Search Results

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.

Ask a specific question about this device