(123 days)
KLS Martin Individual Patient Solutions implant devices are in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
KLS Martin Individual Patient Solutions implant devices are intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction. The purpose of this submission is to add optional metallic fibula and mandible surgical guide accessories to be used by the surgeon in bone graft harvesting and resection procedures.
KLS Martin Individual Patient Solutions is comprised of patient-specific models, metallic fibula and mandible surgical guides, and metallic bone plates. Metallic bone plates are used in conjunction with metallic bone screws for internal fixation of mandibular bone. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated device model over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.
Implants are provided non-sterile, range in thickness from 1.0 – 3.0 mm, and are manufactured using traditional (subtractive) or rapid prototyping (additive) methods from either CP Titanium (ASFM F67) or Ti-6Al-4V (ASTM F136) materials. These patient-specific devices are fixated with previously cleared KLS Martin screws.
KLS Martin Individual Patient Solutions consists of the following components:
• Plates
• Screws
KLS Martin Individual Patient Solutions consists of the following accessories:
• Instrumentation
• Metallic fibula and mandible surgical guides
The provided text describes a 510(k) premarket notification for the KLS Martin Individual Patient Solutions device. This device consists of patient-specific models, metallic fibula and mandible surgical guides, and metallic bone plates used for the stabilization and fixation of mandibular fractures and mandibular reconstruction.
However, the document is a regulatory submission for a medical implant device, not an AI/ML medical device. Therefore, the information typically required for describing the acceptance criteria and the study that proves an AI/ML device meets those criteria (such as performance metrics like sensitivity, specificity, AUC, and details on training/test sets, ground truthing by experts, MRMC studies) is not present in this document.
The "Non-Clinical Performance Testing Conclusion" section does mention compliance with good manufacturing practices, design controls, and various ISO standards (e.g., ISO 10993 for biological evaluation, ISO 17665 for sterilization). These are related to the physical and biological properties of the implant device and its manufacturing, not to the performance of an AI algorithm.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device based on the provided text, as the text describes a hardware medical implant.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.