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The Halt 2000GI™ Electrosurgical Radiofrequency Ablation System is indicated for use in percutaneous, laparoscopic, and intraoperative coagulation and ablation of soft tissue.

The Halt 2000GI™ Electrosurgical Radiofrequency Ablation System includes the following system components:
• Halt 2000GI Radiofrequency Generator (RF Generator): that provides RF energy to the RF Probe
• Disposable RF Probe (Tulip™, TU 1000), a hand piece with a trocar-pointed shaft and 7 deployable RF needle electrodes.
• RF Probe Extension Cable that connects the RF Probe to the RF Generator.
• Dispersive Electrode Pads (TSP 115) Set that provides the return path for the RF energy applied by the RF Probe. (Use only Dispersive Electrode Pads provided by Halt Medical, Inc.)
• Dispersive Electrode Pad Set Extension Cable (TSPCBL) that connects the Dispersive Electrode Pad Set to the RF Generator.
• Power Cord that is a medical grade power cord providing AC power to the RF Generator.
• Foot Pedal that is a pneumatic foot pedal with tubing used to turn RF energy on and off.

The Halt 2000GI™ Electrosurgical Radiofrequency Ablation System is designed to deliver up to 200 W of RF power at 460 kHz in three operational modes: Temperature Control. Manual Control and Coagulation Mode. A touch screen with a graphical user interface (GUI) enables selection of operational parameters such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the RF probe 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 graphical user interface. RF energy during an ablation or coagulation can also be stopped at any time by the user by pressing the foot pedal.

The provided text is a 510(k) Summary for the Halt 2000GI™ Electrosurgical Radiofrequency Ablation System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be found for a novel device. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods, is not explicitly available in the provided text.

However, I can extract and infer some information based on the content.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" in the context of clinical or image-based studies. The testing mentioned includes:

• Electrical, mechanical, and software validation.
• Animal testing.
• Bench testing.
• Biocompatibility testing.

The size of these "test sets" (e.g., number of animals, number of bench tests) is not provided. Data provenance (country of origin, retrospective/prospective) is also not specified for these types of engineering and pre-clinical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The ground truth for the performance testing appears to be based on the outcomes of engineering tests (e.g., meeting electrical safety standards) and observations from animal and bench studies (e.g., "reproducible, discretely demarcated zone of tissue necrosis"). There is no mention of expert consensus for establishing ground truth in the context of a diagnostic or interpretive device.

4. Adjudication method for the test set

Not applicable to the types of testing described. Adjudication methods are typically relevant for human-in-the-loop studies or clinical trials involving subjective assessment, which are not detailed here.

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 conducted. This device is an electrosurgical ablation system, not a diagnostic imaging device utilizing AI that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device does not involve an "algorithm only" component in the sense of AI or image interpretation. Its performance is related to its ability to deliver RF energy and achieve tissue ablation, which was evaluated through animal and bench testing, as well as engineering validation.

7. The type of ground truth used

The ground truth used for performance validation appears to be:

• Engineering specifications and regulatory standards for electrical, mechanical, and software validation.
• Histopathological or visual assessment of tissue necrosis in animal and bench testing.
• Biocompatibility standards (ISO 10993 series) for material safety.

8. The sample size for the training set

Not applicable. This document describes an electrosurgical device, not a machine learning model, so there is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

Not applicable, as no training set is mentioned for this type of device.

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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 RITA System (RF Generator and electrosurgical devices) is designed to create coagulative necrotic lesions in soft tissue, and allow localized delivery of fluid to the lesion. The RF Generator is specifically designed for use with RITA Electrosurgical Devices (Accessories). The RF Generator provides multiple temperature sensors, impedance, and power monitoring to assist the user in delivering the desired energy to the target tissue. The electrosurgical devices consist of monopolar electrosurgical devices that include disposable electrosurgical probes with deployable needle arrays that deliver RF power with temperature and impedance monitoring to ablate predictable volumes of tissue.

The provided text describes the RITA® System, an electrosurgical device, and its intended use and performance data. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving device performance against those criteria.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria (e.g., target specificity, sensitivity, or similar metrics for a diagnostic device). Instead, it describes a clinical study and its observed outcomes as a measure of effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the total number of patients in the clinical study. It refers to percentages of "patients" (75% and 80%) but not the base number.
• Data Provenance: The study was conducted on "patients with lesions that had metastasized to one or more locations in the skeleton." It is a prospective clinical study assessing safety and effectiveness. The country of origin for the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For a therapeutic device like this, "ground truth" would typically relate to clinical outcomes rather than expert-derived labels on images.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of pain palliation as an endpoint, "adjudication" in the sense of expert consensus on image interpretation is less relevant. The effectiveness was measured using a "validated instrument for evaluating cancer pain," suggesting a standardized assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not provided. The study described is a clinical study evaluating the device's effectiveness in alleviating pain, not a comparative effectiveness study involving human readers with/without AI assistance. The device itself is an RF ablation system, not an AI diagnostic tool that assists human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This question is not applicable to the RITA® System as described. It is a physical medical device (RF generator and electrosurgical devices) that requires direct human operation, not a standalone algorithm. The "performance" refers to the device's clinical efficacy and safety when used by a clinician.

7. The Type of Ground Truth Used

The "ground truth" for the effectiveness of the RITA® System's pain palliation indication was based on:

• Outcomes Data: Specifically, patient-reported pain levels assessed using an "instrument validated for evaluating cancer pain."
• Safety Data: Observed adverse events and mortality related to the device's use.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The RITA® System is a physical electrosurgical device, not a machine learning algorithm that requires a "training set" in the computational sense. The "bench studies" mentioned would involve laboratory testing, not a data training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as #8. There is no "training set ground truth" in the context of this device.

In summary, the provided text describes a clinical study demonstrating the RITA® System's effectiveness in pain palliation and its safety profile. However, it does not detail specific, quantitative acceptance criteria in a tabular format, nor does it address aspects related to AI/algorithm performance (like training sets, expert adjudication, or MRMC studies) as the device is a therapeutic electrosurgical system.

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