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The NiTi CAC (Compression Anastomosis Clip) is intended to be used to facilitate colonic side-to-side anastomosis yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi CAC is passed from the body. The NiTI CAC is not applicable through trocars in laparoscopic procedures.

The Compression Anastomosis Clip (CAC) device is a sterile single use device. The CAC provides a simple method for the creation of side-to-side compression anastomosis of the intestine. The CAC device is comprised of two components: CLIP - DOUBLE RING CLIP THAT IS INSERTED INTO THE TWO CUT SEGMENTS OF THE INTESTINE AND PERFORMS THE REQUIRED COMPRESSION ON THE TISSUE. APPLIER - WITH WHICH THE CLIP IS INTRODUCED INTO THE TREATED AREA. After a period of 7-10 days, a compression-induced necrosis of the intestine sides underneath the rings occurs and the whole device, together with the necrosed tissue that was compressed by the rings, detaches and is naturally expelled with the stool.

This looks like a medical device submission, specifically a 510(k) summary for a Compression Anastomosis Clip (CAC). I will extract the information you requested based on the provided text.

It's important to note that the provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices and describes the device's design and intended use. It mentions "comparative animal and clinical studies" in the "Substantial Equivalence" section, but it does not provide details about those studies, their acceptance criteria, or their results within the provided text. Therefore, much of the requested information cannot be found in this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The provided 510(k) summary does not detail specific acceptance criteria or performance metrics derived from studies for the CAC device itself. It states that "validations and performance testing results, including comparative animal and clinical studies" were used to establish substantial equivalence, but the actual data, success/failure criteria, or performance outcomes are not reported here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. The document states "comparative animal and clinical studies" were conducted, but it does not specify the sample sizes for these studies, nor does it detail their design (retrospective/prospective) or data provenance (country of origin).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Cannot be provided. This question typically applies to studies where expert interpretation (e.g., image reading) is a primary outcome. For a surgical device like an anastomosis clip, "ground truth" would likely be established through surgical observation, pathological examination of tissue healing, and patient follow-up, rather than expert interpretation of a "test set" in the traditional sense of diagnostic devices. The document does not describe how ground truth was established for its comparative studies, nor does it mention any experts involved in such a process.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Cannot be provided. Similar to point 3, this question is typically relevant for diagnostic studies involving multiple readers. The nature of the studies for a surgical clip (animal and clinical studies focusing on surgical outcomes like anastomotic integrity, healing, and device expulsion) would not typically involve an adjudication method as described.

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 question is specific to AI-assisted diagnostic devices. The Compression Anastomosis Clip is a surgical device, not an AI-powered diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant to this device.

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

• Not applicable. This question is specific to AI/algorithmic performance. The Compression Anastomosis Clip is a physical surgical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Cannot be determined from the provided text. While it's highly probable that ground truth in the "comparative animal and clinical studies" would involve outcomes data (e.g., anastomotic leakage rates, healing, patency, device expulsion success) and potentially pathology (histological assessment of tissue healing), the document does not explicitly state what type of ground truth was used.

8. The sample size for the training set

• Not applicable / Cannot be provided. A "training set" is relevant for machine learning algorithms. This device is a physical surgical instrument, not an AI model.

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

• Not applicable / Cannot be provided. As above, "training set" and "ground truth for the training set" are concepts related to machine learning and AI, which are not applicable to this physical medical device.

Summary of what is present:

The 510(k) summary provides:

• Device name, applicant, contact, and date.
• Classification information (Class II, implantable clip, FZP).
• Predicate devices used for comparison (Valtrac Biofragmentable Anastomosis Ring, Proximate™ Linear Cutter and Stapler, U-Clip™, Murphy's Button).
• Intended Use statement: "The NiTi CAC (Compression Anastomosis Clip) is intended to be used to facilitate colonic side-to-side anastomosis yielding an inverted serosa-to-serosa anastomosis. Once wound strength is sufficient to maintain the anastomosis, the NiTi CAC is passed from the body. The NiTI CAC is not applicable through trocars in laparoscopic procedures."
• Device Description: A sterile, single-use device comprised of a double ring clip and an applier, designed to create side-to-side compression anastomosis. It explains the mechanism of action (compression-induced necrosis and natural expulsion after 7-10 days).
• A general statement about substantial equivalence being based on "validations and performance testing results, including comparative animal and clinical studies." However, the details of these studies are not provided in this summary.

This document serves as a regulatory filing to establish substantial equivalence for market clearance, rather than a detailed publication of device performance study results.

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