(29 days)
The MIS Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
The CrossRoads MIS Bunion System contains a buttressing implant which can be surgically implanted using a minimally invasive surgical technique to correct hallux valgus. The MIS Bunion implant is to be made of implant grade titanium (Ti-6Al-4V ELI) per ASTM F136 with features allowing it to accept a CrossRoads MotoBAND CP screw (previously cleared in K152306), the subject Ø3.0mm MIS Bunion locking screw, or the optional subject Ø2.7mm non-locking screw in the implant. Instrumentation required for performing this surgery include a k-wire, for use with an osteotomy guide, osteotome guide and osteotome, a suture passing loop, drill bit and handle. Additional general surgical instrumentation utilized include reamers, drill guide/depth gauge. The MIS Bunion implant is tapered on the proximal end so that it can be easily inserted into the intramedullary canal of the metatarsal and the distal head of the implant will seat directly against the osteotomy surface. The MIS bunion implant wedges firmly within the intramedullary canal and acts as a buttress to hold the metatarsal head in place. To accommodate a range of anatomical sizes and severities of corrections, the implant will be offered in an array of configurations; wherein each incremental size will increase in thickness on the distal end, resulting in different buttressing offsets. The tapered proximal end of the implant will also have interrupted surfaces to gain traction within the cancellous bone, thus resisting pullout. Finally, the MIS bunion implant will accept Ø3.0mm or Ø3.5mm CrossRoads MotoBAND CP screws (K152306) or the subject MIS Bunion Ø 3.0mm polyaxial locking screws in the most distal hole, in addition to the optional subject Ø2.7mm non-locking screw accepted only in the angular cross hole for additional fixation of the implant to the metatarsal shaft.
This Special 510(k) submission seeks to modify the design of the previously cleared plate to add an additional angular distal screw hole to accept optional placement of the subject Ø2.7mm non-locking screw for additional plate stability. Additionally, this submission seeks to expand the size range of the plates to include a shorter length plate to better accommodate patient anatomy.
The provided text is a 510(k) summary for the CrossRoads Extremity Systems, LLC MIS Bunion Plating System. This document describes a medical device and its equivalence to a previously cleared device, not an AI or software device that would require specific performance criteria based on an algorithm's accuracy, sensitivity, or specificity.
Therefore, the information required to answer your prompt, which is tailored for performance claims of AI/ML or diagnostic devices (e.g., acceptance criteria for accuracy, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, training set details), is not present in this document.
This 510(k) filing primarily focuses on:
- Device Description: The physical characteristics and materials of the MIS Bunion Plating System.
- Indications for Use: What the device is intended to treat (fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus).
- Substantial Equivalence: How the modified device is similar to a previously cleared predicate device (K181872). The changes are design modifications to the plate (additional screw hole, shorter length plate) and new screw sizes.
- Performance Testing: This refers to mechanical analysis and screw pull-through construct testing to demonstrate that the design changes do not worsen the device's structural performance compared to the predicate device. It explicitly states, "Thus, it was determined that no additional mechanical testing is required."
In summary, this document does not contain the type of data or study design that your questions refer to for evaluating an algorithm's performance on a test set using ground truth established by experts.
§ 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.