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The NiTi Laparoscopic Compression Anastomosis Clip (LapCAC) is intended to be used to facilitate side-to-side anastomosis of the alimentary tract yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi Clip is wassed from the body. The LapCAC is indicated for open, minimally invasive or laparoscopic procedures.

The Laparoscopic Compression Anastomosis Clip (LapCAC) device is a sterile single patient use device. The LapCAC provides a simple method for the creation of side-to-side compression anastomosis of the alimentary tract in open, minimally invasive and laparoscopic procedures. The LapCAC device is comprised of two components: Clip Reload double ring clip that is inserted into the two cut segments and performs the required compression on the tissue, and Applier/Handle with which the Clip is introduced into the treated area. The LapCAC device has an extended 35 or 45 cm. long shaft and is designed to pass through a 12 mm standard trocar. After a period of 7-10 days, a compression-induced necrosis of the tissue undernouth the was compressed by the rings, detaches and is naturally expelled with the stool.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner one might expect for an AI/ML device (e.g., performance metrics like accuracy, sensitivity, specificity).

The document is a 510(k) summary for a medical device called the "Laparoscopic Compression Anastomosis Clip (LapCAC)". This device is a surgical CLIP, not an AI/ML diagnostic or assistive technology. Therefore, the questions related to AI/ML device performance, ground truth, expert adjudication, MRMC studies, and training/test set sample sizes are not applicable to the content provided.

The 510(k) process for this type of device relies on demonstrating "substantial equivalence" to predicate devices, primarily through comparison of intended use, technological characteristics, and performance testing often related to biological safety and mechanical functionality, rather than diagnostic accuracy.

Summary based on the provided text:

• Acceptance Criteria and Reported Device Performance: Not applicable/not provided in the context of diagnostic performance metrics for an AI/ML device. The document states a belief of substantial equivalence based on "performance testing results," but the specific criteria or results of these tests (e.g., mechanical strength, biocompatibility, deployment success rate) are not detailed.

• Sample size used for the test set and the data provenance: Not applicable. The device is a surgical clip, not a software algorithm tested on a dataset.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

• Adjudication method: Not applicable.

• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.

• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

• The type of ground truth used: Not applicable.

• The sample size for the training set: Not applicable.

• How the ground truth for the training set was established: Not applicable.

What is present in the document is information related to regulatory clearance for a hardware medical device:

• Device Name: Laparoscopic Compression Anastomosis Clip (LapCAC)
• Intended Use: To facilitate side-to-side anastomosis of the alimentary tract, yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient, the clip is passed from the body. Indicated for open, minimally invasive, or laparoscopic procedures.
• Classification: Class II device, product code FZP, Regulation No. 21 C.F.R. § 878.4300 (Implantable Clip).
• Predicate Devices: CAC, Compression Anastomosis Clip (K033324, K041751) and Universal Stapler System (K892233, K913802).
• Performance Standards: "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act."
• Substantial Equivalence: Applicant "believes that the Laparoscopic Compression Anastomosis Clip (LapCAC) is substantially equivalent to the predicate device cited above without raising new safety and/or effectiveness issues," based on "performance testing results." (However, the details of these tests are not provided in this summary.)

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