(12 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 RITA System consists of the following components:
RF Generator: Provides RF energy to the Device through the Main Cable.
Disposable Electrode ("the Device"): Consists of a number of deployable electrodes. Some or all are equipped with a thermocouple, depending on the model of the Device. Some Devices are used with saline infusion ("Infusion Devices") and require the use of a pump.
Infusion Pump: When using the RF Generator with the Infusion Devices, an off-the-shelf market-cleared infusion pump or a RITA Pump is used to deliver saline through the Infusion Device during ablation. In the off-the-shelf pump, syringes are connected to the Infusion Device and loaded into the Infusion Pump. In the RITA Pump, a Tubing Kit is connected to the Infusion Device and loaded into the RITA Pump. The RF Generator is connected to the Infusion Pump via an RS-232 cable.
Tubing Kit: The tubing kit is designed to load into the pump head from the front of the pump. On the proximal end of the tubing-set there is a PVC Bag Spike fitting that allows the tubing to be attached to an IV bag. The Bag Spike fitting is attached to a single length of tubing that is connected to a splitter fitting that splits the single tubing into 5 separate tubes. The 5 tubes are held together with clips that allow the tubes to be uniformly loaded into the pump head. The distal end on the tubing-set has 5 female luers to attach to the Infusible devices.
Main Cable: Connects the Device to the RF Generator.
Dispersive Electrode: Provides the return path for the RF energy applied by the Device. Depending on the model, the dispersive electrode may be equipped with thermocouples to measure skin temperature at the dispersive pad. Dispersive pads with temperature sensing capabilities are connected to the RF Generator at the dispersive electrode connection and at the Aux port.
Power Cord: A medical grade line cord that provides AC power to the RF Generator.
Foot Pedal: The Foot Pedal is connected to the front of the RF Generator. The Foot Pedal starts and stops the RF energy delivery when the RF Generator is in "READY" mode.
The provided text is a 510(k) summary for the RITA® System, an electrosurgical device. It describes the device, its intended use, and states that performance data exists, but it does not contain specific acceptance criteria or detailed results from a study proving those criteria are met. Instead, it generally states that the device was subjected to various types of testing.
Therefore, I cannot provide the requested table or answer most of the detailed questions because the information is not present in the provided document.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
- Cannot create this table. The document states: "The RITA System is subjected to design verification, software validation, ablation performance, and sterilization validation testing." However, it does not specify what the acceptance criteria for these tests were or what the reported performance values were.
2. Sample size used for the test set and the data provenance:
- Cannot be determined from the document. The document mentions "ablation performance" testing but provides no details on the study design, sample size, or data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Cannot be determined. This type of information is usually relevant for studies involving human interpretation (e.g., image-based diagnosis). The RITA System is an electrosurgical device, and its performance would likely be assessed through objective measures (e.g., lesion size, temperature, power output) rather than expert ground truth for interpretation. No such expert evaluation is mentioned.
4. Adjudication method for the test set:
- Not applicable / Cannot be determined. As above, adjudication methods are typically used for establishing ground truth from multiple expert opinions, which is not described for this device's performance testing.
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, an MRMC study was not done. The RITA System is an electrosurgical device, not an AI-based diagnostic tool that would assist human readers in interpreting data. Therefore, this type of study is irrelevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Cannot be determined, and likely not applicable in the context of an "algorithm only" device. The RITA System is a physical device (generator, electrodes, pump) operated by a user. Its performance is inherent to the device's function, not a standalone algorithm. While software validation is mentioned, this refers to the software controlling the device, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be determined. The document only generally refers to "ablation performance" testing without specifying the endpoint measurements or how the "truth" of ablation success was established (e.g., by pathology post-ablation, imaging follow-up, etc.).
8. The sample size for the training set:
- Not applicable / Cannot be determined. Training sets are relevant for machine learning algorithms. The RITA System is a medical device, not an AI model requiring a training set in the conventional sense. "Design verification" and "software validation" might involve internal testing and iteration, but this is distinct from "training data" for an AI.
9. How the ground truth for the training set was established:
- Not applicable / Cannot be determined. (See point 8).
Summary of available information related to performance:
- What was tested: Design verification, software validation, ablation performance, and sterilization validation testing.
- Device Type: Electrosurgical cutting and coagulation device.
- Intended Use: Percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue, including non-resectable liver lesions and palliation of pain from metastatic bone lesions.
Conclusion:
The provided 510(k) summary states that performance testing was conducted, but it lacks the granular detail needed to answer specific questions about acceptance criteria, study sizes, ground truth establishment, or specific performance metrics. It's a high-level overview for regulatory clearance based on substantial equivalence to a predicate device, not a detailed scientific publication of study results.
§ 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.