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Heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation

The Thermal RF System is a Class II Medical Device that utilizes monopolar RF energy for the purpose of elevating tissue temperature for selected medical conditions. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics and the user interface. It then has a handpiece that is attached to the console, and through the user interface can be selected for administering the treatment.

The provided text describes a 510(k) premarket notification for a medical device called the "RF Thermal System" and includes information about its performance data and substantial equivalence to a predicate device. However, it does not describe:

• Acceptance criteria expressed as specific quantitative metrics (e.g., sensitivity, specificity, accuracy thresholds).
• A study using a test set with expert-established ground truth for performance evaluation of a diagnostic or AI-based device.
• Sample sizes for test sets in the context of diagnostic accuracy.
• Data provenance (country of origin, retrospective/prospective) for a test set.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used in the context of diagnostic accuracy (e.g., pathology, outcomes data).
• Sample size for a training set or how ground truth for a training set was established.

This document focuses on the safety and basic performance of a therapeutic device (RF Thermal System) which uses heat to relieve pain, muscle spasms, and increase local circulation. The "performance data" refers to technical safety standards (IEC, ISO) and the device's ability to raise and maintain tissue temperature within a therapeutic range, not diagnostic accuracy metrics.

Therefore, based solely on the provided text, it is not possible to answer the detailed questions about acceptance criteria, test sets, ground truth, experts, or AI-specific study designs as they relate to a diagnostic or AI-driven device. The device in question is a therapeutic RF system, and its "performance" is assessed through engineering and biocompatibility tests, and its ability to achieve a therapeutic temperature, not through diagnostic accuracy metrics.

The only "performance data" provided relates to:

• IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2: Standards for general safety, electromagnetic compatibility, and high-frequency surgical equipment.
• ISO 10993-1, -12, -5, -10: Biocompatibility evaluation for medical devices.
• ASTM D 4169: Package validation testing.
• Thermal Testing: "Results showed that the Thermal RF system is capable of raising the temperature to 40°C and then maintain the temperate between 40°C – 44°C for 10 minutes, which meets the requirements for a therapeutic treatment."
• Mechanical performance: "output accuracy of the TRF TIP, all results demonstrate accuracy within ±20%."
• Temperature sensor testing: "tested successfully to demonstrate the device meets design specifications and performance requirements."

There are no details on "acceptance criteria" in the sense of accuracy metrics for a diagnostic device, nor any study design related to AI or human interpretation of images/data. The "study" mentioned is primarily engineering and bio-compatibility testing, along with a small-scale in vivo thermal test.

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