(126 days)
The Radio Frequency System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The Radio Frequency System consists of a host with an LCD touch screen control panel, moving base, treatment handle and pedal switch. The treatment handle includes a handpiece and a sterilized tip. And the sterilized tip is classified into two type, microneedle electrodes and RF electrodes. The treatment parameters are entered via the touchscreen control panel that also displays system output information during treatment. Microneedle electrodes come in light contact with the epidermis of the patient and minimally penetrate the epidermis while RF electrodes not penetrate. RF POWER, ON TIME (RF POWER×ON TIME = RF Energy), DEPTH, are user-selectable via the control panel. The RF Power output is controlled to insure for a given time that a determinate RF Energy is delivered to the bipolar electrodes. The handpiece is held at right angles to the target tissue. As the RF energy passes into the skin, it generates an electro-thermal reaction capable of coagulating the tissue surrounding the uninsulated portion of the electrodes.
The provided text describes a 510(k) summary for a "Radio Frequency System" and its substantial equivalence to a predicate device. However, the document does not contain any information about acceptance criteria or a study proving that the device meets those criteria, especially in the context of an AI/algorithm-based device as implied by your request for information like "effect size of how much human readers improve with AI vs without AI assistance."
The device described is an electrosurgical cutting and coagulation device and accessories, not an AI/software-based diagnostic or assistive device that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance with AI.
The document explicitly states:
- "No preclinical and clinical data was provided in this submission." This means there are no studies evaluating diagnostic performance, reader studies, or patient outcomes data.
- The comparison is based on technological characteristics (e.g., frequency, power, operation mode, tips, material) and performance data related to:
- Biocompatibility (ISO standards)
- Sterilization Validation (ISO standards)
- Shelf-life Validation (ASTM standard)
- Electrical safety and electromagnetic compatibility (IEC standards)
- Software Verification and Validation Testing (FDA guidance for software, noting "moderate" level of concern)
Therefore, I cannot fulfill your request for information regarding acceptance criteria and studies proving the device meets those criteria in the context of AI/algorithm performance. The provided document concerns a hardware medical device cleared via a 510(k) pathway by demonstrating substantial equivalence to a predicate device through engineering and safety testing, not through AI performance evaluation.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.