(108 days)
The Ortho Dx, a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation to be used under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. It is used to, relax muscle spasm, prevent or retard disuse atrophy, increase local blood circulation, reeducate muscles, prevent venous thrombosis with immediate post surgical stimulation in calf muscles, and increase range of motion.
The Ortho De is a non-invasive electrical stimulator that combines symmetrical biphasic neuromuscular stimulation with high volt pulsed direct current neuromuscular stimulation that will operate in both modes simultaneously or independently. This system is a prescription device intended for use on patients who are undergoing rehabilitation for medical diseases and conditions on the order of a licensed practitioner.
The Ortho Dx Neuromuscular Stimulator, Model 6700S, received a 510(k) clearance based on substantial equivalence to existing predicate devices rather than a study against a pre-defined acceptance criteria.
The submission focuses on verifying that the technical performance of the device matches or is identical to the operating parameters of the predicate devices. It does not present a clinical study with acceptance criteria for device performance in treating medical conditions.
Here's a breakdown of the information based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Output Waveform | Within/Identical to predicate devices (symmetric biphasic & high volt pulsed direct current) | "identical to the Mentor Neuromuscular II (NM III™), Model 6800S" and "identical to the GV II™ Model 9700" |
| Amplitude | Within/Identical to predicate devices | "These values are within and/or identical to the operating parameters of the predicate devices." |
| Pulse Width | Within/Identical to predicate devices | "These values are within and/or identical to the operating parameters of the predicate devices." |
| Pulse Rate | Within/Identical to predicate devices | "These values are within and/or identical to the operating parameters of the predicate devices." |
| Treatment Time | Within/Identical to predicate devices | "These values are within and/or identical to the operating parameters of the predicate devices." |
| NMS Off Time | Within/Identical to predicate devices | "These values are within and/or identical to the operating parameters of the predicate devices." |
| NMS Ramp Up Time | Within/Identical to predicate devices | "These values are within and/or identical to the operating parameters of the predicate devices." |
| NMS Ramp Down Time | Within/Identical to predicate devices | "These values are within and/or identical to the operating parameters of the predicate devices." |
| Safety Considerations | No additional safety considerations compared to predicate devices | "proposes no additional safety considerations than the legally marketed predicate devices" |
| Power Supply (Line Powered Repac10) | UL approved | "The Line Powered Repac10 employees a UL approved power supply" |
2. Sample Size Used for the Test Set and Data Provenance
The document describes engineering verification testing focusing on the device's technical specifications, not a test set for clinical performance. Therefore, there is no "sample size" in the context of patient data. The testing involved measurements of the device's output parameters. The data provenance is internal engineering testing conducted at room temperature (72°C) and 50% relative humidity using a calibrated 5V power supply and calibrated measurement equipment. This is a form of prospective testing, as it's performed on the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for the engineering tests was established by comparison to the technical specifications of the predicate devices and the operator's manual. There were no human experts involved in establishing a "ground truth" for clinical performance, as this was not a clinical study.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication. The verification of technical parameters was based on direct measurement and comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The submission is for a medical device (neuromuscular stimulator), not an AI-assisted diagnostic or imaging device where such studies are common. The clearance is based on technological equivalence, not clinical superiority or human reader improvement.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No, a standalone performance study in the context of an algorithm or AI was not performed. This device is a physical medical stimulator, not software with an algorithm. The "standalone" performance verification relates to its electrical output parameters.
7. Type of Ground Truth Used
The "ground truth" for the engineering verification was essentially:
- Predicate Device Specifications: The technical parameters (waveform, amplitude, pulse width, etc.) of the previously cleared predicate devices (Mentor Neuromuscular II, GV II, and TRI-STIM).
- Operator's Manual Technical Requirements: The device's own specified operating parameters.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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).