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The Aragon Surgical Caiman 5 Laparoscopic Instrument is a dedicated bipolar electrosurgical instrument intended for use in general surgical and gynecologic laparoscopic procedures where ligation and division of vessels is desired. The instrument creates a seal by the application of bipolar electrosurgical RF energy to vascular structures (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue.

Indications for use include general laparoscopic procedures, including urologic, vascular, thoracic, and thoracsocopic, and gynecological laparoscopic procedures where ligation and division of vessels is performed. These procedures include: laparoscopically assisted vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy etc.

The Aragon Surgical Caiman 5 Laparoscopic Instrument can be used on vessels up to and including 7mm, and tissue bundles as large as will fit in the jaws of the instrument.

The Aragon Surgical Lektrafuse RF System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

The Aragon Surgical Caiman 5 Laparoscopic Instrument is provided as a sterile, single use device. The device is capable of vessel sealing, blunt dissection, grasping and dividing tissue enclosed within its iaws during open and laparoscopic procedures. The device is designed to be used with the Aragon Surgical RF Generator (K093075) and creates vessel ligation by the application of bipolar electrical RF energy and tissue division with a cutting blade.

The Aragon Surgical Lektrafuse RF Generator is designed to be used with Aragon Surqical RF instrumentation only. The Aragon Surgical Lektrafuse RF Generator is not compatible with any other handheld RF surgical instrumentation.

The provided text describes a 510(k) premarket notification for the Aragon Surgical Caiman 5 Laparoscopic Instrument, not a study performing a comparative effectiveness or standalone performance evaluation against acceptance criteria in the manner typically associated with clinical trials or AI/software validation. The document states that "Results of bench and pre-clinical evaluations were used to demonstrate that the Aragon Surgical Lektrafuse RF Generator and Caiman 5 Laparoscopic Instrument are substantially equivalent to the predicate devices and meets design, safety, and effectiveness criteria."

This is a regulatory submission focused on demonstrating substantial equivalence to predicate devices. It does not contain the detailed information about specific acceptance criteria and a study design with sample sizes, expert ground truth, or MRMC studies that you are asking for in the context of device performance validation against specified criteria.

Therefore, many of the requested fields cannot be filled directly from the provided text.

Here's an attempt to answer the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list specific numerical acceptance criteria (e.g., minimum burst pressure, maximum thermal spread) or corresponding quantitative reported device performance data in a table format. The "acceptance criteria" are generally implied to be that the device performs equivalently to the predicate devices in terms of design, materials, principle of operation, and product specifications, and meets general safety and effectiveness criteria.

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

The document states "Results of bench and pre-clinical evaluations were used," but does not provide specific sample sizes for these tests, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective nature).

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

This information is not provided in the document. The "bench and pre-clinical evaluations" likely involve engineering and possibly veterinary experts, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set

This information is not provided in the document.

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 such study (MRMC or involving AI assistance) is mentioned or implied in the document. This device is a surgical instrument, not an AI-powered diagnostic tool.

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

Not applicable, as this is a physical surgical instrument, not a standalone algorithm.

7. The type of ground truth used

The "ground truth" used for demonstrating substantial equivalence would primarily be the established performance characteristics and safety profiles of the predicate devices, along with the results from the bench and pre-clinical evaluations on the new device. These evaluations would typically involve measurements of parameters like seal strength, burst pressure, thermal spread, and tissue effects. The document does not specify whether pathology, outcomes data, or expert consensus was used specifically as "ground truth" for these evaluations.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would have a training set. The "training" in this context would refer to the development and testing of the physical device.

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

Not applicable. See point 8.

Summary of Limitations:

The provided text is a 510(k) summary for a physical medical device (a laparoscopic electrosurgical instrument), not a report on a clinical study or a validation study for an AI algorithm. Therefore, many of the questions related to clinical study design, expert evaluation, AI performance, and specific statistical metrics are not addressed in this type of regulatory document. The primary goal of this submission is to demonstrate "substantial equivalence" to already marketed predicate devices, usually through technical comparisons and non-clinical testing, rather than a novel clinical effectiveness study against predefined quantitative performance criteria.

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