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Microstim J 1304D is an Electrical Muscle Stimulator to be used by Physiotherapy or clinicians in Physical Medicine for following applications :-

1. Relaxation of Muscle Spasm.
2. Prevention or retardation of disuse atrophy.
3. Increase local body circulation.
4. Muscle re-education.
5. Immediate post surgical stimulation of calf muscles to prevent venous thrombosis.
6. Maintaining or increasing range of motion.

Microstim J-1304D is an electrotherapy unit used for electrical Muscle Stimulator This microprocessor based circuit generates biphasic square pulse, with enhanced accuracy and dependability. The pulse duration is preset to most effectively stimulate motor fibers. The waveforms are delivered in an envelope of trapezium shaped impulse. The stimulation is more effective yet being smooth and comfortable. J-1304D provides such treatment to four patients simultaneously. Each channel separately has power increase and start/stop key. The increase in intensity by touch button key on membrane panel gives very smooth rise. It delivers exact amount of current that can be visualized as % power in display window. There are four frequency parameters to choose from 200,300,600 and 800 Hz. The treatment time can be selected from 15,30,45 and 60 min.Cyclic 'off' time at 0 gives advantage of reaching the maximum tolerance level or desired level of intensity and then selection from 2 sec.4 sec. and 8 sec 'off' time for kind of treatment. The design of Microstim J-1304D, as having slanted front panel, is for the ease of use to the clinician. Made of aluminum it is strong and sturdy. The unit is supplied with lead wire, four electrode wires and four sets of self adhesive electrodes.

This document is a 510(k) Summary for the Microstim J-1304D Electrical Muscle Stimulator. It does not contain information about acceptance criteria or a study designed to prove the device meets such criteria.

The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device, not to prove clinical effectiveness or meet specific performance acceptance criteria through a dedicated study. The document primarily focuses on describing the device, its intended use, and its technical specifications, and comparing it to a legally marketed predicate device (Sys stim 226, K964028) made by Mettler Electronics Corp.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number of experts, their qualifications, or adjudication methods for ground truth.
4. A multi-reader multi-case (MRMC) comparative effectiveness study.
5. Standalone algorithm performance.
6. The type of ground truth used (beyond implying common applications for muscle stimulators).
7. Sample size for a training set.
8. How ground truth for a training set was established.

The provided text simply states that the Microstim J-1304D has the "same intended use as predicate" and is "substantially equivalent" to the predicate device, which is the basis for its 510(k) clearance.

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