(441 days)
The Miracu™ barbed surgical suture is comprised of dyed polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues.
Miracu™ synthetic barded surgical absorbable polydioxanone (PDO) suture with needle is straight, hollow, cannula and is pre-loaded onto the suture. The pigment for the violet dye is D&C Violet No.2. The Miracu™ is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue. Each dyed (violet) suture has bi-directional barbs along axis of the suture monofilament. The Miracu™ Synthetic Absorbable PDO suture with needle approximate tissue without the need to tie surgical knots, by using the opposing barbs on the surface to embed in the tissues after the surgeon precisely places the suture within the tissues. The suture is available in 4-0, 3-0, and 0, suture sizes, which are the sizes identified in the currently recognized United States Pharmacopeia (USP). The Miracu™ is barbed to two sections on suture and the barbs on each section are opposite direction each other.
The provided document is a 510(k) premarket notification for a medical device called "Miracu™ barbed surgical suture." It details the device's characteristics, intended use, and a comparison to a predicate device ("TranQuill Barbed Device"). However, the document does not describe a study involving an AI-powered device, nor does it provide details on acceptance criteria and performance metrics for such a device. The device in question is a physical surgical suture.
Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves an AI device meets those criteria, as the provided text pertains to a physical surgical suture.
The document mainly focuses on proving the substantial equivalence of the Miracu™ suture to a predicate device through:
- Bench Testing (Mechanical Testing): This involved tests for dimension, tensile strength, and bend testing of needles, conducted in accordance with USP 37-NF 32:2014 and ASTM F1874-98.
- Biocompatibility Testing: Performed in accordance with ISO 10993-1:2009, covering intracutaneous, acute systemic toxicity, cytotoxicity, bacteria reverse mutation, implantation, subchronic, sensitization, bacterial endotoxin, and material-mediated pyrogen tests.
- Animal Studies: An in-vivo biodegradation study comparing Miracu™ to the predicate device in Sprague-Dawley rats, evaluating barb holding forces, residual tensile strength, and absorption over 12 weeks.
Since the original request is specifically about an "AI-powered device" and the provided text is about a "surgical suture," it's impossible to extract the requested information as it does not exist within the given document.
If you have a document describing an AI medical device, please provide it, and I will be happy to answer your questions based on that information.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.