(205 days)
The Arsenal Ankle Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, distal tibia, fibula, and other bones appropriate for the size of the device.
The Arsenal Ankle Plating System consists of plates of various shapes and sizes composed of implant grade titanium alloy intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, distal tibia, fibula, and other bones appropriate for the size of the device. The system incorporates multiple locking and nonlocking screws of various lengths and diameters, washers, and the necessary instruments to facilitate the placement of these implants.
This document describes the premarket notification (510(k)) for the Arsenal Ankle Plating System. It is a medical device and not an AI/ML powered device, so the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria is not applicable in the context of an AI/ML powered device. The document refers to non-clinical testing for mechanical safety and performance characteristics, but does not pertain to AI/ML model performance.
Therefore, I cannot provide the requested information about acceptance criteria and study details as they relate to AI/ML powered devices.
However, I can extract the information provided about the non-clinical tests performed for this medical device, which are analogous to proving the device meets its acceptance criteria for mechanical and material properties:
Non-Clinical Test Summary (Analogous to Proving Device Meets Acceptance Criteria for Mechanical Properties):
The following tests were performed for the Arsenal Ankle Plating System:
- Single Cycle Bend Testing: Referencing ASTM F382.
- Axial Pullout Strength Testing: Referencing ASTM F543 and Guidance for Industry & Food and Drug Administration Staff for Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway.
- Torsional Property Testing: Referencing ASTM F543 and Guidance for Industry & Food and Drug Administration Staff for Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway.
- Driving Torque Testing: Referencing ASTM F543 and Guidance for Industry & Food and Drug Administration Staff for Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway.
- Sterilization Testing: Referencing ISO 17665-1:2006 and AAMI TIR30:2011.
- Biocompatibility Testing: Referencing ISO 10993-1.
Additionally, an engineering analysis was conducted for the plates to demonstrate substantial equivalence to the predicate devices. The results of these evaluations indicated that the Arsenal Ankle Plating System is equivalent to the predicate devices in terms of mechanical safety and performance.
Not Applicable Information (for AI/ML powered devices):
The following points are not applicable to the Arsenal Ankle Plating System as it is a traditional medical device, not an AI/ML powered one:
- A table of acceptance criteria and the reported device performance (in terms of AI metrics).
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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.