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The Erase Pen (RF Controller) is only used with the Erase Tip (Single Use Sterile Detachable Electrode Cartridge system) for thermal coagulation of soft tissue and peripheral nerves by creating radiofrequency (RF) lesions in nerve tissue. It is intended for use only by trained clinicians in hospital or clinical setting.

The Erase Pen (hand-held Bi-Polar Radiofrequency battery operated controller) and the Erase Tip (single use, sterile detachable electrode cartridge system) is a hand-held Electrosurgical Device to locate and ablate nerves. The depth of the electrodes, the amount of RF energy. delivered, and the duration of energy applied control the size of the ablation.

The provided 510(k) summary for the Cheng Medical Corporation Erase Pen and Erase Tip System for Nerve Ablation (K101592) does not provide explicit acceptance criteria or details of a specific study proving the device meets them.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Radionic's RFG-3C, K982489) based on shared technological characteristics and similar operating parameters. The "Device Testing Results and Conclusion" section broadly states that "All necessary testing was performed... to ensure that the [device] is substantially equivalent... and to ensure that the new device does not raise new issues regarding safety and effectiveness." This indicates that general safety and performance testing was conducted, but the specifics of what was tested, what the acceptance criteria were, and what the results were are not detailed in this summary.

Therefore, many of the requested items cannot be answered directly from the provided text.

Here is a breakdown of what can be inferred or directly stated based on the given information, and where information is missing:

1. A table of acceptance criteria and the reported device performance

• No explicit acceptance criteria are provided.
• The document presents a table comparing "Erase Pen Operating Characteristics" with the predicate device (Radionics RFG-3C), which serves as a comparison of performance parameters rather than predefined acceptance criteria. The implied "performance" is that these parameters are sufficiently similar to the predicate device for substantial equivalence.

Note: The document states "The set output level Erase Pen and adjustable output level Radionics RF generators would have an output power equivalence when the Radionics RFG-3C is at a setting of 3 to 5, depending on the tissue impedance." This implies that despite some numerical differences, the functional output can be considered equivalent under certain conditions.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The summary mentions "All necessary testing was performed," but does not specify the nature of the test set (e.g., in-vitro, ex-vivo, animal, human clinical). Therefore, details like sample size, provenance, or retrospective/prospective nature are absent.

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)

• Not applicable / Not provided. Since no specific test set involving human interpretation or subjective assessment is described, there's no mention of experts or ground truth establishment in this context. The testing described appears to be engineering/performance testing of the device itself.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. As above, no such test design is described.

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. This device is a radiofrequency ablation system, not an AI-assisted diagnostic or interpretative device. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and was not performed.

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

• Not applicable. This device is a physical electrosurgical instrument, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not provided in detail. For a device like this, the "ground truth" for performance testing typically refers to objective measurements of physical parameters (e.g., power output, lesion size/temperature in a tissue phantom or animal model) and adherence to engineering specifications and safety standards. The document states "to ensure that the product... does not raise new issues regarding safety and effectiveness," implying such testing was done, but specific ground truth types are not detailed.

8. The sample size for the training set

• Not applicable / Not provided. As this is a physical medical device and not an AI/ML algorithm requiring a training set, this information is not relevant and not present in the document.

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

• Not applicable / Not provided. See point 8.

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The Smith & Nephew ElectroThermal® 20S Spine System is intended to create lesions in nervous tissue, and to coagulate and decompress disc material when used in combination with Smith & Nephew thermal/coagulating probes. The generator and accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The proposed Smith & Nephew ElectroThermal® 20S Spine generator is a 20-watt electrothermal generator. It is intended to be used to create lesions in nervous tissue and to coagulate and decompress material when used in combination with Smith & Nephew thermal/coagulating probes. The generator provides temperature and impedance monitoring of energy to maintain effective tissue heating during temperature controlled applications. Smith & Nephew ElectroThermal® 20S Spine generator is designed to be used in conjunction with Smith and Nephew Spine products. These products include the Smith & Nephew SpineCATH® Intradiscal Catheter, the Smith & Nephew Decompression Catheter and the Smith & Nephew RF Denervation Probe and Smith & Nephew RF Probe.

The provided document is a 510(k) summary for the Smith & Nephew ElectroThermal® 20S Spine Generator, which details its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the manner of a clinical trial for diagnostic performance.

Therefore, the detailed information requested regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available in this document, as it pertains to performance studies typically conducted for devices with diagnostic or AI components. This submission is for an electrosurgical generator, and the "performance data" referred to is about its functional equivalence to other similar generators.

Here's an interpretation of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it establishes substantial equivalence based on technological characteristics and functional performance compared to predicate devices. The "reported device performance" is the demonstration of this substantial equivalence.

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

• Not Applicable. This document describes a 510(k) submission for an electrosurgical generator, focusing on its substantial equivalence to predicate devices based on technological characteristics and functional performance rather than diagnostic accuracy or clinical outcomes tested on a "test set" of patient data. Performance testing would typically involve engineering and bench testing to confirm the generator's output parameters match those of the predicate, not a "test set" of patient data in the context of diagnostic AI.

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

• Not Applicable. Ground truth, in the context of diagnostic performance, is not relevant here as this is an electrosurgical device. The "ground truth" for its functional performance would be established by engineering specifications and measurements.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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-powered diagnostic tool. MRMC studies are for diagnostic accuracy, typically involving human readers interpreting images with or without AI assistance.

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

• Not Applicable. This is not an algorithm but an electrosurgical device. Its performance is evaluated through engineering and functional tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Implied Ground Truth: For this type of device, the "ground truth" for its performance would be established through engineering specifications, bench testing, and functional measurements to ensure that the device generates the correct RF energy, monitors temperature and impedance accurately, and performs its intended electrosurgical functions within established parameters that are comparable to the predicate devices. This is not derived from clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an electrosurgical generator. This terminology applies to machine learning algorithms.

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

• Not Applicable. See point 8.

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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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