(87 days)
The Medline Foot Plates and Screws are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of bones of the feet and toes. Specific examples include:
- · 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
Flatfoot Osteotomies:
- · Lateral Column Lengthening (Evans Osteotomy)
- · Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
- · Medial Displacement Calcaneal Osteotomy (MDCO)
Midfoot / Hindfoot Fusions:
- · LisFranc Arthrodesis and/or Stabilization
- · 1st(Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
- · Intercuneiform Fusions
- · Navicular-Cuneiform (NC) Fusion
- · Talo-Navicular (TN) Fusion
- · Calcaneo-Cuboid (CC) Fusion
- · Medial Column Fusions (NC and 1st TMT)
The Medline Locking and Non-Locking Cortical Screws are indicated for use with the Medline Foot Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
The Medline Foot Plates and Screws are manufactured from Titanium Alloy. The System includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 2.7mm and 3.5mm diameter locking and non-locking cortical screws to be used with the polyaxial locking holes and compression slots included in the plates. The non-locking cortical screws can also be used for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture fixation, appropriate for the size of the device. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drill guides, tissue protectors, and drill bits. The Medline Foot Plates and Screws are within the currently marketed sizes and indications of the identified predicate devices.
This appears to be a 510(k) summary for a medical device (Medline Foot Plates and Screws), not a study demonstrating AI algorithm performance. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
However, I can extract the information relevant to the device's mechanical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Static 4-Point Bending (Plates) | ASTM F382 (ensuring equivalence to predicate) | Equivalent to Predicate |
| Static Pullout (Screws) | ASTM F543 (ensuring equivalence to predicate) | Equivalent to Predicate |
| Static Torque (Screws) | ASTM F543 (ensuring equivalence to predicate) | Equivalent to Predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of plates or screws) used for each mechanical test. The data provenance is from in vitro laboratory testing of the physical devices, not from clinical or human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable as the "ground truth" here refers to the physical properties and performance of the device measured against established engineering standards (ASTM F382 and F543), not biological or clinical diagnoses requiring expert consensus.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing results are objective measurements from laboratory equipment, not subjective assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an AI algorithm.
7. Type of Ground Truth Used
The “ground truth” for the performance assessment of these medical devices is defined by recognized international standards for metallic bone fixation implants: ASTM F382 for plates and ASTM F543 for screws. The performance of the Medline devices was compared to the performance of a predicate device (Wright Medical Ortholoc™ System) tested against the same standards.
8. Sample Size for the Training Set
Not applicable. There is no training set as this is not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
§ 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.