(95 days)
FILASILK is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures.
FILAMIDE is intended for use as non-absorbable sutures in general soft tissue approximation including skin tissue closure and/or ligation in cardiac, vascular and ophthalmic procedures.
MERICRON XL suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurosurgery and ophthalmic procedures
FILAPROP sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
FILASILK™ silk suture is a non-absorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. FILASILK™ sutures are processed to remove the natural waxes and gums. FILASILK™ suture is available undyed or dyed black with Logwood extract and coated with bees wax. FILASILK™ suture meets requirements established by the United States Pharmacopoeia (U.S.P.) for non-absorbable surgical suture. FILASILK™ suture is available in U.S.P. size range 9-0 to 2, undyed/dyed form, in paper folder or plastic tray and pack size of 6/12/24/36.
FILAMIDE™ suture is a non-absorbable, sterile, synthetic, monofilament surgical suture composed of polyamide 6 [(NH-CO-(CH2)s]n and Polyamide 6.6 (NH(CH)&-NH-CO-(CH3)2-CO).. FILAMIDE™ sutures are dyed with Logwood extract. Available in a broad range of suture sizes and lengths, FILAMIDE'M is either non-needled or attached to standard stainless steel needles of varying types and sizes. FILAMIDE™ suture is available in U.S.P. size range 10-0 to 2, undyed/dyed form, in paper folder or plastic tray and pack size of 6/12/24/36.
MERICRON XL™ suture is a coated, braided, non-absorbable sterile surgical suture composed of poly (ethylene terephthalate). The empirical molecular formula of the polymer is (C10HgO4),. The suture is coated with bees wax which acts as a lubricant to mechanically improve the ease of passage through tissue and the overall handling quality of the suture. MERICRON XL™ is available undyed or dyed green with D & C Green No.6. MERICRON XL'™ is available in a range of gauge sizes and lengths, or attached to standard stainless steel needles of various types and sizes. MERICRON XLTM suture is available with or with or without PTFE (Polytetrafluoroethylene) Pledget, U.S.P. size range 6-0 to 5, undyed/dyed form, in paper folder or plastic tray and pack size of 5,6,10,12, 24 & 36. PTFE (Polytretrafluoroethylene) pledget are attached to suture for use as a pad between the suture and the tissue surface to increase the load bearing area
FILAPROP™ suture is a monofilament, synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula of polypropylene is (C3H6)n, FILAPROP™ sutures are dyed with phthalocyanine blue. FILAPROP™ is available in a range of gauge sizes and lengths attached to standard stainless steel needles of various types and sizes. FILAPROP™ is available with o or with out suture PTFFE (Polytetrafluoroethylene) Pledget, U.S.P. size range 10-0 to 2, undyed/dyed form, paper folder or plastic tray and pack size of 5,6,10,12, 24 & 36. PTFE (Polytretrafluoroethylene) pledget are attached to suture for use as a pad between the suture and the tissue surface to increase the load bearing area
The provided document is a 510(k) premarket notification for surgical sutures (FILASILK, FILAMIDE, MERICRON XL, FILAPROP). It describes various aspects of the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.
However, this document does not contain information about an AI/ML device. Therefore, I am unable to extract information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML device, as these concepts are not applicable to the traditional medical devices described in this submission (surgical sutures).
The document is solely focused on demonstrating the substantial equivalence of surgical sutures to predicate devices based on material composition, design, performance (e.g., tensile strength, diameter), and biocompatibility. The performance data section refers to standard USP (United States Pharmacopoeia) requirements for sutures, not to performance metrics typical of AI/ML algorithms (e.g., sensitivity, specificity, AUC).
Since the core request is about an "AI/ML device," and the provided document is for traditional surgical sutures, I cannot fulfill the request as stated.
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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.