(55 days)
Buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures in normal or osteopenic bone; non-unions and malunions; and osteotomies of the femur
The subject device includes a total of 14 bones plates for internal fixation of the distal lateral femur. All LOQTEQ Distal Lateral Femur Plates 4.5 are available non-sterile.
The subject device is provided in anatomic designs in overall lengths of 153 mm, 207 mm, 243 mm, 279 mm, 314 mm, 350 mm, and 386 mm, for the left and right distal femur. The plates are provided with 4, 7, 9, 11, 13, 15, and 17 screw holes, respectively, in the shaft of the plate. Lengths of 153 mm, 207 mm, 279 mm, 279 mm, and 314 mm are identical to the plates previously cleared in K121494. Subject device plates in lengths of 350 mm and 386 mm are identical to the plates previously cleared in K121494, except for the length.
The subject device plates include screw holes designed to accommodate appropriately sized locking and non-locking cortical and periprosthetic bone screws, previously cleared in K121494 and K072411 and K-wires, previously cleared in K131459, presently marketed as part of the LOQTEQ Distal Lateral Femur Plate 4.5 System. The compatible screws are 4.5 mm in diameter. The subject device plates also are compatible with 2.0 mm diameter aap K-Wires.
The provided document is a 510(k) summary for the LOQTEQ® Distal Lateral Femur Plate 4.5 System, a Class II medical device. It focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical testing. This document does NOT describe a study involving an AI/software device that requires intricate acceptance criteria related to accuracy, sensitivity, or specificity, nor does it detail a multi-reader multi-case (MRMC) study or complex ground truth establishment processes typical for such devices.
Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and a study proving a device meets those criteria in the context of an AI/software performance study for which your template is designed. The document explicitly states: "Clinical data were not submitted in this premarket notification." and "Any differences in the technological characteristics among the subject and predicate devices do not raise different questions of safety and effectiveness."
Instead, the "performance data" section refers to:
- Biocompatibility referenced from K121494 and K153034.
- Validation of the recommended end-user moist heat sterilization cycle.
- Mechanical testing referenced from K121494.
The "acceptance criteria" here would relate to these engineering and material standards, not to diagnostic or prognostic performance metrics of an AI.
To answer your prompt truthfully based on the provided text, I must state that the information you requested regarding acceptance criteria and studies proving the device meets them (in the context of AI/software performance) is not present in this 510(k) summary. The document is for a traditional medical device (a bone plate system) and details its substantial equivalence based on material, design, and manufacturing similarities to existing devices, supported by non-clinical engineering tests, not AI performance studies.
§ 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.