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Used in conjunction with single or dual plug bipolar electrosurgical generators to endoscopically provide hemostasis throughout the gastrointestinal tract.

The Wilson-Cook Bipolar Probe is comprised of a mono or dual plug, flush port, catheter shaft and probe. The dual or single plug is located at the proximal end of the catheter shaft and is used for connection to the appropriate bipolar generator. The flush port is also located at the proximal end of the catheter and is used as necessary for irrigation. The distal tip of the device is the probe component used for hemostasis.

The Wilson-Cook Bipolar Probe is a medical device intended for endoscopic hemostasis throughout the gastrointestinal tract, used in conjunction with bipolar electrosurgical generators. The provided document is a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria through clinical trials or performance assessments that would typically involve statistical measures like AUC, sensitivity, or specificity.

Here's an analysis of the provided information concerning acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative acceptance criteria for the device's clinical performance (e.g., success rate of hemostasis, safety outcomes in patients). Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device.

The "acceptance criteria" mentioned in the document refer to internal design verification testing, not clinical performance.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of device performance in a clinical setting. The "test set" here refers to internal design verification, for which the sample size is not specified but would typically be a fixed number of manufactured units.
• Data Provenance: The data provenance is from internal "Design Verification" conducted by Wilson-Cook Medical Inc. This is internal company testing, not clinical data from patients or a specific geographical region. It is retrospective in the sense that it evaluates manufactured devices against design specifications.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable for establishing ground truth related to clinical performance, as no clinical study data is presented. The "ground truth" for design verification would be the design specifications and manufacturing standards set by the company's engineers and quality control personnel. Their specific qualifications are not detailed.

4. Adjudication Method

• Adjudication Method: Not applicable, as there is no clinical data requiring expert adjudication for performance outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not performed or reported in this 510(k) submission. This type of study typically involves assessing the performance of human readers (e.g., physicians) with and without the assistance of an AI algorithm, which is not relevant for this, an electrosurgical device.

6. Standalone Performance Study

• Standalone Performance Study: No, a standalone algorithm-only performance study was not performed. The device is a physical electrosurgical probe, not a software algorithm. The "performance" in this context refers to its ability to meet design specifications, which was confirmed through internal design verification testing.

7. Type of Ground Truth Used

• Type of Ground Truth: For the "tests" described, the ground truth is the design specifications, manufacturing standards, and biocompatibility requirements for the materials. There is no clinical or pathological "ground truth" established in this submission as it's not a diagnostic device or a study involving patient outcomes.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. The device is a physical medical instrument, not an AI or machine learning model that requires a "training set."

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

In summary: The 510(k) submission for the Wilson-Cook Bipolar Probe primarily demonstrates substantial equivalence to a predicate device, relying on design verification and biocompatibility established by material history of use. It does not contain information about clinical acceptance criteria, clinical study power analyses, sample sizes for patient data, expert ground truth establishment, or any form of AI performance metrics (e.g., AUC, sensitivity, specificity). The "acceptance criteria" mentioned refer to internal engineering and quality control specifications.

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