(288 days)
The Xcite Clinical Station is intended for general rehabilitation for:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and
- 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:
- A tablet computer –
- Up to two 6 channel stimulators
- One or two stimulation cable(s) which connects the stimulator to cutaneous electrodes
- cutaneous electrodes
- an interface to a remote database for the storage and retrieval of therapy settings and the storage of therapy session logs
- 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.
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance (Xcite Clinical Station) |
|---|---|
| Intended Use: Same as predicate devices. | The Xcite Clinical Station has the same intended use as the RT300 and Elpha 2000 predicate devices. |
| Technological Characteristics: No new questions of safety/effectiveness compared to predicates. | Utilizes the same FES stimulators and stimulation control system as the RT300 predicate device. Differences in technological characteristics (e.g., tablet PC controller, no ergometer on Xcite) do not raise new questions of safety and effectiveness. |
| Electrical Safety Standards: Compliance with mandated standards. | Complies with Electromagnetic Compatibility and Electrical Safety standards: IEC60601-1, ANSI/AAMI ES60601-1, IEC60601-1-2, IEC60601-1-11, and IEC60601-2-10. |
| Performance to Specification (Non-Clinical): Verification of technical specifications. | "Confirm technical specifications for completion of new device details in comparison tables." "Conduct system testing to verify performance to specification." (Details of "specifications" not provided beyond comparison in the table). |
| Functionality: Equivalent functionality to predicate devices. | "Ensure that equivalent functionality is specified and implemented in the new device." |
| Clinical Safety & Effectiveness (Implied Equivalence): As safe and effective as predicate devices. | "RTI's testing and validation testing has demonstrated that Xcite is as safe and effective as the predicate devices." |
Study Details (as inferable from the document):
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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".
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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.
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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.
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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.
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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.
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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.
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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.
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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).
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).