(90 days)
The ALPHALOK™ Plating System bone plates, screws, and washers are intended for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, ankle, and digits. Specific examples include:
- · Forefoot, Midfoot, and Hindfoot Osteotomies
- · Metatarsals and Metacarpals Corrections and Osteotomies
- · Stabilization and Fixation of Metatarsal and Metacarpal Fractures
- Stabilization and Fixation of Ankle Fractures
- Syndesmosis Joint Stabilization
- · Arthrodesis of Metatarsophalangeal (MTP) and Metacarpophalangeal (MCP) joints
- · Flatfoot and Cavus Foot Corrections
- Charcot Fixation
The ALPHALOKTM Ankle Fx Plates are intended for fixation of fractures, and non-unions of the distal tibia and fibula such as:
- · Lateral Malleolar Fractures
- · Syndesmosis Injuries
- · Medial Malleolar Fractures
- Bi-Malleolar Fractures
- Tri-Malleolar Fractures
- · Posterior Malleolar Fractures
- · Distal Anterior Tibia Fractures
- · Vertical Shear Fractures of the Medial Malleolus
- Pilon Fractures
- · Distal Tibia Shaft Fractures
- Distal Fibula Shaft Fractures
- Distal Tibia Periarticular Fractures
- · Medial Malleolar Avulsion Fractures
- Lateral Malleolar Avulsion Fractures
The ALPHALOK™ Plating System is a multi-indication solution providing polyaxial locking technology and low-profile plate designs. The ALPHALOK™ Ankle Fx plates and screws are intended to treat various fracture patterns of the ankle specifically tibia and fibula.
The intent of this submission is to expand indications to include ankle fractures, whereas the previous submissions for the ALPHALOK™ Plating Systems (K221558, K212348) were for forefoot and midfoot respectfully.
All implant components are manufactured from titanium (Ti-6AI-4V, ASTM F136).
Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The ALPHALOK™ instruments are manufactured from stainless steel.
The provided text describes a 510(k) premarket notification for the ALPHALOK™ Plating System, which is a medical device for bone fixation. However, the document does not contain information about acceptance criteria, device performance in terms of clinical accuracy or statistical metrics, a study proving the device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, or multi-reader multi-case studies, as typically requested for AI/algorithm-based diagnostic devices.
The document is a regulatory submission for a physical medical device (bone plates and screws) and primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and mechanical performance testing.
Therefore, I cannot provide the requested information from the given text alone.
Here's a breakdown of why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: Not available. The document mentions "Static four point bend testing per ASTM F382-17" but does not provide specific acceptance criteria values (e.g., minimum load to failure, maximum deflection) or the reported performance data from these tests. These are engineering performance metrics, not clinical performance metrics typically associated with AI devices.
- Sample sized used for the test set and the data provenance: Not available. The performance data mentioned (static bend testing) would involve physical specimens, not a "test set" of data in the context of an AI study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/diagnostic device. Ground truth, in this context, would relate to an objective measurement of mechanical properties rather than expert interpretation of medical images or data.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating diagnostic accuracy with and without AI assistance, which is irrelevant for a physical bone fixation system.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic AI. For the mechanical testing, the "ground truth" would be the physically measured values from the tests.
- The sample size for the training set: Not applicable. No AI model is described.
- How the ground truth for the training set was established: Not applicable. No AI model is described.
In summary, the provided document is a 510(k) clearance for a physical medical device (bone fixation system) and does not contain the type of information requested regarding acceptance criteria and studies for an AI/algorithm-based device.
§ 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.