(139 days)
The RT200 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
The RT200 is intended for use with a surface electrical stimulation garment for population ages 12 and above.
The RT200 is for prescription use only.
The RT200 is a Functional Electrical Stimulation (FES) recumbent elliptical ergometer which is composed of:
- a motorized elliptical ergometer (RTI part number SA110444)
- an FES controller with built in 6 channel stimulator (RTI part number SA109413)
- up to 5 additional wireless single channel stimulators (RTI part number FA106897)
- a stimulation cable 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 recumbent elliptical ergometry both actively (utilizing FES evoked upper or lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).
Here's an analysis of the provided text regarding the RT200 device, focusing on its acceptance criteria and supporting studies:
Acceptance Criteria and Device Performance
The submission for the RT200 does not explicitly list quantitative acceptance criteria in the typical sense of metrics like sensitivity, specificity, or accuracy with threshold values. Instead, its acceptance appears to be based on demonstrating substantial equivalence to predicate devices (RT300 and ERGYS). The "performance data" section focuses on showing that the RT200 has equivalent functionality and characteristics to these predicates.
The core "acceptance criteria" can be inferred from the claims made for substantial equivalence, which are essentially that the RT200 performs the same as the predicate devices for its intended use.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Summary) |
|---|---|
| Same Intended Use as Predicate Devices | RT200 has the same intended use as the RT300 predicate. |
| Same Output Characteristics as Predicate Devices | RT200 has the same output characteristics as the predicate device (RT300). |
| Same Control System as Predicate Devices | RT200 utilizes the same control system as the predicate device (RT300). |
| Different Technological Characteristics Do Not Raise New Safety/Effectiveness Questions | RTI concludes this after non-clinical and clinical testing. |
| As Safe and Effective as Predicate Devices | RTI's clinical and non-clinical testing demonstrated this. |
Detailed Study Information:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: "seven SCI individuals" (Spinal Cord Injury).
- Data Provenance: Not explicitly stated, but given the US submission, it's highly likely the study was conducted in the US. It's also not specified if it was retrospective or prospective, though clinical validation studies are typically prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The study description is very brief and does not detail how "validation" was determined in terms of expert assessment or ground truth establishment.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. The document describes a clinical "validation" study but offers no details on how outcomes were adjudicated or if multiple expert opinions were reconciled.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-assisted diagnostic device. The RT200 is a physical therapy device (Functional Electrical Stimulation elliptical ergometer). Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not an algorithm-only device. The RT200 is a medical device that requires human interaction (prescription, setup, patient use, and monitoring). It is not a standalone diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that the validation was based on the RT200 performing "as intended" for general rehabilitation purposes (relaxation of muscle spasms, prevention of disuse atrophy, increasing local blood circulation, maintaining/increasing range of motion). However, the specific ground truth used to assess these outcomes in the clinical validation with the seven SCI individuals is not detailed. It could have been physician assessments, functional outcome measures, or physiological measurements, but the document does not specify.
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The sample size for the training set:
- This information is not applicable/not provided. The RT200 is a physical therapy device, not a machine learning or AI-driven system that would have a "training set" in the computational sense. Its development involved engineering design, manufacturing, and testing against specifications and predicate functionalities, not data-driven model training.
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How the ground truth for the training set was established:
- This question is not applicable as there is no "training set" in the context of this device.
§ 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).