(93 days)
The Fixion Dynamic Hip Screw System (Fixion DHS) is intended for use in fixation of fractures in the proximal femur. The Fixion DHS is indicated for use in pertrochanteric, intertrochanteric, and base of femur neck fractures.
The Fixion DHS can be implanted in an open or in a minimally invasive approach.
The Fixion DHS System consists of the following components:
- Plate a solid, titanium-made, component, incorporating holes for the insertion of the Hip Peg, Locking Pin and Screws. The Plate Body is shaped to comply with the hone curvature and the Barrel is located at 135° - 145° relative to the Plate Body.
- Hip Peg a titanium-made tube with a distal expandable section, to enhance the abutment of the Hip Peg inside the femoral head. The expandable body ends with a conical shaped distal end.
- Locking Pin a titanium-made pin. It is used to provide additional fixation of the fragment, if needed, and for stabilizing bone fragments in case of torsional instability
- Screws titanium screws. Maximum of 3 7 Screws (Plate length dependant) can be used to attach the plate to the bone (the femur shaft) at its distal section.
- Instrumentation Set ~ a set of accessories to be used with the Fixion DHS implants. Accessories for both open and minimally invasive surgical approaches are available.
- Inflation Device (Pump) - a manual pump used to expand the Hip Peg.
The provided text is a 510(k) summary for the Disc-O-Tech Medical Technologies Ltd. Fixion® Dynamic Hip Screw System (Fixion® DHS). This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria in the manner requested.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:
- No acceptance criteria are explicitly stated.
- No study proving device performance against acceptance criteria is described. The document refers to standards like ASTM F 382, ASTM F 384, etc., but these are general specifications for metallic bone plates and orthopedic fracture fixation devices, not specific performance metrics or a study demonstrating the Fixion® DHS meets them.
- There is no mention of a test set sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance studies, training set details, or how ground truth was established for any performance evaluation.
The 510(k) summary focuses on:
- Predicate Devices: Listing devices to which the Fixion DHS is claimed to be substantially equivalent.
- Performance Standards: Identifying industry standards that the materials and general design specifications refer to, rather than reporting device performance against specific criteria.
- Intended Use and System Description: Detailing what the device is for and how it is constructed.
- Substantial Equivalence Argument: Stating that the device's characteristics are similar to the predicate devices.
In summary, the provided text does not contain the information necessary to fulfill the request for a table of acceptance criteria and a detailed description of a study proving the device meets those criteria.
§ 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.