(14 days)
INTENDED USE
- Interferential Current Stimulation is indicated for : A)
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- Symptomatic relief and management of chronic and intractable pain.
- Adjunctive treatment in the management of post-surgical and post-traumatic, acute pain 2. conditions.
- B) Electrical Muscle Stimulation (EMS or Russian) is indicated for:
- 1 . Relaxation of Muscle spasm.
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- Prevention or Retardation of disuse atrophy.
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- Increasing local blood circulation.
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- Muscle re-education.
- న్. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
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- Maintaining or increasing range of motion.
Johari 'Combo Stimulator' is a Neuromuscular Electrical Stimulation System, consists of programmable controller just like the predicate device Analgesic Pulsar AP-439. This unit Combo Stimulator allows the treatment specifically tailored to the precise needs of the patient in the clinic and for subsequent treatment off site. The clinicians can set the treatment parameters and lock it, so patient can repeatedly use the unit as prescribed by the clinician. The stimulation is most comfortable and the waveforms are unique.
It has been the clinician requirement many a times where they wanted to have a unit that can perform for muscle stimulation followed by interferential, so that, the painful muscle condition can be treated. Usually they have to turn the machine On and Off for different stimulation waveforms. The unique feature of Combo Stimulator is that in such above conditions, the clinicians can set the unit to perform in such a way that desired muscle stimulation can be followed by desired Interferential stimulation just by pressing one key "Combo", otherwise in itself the unit can perform muscle stimulation through all the outputs or Interferential stimulation through all the output.
The ease and simplicity by which the programming can be done is not more than touch of the key on the panel and LCD display. All the parameters remain in the system control except the amplitude & time which can be set by the patient himself. This unit is ergonomically designed, so that, it is comfortable to hold in hands.
It is portable and has two output channels, four channels works on rechargeable battery system. The unit can perform offsite wherein the hospital room, clinic or home while the predict device Analgesic Pulsar could not run on rechargeable battery system and so limited its use near to the AC outlet. This has always limited the clinicians to perform on their patient. Also many times, the patient may be in need to have a repeated treatment and this modified device "Combo Stimulator" can work in such cases. The Combo Stimulator can provide True Interferential with desired frequency, sweep selection and muscle stimulation of desired mode similar to Analgesic Pulsar.
The provided document is a 510(k) Special Summary for the "Combo Stimulator IF-5000". It describes the device, its intended use, and compares its technical specifications and technological characteristics to an already legally marketed predicate device, the "Analgesic Pulsar AP-439".
Based on the information provided, here's a description of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Combo Stimulator IF-5000 are implicitly defined by its substantial equivalence to the predicate device, Analgesic Pulsar AP-439. The study demonstrates that the modified device has technical characteristics that are either identical, improved (e.g., portable, battery-operated), or within acceptable ranges compared to the predicate, and serves the same intended use.
| Feature | Acceptance Criteria (based on Predicate AP-439) | Reported Device Performance (IF-5000) |
|---|---|---|
| Intended Use | Alleviate pain (Interferential), Muscle stimulation (EMS/Russian) | Identical |
| Power Source | 110V AC, 50/60 Hz | 1.2V x 4 Ni-Mh Rechargeable batteries |
| Number of Outputs | Two | Two |
| Channels | Four | Four |
| Synchronous | Yes | Yes |
| Max Output Current | 100mA (max. @ 500 ohm loads) | Select PW & Ramp Burst - 90mA pp @ 500 ohm load |
| Russian & IFT – 54mA RMS @ 500 Ohm Load | ||
| Max Output Voltage | 132V pp (max. @ 10K ohm loads) | Select PW & Ramp Burst - 90mA vpp @ 10K ohm load |
| Russian & IFT – 37V RMS @ 10k Ohm Load | ||
| Channel Isolation | Yes, confirm to ANSI 3.2.3.2, 1985 | Yes, confirm to ANSI 3.2.3.2, 1985 |
| Waveform | Monophasic, Biphasic, Sinewave & D.C. Line | Biphasic & Sinewave (with additional combination modes) |
| Current Density | 3.55mA/cm2 (max @ 500 ohm load) | Select PW & Ramp Burst - 0.533 mA/cm2 @ 500 ohm |
| Russian & IFT - 2.66mA/cm2 @ 500 Ohm | ||
| Power Density | 0.127 W/cm2 (max @ 500 ohm load) | Select PW & Ramp Burst – 0.024 W/cm2 @ 500 ohm |
| Russian & IFT – 0.072 W/cm2 @ 500 Ohm | ||
| Max Phase Charge | 40 micro coulomb (max @ 500 ohms load) | Select PW & Ramp Burst: 18 micro coulomb (500 Ohm) |
| Russian: 5.4 micro coulomb (500 Ohm) | ||
| IFT: 2.7 micro coulomb (500 Ohm) | ||
| Modulation Options Amplitude | Preset IFT only | Preset IFT & Russian only |
| Modulation Options Frequency | IFT section only | IFT section only |
| Size | 12.2" (l)X 3.5" (h)X 7.5" (d) | 3.9"(l) x 1.6"(h) x 4.0(d) |
| Weight | 5.5 Lb | 1 Lb |
| Microcontroller | 87C51 (12M Hz crystal) | HMOS Micro-controller |
| Display | LED display | LCD (Liquid Crystal Display) |
| Safety Features | Insulation through transformers, membrane keypads, auto intensity reduction on failure. | Identical, plus self-contained safety circuit, open/short circuit performance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes a comparison to a predicate device (Analgesic Pulsar AP-439) rather than a clinical trial with a specific test set of patients/data. Therefore, there is no explicit sample size or data provenance provided for a test set in the traditional sense of a clinical study. The evaluation focuses on engineering and performance specifications.
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)
This is a regulatory submission for a device modification, relying on technical specifications and functional equivalence. No experts are mentioned as establishing ground truth for a test set, as this is not a study assessing diagnostic accuracy or clinical outcomes based on interpretation. The "ground truth" for the device's acceptable performance is its compliance with recognized standards (ANSI 3.2.3.2, 1985 for channel isolation) and demonstration of equivalent (or improved) technical characteristics to a legally marketed predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this is a technical comparison for regulatory clearance, not a clinical study involving human judgment or interpretation 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 MRMC comparative effectiveness study was done. This is a medical device for physical medicine applications, not an AI or imaging device where such a study would typically be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an electrical stimulator, not an algorithm. Its performance is inherent in its hardware and firmware function, which is designed to be user-controlled ("human-in-the-loop" in the sense of a clinician/patient operating it). The "standalone" performance here refers to its electrical and functional characteristics as presented in the technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is the documented technical specifications and safety standards compliance of the predicate device (Analgesic Pulsar AP-439), as well as general engineering principles and safety regulations for electrical medical devices. The manufacturer demonstrates that the modified device's specifications and functionality are substantially equivalent to or improved upon the predicate device's established performance, which was already accepted by the FDA.
8. The sample size for the training set
Not applicable. This is a hardware medical device submission, not a machine learning or AI context that would involve training sets.
9. How the ground truth for the training set was established
Not applicable. As per point 8, there is no training set for this type of device submission.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).