(457 days)
The Tissue Approximation System (TAS) is indicated for use in soft tissue approximation, including use in general surgery procedures such as minimally invasive ventral hernia and abdominal wall closure less than 10cm, but not for use in ophthalmic, neurologic, or cardiovascular procedures.
The Tissue Approximation System (TAS) consists of a polyamide (nylon) "zip-tie" attached to a braided polyethylene terephthalate (PET, or Dacron) leader to aid insertion. A one-way clasp allows for fixation of the tissue approximation without the need to tie surgical knots.
When packaged for commercial distribution, four zip-ties with integrated suture leaders are accompanied by hand-held instruments that can be optionally used for insertion. The kit will be provided sterile within a polyethylene/Tyvek pouch.
The provided text describes the regulatory clearance of a medical device, the Tissue Approximation System (TAS), and discusses its substantial equivalence to a predicate device. However, the text does not contain the specific information requested about acceptance criteria for a study proving the device meets those criteria, particularly in the context of an AI/algorithm-driven device performance study.
The document is a 510(k) summary for a physical medical device (suture-like "zip-tie") and not for an AI/software as a medical device (SaMD). Therefore, the questions related to AI/algorithm performance studies (e.g., acceptance criteria for model performance metrics like sensitivity/specificity, sample size for test sets with ground truth established by experts, MRMC studies, standalone performance, training sets, etc.) are not applicable to the content provided.
The performance data mentioned in the document relates to:
- Large animal GLP compliant study: Comparing incision healing, absence of adverse events (swelling, necrosis, dehiscence, hematoma, extrusion) for TAS versus the predicate device.
- Biocompatibility testing: Per ISO 10993.
- Sterilization validation: Per ISO 11137.
- Individual device testing: To demonstrate function.
- Shelf-life validation: Using accelerated aging.
- Human factors validation: To demonstrate usability by intended users without errors.
- USP Monograph testing: For tensile strength, length, and security compared to a standard square knot.
These are standard tests for a physical medical device. The document does not describe the kind of study that would involve acceptance criteria for AI model performance metrics, expert adjudication, or MRMC studies that involve human readers interacting with AI.
Therefore, I cannot fulfill the request for information on acceptance criteria for an AI/software performance study based on the provided text, as the text describes a different type of medical device and associated testing.
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this 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.