(115 days)
The AOS Small Fragment Plating System is intended to be used for fixations of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
The AOS Small Fragment Plating System consists of titanium plates, screws, and washers in various configurations and sizes. The system includes Kirschner wires, non-locking screws in diameters of 2.7mm, 3.5mm, and 4.0mm. The system includes variable angle locking screws in diameters of 2.7mm, and 3.5mm. The plate system includes 3.5mm headless compression screws, 4.0mm cannulated screws, and 4.0mm partially threaded cannulated screws.
This document describes a Special 510(k) premarket notification for the AOS Small Fragment Plating System, which is a metallic bone fixation appliance. The purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, K152732. This submission does not involve an AI/ML powered device, therefore the information requested is not present.
Here's a breakdown of the relevant information from the provided text:
- Device Name: AOS Small Fragment Plating System
- Regulation Number & Name: 21 CFR 888.3030, Single/multiple component metallic bone fixation appliances and accessories. Also 21 CFR 888.3040, Smooth/threaded metallic bone fixation fastener.
- Regulatory Class: Class II
- Product Code: HRS, HWC, HTN
- Indications for Use: Fixations of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
- Predicate Device: AOS Small Fragment Plating System (510k): K152732
- Modifications in K161913 (this submission): Longer and shorter plates, shorter screws, and screw cannulation.
- Basis for Substantial Equivalence: The modified device has the same intended use, indications for use, raw material, method of manufacture, design, type of interface, shelf life, biocompatibility, sterilization, packing methods, and physical limitations as the predicate. It also has similar sizes and dimensions.
Information related to acceptance criteria and study for an AI/ML device (which this is not):
The provided document details a mechanical testing study for a medical device (bone plating system), not an AI/ML powered device. Therefore, the specific criteria requested for AI/ML device performance (such as sensitivity, specificity, AUC, etc.) and studies like MRMC comparative effectiveness studies are not applicable and not present in this document.
The "study" described in this document is a pre-clinical mechanical test:
- Preclinical Testing: "The AOS Small Fragment Plating System was subjected to comparative mechanical testing per a four point bend test based on ASTM F382-14. The results demonstrate that the AOS Small Fragment Plating System and accessories are substantially equivalent to the predicate."
- Acceptance Criteria & Reported Performance: The document states that the results of the comparative mechanical testing "demonstrate that the AOS Small Fragment Plating System and accessories are substantially equivalent to the predicate." It implies that the acceptance criteria were met if the mechanical performance of the modified device was comparable to the predicate device per ASTM F382-14. The specific numerical values for performance are not included in this summary, but the conclusion of substantial equivalence implies they were acceptable.
- Clinical Data: The document explicitly states: "There is no clinical data referenced in this special 510(k)".
Therefore, the requested information for an AI/ML device is not applicable to this submission. This document pertains to a physical medical device (bone plates and screws) and its mechanical performance.
§ 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.