(79 days)
The Additive Orthopaedics Locking Lattice Plate is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle.
The Additive Orthopaedics Lattice Locking Plates consist of a plate and locking and non-locking screws with surgical site preparation and insertion instruments. It is indicated for alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as the foot and ankle. The plates are additively manufactured from medical grade titanium alloy (Ti-6AL-4V Eli). The screws are manufactured from medical grade titanium alloy. (Ti-6AL-4V Eli). The implants are provided sterile and intended for single use only. The locking lattice plate and screws come in multiple sizes.
The provided text is a 510(k) premarket notification for a medical device (Additive Orthopaedics Locking Lattice Plate). It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical evidence. However, this document does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/algorithm-based diagnostic or assistive device.
The document describes a mechanical device, specifically a surgical plate, and the assessment of its physical properties for substantial equivalence to existing similar devices. It does not involve any AI algorithms, human readers, ground truth establishment through expert consensus, or performance metrics like sensitivity, specificity, or AUC, which are typically found in studies for AI-powered medical devices.
Therefore, I cannot provide the requested information based on the provided text, as the context is entirely different.
Here's why and what the document does discuss regarding evaluation:
- Device Type: The "Additive Orthopaedics Locking Lattice Plate" is a physical implant used for bone fixation.
- Evaluation Method: The document relies on "Substantial Equivalence - Non-Clinical Evidence" which includes mechanical testing (e.g., 4-point bending, static torsion, static axial pullout) per ASTM standards (F382, F543) and bacterial endotoxin testing (LAL pyrogen testing).
- "Acceptance Criteria" in this context: The "acceptance criteria" are implied by meeting the performance demonstrated by the predicate devices through the specified ASTM standards and pyrogen limits (e.g., "Pyrogen levels for the device system were below the 20 EU/device limit"). The study demonstrating this is the mechanical and biological testing itself.
- No AI/Algorithm: The concepts of "test set," "training set," "ground truth experts," "adjudication," "MRMC study," or "standalone algorithm performance" are not applicable because this is not an AI-driven device.
To reiterate, the requested information cannot be extracted from the provided text because it pertains to an entirely different type of medical device evaluation (mechanical implant vs. AI/diagnostic software).
§ 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.