(66 days)
The Silhouette Instalift device is indicated for use in mid-face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position.
Silhouette Instalift Sutures are absorbable, sterile sutures. It is manufactured from a USP size 3-0 Poly/Glycolide/I-lactide suture material and an implantable grade of bioabsorbable PLGA resin (100% Poly (L-lactideco-glycolide) (co-monomer ratio: L-Lactide =82mol%: glycolide=18mol%). The 30 centimeter suture (+- 10 %) (SMS 28-PLG-3.0.1- NA), 27.5 centimeter suture (+- 10 %) (SMS 29-PLG-3.0.1-NA) or 26.8 centimeter suture (+- 10 %) (SMS 30-PLG-3.0.1-NA) are attached to two 12 centimeter straight stainless steel needles. All products are supplied sterile (EO) for single use only. Silhouette Instaliff Sutures elicit a minimal acute inflammatory reaction in tissue that is followed by gradual encapsulation.
The provided text is a 510(k) summary for a medical device called Silhouette Instalift. It primarily discusses a change to the device's labeling and asserts substantial equivalence to a previously cleared device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
The document states:
- "No changes have been made to the intended use or fundamental scientific technology and therefore the supporting information on sterilization, biocompatibility, and clinical data remain unchanged from the original application."
- "The only modification made to the predicate device is the modification to the labelling of the device."
Therefore, I cannot provide the requested information such as acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC study results, standalone performance, or ground truth details, because this information is explicitly stated as unchanged from the original application and is not provided in this specific 510(k) summary document.
To obtain this information, one would need to refer to the original 510(k) applications (K142061 and K163676) mentioned in this document.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.