(125 days)
The Acumed Clavicle Hook Plating System is intended for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions and dislocations of the acromioclavicular joint.
The Acumed Clavicle Hook Plating System contains pre-contoured hook plates, 3.5mm locking screws and other typical instrumentation for AC joint reduction or distal clavice fragments cases. All implants are manufactured from Titanium Alloy (Ti 6AL-4V) per ASTM F136 and are provided both sterile and non-sterile.
The provided document is a 510(k) Premarket Notification for the Acumed Clavicle Hook Plating System. It details the device's substantial equivalence to existing predicate devices based on technological characteristics and non-clinical testing. Crucially, this submission does NOT describe a study involving an AI/software device whose performance needs to be proven against acceptance criteria related to accuracy or diagnostic capabilities.
The 'acceptance criteria' and 'study' mentioned in the document relate to mechanical testing of the bone fixation device (plates and screws), not to the performance of a diagnostic or AI-driven system. Therefore, I cannot extract the information required in your prompt's format, as the prompt is designed for the evaluation of AI/software as a medical device (SaMD).
Here's why and what the document does discuss:
- Device Type: The Acumed Clavicle Hook Plating System is a physical medical device (metallic bone fixation appliances and accessories), not a software or AI product.
- Purpose of Study/Testing: The "studies" described are non-clinical bench tests (mechanical tests) to ensure the device meets required strength criteria and performance for its intended use, demonstrating its safety and effectiveness.
- Acceptance Criteria Mentioned: These refer to the mechanical performance of the plates (static and dynamic bending tests per ASTM F382-17) and screws (torsion torque, pullout strength per ASTM F543-17), compared against predicate devices and FDA guidance for orthopedic metallic bone screws.
- No AI/Software: There is no mention of any AI component, image analysis, diagnostic aid, or human-in-the-loop performance evaluation in the context of AI.
Therefore, I cannot populate the table or answer the specific questions about AI/software device performance, ground truth, expert adjudication, or MRMC studies, as these concepts are not relevant to the content of this 510(k) submission.
§ 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.