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netwaye Interferential Stimulator is a multifunction device intended to be used for muscle and nerve stimulation using either of its two therapy modes, Interferential Current Stimulation or Neuromuscular Electrical Stimulation.

In the Interferential Current Mode, netwave 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, netwave 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 Ryan Telemedicine netwave Interferential Stimulator is a battery powered (rechargeable) device intended for clinic, and outpatient use. Prescribed by a physician, netwave gives the clinician a variety of electrotherapy modes to treat a range of indications. netwaye is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. netwave incorporates the following features:

• independent stimulation channels, which provide true ● Two interferential current and neuromuscular stimulation.
• Continuous or pulsed stimulation. Adjustable sweep and ramp times. ●
• . Adiustable 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 its 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)
• . Charging / communicating cradle which serves as "home base" for netwave and provides a simple recharging system for the user/patient. The use of the charging cradle ensures netwave is always at peak battery power.
• The communication functions of the cradle allow for the uploading of patient data (compliant with HIPAA requlations) to an Internet data server for use by the patient's authorized caregivers. NO INDIVIDUALLY IDENTIFIABLE PATIENT DATA is transmitted.
• netwave user interface incorporates a touch screen Liquid Crystal Display (LCD) as the main device/user interface.

The provided document is a 510(k) summary for the netwave Interferential Stimulator, which is focused on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.

The core of this submission is not a clinical study with acceptance criteria and reported device performance in the way typically associated with AI/software devices. Instead, it's a comparison to a legally marketed predicate device (RTM 1000 Interferential Stimulator) to show that the new device is "substantially equivalent" in design, features, function, and intended therapy.

Therefore, many of the requested items (sample size, experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission.

However, I can extract the relevant information and structure it as if there were "acceptance criteria" based on the comparison made in the document.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

• Improvements over predicate: Simplified battery charging, lower charging temperature, improved safety (no therapy while charging), simplified user interface, easy-to-read screens, large "Pause" and "Quit" buttons, "Initial Activation Code" for compliance, HIPAA "Patients Rights" acknowledgment, detailed treatment compliance data, bi-directional communication, secure HTTPS communication. |
  | Safety and Effectiveness (to deliver intended therapy in a safe and effective manner) | Claimed to "provide the intended therapy in a safe and effective manner" based on substantial equivalence to the legally marketed predicate device. Safety improvements (like preventing therapy during charging) are highlighted. |

2. Sample Size used for the test set and the data provenance

• Sample Size: Not applicable. This document describes bench testing comparing a new device (netwave) to a predicate device (RTM 1000 Interferential Stimulator). It does not involve a "test set" of patient data or clinical samples.
• Data Provenance: Not applicable. The "study" mentioned is bench testing, which would have been conducted by the manufacturer, Ryan Telemedicine, LLC.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. There was no "ground truth" derived from expert consensus on patient data for this type of submission. The ground truth for the bench testing would be the measured electrical output and performance characteristics of the devices themselves, verified against engineering specifications.

4. Adjudication method for the test set

• Not applicable. No clinical test set requiring adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission focuses on the electrical and functional equivalence of the device, not on reader performance or AI assistance.

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, and its performance inherently involves human interaction (patient placement of electrodes, clinician programming, etc.). The "performance" assessment was through bench testing of its electrical output.

7. The type of ground truth used

• For the "study" (bench testing), the ground truth was the measured electrical output and performance characteristics of both the netwave device and the predicate RTM 1000 Interferential Stimulator, compared against their respective design specifications and industry standards for such devices.

8. The sample size for the training set

• Not applicable. This device does not use an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

• Not applicable. No training set was used.

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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."

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.

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