(57 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 250 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 Dispersive Electrode is placed on the appropriate location of the body and is connected to its port on the RF Generator. 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 describes the RITA® Model 1500X Electrosurgical RF Generator and its 510(k) submission. However, it does not contain detailed information regarding acceptance criteria and a study proving the device meets those criteria in the way typically expected for performance claims of AI-driven diagnostic devices (e.g., sensitivity, specificity, AUC).
Instead, the "Performance Data" section of the 510(k) summary simply states: "The Model 1500X RF Generator is subjected to software validation testing." This implies that the device's performance was evaluated against functional and safety requirements, which are inherent to software validation for medical devices, rather than a clinical effectiveness study with specific diagnostic metrics.
Given this, I will interpret "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of general device validation for an electrosurgical generator, focusing on safety and functional performance rather than diagnostic accuracy.
Here's an attempt to answer your questions based only on the provided text, highlighting the limitations:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific quantitative acceptance criteria for clinical performance (like sensitivity, specificity, etc.) are not mentioned. The performance data section vaguely states "software validation testing," which implies functional and safety criteria were met.
Since no specific performance metrics are given, I can only infer the general intent which is functioning as described and safely.
| Acceptance Criteria (Inferred from Device Description & General Medical Device Requirements) | Reported Device Performance (Inferred from "Software Validation Testing" and 510(k) Clearance) |
|---|---|
| Functional Performance: | |
| Delivers monopolar radiofrequency (RF) energy. | Yes, the device is designed to provide monopolar RF energy. |
| Delivers up to 250 W of RF power. | Yes, it is a 250 W electrosurgical generator. |
| Can read multiple temperature sensors. | Yes, it can read multiple temperature sensors. |
| Includes impedance monitoring. | Yes, it includes impedance monitoring. |
| Includes power monitoring. | Yes, it includes power monitoring. |
| Assists physician in monitoring and controlling ablation. | Yes, through temperature, impedance, and power monitoring. |
| Allows user to set parameters (mode, time, target temperature, power level). | Yes, the user can set these parameters. |
| Continuously monitors and displays system parameters. | Yes, system parameters are continuously monitored and displayed. |
| Automatically stops RF energy delivery if measured parameters are outside acceptable limits. | Yes, RF energy delivery automatically stops if parameters are outside limits. |
| Displays a message on LCD if parameters are outside limits. | Yes, a message appears on the LCD. |
| Automatically ceases RF energy delivery once ablation is completed based on user-defined parameters. | Yes, automatically ceases when ablation is completed. |
| Allows RF energy to be stopped at any time by pressing ON/OFF switch. | Yes, RF energy can be stopped using the ON/OFF switch. |
| Device is safe for intended use. | Implied by 510(k) clearance following software validation and general safety testing. |
| Device is substantially equivalent to predicate device. | Yes, determined by FDA. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "software validation testing" but provides no details on what was tested (e.g., number of test cases, specific scenarios, or any clinical data). Therefore, the sample size, data provenance, and whether it was retrospective or prospective are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As "software validation testing" is mentioned, it likely refers to engineering and quality assurance personnel performing functional tests against specifications, rather than clinical experts establishing ground truth for diagnostic or therapeutic outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Given the nature of "software validation testing" for an electrosurgical generator, clinical adjudication methods would typically not be applicable.
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
An MRMC comparative effectiveness study was not mentioned and is not applicable to this device. The RITA Model 1500X is an electrosurgical RF generator, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to an electrosurgical RF generator. The device delivers energy under physician control. The "software validation testing" would be for the internal algorithms controlling power delivery, monitoring, and safety features, which are inherently "standalone" in their function but always within a human-in-the-loop context for actual patient use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For "software validation testing" of an electrosurgical generator, the "ground truth" would typically be the pre-defined functional specifications and safety requirements of the software and hardware. This is not clinical ground truth (like pathology results for a lesion). The text does not provide specifics.
8. The sample size for the training set
This information is not provided. Electrosurgical generators typically operate based on established physical principles and control algorithms, not machine learning models that require "training sets" in the conventional sense. The "software validation testing" is more about verifying correct implementation of these algorithms.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as there is no mention of machine learning or a "training set" in the context of this device. The "ground truth" for verifying its function would be based on engineering specifications and regulatory standards.
§ 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.