(80 days)
The NiTi Compression Anastomosis Ring (CAR) is intended for use throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. Once wound strength is sufficient to maintain the anastomosis, the NiTi Compression Anastomosis Ring is passed from the body.
The Compression Anastomosis Ring (CAR) device is a sterile single use device. The CAR provides a simple method for the creation circular compression anastomosis of the alimentary tract. After a period of 5-10 days, a compression-induced necrosis of the tissue sides underneath the ring occurs and the whole device, together with the necrosed tissue that was compressed by the ring, detaches and is naturally expelled with the stool.
The provided document, a 510(k) summary for the Compression Anastomosis Ring (CAR), does not contain specific acceptance criteria or a detailed study description with performance outcomes. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against predefined criteria.
However, based on the information provided, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided document. The 510(k) summary states, "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act." Therefore, specific acceptance criteria and detailed device performance metrics (e.g., success rate of anastomosis, incidence of leakage, time to expulsion of the device) are not presented in this document.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "validations and performance testing results, including animal studies" (Section {2}). However, it does not specify the sample size for any test set or the provenance of this data. It's only stated that these studies were conducted by NiTi Medical Technologies Ltd.
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)
This information is not available in the provided document. The summary only refers to "animal studies" as part of the performance testing, but no details regarding expert involvement or ground truth establishment are given.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available in the provided 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
This information is not applicable/available. The device is a surgical implant (Compression Anastomosis Ring), not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable/available. The device is a physical surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the mention of "animal studies," the ground truth likely involved observational outcomes and possibly pathological examination of the anastomoses in the animal subjects. However, the specific type and methodology are not detailed in this document.
8. The sample size for the training set
This information is not applicable/available. The device is a physical surgical implant, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/available. The device is a physical surgical implant, not a machine learning model.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.