(138 days)
The RT300 (adult and pediatric version) are intended for general rehabilitation for:
a. Relaxation of muscle spasms
b. Prevention or retardation of disuse atrophy
c. Increasing local blood circulation
d. Maintaining or increasing range of motion
The RT300 is for prescription use only.
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 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 built in 6 channel stimulator (RTI part number SA100090)
- up to 5 additional wireless single channel stimulators (RTI part number FA106897)
- a leg and optional arm stimulation cable (either bilateral or unilateral) which connects the controller / stimulator to cutaneous electrodes
- cutaneous electrodes (up to 22 electrodes for up to 11 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 stimwear 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 ergometry both actively (utilizing FES evoked upper or lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).
This 510(k) premarket notification for the RT300 Functional Electrical Stimulation (FES) cycle ergometer describes the device's substantial equivalence to previously marketed devices. The document highlights technological characteristics and the results of non-clinical and clinical testing.
Here's an analysis of the provided information regarding acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define acceptance criteria with quantifiable metrics for a specific performance characteristic (e.g., a minimum sensitivity or maximum error rate). Instead, the acceptance is based on demonstrating "safety and effectiveness" and "equivalence" to predicate devices through various tests.
The reported device performance is qualitative, stating that:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence in functionality | "Ensure that equivalent functionality is specified and implemented in the new device." |
| Conformance to technical specifications | "Confirm technical specifications for completion of predicate details in comparison tables" and "Confirm technical specifications for completion of new device details in comparison tables." The detailed comparison tables (see section 4) indirectly serve as performance targets by showing that the RT300 either matches or improves upon the predicate devices' specifications, particularly regarding additional stimulation channels and muscle groups. |
| Verification of performance to specification | "Conduct system testing to verify performance to specification." (No specific quantitative results provided in the summary) |
| Safety and effectiveness of additional stimulation channels | "The safety and effectiveness of providing up to 5 additional channels of electrical stimulation utilizing the RT50 to the upper and lower extremities, erector spinae and abdominal muscle groups has been demonstrated during validation testing." |
| Safety and effectiveness of Stimwear garment | "The safety and effectiveness of utilizing Stimwear and carbon electrodes has been demonstrated during validation testing." |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" in this context refers to the clinical testing conducted for the new features of the RT300.
- Sample Sizes:
- RT50 stimulation (standalone and with RT300): Five able-bodied individuals.
- Stimwear garment: One able-bodied individual.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given the small sample sizes and the nature of the testing (validation of new features on able-bodied individuals), it is most likely a prospective study conducted by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not describe the use of "experts" to establish a ground truth in the traditional sense for the clinical testing. The validation appears to be focused on functional performance and safety directly observed or measured in able-bodied individuals, rather than diagnostic interpretation. Therefore, there's no mention of a traditional ground truth established by independent experts (like radiologists for imaging devices).
4. Adjudication Method for the Test Set
Not applicable. As there were no multiple "readings" or interpretations that would require adjudication (e.g., in a diagnostic setting), no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is not an imaging or diagnostic device where human reader interpretations are compared. The clinical testing mentioned focused on validating the functional aspects and safety of the electrical stimulation features.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
The submission describes a "stand alone stimulation mode" for the wireless battery-powered stimulation channels (RT50). It states: "The RT50 in standalone mode was validated with five able bodied individuals." This indicates a test of the device's function without being integrated into the larger RT300 cycle ergometer system, which aligns with the concept of standalone performance for that specific component.
7. Type of Ground Truth Used
The "ground truth" for the clinical validation appears to be the direct observation and measurement of the device's functional integrity and safety in able-bodied individuals. This would include verifying that:
- The stimulator delivers stimulation as intended.
- The stimulation does not cause adverse effects.
- The Stimwear garment properly conducts electrical stimulation.
- The additional muscle groups can be stimulated.
This is distinct from, for example, pathology reports for cancer detection or outcome data for therapeutic efficacy, as the primary goal here is demonstrating equivalence and safety of the FES technology itself, especially for its new features.
8. Sample Size for the Training Set
The document does not refer to a "training set" in the context of machine learning or AI models. The RT300 is an FES device, not a diagnostic algorithm that would typically require a training set of data. The "system testing" mentioned might involve some internal data for calibration or software development, but it's not described as a formal training set for an AI/ML component.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/ML model.
§ 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).