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The Body System is intended for muscle conditioning to stimulate healthy muscles.

The Body System is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. The Body System is intended to be operated by a trained professional who is present to monitor treatment.

Body System (available in models: SX101 and OS2911). Both models utilize the same internal electrical components. The models differ only in the control/display features and exterior casing/dimensions. The Body System is a Powered Muscle Stimulator with 16 channel ports using self adhesive pad applicators attached to the body for muscle conditioning. The pad applicator is a 510K cleared device (K970426), itself.

The Body System uses the same technological characteristics as the predicate devices (listed below); it is an electrically powered device that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. The Body System muscle stimulators provide selections of different programs through manual adjustment of five different frequency programs of the device from 200 Hz, to 1250 Hz. The Body System has a maximum output voltage of 88V @ 2k Ω, rated at 200 volts. A display shows the balance treatment time. The output signal is biphasic, rectangular and based on a voltage and current regulated technology. All channel outputs are isolated from each other; they have their own transformers and amplifiers which are Independent from neighboring channels or outputs. The only commonality between the outputs are their connectors to the power supply, the start button, the programs button, and the pulse button. The Body System power source is 110 V - 240 V AC Mains, 50-60 Hz. The patient leakage current tested at 240VAC 60Hz is 5 microamps for both the normal and fault conditions. The Body System Channels are synchronous and are isolated by separate transformers.

The provided document is a 510(k) Premarket Notification for the "Body System" device, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical or diagnostic performance through a typical study with acceptance criteria.

Therefore, the information required to answer the prompt (acceptance criteria, study details, expert involvement, ground truth, etc.) is not present in this document. This submission primarily relies on non-clinical performance data (electrical safety, biocompatibility, electromagnetic compatibility) and a comparison of technological characteristics to already cleared devices.

Specifically:

• There are no acceptance criteria listed for clinical or diagnostic performance, as the device is not claiming to diagnose or treat medical conditions, but rather for "muscle conditioning to stimulate healthy muscles."
• There is no study described to prove the device meets performance criteria in the way a diagnostic AI/ML device would, as this is a physical muscle stimulator. The "non-clinical performance data" mentioned refers to engineering and safety tests, not a clinical trial.
• No sample size for test sets or training sets are provided because there isn't a machine learning algorithm being trained or tested for diagnostic performance.
• No experts were used to establish ground truth for any diagnostic test set, as such a test set does not exist for this device's intended use.
• No adjudication method, MRMC comparative effectiveness study, or standalone algorithm performance are discussed.
• No ground truth type is specified, again, because there is no diagnostic or classification task being performed by an algorithm.

The document states:

• "The Body System has been tested to establish is safety and performance. Performed on the The following tests have been performed on the patient contacting parts: Biocompatibility - Cytotoxicity (ISO-10993-5) - result: Pass, Biocompatibility – irritation (ISO-10993-10) – result: Pass, Biocompatibility - Sensitization (ISO-10993-10) - result: Pass. Performance – including Output Waveforms of the Body System as compared to a predicate. Electromagnetic Compatibility - according to EN 60601-1-2:2015, IEC 60601-1-2:2014, IEC 60601-2-10 2012 + A1 2016. Electrical Safety – according to IEC 60601-1-6:2010, AMD1:2013, IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)." (Page 5)
• The "Comparison of the Subject and Predicate Devices" table (Pages 6-7) details technical specifications (e.g., maximum output voltage, frequency range, waveform) to demonstrate similarity to commercially available devices. The acceptance criteria for these would be meeting the specified electrical and physical parameters, and passing the relevant safety standards (ISO and IEC). For instance, for "Biocompatibility," the reported performance is "Pass" against the ISO standards. For electrical parameters like "Maximum Output Voltage," the reported performance is "58V @ 500 Ω, 88V @ 2k Ω" for the subject device, which is compared to the predicate devices' outputs to argue for substantial equivalence.

In summary, this document proves the device's safety and electrical performance through non-clinical testing and comparison to predicates, not through a clinical performance study with the types of acceptance criteria and methodologies typically used for AI/ML or diagnostic devices.

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Ennova Self-adhesive Electrode is intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.

Ennova Self-adhesive Electrode is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. Ennova Self-adhesive Electrode is composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient(age=18) multiple application use. Ennova Self-adhesive Electrode has various shapes and sizes. To connect with a nerve or muscle stimulator, this Electrode has lead wire type and snap button type. For lead wire type electrode, the wire is at least 40mm long, with 2.0~3.5mm diameter female socket. For snap button type electrode, the connector is male snap button. The individual electrodes are electrically connected in pairs. When not in use, the hydrogel face is covered by a PET (polyethylene terephthalate) release liner.

The provided text describes a 510(k) premarket notification for the Ennova Self-adhesive Electrode. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested details about a study proving device acceptance criteria cannot be extracted from this document, as a clinical study was explicitly not included in this submission.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance:

The document doesn't define "acceptance criteria" in the traditional sense of a clinical trial's primary or secondary endpoints. Instead, it outlines design specifications and performance standards for the device and compares them to predicate devices to establish substantial equivalence.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not applicable for a clinical study in this submission. The tests performed are bench tests on the physical device components. The document does not specify the number of individual electrodes or batches tested for these non-clinical evaluations.
• Data Provenance: The tests were conducted by Suzhou Ennova Electronics Technology Co., Ltd. in China ("Bench tests were conducted on the proposed Self-adhesive Electrode to verify that the proposed device met all design specifications"). The data is non-clinical, originating from laboratory testing. It is neither retrospective nor prospective in the clinical study sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This submission relies on non-clinical bench testing against recognized industry standards (e.g., ASTM, ISO, AAMI/ANSI, IEC) and comparison to legally marketed predicate devices. Ground truth in the context of expert consensus (e.g., for image interpretation) is not relevant here. The "ground truth" for these tests comes from objective measurements and adherence to specified performance metrics in the standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are typically used in clinical studies, particularly for subjective assessments or when reconciling differing expert opinions. The tests performed here are objective bench tests.

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 self-adhesive electrode, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This is a hardware component (electrode), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this submission is based on established industry standards (e.g., ISO, ASTM, AAMI/ANSI, IEC) and the performance characteristics of legally marketed predicate devices. For example, biocompatibility is assessed against ISO standards, and electrical performance against AAMI/ANSI and IEC standards. The efficacy is inferred from the substantial equivalence to predicate devices that have already demonstrated safety and effectiveness for their intended use.

8. The sample size for the training set:

• Not applicable. This device's approval is based on substantial equivalence demonstrated through bench testing and comparison to predicates, not through machine learning model training.

9. How the ground truth for the training set was established:

• Not applicable. See point 8.

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Arasys Genius is intended for muscle conditioning to stimulate healthy muscles. The Arasys Genius is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the Arasys Genius programs is designed for injured or ailing muscles and its use on such muscles is contraindicated. The Arasys Genius is only offered under prescription given by a physician licensed in the state in which he or she practices. The Arasys Genius is intended to be operated by a trained professional who is always present to monitor treatment.

The Arasys Genius has the exact same technological characteristics, the same number of channels and the exact same frequencies as the predicate. Arasys Genius is made by UV Innovations by the same engineers and technicians that make the lon Magnum Genius K12315B. Arasys Genius has the exact same technology of the predicate, lon Magnum Genius K123158 with the exceptions. The Arasys Genius is a muscle stimulator with six ports just like the predicate and one output that is the same for all ports just like the predicate. The unit is designed for healthy men & women to provide muscle conditioning. Arasys Genius stimulator provides selections of different programs through manual adjustment of the three different frequencies of the device, 90 Hz, 100 Hz, in an identical fashion as the predicate. The Arasys Genius maximum output current is 100 ma which is equivalent to the maximum output current of the predicate. The Arasys has a maximum output voltage of 200 volts which is equivalent to the maximum output voltage of the predicate. An LCD display shows the balance treatment time in the same fashion as it happens with the predicate. The output signal is biphasic, rectangular and based on a voltage and current regulated technology as it does in the predicate. The unit is easy and simple to use. The Arasys has an identical indication for use just like the predicate as it is intended for muscle conditioning to stimulate healthy muscles. The Aras is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the Arasys Genius programs is designed for ailing muscles and its use on such muscles is contraindicated. The Arasys Genius is only offered under prescription given by a physioian licensed in the state in which he or she practices.

The Arasys Genius (K132179) device's acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document establishes substantial equivalence of the Arasys Genius to a predicate device, the Ion Magnum Genius (K123158), rather than setting specific acceptance criteria for a new type of performance. The acceptance criteria are, therefore, based on demonstrating that the Arasys Genius's technical characteristics, indications for use, and safety and effectiveness aspects are "equivalent" to those of the predicate device.

2. Sample size used for the test set and the data provenance:

The provided document describes a 510(k) Premarket Notification for a muscle stimulator. This type of submission generally relies on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than conducting new clinical trials with a test set of patients to prove efficacy and safety from scratch.

Therefore, there is no specific "test set" sample size in the traditional sense of a clinical study for product performance validation mentioned here. The device's performance is not demonstrated through a separate clinical trial on a patient cohort for this submission. Instead, the performance is inferred by demonstrating that its technical specifications and other characteristics are equivalent to the predicate device.

The data provenance for the information presented is the technical specifications and design choices of both the Arasys Genius and the predicate device (Ion Magnum Genius K123158), as well as compliance with relevant standards (e.g., IEC 60601-1:2005) and previous FDA clearances for components (e.g., K970426 for electrodes). This represents retrospective data derived from the design and manufacturing of the devices. The source is the manufacturer's internal documentation and comparisons. The country of origin for the manufacturing facility for Ion Genius, Inc. is the UK (UV Innovations Ltd, Enfield, Middlesex).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

As explained above, this submission relies on substantial equivalence rather than a new clinical study with a "ground truth" derived from expert assessment of patient data. Therefore, no experts were explicitly used to establish ground truth for a test set in this context. The "ground truth" for the comparison is the established performance and safety profile of the predicate device, accepted by the FDA based on its own prior regulatory clearance (K123158).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Since there is no "test set" clinical study described, there was no adjudication method for a test set. The regulatory review process for 510(k) submissions involves the FDA reviewing the manufacturer's documentation and claims of substantial equivalence.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study is not relevant to demonstrating substantial equivalence for a powered muscle stimulator in this context, especially as the device does not involve "human readers" or "AI assistance" in interpreting medical images or data.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No standalone algorithm performance study was done. The device is a hardware electrical muscle stimulator, not an algorithm, and its operation inherently involves a trained professional (human-in-the-loop).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" in this context is the established regulatory clearance and documented specifications of the predicate device, Ion Magnum Genius (K123158). The Arasys Genius demonstrates substantial equivalence by showing that its design, technical characteristics, materials, and intended use are identical or equivalent to this predicate, which has already been deemed safe and effective for its intended use by the FDA. There is no new clinical outcomes data or pathology review presented for the Arasys Genius in this submission to establish a new ground truth.

8. The sample size for the training set:

There is no "training set" sample size mentioned or implied in this 510(k) submission. Training sets are typically associated with artificial intelligence or machine learning model development. This device is an electrical muscle stimulator, and its development does not involve machine learning.

9. How the ground truth for the training set was established:

As there is no training set for an AI/ML model, this question is not applicable.

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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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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:

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.

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The self-adhesive electrode is intended to be used to apply electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS (Transcutaneous Electrical Nerve Stimulation) EMS (Electrical Muscular Stimulation)

Jiajian branded Self-adhesive Electrodes, wire type, are non-sterile flexible structures, composed of materials commonly used in this application: First layer: Nonwoven fabric tape Second layer. Electrically conductive carbon cloth (ValueTrode® Carbon, K970426) Third layer: Biocompatible conductive hydrogel coupling media (ValueTrode GEL, K970426), which has passed the required skin sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specifeid in ISO ISO 10993-5. The electrodes are designed for single patient / multiple application use. It can be used for low-frequency or medium-frequency nerve or muscle stimulators, as the conduction film adhered to body skin. There are six shapes of round, rectangle, oval, gourd, butterfly and saddle of the electrodes. For the electrical connection, Jianjian provides wire type: Lead wire assembly - at least 40mm long wire with 2.5mm diameter female socket, connected to one side of the wire. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR Part 898 by testing under IEC 60601-1. subclause 56.3(c).

This document is a 510(k) Premarket Notification for the Jiajian Self-adhesive Electrode. It's a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, not a study reporting on specific acceptance criteria and device performance in the way a clinical trial or detailed engineering report would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be directly extracted from this document, as this type of information is generally NOT part of a 510(k) summary for this class of device.

510(k) submissions for devices like a self-adhesive electrode typically focus on demonstrating substantial equivalence in terms of:

• Intended Use: The purpose of the device.
• Technological Characteristics: How the device works and its materials.
• Performance Data: This usually involves non-clinical bench testing (e.g., biocompatibility, electrical performance, adhesive strength) to show it meets recognized standards or performs similarly to the predicate. It does not typically involve extensive clinical trials or human-in-the-loop studies.
• Biocompatibility: Showing materials are safe for human contact.

Based on the provided text, here's what can be gathered, addressing the spirit of your request where possible, and noting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of quantitative acceptance criteria with corresponding performance data in the way you might expect from a detailed validation report. Instead, it relies on demonstrating compliance with recognized standards and similarity to predicate devices.

• Both (predicate and proposed) were established biocompatibility on standards of ISO 10993-5-1999: Tests for cytotoxicity: In vitro methods; ISO 10993-10: 2002: Tests for Irritation and Sensitization. |
  | Electrical Lead Wire Conformity: | |
  | - FDA performance standard 21 CFR Part 898 | - Lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR Part 898 by testing under IEC 60601-1. subclause 56.3(c).
• Both predicate 2 and proposed device lead wires conform to FDA 21 CFR Part 898. |
  | Electrical Current Distribution: | - Both (predicate 1 and proposed) electrodes distribute electrical current evenly. (This is a qualitative statement of similarity, not a measured performance against a specific criterion). |
  | Impedance and Adhesive Testing: | - Predicate 2 and proposed device are safe and effective by impedance and adhesive testing. (This indicates that such testing was performed, but specific values or criteria are not detailed in this summary). |
  | Intended Use: (Applying electrical stimulation current) | - The device is intended to be used to apply electrical stimulation current to the patient's skin. (Demonstrated through similarity to predicate devices with the same intended use). |

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

• Sample Size for Test Set: Not specified in this 510(k) summary. For devices of this nature, testing typically involves bench-top studies on a certain number of manufactured units rather than large clinical test sets with human subjects.
• Data Provenance: Not explicitly stated as "country of origin" for tests, but the manufacturer is Wuxi Jiajian Medical Instrument Co., Ltd in China. The testing itself is referenced against international standards (ISO, IEC) and FDA regulations. It is not specified if tests were retrospective or prospective, but typically bench testing would be considered prospective for the submission.

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

• Experts and Qualifications: Not applicable/not specified in this type of 510(k) submission. "Ground truth" in the clinical imaging or diagnostic sense is not relevant for this device. The assessment is primarily based on engineering and biocompatibility testing against established standards.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable/not specified.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No, this type of study is not relevant or reported for a self-adhesive electrode. An MRMC study is typically for evaluating diagnostic imaging devices or AI algorithms that assist human readers in interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Not applicable. This device is a passive electrode, not an algorithm.

7. The Type of Ground Truth Used:

• Ground Truth: For this device, "ground truth" equates to established international standards (ISO 10993, IEC 60601) and FDA regulations (21 CFR Part 898) for biocompatibility, electrical performance, and safety. The device's performance is measured against the requirements of these standards.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This device is not an AI algorithm that requires a training set. The "design" or "development" of the product is distinct from machine learning training.

9. How the Ground Truth for the Training Set was Established:

• Training Set Ground Truth Establishment: Not applicable, as there is no training set for this device.

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The NAImco, inc. EZ-stik electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. NAlmco's reusable electrodes are designed and intended to be used with marketed, Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).

Electrodes, Cutaneous

The provided document is a 510(k) summary for the Naimco EZ-stik Electrodes. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The document does not define specific acceptance criteria based on performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it asserts substantial equivalence based on component usage and physical testing.

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. No separate "test set" in the context of AI/machine learning or clinical performance evaluation is mentioned. The submission relies on "non-clinical testing" which refers to comparing the components of the proposed device to those of predicate devices.

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. There is no mention of experts establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No adjudication method is mentioned as there is no test set or expert review process described.

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 is not an AI/machine learning device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. "Ground truth" in the context of device performance is not explicitly discussed. The comparison is based on the characteristics of the device's components and physical testing, with the implicit "ground truth" being the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable. No training set is mentioned.

Summary of available information from the K050469 510(k) submission:

• Acceptance Criteria/Performance: The device (EZ-stik Electrodes) is deemed to meet acceptance criteria by demonstrating substantial equivalence to legally marketed predicate devices (K945676, K970426, K012463).
• Study Proving Acceptance: The study provided is a non-clinical testing comparison.
  • Method: The submission states that the "critical components used in NAImco, Inc. EZ-stik electrodes (Amgel 703 or Amgel 702 and Conductive Plastic Film) are the same as used in the predicate device." Physical testing was also conducted, but no details are provided about the specifics of this testing or its results beyond the general statement of "technological characteristics that are substantially equivalent."
  • Conclusion: "Therefore there is no reason to believe that the NAlmco, Inc. EZ-stik electrodes will perform any different than the predicate device."
• Clinical Testing: The document explicitly states "Clinical Testing: Not Applicable."

In essence, this 510(k) submission relies on the established safety and effectiveness of predicate devices and demonstrates that the new device is fundamentally the same in its critical components, thus inferring equivalent performance without requiring a new clinical study.

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Interferential stimulation can be used for the following applications:

• Relieve acute pain .
• . Relieve and manage chronic pain
• Relax muscle spasms .
• Maintain and increase the range of motion .
• Increase local blood circulation .

Neuromuscular stimulation can be used for the following applications:

• Relax muscle spasms .
• Prevent or retard disuse atrophy .
• Increase local blood circulation .
• Re-educate muscles .
• Maintain or increase the range of motion .
• Prevent venous thrombosis using immediate postsurgical stimulation on calf . muscles

Pulsed direct current stimulation can be used for the following applications:

• Reduction of edema (under negative electrode) t
• Reduction of muscle spasm .
• Influencing local blood circulation (under negative electrode) .
• Retardation or prevention of disuse atrophy .
• Facilitation of voluntary motor function .
• Maintenance or increase of range of motion .

Interferential and Neuromuscular combination stimulation can be used for the following applications:

• Reduction of edema (under negative electrode) .
• Reduction of muscle spasm .

The IF 3 Wave is a non-invasive medium/low frequency interferential muscle rie it -> wave is a intended for treating patients that have acute and chronic pain, edema, tight musculature, muscle spasms and muscular weakness due to disuse atrophy. The IF 3 Wave stimulator is a microprocessor controlled dual channel Interferential electro-stimulator with neuro-muscular and pulse direct current micronital expabilities. It will offer 4 separate electro-therapy stimulation modalities. Stimulation capacificies: 17 Will on P), neuromuscular electrical stimulation (NMES), r neso direct current (PDC) electrical stimulation, and a combination of interferential and neuromuscular electrical stimulation (IF/NMES).

The IF 3 Wave will be capable of storing device settings, use, and compliance data for up to 90 days. It will be capable of down loading the above compliance date through a up to 90 days. which is contained within the battery charger base. Once per phone mic modelin, will be instructed to download the stored data from their device, month, the patient will over compliance report which is forwarded to their physicians for which will ereate a paysician will review the report and provide adjustment to the patient treatment regimen and device setting accordingly.

Accessories provided with the IF 3 Wave include lead wires, electrode pads, Accessories proTracu wik, battery charger/modem, phone cable, power supply, and a users manual.

This K510(k) submission describes the IF 3Wave Interferential Muscle Stimulator System, Model 7110S. The submission focuses on establishing substantial equivalence to previously cleared predicate devices rather than reporting on a new clinical study with acceptance criteria.

Therefore, many of the requested sections related to acceptance criteria and study data are not applicable to this 510(k) submission.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) summary demonstrating substantial equivalence, there are no explicit "acceptance criteria" in the sense of predefined thresholds for clinical or diagnostic performance metrics. Instead, the device's technical characteristics are compared to those of its predicate devices to demonstrate equivalence. The "reported device performance" is essentially the listed technical specifications of the IF 3Wave.

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The TENS and Microcurrent modes of the Trio 300 are indicated for the symptomatic relief of chronic intractable pain. They are also indicated for the treatment of post-traumatic and post-surgical pain. The electrical muscle stimulation (EMS) mode is indicated for relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

The Trio 300 Multi-Mode Electrical Stimulator is a small, portable, battery-powered electrical stimulator device that has four stimulation modes, (1) TENS, (2) EMS, (3) microcurrent, and (4) programmable. The device has an LED screen that serves as the interface with the user to specify options, provide messages, and display parameters. The device is supplied with an AC adaptor for line current operation.

The Trio 300 consists of the pulse generator, A/C power adapter, and the surface electrodes.

The Trio 300 is a dual-channel electrical stimulator with four output modes. The device is equipped with a liquid crystal display (LCD) for communication with the user. The SELECT key allows the user to scroll through the options (e.g., mode) available at a particular point and the SET key allows the selection of the displayed option. The UP-ARROW and DOWN-ARROW keys allow the user to increase or decrease certain selected parameters.

The provided text is a 510(k) summary for the Trio 300 Multi-Mode Electrical Stimulator, which is a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this type of regulatory submission. This document primarily addresses electrical safety and electromagnetic compatibility, and design qualification to meet internal specifications, not clinical performance against acceptance criteria for an AI/algorithm-based device.

Here's an breakdown of what can be extracted and what information is not available from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not Applicable. The described testing is for electrical safety, electromagnetic compatibility, and design qualification, not for clinical performance using a "test set" in the context of an AI/algorithm study. There's no mention of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No clinical ground truth was established from experts for the stated testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not Applicable. No clinical ground truth adjudication method is described.

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 is not an AI-assisted device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a direct electrical stimulator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. The "ground truth" for the reported tests refers to standards (electrical safety, EMC) and internal design specifications, not clinical outcomes or expert labels.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no training set mentioned.

9. How the ground truth for the training set was established:

• Not Applicable. There is no training set.

Summary based on the provided document:

The Trio 300 Multi-Mode Electrical Stimulator is a hardware device. The "acceptance criteria" and "study" described in the 510(k) summary pertain to basic device safety and functionality standards (electrical safety, electromagnetic compatibility, and meeting design specifications). These are not performance criteria related to clinical efficacy or diagnostic accuracy, which would be typical for an AI/algorithm-based medical device where the requested information would be relevant. The document's purpose is to demonstrate substantial equivalence to existing predicate devices based on technological characteristics and intended use, supported by adherence to safety and design standards.

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