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The Oncobionic Bipolar Electrode is intended to be used only with the Oncobionic System and is intended for surgical ablation of soft tissue.

The Oncobionic Bipolar Electrode combines two electrodes into one device. The combined electrodes operate to deliver energy from the previously cleared Oncobionic System (K060054). The Oncobionic Bipolar electrode applies a LEDC pulse or series of pulses between two electrodes to cause an ablation effect to occur.

The provided document describes a 510(k) summary for the "Oncobionic Bipolar Electrode" and a letter from the FDA. This document is a premarket notification for a medical device and does not include detailed study reports with specific acceptance criteria, performance metrics, or study designs typically found in clinical trials for AI/software devices. The device described is a physical electrode for surgical ablation, not an AI device.

Therefore, I cannot provide the requested information, particularly items 1-9, which are largely pertinent to AI/software device performance studies.

Here's what the document does state regarding performance:

1. Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantifiable acceptance criteria. The general goal was "at least as safe and effective as the predicate devices" and to create "equivalent tissue ablation."
• Reported Device Performance: "We have included in-vivo test data, Attachment 1, which shows the Oncobionic Bipolar Electrode to be at least as safe and effective as the predicate devices. This test shows that the Oncobionic Bipolar Electrode is substantially equivalent to the predicate devices for creating ablation zones in soft tissue."

The following information cannot be extracted from the provided text because it describes a physical medical device (bipolar electrode) and not an AI or software-based device.

• 2. Sample size used for the test set and the data provenance: Not applicable.
• 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 (e.g., 2+1, 3+1, none) 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.
• 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.

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The Oncobionic System with 6 probe output is indicated for use for surgical ablation of soft tissue.

The Oncobionic System with 6 probe output is identical in design specification to the Oncobionic System cleared under K060054. The only change to the Oncobionic System with 6 probe output is the addition of 4 output ports to allow for the connection of up to six electrodes to the Generator. This design addition has been added for convenience to the use. The user can connect multiple pairs of probes thus to removing the need to connect and disconnect pairs of electrodes when treating multiple treatment sites.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

The provided documents do not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy. This 510(k) submission is for a modification to an existing device, specifically adding more output ports for convenience. The primary "study" mentioned is a benchtop test to confirm the new configuration still meets the output specifications of the original device, not a performance study in a clinical setting.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Acceptance Criteria and Device Performance

Study Details (Based on available information)

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

• Sample Size: Not specified in terms of units or cases. The study was a "Bench Top Test of Generator Output," implying measurement of the device itself rather than patient data.
• Data Provenance: Benchtop testing, not clinical data from a specific country or population.

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

• Not applicable. This was a technical benchtop test, not a clinical study requiring expert ground truth.

4. Adjudication method for the test set:

• Not applicable. No clinical test set or human interpretation was involved.

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 MRMC or human-in-the-loop study was done. This device is an electrosurgical ablation system, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithm-based device. The "standalone" performance here refers to the device's technical output, which was confirmed through bench testing.

7. The type of ground truth used:

• The "ground truth" for this technical assessment was the established output specifications of the predicate Oncobionic System (K060054).

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. No training set was used.

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The Oncobionic System is indicated for surgical ablation of soft tissue

The Oncobionic System includes additional treatment parameters. These additional treatment parameters allow for the application of the Oncobionic System to target and ablate additional volumes of soft tissue. The Oncobionic System with additional treatment parameters applies a I .EDC pulse or series of pulses between two clectrodes to cause an ablation clicel to occur. The fundamental application and design of the device has not changed, but new treatment parameters have been tested and added to the device to cause additional volumes of soft tissue ablation

The provided 510(k) summary for the Oncobionic System (K080376) primarily focuses on demonstrating substantial equivalence to predicate devices through in-vivo testing related to tissue ablation efficacy and safety.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the sample size used for the in-vivo test set. It only mentions "in-vivo test data, Attachment 1."
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "in-vivo test data."

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

This information is not provided in the document. The study described is an in-vivo test, likely involving direct measurement of ablation zones or assessment of safety parameters, rather than expert interpretation of images or other data requiring a "ground truth" established by human experts in the way an AI diagnostic device might.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided, as the study described is an in-vivo performance test rather than an expert-adjudicated study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a tissue ablation system, 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 question is not applicable in the context of this device. The Oncobionic System is a physical device used for surgical ablation, not an algorithm, and thus standalone performance in this sense is not relevant. The software validation mentioned refers to the controlling software for the device's functional operation, not a diagnostic algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the in-vivo performance study would be direct physiological measurements or observations of the effects of tissue ablation within the test subjects. This could include:

• Physical dimensions (volume, diameter, depth) of the ablated tissue.
• Histopathological assessment of the ablated and surrounding tissue to confirm the extent of ablation and any non-target tissue damage (safety).
• Physiological parameters confirming the "safety" aspect mentioned.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided, as the Oncobionic System and its evaluation as described do not involve machine learning or a "training set" in the typical sense. The software validation refers to functional testing of the controlling software, not training of an AI model.

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

This information is not applicable for the reasons stated in point 8.

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