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The RT300-S (adult version) and RT300-SP (pediatric version) are intended for general rehabilitation for:

1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. 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:

1. a motorized cycle ergometer (RTI part number SA100047 for adults and 1 SA100044 for children)
2. an FES controller / stimulator (RTI part number SA100090)
3. a bilateral and / or unilateral stimulation cable which connects the controller / stimulator to cutaneous electrodes (RTI part number SA100091)
4. cutaneous electrodes (up to 12 electrodes for up to 6 stimulation channels and 10 muscle groups, RTI part number FA100015)
5. an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
6. an optional motorized arm crank (RTI part number PP102663)
7. an interface to a pulse oximeter for the display and recording of pulse and SpO2 levels and provision of alarming based on the data.

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 document, K071486 for the RT300-S and RT300-SP FES cycle ergometer, describes a submission for substantial equivalence to a predicate device (K071113). The focus of this submission is to demonstrate that the new device is as safe and effective as the predicate, rather than establishing de novo performance criteria against a disease condition.

Here's an analysis of the acceptance criteria and study information, addressing your specific points:

1. A table of acceptance criteria and the reported device performance

Based on the submission, the acceptance criteria are primarily framed around demonstrating substantial equivalence to the predicate device (K071113). The reported device performance is presented as matching or being equivalent to the predicate's performance and technical specifications.

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

• Test Set Sample Size:
  • Clinical Testing for Unilateral Stimulation Mode: 5 individuals.
  • Non-clinical testing (System testing, Output characteristics, etc.): No specific sample size of devices or test repetitions is provided beyond "system testing" and "output characteristic measurement of new device."
• Data Provenance: Not explicitly stated, however, the clinical test involved "able bodied individuals," suggesting it was prospective testing conducted by Restorative Therapies Inc. (RTI) as part of their development process. No information on country of origin is given.

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

• Number of Experts: Not applicable/not specified. The testing described is primarily technical and a small-scale usability/safety validation rather than a diagnostic performance study requiring expert ground truth interpretation.
• Qualifications of Experts: Not applicable/not specified.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. The testing described (e.g., output characteristics, system testing, unilateral stimulation mode validation) does not involve adjudication by multiple experts, as it is not a comparative diagnostic or interpretative study.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission focuses on comparing the technical and safety aspects of a new device to an existing predicate device, not on assessing human reader performance with or without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Standalone Performance: Not applicable. The RT300-S is a medical device, an FES cycle ergometer, not an AI algorithm. Its performance is inherent to its physical and functional operation, which was tested.

7. The type of ground truth used

• Ground Truth: For the "unilateral stimulation mode" testing, the "ground truth" would likely be the direct observation of appropriate muscle stimulation and user experience in the "able bodied individuals," confirming the mode functions as intended without adverse effects. For non-clinical tests, the ground truth would be established by engineering specifications, calibration standards, and direct measurements of the device's output. There is no mention of pathology, outcomes data, or expert consensus in the context of diagnostic interpretation.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is an FES cycle ergometer, not a machine learning model that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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