(70 days)
The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plates are designed to assist the surgeon in the management of:
- Intra-articular fractures of the calcaneus .
- Extra-articular fractures of the calcaneus .
The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate is a fracture fixation plate intended for both intraarticular and extra-articular fractures of the calcaneus. The plate profile is an enclosed box structure with a smaller anterior section, larger posterior section, a distal to posterior angled strut for additional strength and 12 anatomically relevant screw hole locations. The plate thickness is 1mm and provides a low profile fit to reduce peroneal tendon irritation. The open architecture of the plate allows easy contouring by the surgeon to accommodate the anatomical topography of the calcaneous and also to promote fracture healing. The enclosed box structure has been shown in biomechanical testing to be stronger in intra and extra articular fractures of the calcaneous as well as analysis of the tuberosity shifting laterally and distally due to loading from the talus. The screw holes are also contourable, designed to allow low profile interaction with the heads of the following screws: 3.5mm cortical screw, 4.0mm cancellous screw, and the periarticular screw. The plate has countersinks on both sides to allow universal application of the plate; the same plate may be used on either the right or left side. The plate will be offered in two sizes: small and large. The DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate is manufactured from Titanium 6Al-4V ELI (per ASTM standard F136).
This document is a 510(k) summary for a bone fixation plate, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for AI/ML device performance is not present in the provided text.
The document describes the DePuy ACE TiMAX™ Calcaneal Peri-Articular Plate, which is a metallic bone fixation appliance used for treating intra-articular and extra-articular calcaneus fractures. The information provided focuses on the device's design, materials, intended use, and substantial equivalence to a predicate device (Synthes Calcaneal Plates K915818).
Here's why the specific questions about acceptance criteria for AI/ML and associated studies cannot be answered from this text:
- No AI/ML Component: The device described is a physical implant (a metal plate). There is no mention of any artificial intelligence, machine learning, software algorithm, or diagnostic function that would require specific performance metrics like sensitivity, specificity, AUC, or the need for ground truth established by experts.
- Regulatory Pathway: A 510(k) premarket notification for a traditional medical device like a bone plate primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves comparisons of:
- Intended use
- Design features
- Materials
- Performance characteristics (e.g., mechanical strength, biocompatibility – often demonstrated through bench testing or literature review, not clinical studies like those for AI/ML).
- Absence of Relevant Data: The document does not contain:
- A table of acceptance criteria or reported device performance metrics relevant to an AI/ML system.
- Information on test sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for diagnostic performance.
- Any discussion of multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- Details about training sets or how ground truth was established for "training."
In summary, the provided text describes a traditional medical device and its 510(k) clearance process, which is fundamentally different from the regulatory and testing requirements for an AI/ML-driven medical device.
§ 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.