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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:

• 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
• an optional motorized arm crank (RTI part number PP102663)
• 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 text describes a 510(k) premarket notification for the RT300-S and RT300-SP Functional Electrical Stimulation (FES) cycle ergometers. The submission aims to demonstrate substantial equivalence to a predicate device (RT300-S, K060032). It outlines the device's technological characteristics, intended use, and the performance data gathered to support its safety and effectiveness.

However, it does not include information about acceptance criteria or a detailed study proving the device meets specific performance metrics in the way one might expect for a diagnostic or AI-driven medical device study.

The "performance data" section primarily focuses on demonstrating equivalence to the predicate device through technical reviews and system testing, rather than explicit acceptance criteria and corresponding performance metrics for new or enhanced features.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it's absent:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in the format of a table with specific thresholds for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance" is framed around demonstrating substantial equivalence to the predicate device through technological similarities and confirming the proper functioning of new features.

The "Performance data" section describes the activities undertaken to support equivalence, which are implicitly aimed at "accepting" that the new device performs as intended and is as safe and effective as the predicate.

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: For the pulse oximeter interface validation, the test set consisted of four able-bodied individuals.
   • Data Provenance: Not explicitly stated, but given the US submission, it's likely US-based. It does not specify if it was retrospective or prospective, but testing on "able-bodied individuals" suggests a prospective, controlled evaluation for that specific component. Other testing mentioned ("Review of user documentation," "Review of 510(k) submission," "Output characteristic measurement," "Conduct of system testing") does not involve a "test set" in the typical sense of patient data.

2. 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 document describes technical evaluations and a small-scale validation for a specific interface, not studies requiring expert-established ground truth for diagnostic accuracy.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessment, which is not the primary focus of the described performance data.

4. 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 MRMC comparative effectiveness study was done or mentioned. This type of study is relevant for AI-driven diagnostic tools, which the RT300-S/SP is not. This device is a therapy delivery system.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   The document describes device performance in terms of its ability to function according to specifications and equivalence to a predicate, which inherently assesses its standalone operation for its intended therapeutic function. However, it's not "standalone performance" in the context of a diagnostic algorithm's output. The "system testing" and "output characteristic measurement" would fall under this category as they refer to the device's inherent operation.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
   For the technical tests, the "ground truth" was likely the technical specifications and expected outputs of the device based on its design and the predicate device's characteristics. For the pulse oximeter, the ground truth would be the actual physiological parameters (pulse and SpO2) of the able-bodied individuals, measured by a gold standard method if a reference was used. The document does not specify if a gold standard reference was employed for the pulse oximeter validation.

7. The sample size for the training set:
   This information is not applicable/not provided. The RT300-S/SP is a hardware and software system for FES, not an AI or machine learning model that undergoes "training."

8. How the ground truth for the training set was established:
   This information is not applicable/not provided as there is no mention of a training set for an AI/ML model.

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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

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.

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