EDGE Orthopaedics' VIEW™ and REDUCE™ Plating Systems are intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with EDGE Orthopaedics locking and non-locking bone screws.
Plates and screws are intended for single use only. Screws are not intended for use in the spine.
The EDGE Orthopaedics' VIEW™ Plating System has been designed to support multiple indications within the mid-foot. The system includes titanium alloy, sterile packaged Lapidus, First Metatarsophalangeal (MTP), Calcaneal-Cuboid (CC), Evans and Talonavicular (TN) Plates along with sterile titanium alloy bone screws. The design creates a "window" offering a continuous view into the healing process.
The EDGE Orthopaedics' REDUCE® Fracture Plating System has been designed to support multiple indications within the forefoot and mid-foot. The system includes titanium alloy, sterile packaged T. L. Y. and Straight Plates along with sterile titanium alloy bone screws.
VIEW and REDUCE Plating Systems are offered in a variety of sizes for use with the nonlocking and locking bone screws. The screws are available in variety of diameters and lengths to help support the fixation, correction or stabilization of bones.
The corresponding instrumentation (depth gauges, screwdrivers, reamers, and plate benders) to facilitate insertion is found in EDGE's RIVAL Instrument Tray.
The provided document is a 510(k) Premarket Notification for the EDGE Orthopaedics VIEW and REDUCE Plating Systems. This type of submission is for medical devices that demonstrate substantial equivalence to a legally marketed predicate device, rather than requiring a comparative effectiveness study with specific acceptance criteria related to a diagnostic algorithm or AI.
Therefore, the information requested in your prompt (e.g., acceptance criteria for device performance, sample size for test sets, ground truth establishment for AI, MRMC studies) is not applicable to this type of device and submission. This device is a bone fixation plate and bone screw, which is a physical orthopedic implant, not a diagnostic or AI-driven system.
However, I can extract the information that is relevant to how the device's safety and effectiveness were demonstrated:
Acceptance Criteria and Device Performance (based on substantial equivalence):
| Acceptance Criteria Category | Device Performance (How safety and effectiveness were supported) |
|---|---|
| Mechanical Properties | Demonstrated through non-clinical testing to meet relevant ASTM standards. These tests verify the physical and mechanical characteristics of the device. |
| Design Similarity | "substantially equivalent" in design to the predicate devices. |
| Material Similarity | "substantially equivalent" in material to the predicate devices. |
| Indications for Use | "substantially equivalent" in indications to the predicate devices. |
Study Information (Non-Clinical Testing):
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit): Conformance to specified ASTM standards for mechanical properties, and substantial equivalence to predicate devices in design, materials, and indications for use.
- Reported Device Performance: The device's safety and effectiveness are "adequately supported by the substantial equivalence information, materials information and the following non-clinical testing":
- Torsional strength per ASTM F543
- Driving and removal torque per ASTM F543
- Axial pull out strength per ASTM F543
- Single Cycle Bend Testing per ASTM F382
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Sample size used for the test set and the data provenance: Not applicable. These were non-clinical, mechanical tests. The "sample size" would refer to the number of devices tested for each mechanical property, which is not specified in the summary document. Data provenance is internal laboratory testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on objective physical measurements and adherence to ASTM standards, not expert clinical consensus.
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Adjudication method: Not applicable.
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Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is a physical device, not an AI or diagnostic system.
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Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. This is a physical device.
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The type of ground truth used: For mechanical testing, the ground truth is the physical properties of the material and design as measured according to standardized methods (ASTM F543, ASTM F382). For demonstrating substantial equivalence, the "ground truth" is the established safety and effectiveness of the legally marketed predicate devices.
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The sample size for the training set: Not applicable. There is no training set for a physical device being cleared via substantial equivalence.
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How the ground truth for the training set was established: Not applicable.
In summary: This 510(k) submission for the EDGE Orthopaedics Plating Systems relies on non-clinical mechanical testing and a demonstration of substantial equivalence to existing predicate devices (DARCO Locking Plating System K061808 and ORTHOLOC® 2.0/2.4 Plate System K090692). Clinical data was explicitly stated as not being used to determine substantial equivalence. The prompt's questions are generally geared towards AI/diagnostic device evaluations, which are not relevant to this orthopedic implant's clearance pathway.
§ 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.