(87 days)
The DePuy ACE TK2 Hip Screw System is indicated for fractures of the proximal femur extending from the subcapital area to the lesser trochanter, as well as proximal femoral osteotomies. Appropriate utilization of this device ultimately depends on the surgical judgement surrounding each paticular situation.
The TK2 Hip Screw System will be a fixed-angle plate with the option to be rotationally locked. The system will offer two lag screws: one with external keys to rotationally "lock," and the other without keys. The design will allow the lag screw assembly to slide within the barrel to ensure continuous compaction of the fracture sight, transfer of the bone instead of the implant, and reduce the risk of acetabular penetration.
The plates will initially be offered in 2 through 14 hole lengths. The plate will be offered in all lengths in 130°, 135°, 140°, 145°, and 150°; and in a short barrel and standard barrel lengths. The lag screws will initially be offered in a keyed and keyless version in lengths from 50mm through 140mm. The lag screws will be offered in a super and standard thread form.
The provided 510(k) summary for the DePuy ACE TK2 Hip Screw System does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of performance metrics like accuracy, sensitivity, or specificity. This submission focuses on demonstrating substantial equivalence to previously marketed devices (Synthes Dynamic Hip System and DePuy ACE Select Lock Hip Screw System) based on similar design and intended use, rather than on a performance study with defined acceptance criteria and statistical analysis.
Therefore, I cannot populate the requested table or answer the specific questions related to sample sizes, ground truth establishment, expert involvement, or comparative effectiveness studies, as these types of studies are typically associated with devices that either have novel performance claims or are classified differently, requiring clinical or performance data.
The 510(k) submission primarily relies on:
- Intended Use: The device is indicated for "fractures of the proximal femur extending from the subcapital area to the lesser trochanter, as well as proximal femoral osteotomies."
- Device Description: Details on its design (fixed-angle plate, rotational locking option, two lag screws, sliding barrel, various lengths and angles).
- Substantial Equivalence Rationale: Explicitly states that the TK2 Hip Screw System is "similar in design" and "substantially equivalent" to the predicate devices.
In summary, the provided document does not include the type of performance data and acceptance criteria you've asked for because it's a 510(k) summary focused on demonstrating substantial equivalence to predicate devices, not on a new performance claim or a clinical efficacy study with statistical endpoints.
§ 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.