(24 days)
The RITA® System (RF generator and electrosurgical devices) supplies energy for use in electrosurgery and is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including:
- . the partial or complete ablation of non-resectable liver lesions and
- the palliation of pain associated with metastatic lesions involving . bone in patients who have failed or are not candidates for standard pain therapy.
The Model 1500X Electrosurgical RF Generator is designed to provide monopolar radiofrequency (RF) energy. The RF Generator is a 150/200 W electrosurgical generator specifically designed for use with RITA electrosurgical devices. It can read multiple temperature sensors and includes impedance and power monitoring to assist the physician in monitoring and controlling the ablation.
To use the system, the RF Generator is plugged into the wall outlet via the Power Cord. The electrosurgical device is connected to the RF Generator via the Main Cable. The Thermo Pad is placed on the appropriate location of the body and is connected to its ports on the RF Generator via a cable adapter. Once the system is successfully powered up, the user can set the parameters of the ablation such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the electrosurgical device placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the RF Generator. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the liquid crystal display (LCD). The RF energy delivery also automatically ceases once the ablation is completed based on the initial user-defined parameters. RF energy can be stopped at any time by pressing the RF ON/OFF switch.
The provided text is a 510(K) summary for the RITA Model 1500X Electrosurgical RF Generator. It describes the device, its intended use, and indicates that performance data was submitted. However, it does not include the specific acceptance criteria or the detailed study results proving the device meets those criteria.
The "Performance Data" section states: "The Model 1500X RF Generator and accessories were subjected to a battery of electrical, mechanical, and software validation testing." This is a general statement and does not provide the specific information requested in your prompt.
Therefore, I cannot fulfill your request for the following information based solely on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no such study is detailed.
- Adjudication method: Not applicable.
- 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, as this device is an electrosurgical generator, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document is primarily focused on the administrative aspects of FDA clearance (510(k)), affirming substantial equivalence to a predicate device, and outlining general device characteristics and intended use. Detailed performance study results and acceptance criteria are typically found in the full 510(k) submission, which is more comprehensive than the publicly available summary.
§ 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.