(33 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 Avulsion Fractures
ORTHOLOC® 3Di Locking Screws:
The ORTHOLOC® 3Di locking screws are intended for use with Wright's ORTHOLOC® 3Di Plating Systems of the same base material.
ORTHOLOC® Bone Screws:
ORTHOLOC® Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Washer
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 plates belonging to 1 of 2 general categories-distal tibia and fibula-based on the contouring of each plate: All plates feature polyaxial 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 ORTHOLOC® 3Di locking screws. 2.7mm. 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.
Here's an analysis of the provided text regarding the Ortholoc® 3Di Ankle Plating System, focusing on acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The provided document (K131093) is a 510(k) summary for a medical device. For a 510(k) submission, the primary acceptance criteria for a new device are typically Substantial Equivalence to a legally marketed predicate device. This means the new device must be as safe and effective as the predicate.
The document does not outline specific, quantitative acceptance criteria in terms of performance metrics (e.g., bone healing rates, complication rates, specific mechanical load tolerances against a statistically defined threshold). Instead, it relies on a comparison to the predicate device.
| Acceptance Criteria (Implicit from 510(k) Process) | Reported Device Performance (as stated in document) |
|---|---|
| Substantial Equivalence in Design Features | "The design features of the ORTHOLOC® 3Di Ankle Plating System - Line Addition are substantially equivalent to the design features of the predicate ORTHOLOC® 3Di Ankle Plating System" |
| Substantial Equivalence in Indications for Use | "The ORTHOLOC® 3Di Ankle Plating System - Line Addition and the legally marketed predicate ORTHOLOC® 3Di Ankle Plating System have identical indications..." |
| Substantial Equivalence in Material, Sterilization, Selection, and Instrumentation | "...utilize the same instrumentation, and are identical in material, sterilization methods, and selection." |
| Expected Performance at least as well as Predicate | "From the evidence submitted in this 510(k), the subject line addition can be expected to perform at least as well as the predicate systems." |
| No New Worst-Case Scenario (Mechanical) | "Through mechanical analysis the new plates do not represent a new worst-case." |
| No New Types of Safety or Effectiveness Questions | "The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "(b)(2). Substantial Equivalence - Clinical Evidence N/A". This indicates that no clinical test set (human patient data) was used in this 510(k) submission. The comparison for substantial equivalence was based on non-clinical evidence (mechanical analysis and comparison of design/materials/indications to the predicate). Therefore, there is no sample size for a clinical test set, no data provenance (country, retrospective/prospective) to report for human studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical test set was used, and specifically no human data requiring expert assessment for ground truth, this information is not applicable to this submission. The "ground truth" for the submission was established by comparing the device's design and mechanical properties to those of the predicate device, likely by Wright Medical Technology's internal engineering and regulatory teams, and subsequently reviewed by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical test set was utilized requiring expert adjudication, this information is not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done. This device is a bone plating system, not an imaging or diagnostic device that would typically involve human readers or AI assistance in interpretation. The nature of the device (implantable hardware) means this type of study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a bone plating system and does not involve algorithms or AI for diagnostic or interpretive purposes. Performance is related to its mechanical properties and biocompatibility as an implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this 510(k) submission, the "ground truth" for the device's safety and effectiveness was established by:
- Comparison to the Predicate Device: The predicate device, ORTHOLOC® 3Di Ankle Plating System (K102429), serves as the primary "ground truth" reference. The new device must demonstrate it is as safe and effective as this previously cleared device.
- Non-Clinical Mechanical Analysis: This involves engineering evaluations (e.g., stress testing, fatigue testing) to ensure the new plates do not represent a "new worst-case" scenario compared to the predicate. The "ground truth" for these tests would be established by validated engineering standards and methods.
8. The sample size for the training set
Since no clinical studies were performed, and no AI/algorithm components are part of this device, there is no training set in the context of machine learning or clinical trials. The "development" of the device would involve engineering design and validation, not a training set of data.
9. How the ground truth for the training set was established
As there is no training set for this device type within the context of the 510(k) submission, this question is not applicable.
§ 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.