(140 days)
Wright's ORTHOLOC™ 3Di Ankle Fusion Plating System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodeses, in conjunction with osteotomies and fractures of the distal tibia, talus, and calcaneus.
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.
ORTHOLOC™ 3Di Ankle Fusion Plating System: The ORTHOLOC™ 3Di Ankle Fusion Plating System contains 22 plates belonging to 1 of 3 general categories based on the contouring of each plate and intended surgical approach. All plates feature poly-axial locking screw holes and one or two compression slots. The plates are made from titanium alloy conforming to ASTM F136 or ISO 5832-3 and accept 4.5mm and 5.5mm ORTHOLOC™ 3Di locking screws, 4.5mm and 5.5mm ORTHOLOC™ Fully Threaded Bone Screws, and 5.5mm ORTHOLOC™ Partially-Threaded Bone Screws. Washers of the same material are also available for use with the ORTHOLOC™ Bone Screws.
ORTHOLOC™ Bone Screws: ORTHOLOCTM Bone Screws are cancellous or cortical, partially or fully threaded non-locking screws offered in various diameters and lengths. All screws are manufactured from ASTM F136 or ISO 5832-3 titanium alloy and intended for single use only. These screws are intended to be used with the appropriately sized washers to prevent the screw head from breaking through the cortex of the bone by distributing the forces/loads over a large area.
The provided document, K121425 for the ORTHOLOC™ 3Di Ankle Fusion Plating System and ORTHOLOCTM Bone Screws, describes non-clinical evidence for substantial equivalence, primarily focusing on mechanical testing rather than a clinical study or AI-based performance. Therefore, many of the requested elements for AI-based device evaluation (like sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance with AI) are not applicable or not explicitly detailed in this 510(k) summary.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Polyaxial Locking Feature Effectiveness (Mechanical) | Acceptable for off-axis mechanical screw locking up to 3x as compared to a non-locking screw. (This implies it met pre-defined mechanical performance thresholds for successful locking at angles). |
| Screw Torque / Pullout Resistance | Results exceeded the pre-determined acceptance criteria. (Specific numerical values for acceptance criteria or results are not provided). |
| Stress Response of Plates (Worst-case) | Found to be similar to a predicate plate through mechanical engineering analysis. (This implies the stress distribution and magnitude under load were comparable and acceptable relative to an already cleared device). |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as this was mechanical testing of device components, not a clinical study on patient data.
- Data Provenance: The data is generated from in vitro mechanical testing of the physical device components (plates and screws). There is no patient data involved from specific countries or retrospective/prospective studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This submission relies on engineering and mechanical testing, not a ground truth established by human experts interpreting clinical data for diagnosis or treatment decisions. The "ground truth" or acceptance criteria for mechanical properties would be established by engineering standards and internal specifications, likely vetted by qualified engineers.
4. Adjudication Method for the Test Set:
- Not Applicable. As this is mechanical testing, there is no human interpretation of images or clinical data that would require an adjudication method. The results are quantitative measurements against pre-defined engineering thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC study was not done. This submission is for a medical implant (bone plates and screws) and primarily relies on mechanical performance testing for substantial equivalence, not on the interpretation capabilities of human readers, with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This is not an AI algorithm. The device is a physical surgical implant.
7. The Type of Ground Truth Used:
- The "ground truth" for the mechanical performance testing would be the established engineering specifications, ASTM or ISO standards, and internal design requirements for strength, locking mechanism efficacy, and pullout resistance for bone plates and screws. These are quantifiable, objective physical properties.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for an AI algorithm, this question does not apply.
§ 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.