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The Laparoscopic Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the laparoscopic delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the laparoscopic delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue.
Device Components and Operation:

1. Insulated Handle: The Insulated Handle encases the controlling mechanism for the flow of saline, and activation of the RF current for the device. The activation of RF current is accomplished by a single push button on the top of the handle. The Handle has a flow control mechanism so the flow of saline can be regulated by the user within the sterile field. The tubing length is approximately ten (10) feet in length and incorporates an I.V. spike on the end to attach directly to a hanging IV (saline) bag. The Handle power cord is approximately ten (10) feet in length and incorporates a 3-prong electrical plug. The insulation of the Insulated Handle and Power Cord meets the requirements for Dielectric Withstands of Accessories.
2. Shaft and Electrode Tip: The electrode tip delivers RF energy for cutting and coagulation and delivers saline which is gravity-fed from an Intravenous bag to the tip. The electrode shaft measures 32 centimeters (12.6 inches) in length and is intended to be placed through a cannula with a minimum diameter of 10 millimeters.

This document is a 510(k) summary for the Bovie Medical Laparoscopic Saline Enhanced Electrosurgical Resection (SEER) Device. It does not contain a study demonstrating device performance against acceptance criteria.

The purpose of a 510(k) summary is to demonstrate substantial equivalence to a predicate device, not necessarily to present a de novo study with acceptance criteria and performance data. In this case, the manufacturer is relying on the established safety and effectiveness of their previously cleared device (Bovie Medical Resection Device, K-082568) and highlighting the technological similarity, with the primary difference being the laparoscopic application.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because this information is not present in the provided text.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "The Laparoscopic Resection Device conforms to the requirements of safety standard IEC 60601-2-2," but it does not detail specific performance criteria or how the device met them.
2. Sample sizes used for the test set and the data provenance: Not provided. No specific test set or associated data is discussed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No test set requiring ground truth establishment is mentioned.
4. Adjudication method for the test set: Not provided.
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. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical device, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable. This is a hardware device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on establishing substantial equivalence to a predicate device by comparing:

• Intended Use: Both devices are for cutting and coagulating soft tissue using RF current. The new device specifies "laparoscopic delivery" and "sterile saline."
• Technology: Both use a "sintered stainless steel electrode tip" for RF energy delivery.
• Differences: The primary difference is the laparoscopic application versus open surgical procedures.
• Safety Standards: The laparoscopic device conforms to IEC 60601-2-2.

The conclusion is that "There are no significant differences in technology, intended use, or performance between the Laparoscopic Resection Device and the given predicate device. There are no new questions raised regarding safety or effectiveness." This statement is the basis for the 510(k) clearance, rather than a detailed performance study with acceptance criteria.

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