(406 days)
The Leith Medical Foot and Ankle System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.
The Leith Medical Ankle Fracture Plates are intended and designed for open reduction, internal fixation of ankle fractures, revision of ankle fractures, as well as osteotomies, and non-unions of the distal tibia and fibula.
The Leith Medical First Tarsal-Metatarsal Joint (1st TMT) Arthrodesis Plates are intended and designed for primary arthrodesis of the 1st TMT joint due to degenerative joint disease and/or hallux valgus, or revision of prior 1st TMT joint arthrodesis.
The Leith Medical Medial Malleolar Fracture Plates are intended and designed for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula.
The Leith Medical First Metatarsal Phalangeal Joint Arthrodesis Plates are intended and designed for primary arthrodesis of the 1st MTP joint due to degenerative joint disease and/or hallux valgus, revision of prior 1st MTP joint arthrodesis, or revision of failed 1st MTP joint implant arthroplasty.
The Leith Medical Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
The Leith Medical Foot and Ankle System consists of various shape and size plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited contact, a highly radiused edge configuration, capability of dynamic/manual compression. All plates have standard screw holes with a locking feature, and some plates have oval screw holes for compressing the fracture intraoperatively. The system also consists of cortical screw with multiple lengths and diameters.
The provided text describes a medical device submission (K200062) for the Leith Medical Foot and Ankle System. This document does not describe an AI/ML device nor a study proving it meets specific acceptance criteria based on its performance in aiding human readers or as a standalone diagnostic tool.
Instead, this is a 510(k) Premarket Notification for a traditional medical device (bone plates and screws). The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to evaluate diagnostic performance or AI model efficacy.
Therefore, most of the questions regarding acceptance criteria for an AI device, human reader studies, ground truth establishment, and training/test set details are not applicable to this document.
Here's what can be extracted and inferred from the provided text, focusing on the device's substantial equivalence claim:
1. A table of acceptance criteria and the reported device performance:
Since this is a substantial equivalence submission for a traditional implantable device, the "acceptance criteria" are not framed in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, they are related to the material, mechanical properties, and safety of the device compared to predicates.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence | "The Leith Medical Foot and Ankle System and the predicate devices are all intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device." |
| Material Equivalence | "The Leith Medical Foot and Ankle System uses the same material as the predicates." (Materials are Titanium alloy, Ti-6Al-4V per ASTM F136; Nitinol per ASTM F2063). |
| Design Equivalence | "The Foot and Ankle System and the predicates are equivalent in terms of shape and function." |
| Dimensions Equivalence | "The Leith Medical Foot and Ankle System and the predicates are equivalent in their dimensions." |
| Mechanical Strength Equivalence/Superiority | "The Leith Medical Foot and Ankle System has greater or equivalent strength values compared to the predicates." This was evaluated through non-clinical mechanical testing: |
| * Static and dynamic 4-point bending | Tested per ASTM F382-17. Results indicate equivalence. |
| * Torsional Properties | Tested per ASTM F543-17, Annex 1. Results indicate equivalence. |
| * Driving Torque | Tested per ASTM F543-17, Annex 2. Results indicate equivalence. |
| * Axial Pullout | Tested per ASTM F543-17, Annex 3. Results indicate equivalence. |
| Biocompatibility/Sterilization Efficacy | * Bacterial Endotoxins Test (BET): Tested per AAMI ST72. Results indicate compliance. |
| Packaging Performance and Stability | * Package Performance and Stability Testing: Performed. Results indicate compliance. |
| Overall Substantial Equivalence to Predicate Devices | "The results of these evaluations indicate that the Leith Medical Foot and Ankle System is equivalent to predicate devices." |
| "Leith Medical considers the Leith Medical Foot and Ankle System to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use." |
The following questions are NOT APPLICABLE to this document as it pertains to a traditional non-AI medical device submission:
- Sample sized used for the test set and the data provenance: Not applicable. No test set of data (e.g., medical images for AI evaluation) was used for performance assessment in this submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. This is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. There is no AI model to train.
- How the ground truth for the training set was established: 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.