(89 days)
TephaFLEX absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
TephaFLEX suture is a sterile, monofilament, absorbable surgical suture constructed of poly-4-hydroxybutyrate. The TephaFLEX sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery, or ophthalmic surgery.
The provided text describes the TephaFLEX® Absorbable Suture and its premarket notification (K081099). However, it does not include information about a study proving the device meets acceptance criteria in the context of an AI/ML device. The document details the device's classification, predicate devices, description, and indications for use, focusing on its physical and biological properties.
The "Safety and Performance" section states: "Physical testing was performed on the TephaFLEX sutures to USP 28, including Suture Diameter, Suture Needle Attachment, Tensile Strength. Animal testing was performed for conformance to ISO 10993 for biocompatibility and implant studies were conducted to demonstrate rates of tensile strength and mass loss."
This describes the types of tests conducted, but not an "acceptance criteria and reported device performance" table in the format typically used for AI/ML device evaluation, nor does it refer to a study using sample sizes, ground truth established by experts, or MRMC studies.
Therefore, I cannot provide the requested information for an AI/ML device as it is not present in the provided text.
§ 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
(a)
Identification. An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).