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.

Device Description

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)

AI/ML Overview

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.

Summary

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K030254

FEB 2 6 2003

Image /page/0/Picture/2 description: The image shows the logo for Ryan Telemedicine. The word "RYAN" is written in large, bold, black letters. Below the word "RYAN" is the word "TELEMEDICINE" in smaller, thinner, black letters. There are black dots arranged in a semi-circle around the word "RYAN".

510(k) Summary for RTM1000 Interferential Stimulator

1. Sponsor

Ryan Telemedicine 1011 Brioso Drive Suite 102 Costa Mesa, Ca 92627

Contact Person:	Jim Klett
Telephone:	(949) 645-4140
Fax:	(949) 645-1145

Date Prepared: January 7, 2003

2. Device Name

Proprietary Name:	RTM1000 Interferential Stimulator
Common/Usual Name:	Electrical Muscle and Nerve Stimulator
Classification Names:	Interferential Current Stimulator, Powered
	Muscle Stimulator
Classification Panel:	Physical Medicine
Panel/Product Code:	890.5850 / IPF

3. Legally Marketed Device to Which Equivalence is Claimed

Proprietary Name:	CS3101 Interferential Stimulator
Common/Usual Name:	Electrical Muscle and Nerve Stimulator
Classification Names:	Interferential Current Stimulator, PoweredMuscle Stimulator
Classification Panel:	Physical Medicine
Panel/Product Code:	890.5850 / IPF

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4. Intended Use

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.

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Device Description 5.

. 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)

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Basis for Substantial Equivalence 6.

The RTM1000 is substantially equivalent to the legally marketed device and is similar in design, features and function and provides the intended therapy in a safe and effective manner. Both devices offer various preprogrammed treatment protocols and the clinician or patient can choose one or more of these pre-set options. Furthermore, both allow the clinician to customize a treatment protocol for each individual patient within the parametric ranges and save the treatment into memory.

Bench testing was performed on the marketed device and the RTM1000 and the therapy output and performance characteristics for both units was very similar and consistent

Differences Between the Marketed Device and the RTM1000 7.

The RTM1000 incorporates several improvements over the legally marketed device, including:

Equal recharge time at a lower charging temperature. .
. Improved safety due to the device software preventing therapy treatment while connected to wall current (recharging).
. 29% smaller size while maintaining equal output characteristics and power.
. Separate on and off buttons with easy to understand color-coding provides safer user interface.
. Improved patient lead wire/cable assembly provides easier wire management and easier electrode connections due to colorcoding.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2003

Ryan Telemedicine C/O: Mr. John So Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas, WA 98607-8542

Re: K030254 Dated: February 11, 2003 Received: February 12, 2003

Trade/Device Name: Interferential Stimulator, Model RTM1000 Regulation Numbers: 21 CFR 890.5850 Regulation Names: Powered muscle stimulator Regulatory Class: Class II Product Codes: IPF, LIH

Dear Mr. So:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. So

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miall H. Williamson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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K030254 510(k) Number (if known):

Interferential Stimulator, Model RTM1000 Device Name:

Indications For Use:

The RTM1000 Electrotherapy device is a multifunction nerve stimulation device intended to be used for muscle and nerve stimulation using any one of its two therapy modes, Interferential Current Stimulation, Neuromuscular Electrical Stimulation.

In the Interferential Current Mode the RTM1000 is indicated for the following conditions:

. Symptomatic relief of 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 muscle to prevent venous thrombosis: ● and
. Maintaining or increasing range of motion.

for Mark n Mulkerson
Division Sign-Off

and Neurological Devi

10(k) Number _________________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 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).