive capsulitis
   b) Bursitis with slight calcification
   c) Myositis
   d) Soft tissue injuries
   e) Shortened tendons due to past injuries and scar tissues
3. Relief of sub-chronic and chronic pain and joint contractures resulting from:
   a) Capsular tightness
   b) Capsular scarring

Vectra Genisys electrotherapy product lines offer clinicians a modular design of muscle stimulation, ultrasound, and biofeedback modalities in one combination device. These clinical product lines are designed to give the most treatment options in one compact and integrated package. The award winning design offers a 5 inch TFT LCD vibrant color display screen and hand held accessories.
Clinicians have a variety of choices to best suit the needs of the individual practice. Below is an overview of the system choices. The electrotherapy mode offers one of the largest selections of multiple waveforms cleared to market by the FDA. The numeric pain scales can be recorded with the patient data management system. The therapy system cart provides six concealed storage bins to conveniently house clinical essentials.
The electrotherapy module offers multiple waveforms; Interferrential, Premodulated, Asymmetrical Biphasic, Microcurrent, VMS-(Pulsed Mode, Burst Mode, and FR Mode), Russian, High Voltage Pulsed Current, Symmetrical Biphasic, Direct Current.
The dual frequency ultrasound module offers Pulsed and Continuous Duty Cycles (10%, 20%, 50%, and 100%), Low BNR (5:1), Four different size ultrasound applicators, 1cm², 2cm², and 10 cm².
The sEMG biofeedback module provides two channels of surface EMG. Feedback can be stored onto the sEMG Data Card. The sEMG features a clinician chosen trigger point that activates therapeutic stimulation. The sEMG feature is often used to treat stroke patients and for muscle re-education.
The online-guided assistance through Clinical Protocols and On-Board Indications to help guide therapy selections: electrotherapy waveform rationale, parameter selections, electrode placement images, ultrasound applicator recommendations.
The combination electrotherapy is used for the management of pain and muscle spasm. All functions of 1 or 3.3 MHz Ultrasound can be combined with Interferrential, Premodulated, Asymmetrical Biphasic, VMS-(Pulsed Mode, Burst Mode, ), and High Voltage Pulsed Current.

The provided text is a 510(k) premarket notification summary for the Vectra Genisys device. It describes the device, its intended uses, and declares conformity to safety standards. However, it does not contain information about acceptance criteria, efficacy studies, or performance data in the way typically expected for demonstrating AI/software performance.

The 510(k) process for a device like Vectra Genisys, which is an electrotherapy and ultrasound combination device, primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove new effectiveness claims. The "study" mentioned below refers to the comparison with predicate devices and compliance with recognized standards for safety and performance of such devices, not a study evaluating an AI algorithm's performance.

Therefore, many of the requested fields cannot be answered from the provided text.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not specify quantitative acceptance criteria or detailed performance metrics for the Vectra Genisys device. The primary "acceptance criteria" for 510(k) clearance in this context are demonstrating:

1. Substantial Equivalence: The device is as safe and effective as a legally marketed predicate device.
2. Compliance with Recognized Standards: The device meets relevant electrical and medical device safety and EMC standards.

• Same intended use.
• Same technological characteristics (or differences don't raise new safety/effectiveness questions). | The device's indications for use (muscle stimulation, pain relief, ultrasound therapy, biofeedback) are consistent with its predicate devices (Omnistim FX2 and Omnistim FX2 Pro).
  The technical description of waveforms, ultrasound modules, and sEMG biofeedback aligns with established technologies for these types of devices. |
  | Compliance with Recognized Consensus Standards for Safety and EMC:
• UL 60601-1
• IEC 60601-1-2 | The submitter declares conformity to:
• UL 60601-1: 2003 (Medical Equipment Part 1: General Requirements for Safety, 1st Edition)
• IEC 60601-1-2: 2001 (Medical Electrical Equipment Part 1 - 2: General requirements for Safety - Collateral Standard, Electromagnetic Compatibility - Requirements and Tests, 2nd Edition) |
  | Manufacturing Quality System Compliance | Implied by the 510(k) clearance, which assumes adherence to Good Manufacturing Practices (21 CFR Part 820). No specific performance statistics are reported related to manufacturing quality itself within this summary. |

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided in the 510(k) summary. Given the nature of a conventional electrotherapy/ultrasound device 510(k), it's highly unlikely that a "test set" in the context of an AI/software performance evaluation would have been used. The submission focuses on technical specifications, safety, and equivalence to predicates, not novel clinical data generation for efficacy in a study with a test set of patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable/provided. There is no indication of a test set requiring expert-established ground truth within this 510(k) submission.

4. Adjudication Method for the Test Set

This information is not applicable/provided. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not applicable/provided. An MRMC study is relevant for evaluating human reader performance, often with and without AI assistance for interpretation. The Vectra Genisys is a direct treatment device, not an imaging interpretation or diagnostic AI tool, so such a study would not typically be part of its 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This information is not applicable/provided. The Vectra Genisys is a physical medical device that delivers therapies (electrotherapy, ultrasound, biofeedback), not a standalone algorithm. Its performance is tied to the physical delivery specifications and safety, not an independent algorithm's output.

7. The Type of Ground Truth Used

This information is not applicable/provided. As there is no described performance study requiring ground truth for clinical efficacy, this concept is not relevant to the provided 510(k) summary. The "ground truth" for this type of device's 510(k) clearance primarily relates to its manufacturing documentation, compliance with standards, and comparison to its predicate device's established safety and effectiveness.

8. The Sample Size for the Training Set

This information is not applicable/provided. The device does not appear to employ machine learning or AI that would require a "training set" in the typical sense for algorithm development and validation.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided. No training set or associated ground truth establishment is mentioned or relevant to this 510(k) submission.

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