(308 days)
The RT300 is intended for general rehabilitation for:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Maintaining or increasing range of motion
- Muscle re-education
The RT300 pediatric version is intended for population ages 4 to 12 years.
The RT300 is intended for use with a surface electrical stimulation garment for population ages 12 and above.
The RT300 is for prescription use only.
The RT300 is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of:
- A motorized leg cycle ergometer (RTI part number SA100047 for adults and SA100044 for children)
- An optional motorized arm crank (RTI part number PP102663)
- An FES controller with up to two 6 channel stimulators (RTI part number SA216172)
- Up to 5 additional wireless single channel stimulators (RTI part number SA216128)
- A leg and optional arm stimulation cable which connects the stimulator to cutaneous electrodes
- Cutaneous electrodes (up to 24 electrodes for up to 12 stimulation channels)
- An interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
- An interface to a pulse oximeter for the display and recording of pulse and SpO2 levels and provision of alarming based on the data
- A garment incorporating electrodes for lower extremity cycling in population ages 12 and above (RTI part number FA105486)
This system allows a person with impaired upper or lower extremity movement to undertake cycle erqometry both actively (utilizing FES evoked upper or lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor). The system combines a Windows based tablet, cycle ergometer, and stimulators in a single unit. The system is controlled by the Sage software that runs on the tablet. The Sage software delivers stimulation to the designated muscle groups in a coordinated fashion based on angle information from the ergometer. In doing so the system facilitates a smooth cycling motion throughout the therapy session.
Here are the acceptance criteria and study details for the RT300 FES Cycle Ergometer based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are defined by its safety and effectiveness endpoints across different intervention groups. The device's performance is reported across these same metrics.
| Category | Intervention Group | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Safety | All Interventions | No treatment-related adverse reactions, muscle strain, joint strain, or fracture. Minimization of normal or blancheable erythema. | Cycling (15 patients, 434 sessions): 3 patients had normal erythema, 0 adverse reactions/injuries. |
| Lower Extremity (33 patients, 920 sessions): 8 patients had normal erythema, 1 patient had blancheable erythema, 0 adverse reactions/injuries. | |||
| Trunk (13 patients, 172 sessions): 3 patients had normal erythema, 1 patient had blancheable erythema, 0 adverse reactions/injuries. | |||
| Upper Extremity (14 patients, 65 sessions): 8 patients had normal erythema, 0 adverse reactions/injuries. | |||
| Pediatric (8 patients, 324 sessions): 6 patients had normal erythema, 0 adverse reactions/injuries. | |||
| Effectiveness | Cycling with Lower Extremity | Meet primary safety endpoint (no adverse reactions or other injuries). | Met primary endpoint with no adverse reactions or other injuries. |
| Effectiveness | Lower Extremity NMES | Clinically significant improvements in functional outcome measures (NRS, Berg Balance Scale, Biodex Dynamometer Torque, Overground Standing Test). | 23 patients increased NRS by 16%; lower extremity NRS by 11%. 15 patients increased Berg scores by 47%. MVC torque increased for 8 lower extremity muscle groups in average of 9 patients by 152% - 3796%. 8 patients increased Overground Standing Test times by 7108%. Met primary endpoint. |
| Effectiveness | Trunk NMES | Clinically significant improvements in functional outcome measures (NRS, Berg Balance Scale, Modified Functional Reach, Independent Sitting, Trunk Scale). | 11 patients increased NRS by 18%. 5 patients increased Berg scores by 50%. Modified reach scale increased 9 patients by 196%. Independent Sitting times increased in 3 patients 26583%. Trunk scale increased in 2 patients by 180%. Met primary endpoint. |
| Effectiveness | Upper Extremity NMES | Clinically significant improvements in functional outcome measures (NRS, Modified Functional Reach, Bilateral Upper Extremity Basic Strength, Modified Ashworth Upper Extremity scale). | 11 patients increased NRS by 8%. Modified reach scale increased in 4 patients by 122%. Bilateral Upper Extremity Basic Strength increased in 3 patients by 8%. Modified Ashworth Upper Extremity scale increased in 3 patients by 3%. Met primary endpoint. |
| Effectiveness | Pediatric NMES | Clinically significant improvements in functional outcome measures (Pediatric NRS, Segmental Assessment of Trunk Control (SATCo)). | 4 patients increased NRS by 88%. 3 patients increased SATCo by 35%. Met primary endpoint. |
| General Equivalence | All (device overall) | Safety and effectiveness profile similar to the predicate device, with new technological characteristics not raising new questions of safety and effectiveness. | Clinical testing demonstrated that the RT300 is as safe and effective as the predicate devices. The wider stimulation pulses utilize the same stimulators and control system and do not raise new questions of safety and effectiveness. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Sizes:
- Cycling with Lower Extremity NMES: 15 patients
- Lower Extremity NMES: 33 patients
- Trunk NMES: 13 patients
- Upper Extremity NMES: 14 patients
- Pediatric NMES: 8 patients (ages 2-13 years old)
- Data Provenance: The document does not specify the country of origin. The study was a "multi-arm study with patients serving as their own control," indicating a prospective study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy studies. Instead, the study uses functional outcome measures (e.g., Neuromuscular Recovery Scale, Berg Balance Scale) and clinical observation for adverse events, which are assessed by the study's clinical team. No specific number or qualifications of experts for ground truth establishment are provided.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (like 2+1 or 3+1) for the test set. The effectiveness endpoints involved changes in various clinical scales and measurements, likely recorded by the clinical team, and safety endpoints were observed and documented.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study evaluates the effectiveness of a medical device (FES cycle ergometer) for rehabilitation, not a diagnostic imaging AI system or a system that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The RT300 FES Cycle Ergometer is a therapeutic device that requires human interaction (patient use, clinician setup and monitoring) and is not an algorithm-only diagnostic tool. Therefore, a standalone (algorithm only) performance assessment, as might be done for an AI diagnostic device, was not performed. The device itself is the "standalone" subject of performance testing, but always with a human-in-the-loop for its intended use.
7. The Type of Ground Truth Used
The "ground truth" for this study is based on:
- Clinically significant improvements in functional outcome measures: These include scores from standardized scales (e.g., Adult/Pediatric Neuromuscular Recovery Scale, Berg Balance Scale, Modified Functional Reach, Modified Ashworth Upper Extremity scale, Segmental Assessment of Trunk Control), objective measurements (Biodex Dynamometer Torque, Overground Standing Test, Independent Sitting times), which represent a patient's actual functional ability and recovery.
- Absence of treatment-related adverse events: Clinical observation and documentation of safety metrics such as adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.
8. The Sample Size for the Training Set
The document describes a clinical study to evaluate the device's safety and effectiveness. It does not refer to a "training set" in the context of machine learning or AI model development. The numbers of patients listed under each intervention (15, 33, 13, 14, 8) represent the participants in the clinical evaluation.
9. How the Ground Truth for the Training Set Was Established
As this study is a clinical evaluation of a medical device and not the development of an AI model, the concept of a "training set" and its associated ground truth establishment does not apply. The functional outcome measures and safety observations described above serve as the evaluation criteria for the device's performance in the clinical study.
§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).