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The RT300 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
5. Muscle re-education

The RT300 pediatric version is intended for population ages 4 to 12 years.
The RT300 is intended for use with a surface electrical stimulation garment for population ages 12 and above.
The RT300 is for prescription use only.

The RT300 is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of:

1. A motorized leg cycle ergometer (RTI part number SA100047 for adults and SA100044 for children)
2. An optional motorized arm crank (RTI part number PP102663)
3. An FES controller with up to two 6 channel stimulators (RTI part number SA216172)
4. Up to 5 additional wireless single channel stimulators (RTI part number SA216128)
5. A leg and optional arm stimulation cable which connects the stimulator to cutaneous electrodes
6. Cutaneous electrodes (up to 24 electrodes for up to 12 stimulation channels)
7. An interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
8. An interface to a pulse oximeter for the display and recording of pulse and SpO2 levels and provision of alarming based on the data
9. A 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 cycle erqometry both actively (utilizing FES evoked upper or lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor). The system combines a Windows based tablet, cycle ergometer, and stimulators in a single unit. The system is controlled by the Sage software that runs on the tablet. The Sage software delivers stimulation to the designated muscle groups in a coordinated fashion based on angle information from the ergometer. In doing so the system facilitates a smooth cycling motion throughout the therapy session.

Here are the acceptance criteria and study details for the RT300 FES Cycle Ergometer based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are defined by its safety and effectiveness endpoints across different intervention groups. The device's performance is reported across these same metrics.

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set Sample Sizes:
  • Cycling with Lower Extremity NMES: 15 patients
  • Lower Extremity NMES: 33 patients
  • Trunk NMES: 13 patients
  • Upper Extremity NMES: 14 patients
  • Pediatric NMES: 8 patients (ages 2-13 years old)
• Data Provenance: The document does not specify the country of origin. The study was a "multi-arm study with patients serving as their own control," indicating a prospective study design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy studies. Instead, the study uses functional outcome measures (e.g., Neuromuscular Recovery Scale, Berg Balance Scale) and clinical observation for adverse events, which are assessed by the study's clinical team. No specific number or qualifications of experts for ground truth establishment are provided.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1) for the test set. The effectiveness endpoints involved changes in various clinical scales and measurements, likely recorded by the clinical team, and safety endpoints were observed and documented.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and 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 study evaluates the effectiveness of a medical device (FES cycle ergometer) for rehabilitation, not a diagnostic imaging AI system or a system that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

The RT300 FES Cycle Ergometer is a therapeutic device that requires human interaction (patient use, clinician setup and monitoring) and is not an algorithm-only diagnostic tool. Therefore, a standalone (algorithm only) performance assessment, as might be done for an AI diagnostic device, was not performed. The device itself is the "standalone" subject of performance testing, but always with a human-in-the-loop for its intended use.

7. The Type of Ground Truth Used

The "ground truth" for this study is based on:

• Clinically significant improvements in functional outcome measures: These include scores from standardized scales (e.g., Adult/Pediatric Neuromuscular Recovery Scale, Berg Balance Scale, Modified Functional Reach, Modified Ashworth Upper Extremity scale, Segmental Assessment of Trunk Control), objective measurements (Biodex Dynamometer Torque, Overground Standing Test, Independent Sitting times), which represent a patient's actual functional ability and recovery.
• Absence of treatment-related adverse events: Clinical observation and documentation of safety metrics such as adverse reactions, normal erythema, blancheable erythema, muscle strain, joint strain, or fracture.

8. The Sample Size for the Training Set

The document describes a clinical study to evaluate the device's safety and effectiveness. It does not refer to a "training set" in the context of machine learning or AI model development. The numbers of patients listed under each intervention (15, 33, 13, 14, 8) represent the participants in the clinical evaluation.

9. How the Ground Truth for the Training Set Was Established

As this study is a clinical evaluation of a medical device and not the development of an AI model, the concept of a "training set" and its associated ground truth establishment does not apply. The functional outcome measures and safety observations described above serve as the evaluation criteria for the device's performance in the clinical study.

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The Xcite Clinical Station is intended for general rehabilitation for:

1. Relaxation of muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
6. Maintaining or increasing range of motion

The Xcite system is for prescription use only.

Xcite is a multichannel Functional Electrical Stimulation (FES) system that delivers electrical stimulation to peripheral nerves in a coordinated fashion to facilitate various activities. The system is composed of:

1. A tablet computer –
2. Up to two 6 channel stimulators
3. One or two stimulation cable(s) which connects the stimulator to cutaneous electrodes
4. cutaneous electrodes
5. an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
6. a mobile cart

Here's an analysis of the provided text regarding the acceptance criteria and study for the Xcite Clinical Station, formatted according to your request.

Please note: The provided document is a 510(k) summary for a medical device seeking substantial equivalence, not a detailed clinical study report. Therefore, much of the requested information (especially regarding clinical efficacy and AI performance metrics) is not present in the document. The device in question is a Powered Muscle Stimulator, which typically relies on established physiological principles rather than complex algorithmic AI for its primary function.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" or present a table of quantitative performance metrics for the Xcite Clinical Station in the context of clinical efficacy (e.g., specific improvement in range of motion percentage, reduction in muscle spasm duration). Instead, the "acceptance criteria" appear to be met through demonstrating substantial equivalence to predicate devices with established safety and effectiveness.

The document focuses on technological characteristics and non-clinical testing to demonstrate that the new device is as safe and effective as the predicates.

Therefore, the table below reflects what can be inferred from the document regarding "acceptance" in the context of a 510(k) submission, primarily based on comparison to predicate devices and adherence to relevant standards.

Study Details (as inferable from the document):

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

   • Sample Size: "five neurologically impaired individuals" were evaluated during "Validation Testing."
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given the small sample size and context as "validation testing" within a 510(k) summary, it was likely conducted in a controlled environment, potentially at the manufacturer's site or a clinical partner. The document states it was "conducted on the Xcite Clinical Station".

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. For a powered muscle stimulator, "ground truth" for clinical efficacy would typically involve objective physiological measurements or expert clinical assessments, but the details of who conducted these or their qualifications are absent.

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

   • This information is not provided in the document. Adjudication methods are typically relevant for studies involving subjective interpretations (e.g., image reading by multiple radiologists). For a device like this, clinical evaluations might involve direct observation or measurement, not necessarily a formal adjudication process.

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, an MRMC comparative effectiveness study was not done. This type of study (MRMC, measuring improvement with AI assistance) is typically performed for AI/CADe/CADx devices that assist human readers in diagnostic tasks (e.g., radiology). The Xcite Clinical Station is a Powered Muscle Stimulator, a therapeutic and rehabilitative device, not an AI-driven diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" does not apply to this device's function or the described studies.

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

   • This is not applicable in the AI/algorithm sense. The device is a physical stimulator. Its "performance" is in delivering electrical stimulation and facilitating muscle activity. The "Validation Testing" involving five individuals would represent the device in its intended use, which inherently involves human interaction (patient receiving stimulation, clinician setting parameters). There isn't an "algorithm only" performance metric in the way it would be understood for an AI device.

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

   • For the "Validation Testing" with five individuals, the document does not specify the "ground truth" used. For a physical therapy device, this would typically involve clinical assessments (e.g., measurement of muscle spasms, range of motion, blood circulation, muscle re-education markers) conducted by healthcare professionals. It's likely based on clinical observation and physiological measurements, but the specific details are not provided.

7. The sample size for the training set:

   • This concept is not applicable in the context of the Xcite Clinical Station as described. There is no mention of a "training set" because this device is not an AI/machine learning system that learns from data. It's an electro-mechanical device whose function is based on fixed principles of electrical stimulation.

8. How the ground truth for the training set was established:

   • This is not applicable for the reasons stated above (no training set for an AI/ML algorithm).

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The RT200 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 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.

Detailed Study Information:

1. 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.

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 study description is very brief and does not detail how "validation" was determined in terms of expert assessment or ground truth establishment.

3. 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.

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. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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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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The RT300 (adult and pediatric version) are intended for general rehabilitation for:
a. Relaxation of muscle spasms
b. Prevention or retardation of disuse atrophy
c. Increasing local blood circulation
d. Maintaining or increasing range of motion
The RT300 is for prescription use only.
The RT300 pediatric version is intended for population ages 4 to 12 years.
The RT300 is intended for use with a surface electrical stimulation garment for population ages 12 and above.

The RT300 is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of:

• a motorized leg cycle ergometer (RTI part number SA100047 for adults and SA100044 for children)
• an optional motorized arm crank (RTI part number PP102663)
• an FES controller with built in 6 channel stimulator (RTI part number SA100090)
• up to 5 additional wireless single channel stimulators (RTI part number FA106897)
• a leg and optional arm stimulation cable (either bilateral or unilateral) 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 cycle ergometry both actively (utilizing FES evoked upper or lower extremity muscle contractions) and passively (utilizing power developed by the ergometer's motor).

This 510(k) premarket notification for the RT300 Functional Electrical Stimulation (FES) cycle ergometer describes the device's substantial equivalence to previously marketed devices. The document highlights technological characteristics and the results of non-clinical and clinical testing.

Here's an analysis of the provided information regarding acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define acceptance criteria with quantifiable metrics for a specific performance characteristic (e.g., a minimum sensitivity or maximum error rate). Instead, the acceptance is based on demonstrating "safety and effectiveness" and "equivalence" to predicate devices through various tests.

The reported device performance is qualitative, stating that:

2. Sample Size Used for the Test Set and Data Provenance

The "test set" in this context refers to the clinical testing conducted for the new features of the RT300.

• Sample Sizes:
  • RT50 stimulation (standalone and with RT300): Five able-bodied individuals.
  • Stimwear garment: One able-bodied individual.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. Given the small sample sizes and the nature of the testing (validation of new features on able-bodied individuals), it is most likely a prospective study conducted by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not describe the use of "experts" to establish a ground truth in the traditional sense for the clinical testing. The validation appears to be focused on functional performance and safety directly observed or measured in able-bodied individuals, rather than diagnostic interpretation. Therefore, there's no mention of a traditional ground truth established by independent experts (like radiologists for imaging devices).

4. Adjudication Method for the Test Set

Not applicable. As there were no multiple "readings" or interpretations that would require adjudication (e.g., in a diagnostic setting), no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is not an imaging or diagnostic device where human reader interpretations are compared. The clinical testing mentioned focused on validating the functional aspects and safety of the electrical stimulation features.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

The submission describes a "stand alone stimulation mode" for the wireless battery-powered stimulation channels (RT50). It states: "The RT50 in standalone mode was validated with five able bodied individuals." This indicates a test of the device's function without being integrated into the larger RT300 cycle ergometer system, which aligns with the concept of standalone performance for that specific component.

7. Type of Ground Truth Used

The "ground truth" for the clinical validation appears to be the direct observation and measurement of the device's functional integrity and safety in able-bodied individuals. This would include verifying that:

• The stimulator delivers stimulation as intended.
• The stimulation does not cause adverse effects.
• The Stimwear garment properly conducts electrical stimulation.
• The additional muscle groups can be stimulated.

This is distinct from, for example, pathology reports for cancer detection or outcome data for therapeutic efficacy, as the primary goal here is demonstrating equivalence and safety of the FES technology itself, especially for its new features.

8. Sample Size for the Training Set

The document does not refer to a "training set" in the context of machine learning or AI models. The RT300 is an FES device, not a diagnostic algorithm that would typically require a training set of data. The "system testing" mentioned might involve some internal data for calibration or software development, but it's not described as a formal training set for an AI/ML component.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for an AI/ML model.

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The RT300 adult and pediatric versions 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 pediatric version is intended for population ages 4 to 12 years.

The RT300 is a Functional Electrical Stimulation (FES) cycle ergometer which is composed of:

• a motorized leg cycle ergometer (RTI part number SA100047 for adults and SA100044 for children)
• an optional motorized arm crank (RTI part number PP102663)
• an FES controller / stimulator (RTI part number SA100090)
• a leg and optional arm stimulation cable (either bilateral or unilateral) which connects the controller / stimulator to cutaneous electrodes
• cutaneous electrodes (up to 12 electrodes for up to 6 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
  This system allows a person with impaired upper or lower extremity movement to undertake cycle 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 RT300 device's acceptance criteria and the supporting study, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a 510(k) submission, which focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than setting or meeting specific quantitative performance acceptance criteria in the same way a de novo device might. Therefore, the "acceptance criteria" here are primarily about demonstrating that the new device (RT300) is just as safe and effective as the predicate device (RESTORATIVE THERAPIES, INC. product: "RT300", K071486).

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The clinical test for upper extremity stimulation involved five able-bodied individuals.
• Data Provenance: The text does not specify the country of origin. It indicates this was a prospective validation testing, performed specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information regarding the number or qualifications of experts used to establish ground truth for this validation. Given the nature of validating electrical stimulation (e.g., confirming muscle contraction, user comfort, absence of adverse events), it is likely that physical therapists, physicians, or the device developers themselves observed and evaluated the outcomes. However, this is not explicitly stated.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. With a small sample size of five individuals for a validation of upper extremity stimulation, it's possible that a single observer or development team assessed the outcomes without a formal adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No MRMC comparative effectiveness study was done.
• This device is not an AI-assisted diagnostic or interpretative device. It is a physical therapy device (Functional Electrical Stimulation cycle ergometer). Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable to the RT300. The study focused on demonstrating the physical effectiveness and safety of stimulating upper extremity muscles.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• A standalone performance assessment was conducted for certain aspects. The "output characteristic measurement of new device" performed without human interaction, to confirm technical specifications like current output, falls under a standalone assessment of the device's electrical performance.
• However, the clinical testing itself (upper extremity stimulation) inherently involved human interaction (the five able-bodied individuals and those observing/administering the stimulation). Since the device's function is to interact with a human body for therapeutic effect, a purely "algorithm-only" performance for its intended use isn't directly applicable beyond its electrical output.

7. The Type of Ground Truth Used

• For the upper extremity stimulation validation, the ground truth was likely based on direct observation of physiological response (e.g., muscle contraction, range of motion changes, absence of pain/adverse effects) in the able-bodied individuals. It's an assessment of the physical efficacy and safety of the stimulation, not a diagnostic accuracy against a histological or imaging ground truth.

8. The Sample Size for the Training Set

• The document does not refer to a training set in the context of an algorithm or AI development. The RT300 is an FES device, not a machine learning-based system that requires a training set for model development. The "training" here refers more to product development, testing, and validation against design specifications and predicate performance.

9. How the Ground Truth for the Training Set Was Established

• As there is no mention of a "training set" in the context of AI or algorithm development, this question is not applicable. The device's electrical and mechanical design was likely developed based on established physiological principles of FES and engineering standards, not through a data-driven training process.

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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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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.

Ask a specific question about this device

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

• a. Relaxation of muscle spasms
• b. Prevention or retardation of disuse atrophy
• c. Increasing local blood circulation
• d. 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)

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).

RT300-S Acceptance Criteria and Supporting Study

The RT300-S and RT300-SP devices are Functional Electrical Stimulation (FES) cycle ergometers intended for general rehabilitation. The substantial equivalence determination for K050036 is based on its comparison to the predicate device, THERAPEUTIC ALLIANCES, INC. product: "ERGYS" (K841112).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the RT300-S and RT300-SP are implicitly defined by demonstrating substantial equivalence to the predicate device, "ERGYS" (K841112), based on intended use, technological characteristics, and safety and effectiveness.

• Controller: Pocket PC-based custom software (different from predicate's custom controller). The safety and effectiveness of the controller has been demonstrated over its development.
• Stimulator: 0-140mA charge-balanced (same as predicate)
• Flywheel: Motorized to create flywheel effect (different from predicate's heavy mechanical flywheel). Safety and effectiveness "extensively demonstrated" by ongoing clinical use of the motorized ergometer without the stimulation component.
• Seating: Allows user to remain in their own seating (different from predicate's dedicated seating)
• Passive cycling: Utilizes motor assistance (different from predicate's manual assistance). Safety and effectiveness "extensively demonstrated" by ongoing clinical use of the motorized ergometer without the stimulation component. |
  | Performance to specification (non-clinical) | System testing conducted to verify performance to specification. Specific metrics not detailed but implied by the successful testing. |
  | Correct operation, including electrode off detection (clinical) | Tested on able-bodied subjects to confirm correct operation and detection of electrode off conditions with varying skin impedances. |

2. Sample Size Used for the Test Set and Data Provenance

• Able-bodied subjects: "able bodied subjects" - specific number not provided.
• Spinal cord injured subjects: "spinal cord injured subjects" - specific number not provided.
• Data Provenance: Not explicitly stated, but the submission is from a US company (Restorative Therapies Inc, Baltimore, MD), suggesting the testing likely occurred in the US. The phrase "European Infotoneous in the U.S.A." for the motorized ergometer suggests some broader context of use, but the immediate testing is not localized. It is prospective for the able-bodied and spinal cord injured subjects, as the device is being utilized or was tested for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. This submission is for a therapeutic device that relies on physical performance and functional equivalence rather than diagnostic interpretation requiring expert-established ground truth. The "ground truth" here is the physical function and safety of the device as tested.

4. Adjudication Method

Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a therapeutic device, not an imaging or diagnostic device that would typically involve human readers for interpretation. The comparison is between the performance of the new device and a predicate device.

6. Standalone Performance Study

Yes, a standalone study of the algorithm/device performance was conducted. This includes:

• Non-clinical testing: Output characteristic measurements of the new device to confirm technical specifications and comparison to the predicate. System testing to verify performance to specification.
• Clinical testing:
  • Testing with able-bodied subjects to confirm correct operation of the system, including correct detection of electrode off conditions with varying skin impedances.
  • The RT300-S "is being utilized in clinical studies involving spinal cord injured subjects," indicating further evaluation of the device in its target population.

7. Type of Ground Truth Used

The "ground truth" in this context is based on:

• Technical specifications and performance standards: Non-clinical tests confirmed the device met its technical specifications and demonstrated output characteristics equivalent to the predicate.
• Observed physical operation and safety: Clinical testing on able-bodied subjects confirmed the "correct operation of the system" and safety features like electrode off detection.
• Clinical utility/ongoing use: The ongoing clinical use in spinal cord injured subjects further supports its intended function, and the "extensive demonstration" of safety and effectiveness of the motorized ergometer (without stimulation) through ongoing clinical use in Europe and the USA for the "flywheel" and "passive cycling" components.

8. Sample Size for the Training Set

Not applicable. No "training set" in the machine learning sense is mentioned or implied for this device. The development process would have involved iterative design and testing, but not a formal machine learning training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

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