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For VMS-(Pulsed Mode, Burst 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), Symmetrical Biphasic (TENS), and HAN

• Symptomatic relief or management of chronic, intractable pain
• Post-traumatic acute pain
• Post-surgical acute pain

For DC Continuous Mode

• Relaxation of muscle spasm

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 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 EMG

• To determine the activation timing of muscles for:
• Retraining of muscle activation
• Coordinating 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 Ultrasound
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

• Relief of pain, muscle spasms and joint contractures
• Relief of pain, muscle spasms and joint contractures that may be associated with :
• -Adhesive capsulitis
• Bursitis with slight calcification
• -Myositis
• Soft tissue injuries
• Shortened tendons due to past injuries and scar tissues
• Relief of sub-chronic and chronic pain and joint contractures resulting from:
• Capsular tightness
• Capsular scarring

For Infrared Lamp (laser)
To provide topical heating for the following:

• Temporary increase in local blood circulation
• Temporary relief of minor muscle and joint aches, pains and stiffness
• Relaxation of muscles
• Temporary relief of muscle spasms
• Temporary relief of minor pain and stiffness associated with arthritis

The Vectra Neo Clinical Therapy System is an electrotherapy product offering clinicians a modular design of muscle stimulation, ultrasound, laser and biofeedback modalities in one combination device. The Vectra Neo Clinical Therapy System is designed to give the most treatment options in one compact and integrated package.

The electrotherapy mode offers one of the largest selections of multiple waveforms cleared to market by FDA. The numeric pain scales can be recorded with the patient data management system. The therapy system cart provides three storage drawers to conveniently house clinical essentials. The leadwire management system allows for easy, quick access in an uncluttered arrangement.

The electrotherapy module offers 12 waveforms: Interferential, Premodulated (IFS), Asymmetrical Biphasic (TENS), Microcurrent, VMS, VMS Burst, VMS FR, Russian, High Voltage Pulsed Current, Symmetrical Biphasic (TENS), Direct Current, and HAN (TENS). The Vectra Neo Clinical Therapy System allows to sequence these waveforms for ease of use.

The Neo ultrasound module is dual frequency (1 MHz and 3.3 MHz) with selectable duty cycles of 10%, 20%, 50% and 100%, low BNR (5.0:1) {FDA method of measurement), pulse frequency 100Hz and selectable pulse durations of 1 mSec, ±20%; 2 mSec, ±20%; 5 mSec, ±20%.

The laser therapy module is indicated for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relaxation of muscles, temporary relief of muscle spasms, temporary relief of minor pain and stiffness associated with arthritis.

The sEMG biofeedback module provides two channels of surface EMG. Feedback can be stored onto a USB Thumb Drive. 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.

Online guided assistance is provided through Clinical Protocol Setup and On-Screen Indications to help guide therapy selections for electrotherapy waveform rationale, parameter selections, electrode placement images, laser and ultrasound applicator recommendations.

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 Interferential, Premodulated (IFS), Asymmetrical Biphasic (TENS), VMS, VMS Burst, VMS FR and High Voltage Pulsed Current.

Acceptance Criteria and Study for Vectra Neo Clinical Therapy System

This document outlines the acceptance criteria and the study that demonstrates the Vectra Neo Clinical Therapy System meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Vectra Neo Clinical Therapy System are primarily based on its substantial equivalence to predicate devices, Vectra Genisys (K062354) and Vectra Genisys Laser System (Intelect XT Laser System) (K040662). This equivalence is demonstrated by meeting recognized consensus standards and showing comparable performance characteristics.

• Same fundamental technology.
• Intended for the same target population and clinical environments. | - Indications for Use: The Vectra Neo Clinical Therapy System has the same Indications for Use as the Vectra Genisys (K062354) for electrotherapy (VMS, Russian, Monophasic Hi-Volt, Interferential, Premodulated, Microcurrent, TENS, HAN, DC Continuous Mode, FES, EMG triggered Stim, EMG) and Ultrasound. It also has the same Indications for Use as the Vectra Genisys Laser System (K040662) for Infrared Lamp (laser).
• Fundamental Technology: The device uses the same fundamental technology as the predicate devices, simply combining their functionalities.
• Target Population/Environment: Intended to be used by the same target population and in the same clinical environments. |
  | Safety and Performance (Bench Testing & Compliance) | - Compliance with relevant FDA-recognized international consensus standards for medical electrical equipment, ultrasonic physiotherapy, nerve and muscle stimulators, and laser safety.
• Software validation meeting FDA guidance.
• Usability validation demonstrating safe and effective use.
• Biocompatibility for patient-contacting accessories.
• Outputs (waveforms) comparable to predicate devices. | - Standards Compliance: The device was tested and found to comply with:
  • IEC 60601-1 (basic safety & essential performance)
  • IEC 60601-1-2 (EMC)
  • IEC 60601-2-5 (safety of ultrasonic physiotherapy equipment)
  • IEC 60601-2-10 (performance of nerve and muscle stimulators)
  • IEC 60601-2-22 (safety & performance of surgical, cosmetic, therapeutic & diagnostic laser equipment)
  • IEC 60601-2-57 (safety & performance of non-laser light source equipment)
  • IEC 60825-1 (safety of laser products)
• Software Validation: Software was validated per FDA guidance (May 11, 2005); tests demonstrated software meets design requirements.
• Usability Study: A Summative Validation study supported instructions for use and substantiated acceptability of risks.
• Biocompatibility: Evaluation per ISO 10993-1:2009 – Annex C for new accessories (Patient Remote) and equivalence to predicate materials for others, indicating safety.
• Outputs: Bench performance testing demonstrated the same waveforms and other outputs as predicate devices, passing all verification and validation activities. |
  | Minor Differences Impact | - Minor differences (e.g., user interface, updated components) do not raise new issues of safety or effectiveness and do not affect performance or efficacy. | - User interface simplified (16 buttons to 2 buttons + touchscreen), updated modern components, slightly modified outputs.
• These differences are minimal, do not affect performance or efficacy, and could only improve device safety.
• Bench testing confirmed comparable performance despite these changes. |

The study supporting these criteria involves a combination of engineering analysis, software validation, usability testing, biocompatibility assessment, and extensive bench performance testing against recognized standards and predicate device characteristics.

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

The provided 510(k) summary does not detail specific "test set" sample sizes in terms of patient data or clinical trials, as it's a device substantially equivalent to existing predicates.

• Test Sets:

  • Software Validation: The summary states "The software validation tests demonstrated that the software version meets its design requirements." This implies a set of test cases for software functionality, but the number of test cases or the data used for these tests is not quantified.
  • Usability Study: A "Summative Validation" usability study was conducted. Details on the number of participants or specific scenarios are not provided.
  • Bench Performance Testing: The summary mentions "Bench performance testing has demonstrated that the Vectra Neo Clinical Therapy System has the same waveforms and other outputs as the predicate devices and has passed all verification and validation activities." This would involve testing specific device parameters (e.g., BNR, ERA, frequencies, output power for ultrasound applicators, and various waveform outputs for electrotherapy) against their specifications and comparison with predicate data. No specific sample size for these tests (e.g., number of devices tested, number of measurements taken) is given, but it is implied to be sufficient for verification and validation.
  • Biocompatibility: For new accessories like the Patient Remote, a literature review was conducted and compared to existing predicate device materials. This is a review-based approach rather than a direct physical 'test set' sample size.

• Data Provenance: Not applicable in the context of a substantial equivalence submission relying primarily on bench testing, software validation, and a usability study for a therapy system. The data is generated internally by the manufacturer through testing and development processes. It is generally prospective relative to the device development but not retrospective clinical data. The document does not mention any country of origin for clinical data as no clinical trials were presented.

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

• Software Validation: Ground truth is established by the documented software design requirements and specifications, which are typically developed by qualified software engineers and systems engineers. The number of such experts is not specified.
• Usability Study: A "Usability Study" was conducted. The "ground truth" for usability is typically established via human factors engineering principles and user feedback (often healthcare professionals or simulated patients). The number and qualifications of experts involved in designing the study, observing users, and interpreting results are not provided.
• Bench Performance Testing: The "ground truth" for technical performance parameters (e.g., BNR, ERA, waveform output) is established by recognized international standards (e.g., IEC 60601 series, IEC 60825-1) and the specifications of the predicate devices. The engineers and technicians conducting these tests are qualified in electrical engineering, biomedical engineering, and quality assurance. Their specific number and detailed qualifications are not disclosed in the summary.
• Biocompatibility: The "ground truth" for biocompatibility is established by ISO 10993-1:2009. Experts in material science and toxicology would be consulted or involved in the literature review process to assess material safety.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used in clinical studies for interpretation of imaging or clinical endpoints by multiple readers. This type of adjudication is not applicable to the testing performed for the Vectra Neo Clinical Therapy System as described in the 510(k) summary. The testing consists of:

• Software Validation: Automated and manual testing against documented requirements.
• Usability Study: Observation and data collection from users performing tasks, with analysis against predefined success criteria. Not an adjudication of a clinical outcome.
• Bench Testing: Objective measurements against engineering specifications and international standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was performed or cited in this 510(k) submission. MRMC studies are typically done for diagnostic imaging devices where multiple human readers interpret cases, often with and without AI assistance, to assess the AI's impact on diagnostic accuracy, sensitivity, and specificity. The Vectra Neo Clinical Therapy System is a therapeutic device, not a diagnostic one, and its equivalence was established through technical and performance comparisons with predicate devices and compliance with safety standards, rather than through comparative clinical effectiveness studies with human readers.

6. Standalone Performance Study

Yes, standalone performance (i.e., algorithm only without human-in-the-loop performance) studies were done for various aspects of the device:

• Software Validation: The software was validated as a standalone component to meet its design requirements.
• Bench Performance Testing: The device's various modules (electrotherapy, ultrasound, laser) were tested for their inherent performance characteristics (e.g., waveform accuracy, output power, BNR, ERA) against specifications and international standards. This demonstrates the device's capability to operate as intended independent of human interaction for its core therapeutic functions.
• Biocompatibility: The materials used in patient-contacting accessories were evaluated in standalone fashion (via literature review and comparison to established materials).

7. Type of Ground Truth Used

The ground truth used for demonstrating the device's performance and safety is multifaceted:

• Predicate Device Specifications: The technical specifications and established safety/efficacy profiles of the Vectra Genisys (K062354) and Vectra Genisys Laser System (K040662) serve as a primary ground truth for equivalence.
• International Consensus Standards: Recognized standards such as the IEC 60601 series, IEC 60825-1, and ISO 10993-1 provide objective, independently established ground truth for safety, essential performance, and biocompatibility.
• Internal Design Requirements: For software and specific hardware functions, the manufacturer's own detailed design requirements and specifications served as the ground truth for verification and validation.

No pathology, clinical outcomes data, or expert consensus (in the sense of clinical diagnostic agreement) was explicitly used or required for this 510(k) submission, as it relies on substantial equivalence to previously cleared devices through technical and performance testing.

8. Sample Size for the Training Set

Not applicable/Not mentioned.

The Vectra Neo Clinical Therapy System is a physical therapy device and not an AI/ML-driven diagnostic or predictive algorithm that typically requires a "training set" of data to learn patterns. The summary describes a system with pre-programmed waveforms, fixed ultrasound parameters, and biofeedback capabilities. There is no indication of machine learning or adaptive algorithms that would require a distinct "training set" of data in the conventional sense.

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

Not applicable/Not mentioned.

As there is no mention of a "training set" for an AI/ML algorithm, the method for establishing its ground truth is not relevant to this submission. The "ground truth" for the device's functionality is established by its engineering design specifications, compliance with international standards, and comparison with predicate device performance, as detailed in section 7.

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The MyoTrac Infiniti system is indicated for the ongoing treatment of the following conditions: Relaxation of Muscle Spasms, Prevention of disuse atrophy, increasing local blood circulation, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion and Stroke Rehab by Muscle re-education. It is also used for Relaxation & Muscle Re-Education purposes.

The MyoTrac Infiniti device is an electrical muscle stimulator for contraction of muscles as indicated below. The MyoTrac Infiniti is also an electromyography device. It is intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves and to monitor and display the electrical activity produced by nerves. The indications for use are muscle re-education, relaxation and biofeedback.

Here's an analysis of the provided text regarding the MyoTrac Infiniti System, focusing on acceptance criteria and supporting studies:

This 510(k) premarket notification (K053266) for the MyoTrac Infiniti System does not contain specific acceptance criteria or a dedicated study designed to prove the device meets such criteria in the conventional sense of a clinical trial demonstrating performance metrics against quantitative thresholds.

Instead, the submission focuses on substantial equivalence to predicate devices. The "performance data" section primarily refers to non-clinical tests verifying product specifications, system validation, safety, and EMC testing, along with biocompatibility assessments of electrodes. The core argument for equivalence is a direct comparison of functional and hardware specifications with legally marketed predicate devices.

Therefore, many of the requested categories within your prompt cannot be directly answered from the provided text. I will address what is available and indicate when information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit "acceptance criteria" (e.g., "sensitivity > X%", "accuracy > Y%") are not presented in this 510(k) summary. The "performance" is demonstrated through substantial equivalence to predicate devices based on technical specifications and safety testing.

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

• Sample Size for Test Set: Not applicable. This document describes a 510(k) submission for substantial equivalence based on technical comparisons and non-clinical testing, not a clinical study with a "test set" of patient data.
• Data Provenance: Not applicable for a patient data test set. The data provenance for component testing (e.g., biocompatibility) would be laboratory testing reports.

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

• Not applicable. There is no clinical "test set" with ground truth established by experts discussed in this submission.

4. Adjudication Method for the Test Set

• Not applicable. There is no clinical "test set" requiring an adjudication method.

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

• No. This device is a biofeedback and muscle stimulation system, not an AI-assisted diagnostic tool that would typically undergo an MRMC study with human readers interpreting results.

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

• This device is not an algorithm-only medical device. It is a physical medical device (stimulator and biofeedback unit) used with human-in-the-loop operation.
• The "standalone performance" is addressed by the comparison of its technical specifications to predicate devices and verification of its own product specifications.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• For the purpose of this 510(k) submission, the "ground truth" for proving substantial equivalence is the technical specifications and established safety/effectiveness profiles of the predicate devices, along with the results of internal non-clinical tests (verification, validation, safety, EMC). There is no patient-reported outcomes, pathology, or expert consensus used to establish ground truth for a novel performance claim in this documentation.

8. The Sample Size for the Training Set

• Not applicable. This device does not employ an AI algorithm requiring a "training set" of data.

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

• Not applicable, as there is no training set for an AI algorithm.

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