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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.

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.

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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:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not provided.
3. 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.
4. Adjudication method: Not 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: Not applicable, as this device is an electrosurgical generator, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. 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.

Ask a specific question about this device

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 Dispersive Electrode is place 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 a 510(k) summary for the RITA® Model 1500X Electrosurgical RF Generator. This document is a regulatory submission for a medical device and, as such, does not contain the detailed information typically found in a clinical study report regarding acceptance criteria and performance data as requested in your prompt.

Specifically, the text states:

• Performance Data: "The Model 1500X RF Generator was subjected to a battery of electrical, mechanical, and software validation testing."
• Performance Standards: "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act."

This indicates that the submission relies on engineering and software validation rather than a clinical study evaluating the device's performance against specific clinical acceptance criteria in a human population. The focus is on demonstrating safety and efficacy through equivalence to a predicate device based on its intended use and technology, rather than a quantifiable clinical performance study with predefined acceptance metrics.

Therefore, I cannot provide the requested information from the given text because:

1. A table of acceptance criteria and the reported device performance: The document does not define specific clinical acceptance criteria or report clinical performance metrics. It refers to "electrical, mechanical, and software validation testing" but does not provide details of these tests or their results.
2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not 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: Not applicable. This device is an electrosurgical generator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of device submission.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on the intended use, device description, and regulatory classification, concluding that the device is "substantially equivalent" to a predicate device based on its design and safety testing, not on a clinical performance study with the metrics you've asked for.

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