(64 days)
The RT300-S (adult version) and RT300-SP (pediatric version) are 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 RT300-SP (pediatric version), is intended for population ages 4 to 12 years.
The RT300-S is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of
- a motorized cycle ergometer (RTI part number SA100047 for adults and SA100044 for children)
- an FES controller / stimulator (RTI part number SA100090)
- a stimulation cable which connects the controller / stimulator to cutaneous electrodes (RTI part number SA100091)
- cutaneous electrodes (12 electrodes for 6 stimulation channels, RTI part number FA100015)
- an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
This system allows a person with impaired lower extremity movement to undertake cycle ergometry both actively (utilizing FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).
The provided text describes the RT300-S and RT300-SP Functional Electrical Stimulation (FES) cycle ergometer, its intended use, technological characteristics, and performance data submitted for 510(k) clearance.
However, the document does not provide specific acceptance criteria or an explicit study proving the device meets those criteria in the format typically used for AI/ML device evaluations. Instead, it focuses on demonstrating substantial equivalence to a predicate device (THERAPEUTIC ALLIANCES, INC. product: "ERGYS", K841112) through non-clinical and clinical testing.
Therefore, an exhaustive table of acceptance criteria and reported device performance, as well as detailed information on sample sizes, expert qualifications, and ground truth establishment, cannot be extracted directly from this document. The information provided is primarily for regulatory clearance based on equivalence, not a standalone performance study with predefined metrics.
Here's a breakdown of what can be inferred and what is missing, structured as closely as possible to your request:
RT300-S/SP Functional Electrical Stimulation Cycle Ergometer
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Safety and Effectiveness equivalent to predicate device (ERGYS, K841112) | "RTI's clinical and non clinical testing has demonstrated that the RT300-S is as safe and effective as the predicate device." |
| Correct operation of system, including electrode off detection. | Confirmed during testing with able-bodied subjects. |
| Consistent performance across multiple devices and a remote database interface. | Demonstrated through testing of the remote database interface at a clinic with multiple RT300-S systems. |
| Technological characteristics do not raise new questions of safety and effectiveness. | Reviewed and concluded that differences (motorized flywheel, passive cycling assistance, database interface) do not introduce new risks, citing ongoing clinical use of motorized ergometers (without stimulation) in EU and USA. |
| Compliance with technical specifications. | Confirmed through output characteristic measurements and system testing. |
| Equivalent functionality as specified in predicate device's user documentation. | Ensured through review of predicate device documentation. |
| Technical specifications for predicate device confirmed. | Obtained from review of 510(k) submission for predicate device. |
2. Sample size used for the test set and the data provenance:
- Able-bodied subjects: The number is not specified, only "able bodied subjects."
- Spinal Cord Injured subjects: The number is not specified. The document states, "The RT300-S is being utilized in clinical studies involving spinal cord injured subjects," implying ongoing or past clinical use, not necessarily a discrete "test set" for this 510(k).
- Clinic utilizing multiple RT300-S systems: The number of systems or specific clinics is not mentioned for the database interface testing.
- Data Provenance: The document does not specify country of origin for the subject data. The studies mentioned appear to be prospective, focusing on system operation and clinical application.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The "ground truth" seems to be based on the established safety and effectiveness of the existing predicate device and the new device's ability to operate according to specifications and perform its intended functions. There's no indication of a diagnostic "ground truth" established by an expert panel in the context of this device.
4. Adjudication method for the test set:
- Not applicable/Not described. This type of adjudication (e.g., 2+1) is typically relevant for diagnostic or AI/ML evaluations where there's interpretive variation, which is not the primary focus of this submission. The evaluation is against engineering specifications and comparison to a predicate.
5. 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:
- Not applicable. The RT300-S is a medical device for physical rehabilitation, not an AI/ML diagnostic or assistive tool for human readers/clinicians, so an MRMC study is outside the scope of this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The RT300-S is a physical device that integrates a stimulator, controller, and ergometer. Its functions (e.g., muscle stimulation, cycling) are inherently "standalone" in the sense of the machine performing the intended action, but always with a human user. The performance data focuses on the device's operational characteristics and functional equivalence, not on an "algorithm only" performance in a diagnostic context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this 510(k) submission is implicitly the established safety and effectiveness of the predicate device and the technical specifications for the new device. The goal is to demonstrate that the RT300-S meets its technical specifications and performs its intended functions without raising new safety or effectiveness concerns compared to the predicate. The "clinical studies" mentioned with SCI subjects are used to support the safety and effectiveness aspect in real-world scenarios, but specific 'outcomes data' used as a ground truth for a quantitative metric are not detailed.
8. The sample size for the training set:
- Not applicable. This document describes a medical device, not an AI/ML model for which "training sets" are typically used.
9. How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set or 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).