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The RT600 is 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 RT600 is intended for use with a surface electrical stimulation garment for population ages 12 and above.

The RT600 is a Functional Electrical Stimulation (FES) upright elliptical ergometer which is composed of:

• a motorized upright ergometer (RTI part number SA211257)
• 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 lower extremity movement to undertake upright elliptical ergometry both actively (utilizing FES evoked lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).

Here's a breakdown of the acceptance criteria and study information for the RT600 device, based on the provided text:

Acceptance Criteria and Device Performance

The provided document is a 510(k) premarket notification for a Class II medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than defining explicit acceptance criteria for novel performance.

Therefore, the "acceptance criteria" for the RT600 are demonstrating that its technological characteristics and performance are substantially equivalent to the predicate device (RT300, K090750) and that these differences do not raise new questions of safety and effectiveness.

The "reported device performance" is essentially the conclusion that the RT600 meets this standard of substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance

Study Information

The document describes non-clinical and a single clinical test conducted to support the substantial equivalence claim.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size for Clinical Test: 10 Spinal Cord Injury (SCI) individuals.
• Data Provenance: Not explicitly stated, but the submission is to the U.S. FDA, implying the data would be relevant to U.S. regulatory standards. It's not specified if it's retrospective or prospective, but clinical validation studies are generally prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not provided in the summary. The clinical test involved "validation with ten SCI individuals," but details on ground truth establishment or expert involvement for this purpose are absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not provided in the summary.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices, not for a functional electrical stimulation ergometer.

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

• Not applicable. The RT600 is a physical FES ergometer device, not an algorithm-only diagnostic or AI product. Its performance inherently involves human interaction (the user and possibly a clinician for setup/supervision).

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the clinical test, the "ground truth" implicitly refers to the device's ability to provide the intended therapeutic effects (relaxation of muscle spasms, prevention of disuse atrophy, increasing circulation, maintaining/increasing range of motion) in SCI individuals. However, the specific metrics or "ground truth" used for validation within the study (e.g., physiological measurements, standardized functional scales) are not detailed in this summary.

8. The sample size for the training set

• Not applicable / not provided. The device is not described as an AI/ML system that utilizes a "training set" in the conventional sense. Its development would involve engineering design, testing, and validation, rather than a data-driven training pipeline for an algorithm.

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

• Not applicable. As a hardware device for FES, it does not have a "training set" or "ground truth" for training in the context of AI/ML. Its design and functional validation would be based on established physiological principles and engineering standards.

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