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These Mirror Finish Bipolar Forceps are indicated for use in any surgical procedure that requires tissue coagulation and/or cauterization to achieve hemostasis. They are indicated for use in:

1. general surgery,
2. neurosurgery,
3. urology, and nephrology.

The JJPI Bipolar Forceps Line is a modification of the bipolar forceps we currently have on the market. These forceps are made of either stainless steel or titanium. The only difference between our currently marketed line of bipolar forceps and the new line under consideration is the mirror finish proprietary coating that is applied to the tips.

The provided SSED (Summary of Safety & Effectiveness Data) for the Johnson & Johnson Professional, Inc. (JJPI) Mirror Finish Bipolar Forceps Line does not contain the level of detail typically found in reports for AI-based medical devices regarding acceptance criteria and detailed study metrics. This document refers to a traditional medical device (bipolar forceps) and therefore the questions provided for AI/ML device studies are not directly applicable.

However, I can extract the relevant information that is available about the "acceptance criteria" (which in this context refers to demonstrating substantial equivalence) and the "study" (which refers to functional testing and physical characteristic comparisons).

Here's an interpretation based on the provided text, addressing the questions where possible and indicating when the information is not present due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

For traditional medical devices seeking substantial equivalence, "acceptance criteria" are not typically expressed as numerical performance metrics like sensitivity, specificity, or AUC, as they would be for AI/ML devices. Instead, they relate to demonstrating that the new device is as safe and effective as a predicate device. The "performance" is shown by functional equivalence and adherence to established design or material specifications.

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

This information is not present in the provided document. For traditional devices undergoing functional or mechanical testing, sample sizes would typically refer to the number of devices tested or the number of simulated uses. Data provenance (country, retrospective/prospective) is not relevant for this type of device submission focused on substantial equivalence through material and functional comparison.

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

This information is not present and is generally not applicable to the type of device and study described. There's no "ground truth" to establish through expert consensus in the sense of image interpretation for an AI/ML device. The "ground truth" here is rather the established performance of the predicate device (JJPI Bipolar Forceps Line and Kirwan Non-Stick Bipolar Forceps) through their own regulatory clearances and extensive market use, against which the new device is compared in terms of physical and functional characteristics.

4. Adjudication Method for the Test Set

This information is not present and not applicable. Adjudication methods are used in scenarios where multiple reviewers interpret data, which is not described 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

No, an MRMC comparative effectiveness study was not done. This type of study is specific to AI-assisted diagnostic or interpretative devices and is not relevant to bipolar forceps.

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

No, a standalone algorithm performance study was not done. This is not an AI/ML device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to AI/ML devices (e.g., pathology for a cancer diagnosis algorithm) is not applicable here. The "ground truth" in this context is the established safety and effectiveness of the predicate devices. The study demonstrates that the "Mirror Finish Bipolar Forceps" are substantially equivalent to these predicates based on:

• Design and Material Specifications: Directly comparing physical characteristics and materials.
• Functional Testing: The statement "The functional testing and the basic mechanical properties exhibited by the JJPI non-stick forceps indicate that the JJPI proprietary coated tips are functionally equivalent..." implies that the device was subjected to tests demonstrating its ability to perform its intended function (e.g., coagulation, non-stick properties) at a level comparable to the predicate devices. The details of these tests are not provided but would typically involve benchtop testing of electrical properties, coagulation efficacy, tip adherence, durability, etc.

8. The Sample Size for the Training Set

This information is not present and not applicable, as this is not an AI/ML device that requires a training set.

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

This information is not present and not applicable, as this is not an AI/ML device.

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