(77 days)
Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® . Suture Anchor (K954443) are indicated for attachment of soft tissue to bone in shoulder, wrist and hand procedures
Both the Surgical Dynamics™ Suture Anchor** and the Polv-Medics Lactosorb® . Suture Anchor (K954443) consist of a suture anchor, with polyester suture attached, that is placed into a predrilled bone hole for anchorage of soft tissue.
This looks like a 510(k) premarket notification for a medical device (Surgical Dynamics™ Suture Anchor), not an AI/ML powered device. The document describes substantial equivalence to a predicate device, rather than providing acceptance criteria and a study demonstrating performance of an AI/ML model.
Therefore, I cannot provide the information requested in your prompt as it pertains to AI/ML device studies. The provided text is a regulatory filing focused on establishing similarity to an existing device for market clearance.
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United States Surgical Corporation 510(k) Premarket Notification Surgical Dynamics™ Suture Anchor**
JUL 1 0 1996
SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS:
As is evident in the submitted information on indications, design, materials, manufacturing, sterilization, packaging and method of use, the Surgical Dynamics™ Suture Anchor** is substantially equivalent to the currently marketed Poly-Medics Lactosorb® Suture Anchor (K954443) and other currently market devices by United States Surgical Corporation.
- Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® . Suture Anchor (K954443) are indicated for attachment of soft tissue to bone in shoulder, wrist and hand procedures
- Both the Surgical Dynamics™ Suture Anchor** and the Polv-Medics Lactosorb® . Suture Anchor (K954443) consist of a suture anchor, with polyester suture attached, that is placed into a predrilled bone hole for anchorage of soft tissue.
- . Both the Surgical Dynamics™ Suture Anchor** and the Polv-Medics Lactosorb® Suture Anchor (K954443) are comprised of biosafe materials.
- . Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are intended for arthroscopic procedures for reattachment of soft tissue to bone fixation.
- . Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are manufactured in the same facilities, using the same materials and process methods and controls.
- . Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are packaged in similar facilities, with the same materials and with the same process methods and controls.
- . Both the Surgical Dynamics™ Suture Anchor** and the Poly-Medics Lactosorb® Suture Anchor (K954443) are sterilized in the same facilities, with the same materials and with the same process methods and controls.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.