(148 days)
The AUTO SUTURE* VCS* Anastomotic** clip cartridge is intended to apply titanium clips for use in the creation of vascular anastomoses and in the attachment of synthetic vascular prosthesis.
The AUTO SUTURE* VCS*Anastomotic** clip cartridge fires multiple titanium clips simultaneously around the junction of 2 vessels to create a vascular anastomosis.
The provided document is a 510(k) premarket notification for a medical device (Auto Suture VCS Anastomotic Clip Cartridge). It primarily focuses on demonstrating substantial equivalence to a predicate device and does not include detailed acceptance criteria or a study proving the device meets those criteria in a typical AI/software context.
Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets those criteria because the document does not contain this type of information.
The document is a regulatory approval letter and a summary of information for a medical device that uses pre-formed titanium clips for vascular anastomoses. This is a physical, mechanical device, not a software-based AI device. The regulatory pathway for such devices typically involves demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance metrics against specific acceptance criteria in the manner one would see for AI/ML algorithms.
Here's why the requested information isn't present in this document:
- Acceptance Criteria & Reported Performance: The document states, "The AUTO SUTURE* VCS* Anastomotic**clip cartridge has been subjected to substantial safety and effectiveness testing." However, it does not detail specific quantitative acceptance criteria (e.g., success rates, force thresholds, leakage rates) or the reported performance outcomes against such criteria.
- Sample Size, Data Provenance, Experts for Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size/Ground Truth Establishment: These categories are typically relevant for AI/Machine Learning algorithms or diagnostic devices where performance is measured against a "ground truth" derived from expert interpretation, pathology, or outcomes. The Auto Suture Clip Cartridge is a surgical instrument. Its "performance" would be assessed through preclinical (e.g., in vitro, animal studies) and potentially clinical studies focusing on aspects like clip integrity, vessel occlusion, patency, and absence of adverse events, not through the metrics typically used for AI.
In summary, the provided text is a regulatory submission for a physical medical device and does not contain the specific type of information requested regarding acceptance criteria and performance studies commonly found in evaluations of AI-powered devices.
§ 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.