(87 days)
Wright's ORTHOLOC® 3Di Ankle Fracture 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 Malleolus
- 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 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 consists of 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 while some plates feature compression slots. The plates are made from titanium alloy and are compatible with 2.7mm and 3.5mm ORTHOLOC® 3Di locking screws, 3.5mm and 4.0mm ORTHOLOC® Bone Screws, and 4.0mm Wright Compression Screws.
The provided text is a 510(k) summary for the ORTHOLOC® 3Di Ankle Fracture Plating System. This document focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as understood in the context of clinical performance of an AI/Software as a Medical Device (SaMD).
Instead, the submission relies on demonstrating substantial equivalence through non-clinical performance testing and engineering analysis of the physical components (plates, screws, washers) against legally marketed predicate devices.
Here's an analysis of the information provided in relation to your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria for Substantial Equivalence (Implicit): The implicit acceptance criterion is that the subject device's performance characteristics (e.g., static and fatigue bending strength, insertion/removal torque, pull-out strength, torsional strength) are "at least as well as" or "substantially equivalent" to the predicate devices.
- Reported Device Performance: The document states that "Performance testing, engineering analysis and rationale was performed to demonstrate substantial equivalence in static and fatigue bending strength." It also mentions "An engineering analysis was performed for the subject device screws to demonstrate substantial equivalence with respect to insertion/removal torque, pull-out strength and torsional strength, and bending strength."
- Missing Specifics: The actual numerical acceptance values (e.g., minimum bending strength in Nm) and the corresponding test results for the ORTHOLOC® 3Di Ankle Fracture Plating System are not provided in this summary document. These would typically be in the full 510(k) submission, but only the conclusion is summarized here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable in this context: Since this is a physical medical device (bone plating system) being evaluated for substantial equivalence through non-clinical (mechanical) testing, terms like "test set," "data provenance," "country of origin," "retrospective," or "prospective" are not relevant. The "sample size" would refer to the number of physical devices tested in the engineering lab, but this detail is not present in the summary.
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)
- Not Applicable: This type of information is relevant for AI/SaMD where human expert consensus is used to establish ground truth for diagnostic or prognostic tasks. For a bone plating system, ground truth is established by objective engineering principles and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are used to resolve disagreements among human experts in clinical studies, particularly for AI/SaMD. This is not relevant for the mechanical testing of a surgical implant.
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
- Not Applicable: MRMC studies are used to evaluate the performance of diagnostic tools, often imaging-based AI solutions, and their effect on human reader performance. This device is a surgical implant, not a diagnostic tool, and there is no AI component mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This question pertains to AI/SaMD performance. The ORTHOLOC® 3Di Ankle Fracture Plating System is a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Standards/Measurements: The "ground truth" for the non-clinical tests would be established by universally accepted engineering standards and validated measurement techniques for properties like strength, torque, and pull-out resistance. The predicate devices serve as the benchmark for "acceptable" performance.
8. The sample size for the training set
- Not Applicable: This concept relates to machine learning models (AI). There is no "training set" for a physical medical device like this, which is evaluated through mechanical testing.
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set, this question is not relevant.
In summary:
This 510(k) document demonstrates substantial equivalence through non-clinical performance testing and engineering analysis of the physical hardware (plates, screws, washers). It explicitly states:
- (b)(1). Substantial Equivalence - Non-Clinical Evidence: "Performance testing, engineering analysis and rationale was performed to demonstrate substantial equivalence in static and fatigue bending strength. An engineering analysis was performed for the subject device screws to demonstrate substantial equivalence with respect to insertion/removal torque, pull-out strength and torsional strength, and bending strength."
- (b)(2). Substantial Equivalence - Clinical Evidence: "N/A" (Not Applicable), indicating no clinical studies were performed to establish effectiveness for this submission.
- (b)(3). Substantial Equivalence - Conclusions: "The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate devices."
The study that "proves the device meets the acceptance criteria" is the non-clinical performance testing and engineering analysis comparing the ORTHOLOC® 3Di Ankle Fracture Plating System to its predicate devices, showing "substantial equivalence" in mechanical properties. Specific numerical details of these tests are not provided in this summary.
§ 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.