(17 days)
Wright's ORTHOLOC® Calcaneal Plating System is intended for use in stabilization of fresh fractures, jount fusion and reconstruction of bones in the feet and ankles. The system can be used in both adult and pediatric patients.
The ORTHOLOC® Calcaneal Plating System consists of 2 styles of plates (Tab and Perimeter) and features 3.5mm diameter locking and non-locking screws that range from 10-60mm each. The Tab plates are offered in three different sizes: small, medium, and large, and feature multiple tabs that can be manipulated or cut to accommodate for various patient anatomy. The Perimeter plates come in two sizes: small and large and also feature removable sections. The ORTHOLOC® hole design on the plates allow for the screws to be inserted from either side. This allows each plate to be used in either a right or a left orientation.
The provided document is a 510(k) summary for the ORTHOLOC® Calcaneal Plating System. This is a medical device submission to the FDA, not a study evaluating an AI device or a diagnostic tool that would typically have acceptance criteria in terms of performance metrics like sensitivity or specificity.
Instead, this document focuses on demonstrating substantial equivalence to a previously approved predicate device. The "acceptance criteria" here are related to fulfilling the requirements for substantial equivalence to warrant market clearance.
Here's an breakdown based on the information provided, framed as closely as possible to your request, but acknowledging the nature of this document:
1. Table of "Acceptance Criteria" (for 510(k) clearance) and Reported Device Performance (as presented for substantial equivalence):
| "Acceptance Criteria" (FDA 510(k) Requirements for Substantial Equivalence) | Reported Device Performance (as evidence for substantial equivalence) |
|---|---|
| Material Strength (Equivalent or superior to predicate) | Made of stronger material than the predicate device. |
| Mechanical Performance (Static Bend Testing) (Equivalent or superior) | Performance shown to be statistically equivalent or greater than the predicate system. |
| Mechanical Performance (Screw through Plate Testing) (Equivalent or superior) | Performance shown to be statistically equivalent or greater than the predicate system. |
| Intended Use (Similar to predicate, no new questions of safety/effectiveness) | Similar intended use for stabilization of fractures, joint fusion, and reconstruction of bones in feet and ankles for adult and pediatric patients. (Compared against predicate with "limited indications" - implying the subject device's indications are at least covered by, or a subset of, the predicate's). |
| Technological Characteristics (Similar to predicate) | Utilizes similar instrumentation, similar sterilization methods. Key differences (e.g., stronger material, different plate styles) addressed. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (for mechanical testing): Not explicitly stated in the provided text. The document mentions "Mechanical testing, including Static Bend Testing and Screw through Plate testing," but does not specify the number of samples tested for each.
- Data Provenance: The mechanical testing was likely conducted in a lab setting by the manufacturer (Wright Medical Technology, Inc.), not from human or animal data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable (N/A). This is a mechanical device, and "ground truth" as typically defined for diagnostic or AI studies (e.g., by expert consensus on images) is not relevant here. The "ground truth" for mechanical testing is established by engineering principles and standardized test methods.
4. Adjudication Method:
- N/A. Adjudication is not applicable to mechanical testing in this context. The results of the mechanical tests (e.g., load to failure, displacement) are quantitative and directly measured.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is a hardware device (bone plating system), not a diagnostic or AI system. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant.
6. Standalone (Algorithm Only) Performance:
- No. This is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used:
- Engineering Standards and Benchmarking: The "ground truth" for the performance of this device is based on established engineering test standards (e.g., ASTM or ISO standards for bone plates) and comparison to the mechanical properties of the legally marketed predicate device.
8. Sample Size for the Training Set:
- N/A. This is a physical medical device, not an AI or machine learning system that requires a "training set" in the computational sense. The design and manufacturing process would involve engineering specifications, and prototypes would be tested, but not in the context of an AI training set.
9. How the Ground Truth for the Training Set Was Established:
- N/A. As above, the concept of a training set and its associated ground truth isn't applicable to this type of device. The design specifications and performance targets are derived from medical requirements, biomechanical principles, and regulatory standards.
§ 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.