(33 days)
The RTM1000 Electrotherapy Device is a multifunction device intended to be used for muscle and nerve stimulation using either of its two therapy modes, Interferential Current Stimulation and Neuromuscular Electrical Stimulation.
In the Interferential Current Mode the RTM1000 is indicated for the following conditions:
- . Symptomatic relief of acute pain
- . Symptomatic management and relief of chronic pain
- . Adjunctive treatment for the management of post traumatic and Post-surgical pain
In the Neuromuscular Stimulation Mode, the RTM1000 is indicated for the following conditions:
- . Relaxation of muscle spasms;
- . Prevention or retardation of disuse atrophy;
- Increasing local blood circulation;
- . Muscle re-education;
- . Immediate post surgical stimulation of calf muscles to prevent venous thrombosis: and
- Maintaining or increasing range of motion.
The Rvan Telemedicine RTM1000 Interferential Stimulator is a battery powered (rechargeable) device intended for clinic, and outpatient use. Once prescribed by a physician it gives the clinician a variety of electrotherapy modes to treat a range of indications. The RTM1000 is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The RTM1000 incorporates the following features:
- . Two independent stimulation channels, which provide true interferential current, neuromuscular stimulation and transcutaneous electrical nerve stimulation.
- . Continuous or pulsed stimulation. Adjustable sweep and ramp times.
- . Adjustable amplitude and frequency
- . Four programmable therapy protocols
- . Five preset therapy protocols
- . Adjustable on and off times
- . Pause button to allow temporary cessation of treatment and a resume button to allow the continuance of treatment. When a treatment session is paused, the timer does not countdown. Upon resumption of treatment, the timer resumes it's countdown and the amplitude (intensity) is reset to zero.
- . Easy to connect, easy to handle, patient lead wire/cable assembly with a "one way" connector and color coded lead wires contribute to improved patient experience and improved therapy outcomes.
- . Timed therapy sessions.
Robust rechargeable Nickel Metal Hydride battery system with . rapid recharge (85% recharge in 30 minutes - full charge in 2 hours)
The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria in the format typically used for AI/ML device evaluations. This document is a 510(k) summary for a medical device (RTM1000 Interferential Stimulator) and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance study against specific acceptance metrics.
However, based on the information provided, here's an attempt to extract and infer relevant details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly related to demonstrating "substantial equivalence" to the predicate device, especially in terms of "therapy output and performance characteristics." The reported "performance" is that these characteristics were "very similar and consistent."
| Acceptance Criteria (Implied) | Reported Device Performance (RTM1000) |
|---|---|
| Similar therapy output to predicate device | Bench testing showed "very similar and consistent" therapy output. |
| Similar performance characteristics to predicate device | Bench testing showed "very similar and consistent" performance characteristics. |
| Safe operation (e.g., lower charging temperature, no therapy during recharging) | Equal recharge time at lower charging temperature; improved safety due to software preventing therapy during recharging. |
| Effective dispensing of desired electrotherapy treatment | Similar in design, features, and function to predicate, providing intended therapy in a safe and effective manner. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "Bench testing was performed on the marketed device and the RTM1000." This implies a comparison between the new device and the predicate device, likely involving multiple measurements or runs, but the specific number of test cases or data points is not provided.
- Data Provenance: Not explicitly stated, but it would be internal lab testing ("Bench testing") conducted by Ryan Telemedicine or a contracted lab. The country of origin is not mentioned. It is prospective testing designed to compare the RTM1000 against the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided. "Ground truth" in the context of this device would refer to the expected electrical outputs and functionality. These would typically be established based on engineering specifications and existing standards for such devices, rather than expert clinical consensus as might be seen for diagnostic AI models.
4. Adjudication Method for the Test Set
This information is not provided. Given it's bench testing, adjudication methods like 2+1 or 3+1 (common in image review) are not applicable. Performance would be assessed against technical specifications and predicate device measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic AI devices where human readers interpret medical images or data. The RTM1000 is an electrotherapy stimulator, and its evaluation focuses on electrical output and functional equivalence, not diagnostic accuracy requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The evaluation described is inherently "standalone" in the sense that the device's electrical output and basic functions were tested independently against the predicate device through bench testing. There is no "human-in-the-loop" concept described for the performance evaluation itself, although the device is designed for human interaction during use.
7. The Type of Ground Truth Used
The "ground truth" for this type of device's performance would be the engineering specifications and expected electrical output parameters for an interferential stimulator, as well as the measured performance of the legally marketed predicate device. The goal was to show that the RTM1000's output matched these established and benchmark values.
8. The Sample Size for the Training Set
Not applicable/Not provided. This device is an electrotherapy stimulator, not an AI/ML diagnostic or therapeutic algorithm that typically requires a "training set" in the conventional sense. Its "programming" would be based on engineering design and pre-set parameters, not learned from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. As stated above, there is no "training set" in the context of this device.
§ 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).