(71 days)
The Pinn – ACL® CrossPin is intended to provide femoral fixation of soft tissue grafts for reconstruction of cruciate ligaments in the knee.
The Linvatec Pinn-ACL® CrossPin consists of absorbable crosspin and graft harness implants made from poly L-lactic acid, high strength polyethylene fiber to be used with manual, re-useable instruments to facilitate the precise positioning of the implants (Crosspin refers to the both the crosspin and graft harness implants. The implants are single-use and sterile. The instruments are supplied non-sterile and must be sterilized prior to use.
The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device called the "Pinn-ACL® CrossPin." It details the device's classification, intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews.
The purpose of a 510(k) submission like this is to demonstrate that a new device is substantially equivalent to a surgically marketed predicate device, not necessarily to present detailed performance study results against specific acceptance criteria in the way a clinical trial or performance study report would.
Therefore, I cannot fulfill your request for the tables and information about the study or acceptance criteria based solely on the provided text. The document states:
- No acceptance criteria are mentioned.
- No specific device performance studies are described. The only "study" implied is the comparison for substantial equivalence to predicate devices.
- No sample sizes for test or training sets are given.
- No information on ground truth establishment or expert qualifications is present.
- No multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance is discussed, as this device is a physical implant, not an AI or imaging diagnostic tool.
The document indicates the device's intended use is "to provide femoral fixation of soft tissue grafts for reconstruction of cruciate ligaments in the knee" and lists predicate devices it is substantially equivalent to. The substantial equivalence argument itself, without explicit performance data, is the basis for its approval in this context.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.