(87 days)
The ORTHOLOC™ 3Di Hallux System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of bones of the feet and toes. Specific examples include:
- First metatarsal osteotomies for hallux valgus correction including:
- Opening base wedge osteotomy
- Closing base wedge osteotomy
- Crescentic osteotomy
- Proximal Chevron osteotomy
- Distal Chevron osteotomy (Austin)
- First metatarsal fracture fixation
- Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
- Arthrodesis of the first metatarsophalangeal joint (MTP) including:
- Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
- Revision MTP Fusion
- Revision of failed first MTP Arthroplasty implant
Wright Medical's ORTHOLOC™ 3Di Hallux System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bones of the feet and toes. The subject plates are modified from the DARCO Locking Bone Plate System (K061808). The system contains 33 plates belonging to 1 of 4 plate styles with various sizes and options, each contoured for specific anatomy and designed for specific procedures. All plates feature polyaxial locking screw holes and k-wire holes, and some plates have nonlocking compression slots. The plates are made from titanium alloy conforming to ASTM F136 or ISO 5832-3 and accept 2.7 mm and 3.5 mm locking and non-locking screws.
This document describes the ORTHOLOC™ 3Di Hallux System, a bone plate system intended for stabilization and fixation of bones in the feet and toes. The device is a Class II medical device.
1. Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to a predicate device (K061808 - DARCO Locking Bone Plate System) rather than defining specific quantifiable acceptance criteria related to clinical endpoints (like success rates in fracture healing). Instead, the acceptance criteria are implicitly met by demonstrating that the new design features perform at least as well as, or better than, the predicate device in relevant mechanical tests, and do not introduce new safety or effectiveness concerns.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Effectiveness of the new polyaxial locking feature | "The subject plate locking mechanism evaluated in this testing was found to be acceptable for off-axis mechanical screw locking up to three times as compared to a non-locking screw." |
| Strength/performance of the new 2.7 mm non-locking screw | "Torque testing was performed on the subject 2.7 mm non-locking screw and results exceeded the minimum safety factor." |
| Overall mechanical performance compared to predicate (specifically in bending, and ensuring no "new worst-case" plates) | "Performance testing supports the effectiveness of the new locking feature and the new screw and shows that no new worst-case plates (in bending) are introduced in this system." |
| "Through mechanically validated FEA analysis, the worst-case subject ORTHOLOC™ 3Di plates were found not to represent a new worst-case in bending for any of the four plate families evaluated." | |
| No new questions of safety or effectiveness introduced | "The new design characteristics of the subject system do not raise any new types of questions of safety or effectiveness." |
| Performance at least as well as the predicate system | "From the evidence submitted in this 510(k) the subject device system can be expected to perform at least as well as the predicate system." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (number of plates or screws tested). It refers to "performance testing" and "torque testing" but doesn't quantify the number of units tested.
- Data Provenance: The data is generated from non-clinical (bench) testing performed by Wright Medical Technology, Inc. The country of origin for the data is not explicitly stated but is implied to be internal testing by the
US-based manufacturer. The testing is prospective for the purpose of this submission, designed to demonstrate substantial equivalence of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This device is a bone plate system demonstrating substantial equivalence primarily through mechanical engineering tests and computational analysis (FEA), not through a diagnostic algorithm interpreting images or clinical data where human expert ground truth would be established.
- Therefore, the concept of "experts establishing ground truth for the test set" (as would be applicable for an AI device) is not relevant in this context. The "ground truth" here is derived from established engineering principles and measurements.
4. Adjudication Method for the Test Set:
- This question is not applicable as the study described is a non-clinical, mechanical performance study, not a study involving human readers or expert consensus on clinical findings.
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 comparative effectiveness study was done.
- This is a mechanical implant device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No standalone algorithm performance study was done.
- This is a mechanical implant device, not an algorithm. Therefore, this question is not applicable.
7. The Type of Ground Truth Used:
- The "ground truth" for this submission is based on mechanical performance metrics and engineering standards. This includes:
- Quantifiable measurements of screw locking strength (e.g., torque values).
- Analysis of bending properties of plates.
- Comparison against established performance of the predicate device.
- Compliance with ASTM F136 or ISO 5832-3 standards for titanium alloy.
- Results from mechanically validated Finite Element Analysis (FEA).
8. The Sample Size for the Training Set:
- This question is not applicable. This is a mechanical device, not an AI or machine learning model that requires a "training set." The design and validation relied on engineering principles, materials science, and mechanical testing.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable for the same reason as #8. There is no training set in the context of this device's validation.
§ 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.