(90 days)
Wright's ORTHOLOC™ 3Di Ankle Plating System is intended for fixation of fractures, osteotomies, 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 Malleolous
- Pilon Fractures
- Distal Tibia Shaft Fractures
- Distal Fibula Shaft Fractures
- Distal Tibia Periarticular Fractures
- Medial Malleolar Avulsion Fractures
- Lateral Malleolar Avusion Fractures
The ORTHOLOC™ 3Di locking screws are intended for use with Wright's ORTHOLOC™ 3Di Plating Systems of the same base material.
ORTHOLOC™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Wright's washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of bone fragments.
The ORTHOLOC™ 3Di Ankle Plating System contains 45 plates belonging to 1 of 2 general categories-distal tibia and fibula-based on the contouring of each plate. All plates feature poly-axial locking screw holes. Some plates have k-wire holes, compression slots, or syndesmosis slots. The plates are made from titanium alloy and accept 2.7mm and 3.5mm ORTHOLOC™ 3Di locking screws, 3.5mm and 4.0mm ORTHOLOC™ Bone Screws, and 4.0mm Wright™ Compression Screws (cleared under K082320, now branded DART-FIRE®). Washers are also available for use with the ORTHOLOC™ Bone Screws.
The provided document, K102429, describes a 510(k) premarket notification for the ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC™ Bone Screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to prove effectiveness or safety by meeting specific performance criteria.
Therefore, the document does not contain information typically associated with acceptance criteria and a study proving a device meets them in the context of diagnostic or AI-driven devices. Instead, it relies on non-clinical (bench) testing to show that the new device performs "at least as well as" the predicate device in relevant mechanical performance aspects.
Here's an analysis based on the provided text, addressing the requested points where applicable, and noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a mechanical medical device, "acceptance criteria" are typically related to engineering and material performance rather than diagnostic accuracy metrics like sensitivity or specificity. The document states that substantial equivalence is shown through various mechanical tests.
| Acceptance Criteria (Demonstration of Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Worst-case plate analysis torque to failure | "The results of the test show that the subject ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC™ Bone Screws can be expected to perform at least as well as the legally marketed predicate ORTHOLOC™ APS and Wright Compression Screws." Specific numerical values for the torque to failure are not provided in this summary, but the conclusion is that equivalence was demonstrated. |
| Polyaxial performance | "The results of the test show that the subject ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC™ Bone Screws can be expected to perform at least as well as the legally marketed predicate ORTHOLOC™ APS and Wright Compression Screws." Specific numerical values are not provided, but the conclusion is that equivalence was demonstrated. |
| Torsional testing | "The results of the test show that the subject ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC™ Bone Screws can be expected to perform at least as well as the legally marketed predicate ORTHOLOC™ APS and Wright Compression Screws." Specific numerical values are not provided, but the conclusion is that equivalence was demonstrated. |
| Pull out/pull through testing | "The results of the test show that the subject ORTHOLOC™ 3Di Ankle Plating System and ORTHOLOC™ Bone Screws can be expected to perform at least as well as the legally marketed predicate ORTHOLOC™ APS and Wright Compression Screws." Specific numerical values are not provided, but the conclusion is that equivalence was demonstrated. The text explicitly states, "Substantial equivalence is shown through worst-case plate analysis torque to failure, polyaxial performance, torisional, and pull out/pull through testing." and "No new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices." |
2. Sample Size Used for the Test Set and the Data Provenance
This document describes non-clinical (bench) testing, not a clinical study with patients or data. Therefore, the concept of "sample size for the test set" in the context of clinical data, or data provenance (country of origin, retrospective/prospective) is not applicable here. The "test set" would refer to the physical devices (plates and screws) subjected to mechanical testing. The specific number of devices tested is not detailed in this summary, but implied by the successful completion of the stated tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. Ground truth, in the sense of clinical diagnoses or pathology, is not relevant for this type of mechanical device submission and the non-clinical testing performed.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of clinical data requiring expert adjudication. The "adjudication" for this type of device would be the interpretation of the results from the mechanical tests, likely by engineers and materials scientists.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is a clinical study typically used for diagnostic devices to assess how human readers perform with and without AI assistance. This submission is for a mechanical fixation device and relies on non-clinical bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. This is not an AI algorithm or diagnostic device.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on engineering standards and established mechanical testing protocols that define the performance characteristics of orthopedic fixation devices. The goal is to demonstrate that the new device meets these engineering benchmarks at least as well as its predicate.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI model, ground truth for it was not 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.