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The Globus Genesy 1100 Electro-stimulator should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. It is intended to be used for therapies employing NMES, Russian, and Premodulated Currents (IFC) to obtain the following:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Additional Indications for Microcurrent, Premodulated Currents (IFC), NMES and TENS waveforms:

• Management of chronic, intractable pain
• Post-traumatic acute pain
• Post-surgical acute pain

The Globus Genesy Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimulators, Transcutaneous Electrical Nerve Stimulator. Premodulated Current Therapy Stimulator, and Microcurrent Therapy Stimulator.

Each device in the family comes with a menu to select different stimulation The Stimulation Programs have been subdivided in menus and programs. submenus to facilitate use for various types of uses. The user can create and store protocols in the device for subsequent recall, and can store them and manipulate them in a PC for labeling and stimulation parameter changes.

The Globus Genesy electrical impulses trigger excitations that are transmitted to the muscle fibers, where they generate mechanical responses that result in muscle work. This work is used for muscle and range-of-motion rehabilitation therapies.

They also interact with the mechanism of pain generation and transmission in the nerve fibers; other stimulation currents interact directly with the affected body part to obtain the effect desired by the physician or licensed practitioner.

The core of the Globus Genesy device is a constant-current generator; a transformer guarantees insulation between outlet current utilized for the battery charger, and the circuits utilized for stimulation current. A micro-processor elaborates the menu selections and drives the constant-current generator that originates the electrical impulses for the electrostimulation. This is accomplished according to the parameters stored for that particular program. The user can regulate the current continuously from 0-120 mA.

The provided text is a 510(k) summary for the Globus Genesy Electro-Stimulator. It outlines the device's description, intended use, and claims of substantial equivalence to a predicate device. However, it does not describe any specific studies conducted by the applicant (Domino S.r.l.) to prove the device meets acceptance criteria.

The document focuses on demonstrating substantial equivalence based on similarity in design, function, and technical characteristics to the predicate device (Chattanooga Vectra GENiSYS Stimulator K031077), rather than presenting independent performance data from the Globus Genesy device itself.

Therefore, many of the requested sections about acceptance criteria, study details, and performance data cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

• Cannot be provided: The document does not define specific acceptance criteria (e.g., performance metrics, thresholds) for the Globus Genesy Electro-Stimulator, nor does it report any direct performance data for the device. It only states that its "maximum current output and its maximum electric charge are very similar to the predicate device."

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

• Cannot be provided: The document does not describe any specific test set or clinical study conducted with the Globus Genesy device.

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

• Cannot be provided: There is no mention of a test set or ground truth establishment.

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

• Cannot be provided: No test set or adjudication method is mentioned.

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

• Cannot be provided: This device is an electro-stimulator, not an AI-powered diagnostic device involving human readers. Therefore, an MRMC study is not applicable, nor is AI assistance relevant to this device type described.

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

• Cannot be provided: Not applicable for this device type. The device operates under medical supervision, inherently involving a human in the loop for application and therapy.

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

• Cannot be provided: No ground truth is established or discussed for the Globus Genesy device's performance.

8. The sample size for the training set

• Cannot be provided: This device is not an AI/ML algorithm that requires a training set.

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

• Cannot be provided: Not applicable.

Summary based on the provided text:

The 510(k) submission for the Globus Genesy Electro-Stimulator relies on demonstrating substantial equivalence to an existing legally marketed device (Chattanooga Vectra GENiSYS Stimulator K031077). This means that instead of conducting new clinical trials or extensive performance studies with the Globus Genesy device itself, the manufacturer asserts that its device is as safe and effective as the predicate device because of its similar design, functionality, and technological characteristics.

The key arguments for substantial equivalence are:

• Similar Design and Function: Both devices are software-driven electro-stimulators offering a variety of treatment currents (biphasic, monophasic, premodulated waveforms, Russian currents, Microcurrents).
• Similar Technical Characteristics: The Globus Genesy device's "maximum current output and its maximum electric charge are very similar to the predicate device."
• Similar Intended Use: Both are intended for adjunctive therapy under medical supervision, addressing conditions like muscle spasms, disuse atrophy, pain management, and increasing range of motion using various waveforms (NMES, Russian, TENS, Premodulated Currents (IFC), and Microcurrents).

The FDA's letter confirms that they have reviewed the submission and determined the device is substantially equivalent, allowing it to be marketed. This determination implies that the FDA found sufficient evidence in the comparison to the predicate device to conclude that the Globus Genesy meets the safety and effectiveness requirements without requiring new clinical performance studies to define and meet specific acceptance criteria.

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The Globus Premium Sport and the Globus Premium Fitness Muscle Stimulators are intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Globus Premium Sport and Globus Premium Fitness Muscle Stimulators are not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Globus Premium training programs are designed for injured or ailing muscles and their use on such muscles is contraindicated

The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in the family comes with a menu to navigate between different stimulation programs. The Stimulation Programs have been subdivided in menus and submenus to facilitate use for various types of uses.

The Globus Premium Stimulators electrical impulses trigger action potentials on motor neurons of motor nerves. These excitations are transmitted via the motor end-plate to the muscle fibers, where they generate mechanical responses that result in muscle work. Depending on the electrical impulse parameters (current intensity, frequency, shape of the impulse, duration of contraction, duration of rest, total session duration) different types of muscle work can be performed. This work is able to improve or facilitate muscle performance, and may therefore be considered a muscle training technique.

The Globus Premium family models include the Globus Premium Sport and the Globus Premium Fitness. The configurations differ in the navigation menus that allow the user to select the pre-stored electrostimulation programs offered, but offer technically-identical electrostimulations. The core of the Globus Premium device is a constant-current generator; a transformer guarantees insulation between outlet current utilized for the battery charger, and the circuits utilized for stimulation current. A micro-processor elaborates the menu selections and drives the constant-current generator that originates the electrical impulses for the electrostimulation. This is accomplished according to the parameters stored for that particular program. The user can regulate the current continuously from 0-120 mA.

This document is a 510(k) summary for the Globus Premium Sport and Fitness Muscle Stimulators. It does not contain information about acceptance criteria or a study proving device performance in the way a clinical trial or performance study for an AI/CADe device would. Instead, this submission focuses on demonstrating substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested fields cannot be populated as they are not relevant to this type of regulatory submission for this device.

Here's an attempt to populate the table and answer the questions based on the provided text, indicating where information is not available or not applicable:

1. Table of acceptance criteria and the reported device performance

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. This submission is a 510(k) for a muscle stimulator based on substantial equivalence to a predicate device, not a performance study involving a test set of data. There is no mention of a test set or data provenance in the context of device performance testing.

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. No test set or ground truth establishment by experts is mentioned or required for this type of 510(k) submission.

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

• Not applicable. No test set and therefore no adjudication method is mentioned.

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 a hardware device (muscle stimulator), not an AI or CADe device. Therefore, no MRMC comparative effectiveness study was performed or is relevant.

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

• No. This is a hardware device, not an algorithm, so standalone performance is not applicable in this context.

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

• Not applicable. No ground truth for performance evaluation of a medical imagery or diagnostic algorithm is mentioned. The "ground truth" in this context is the performance and safety profile of the predicate device, which the new device is compared against.

8. The sample size for the training set

• Not applicable. There is no mention of a training set as this is not an AI/ML device.

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

• Not applicable. No training set is mentioned.

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