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As prescribed by a physician for the following:

Relaxation of muscle spasm

Increasing local blood circulation

Maintaining or increasing range of motion

Preventing or retarding disuse atrophy

Muscle re-education

Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

The GS 3000 is a High Voltage Pulsed Galvanic Current (HVPGC) Stimulator which delivers stimulation by applying an electrical current to electrodes, which are attached on the patient's skin. The device has a twin peak monophasic waveform with a 5 usec fixed duration. The current Amplitude is adjustable from 0-350 Volts (0~190V Max @ 500ohm resistance), with an adjustable pulse frequency range from 2-100 cycles per second.

The GS 3000 is a single channel device, with the option to set the active electrodes (treatment electrode) to either positive or negative polarity in relation to the dispersive electrode (closes patient circuit) and alternating or synchronous treatment mode selection. The device is powered by a 9 volt battery.

It appears this document describes a 510(k) premarket notification for a medical device called the GS 3000, which is a Powered Muscle Stimulator.

However, the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. The "Discussion of performance testing" section specifically refers to:

• IEC 60601-1: General requirements for safety of medical electrical equipment. This covers electrical leakage current, electrode and lead wire safety, output current, and power density.
• IEC 60601-1-2: Collateral standard for electromagnetic compatibility.

These are engineering and safety performance standards, not clinical performance or efficacy studies. The document states that the device "met all applicable requirements" for these standards, indicating successful electrical and EMC testing.

Therefore, I cannot fill in the requested table and sections related to clinical acceptance criteria, study details, sample sizes, ground truth, or MRMC studies because this information is not present in the provided text.

The document primarily focuses on establishing "substantial equivalence" to a predicate device based on technological characteristics (output specifications, device design, waveforms) and safety standards, rather than clinical performance outcomes against defined acceptance criteria.

Based on the provided text, here is what can be extracted, and where limitations exist:

1. A 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)

• No information provided. The performance tests mentioned (IEC 60601-1 and IEC 60601-1-2) are engineering and safety tests, not clinical studies involving patients or a "test set" in the context of diagnostic or clinical outcome performance.

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

• Not applicable. There is no "test set" and no ground truth established by experts for clinical performance in this document.

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

• Not applicable. There is no "test set" and no adjudication method 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. An MRMC study was not done. The device is a "Powered Muscle Stimulator," not an AI-powered diagnostic or assistive tool.

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

• No. This is not an algorithm-based device. "Standalone performance" in this context would refer to the device's electrical output characteristics and safety, which were tested against IEC standards as mentioned.

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

• Not applicable for clinical performance. For the engineering and safety tests, the "ground truth" would be the specifications and limits defined by the IEC standards themselves.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" as it is not an AI/machine learning device.

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

• Not applicable. This device does not involve a "training set."

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As a Transcutaneous Electronic Nerve Stimulation (TENS) device for:

the symptomatic relief of chronic intractable pain, and

as an adjunctive treatment in the management of post-surgical or post-traumatic pain.

As a Neuromuscular Electrostimulation (NMES) device for:

the relaxation of muscle spasms,

prevention or retardation of disuse atrophy,

increasing local blood circulation,

muscle re-education,

immediate post-surgical stimulation of the calf muscles to prevent venous thrombosis

and

to maintain or increase the range of motion.

Acticare HFT/HFI is a hand-held stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves or muscles. It may be used as a TENS device to aid the blocking of pain signals traveling to the brain or as a NMES device for muscle stimulation.

The provided text describes a 510(k) summary for the Bioinduction Acticare HFT/HFI device, a Transcutaneous Electronic Nerve Stimulator (TENS) and Neuromuscular Electrostimulation (NMES) device. However, it does not contain a study that establishes acceptance criteria or proves the device meets specific performance metrics in terms of clinical effectiveness or accuracy.

The document focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and safety testing, rather than a clinical performance study with defined acceptance criteria.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Information that can be extracted related to testing:

The device was tested in accordance with the following non-clinical standards:

• IEC 60601-2-10:2001 (Specific requirements for nerve and muscle stimulators)
• IEC 60601-1:1988 (General requirements for safety of medical electrical equipment), Amendment 1, 1991-11, Amendment 2, 1995
• IEC 60601-1-1:2000 (Safety requirements for medical electrical systems)
• IEC 60601-1-2:2005 (EMC compatibility and additional FCC requirements)
• IEC 60601-1-4:2000 (Software for use in Medical Devices)

The conclusion states that the device has "similar technical characteristics, performances and applications" to predicate devices, and that the "information supplied in the full 510(k) application illustrates that the device does not pose any new questions of safety or effectiveness." This implies that the performance aspects assessed were primarily technical specifications as compared to the predicate devices and adherence to relevant safety standards. There is no mention of a clinical or analytical performance study that would typically define acceptance criteria based on diagnostic accuracy or efficacy.

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