(83 days)
The VLP FOOT Plating, Screw System and Accessories is indicated for the following:
The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for the treatment of fracture fixation, reconstruction or arthrodeses of small bones, including those in the forefoot, midfoot. The Smith & Nephew 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures and non-unions of small bones and small bone fragments; arthrodeses of small joints; bunionectomies and osteotomies; scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
The Smith & Nephew 2.0mm QFX Screw is indicated for osteotomies of the lesser metatarsals, such as Weil osteotomies, Osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand.
Pins and wires are indicated for pelvic, small and long bone fracture fixation.
Subject of this Traditional 510(k) premarket notification is Smith & Nephew, Inc. VLP FOOT Plating, Screw System and Accessories. The system is comprised of a variety of Cannulated Screws, Headless Cannulated Screws, QFX Screws, K-Wires, Cortex Screws, Locking Cortex Screws, Fully and Partially Threaded Osteopenia Screws, Locking Osteopenia Screws and a variety of VLP FOOT plates.
The provided document is a 510(k) premarket notification for the Smith & Nephew VLP FOOT Plating, Screw System and Accessories. This type of submission is for medical devices that are substantially equivalent to a predicate device, meaning they have the same intended use and similar technological characteristics, or if different, the differences do not raise new questions of safety and effectiveness.
Here’s an analysis of the provided information in relation to acceptance criteria and supporting studies:
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A table of acceptance criteria and the reported device performance:
Acceptance Criterion (Implicit) Reported Device Performance Substantial Equivalence: Demonstrate equivalence in indications for use, design, operational principles, and material composition to legally marketed predicate devices. The device's indications for use: "The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for the treatment of fracture fixation, reconstruction or arthrodeses of small bones, including those in the forefoot, midfoot and hindfoot. The Smith & Nephew 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures and non-unions of small bone fragments; arthrodeses of small joints; bunionectomies; scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The Smith & Nephew 2.0mm QFX Screw is indicated for osteotomies of the lesser metatarsals, such as Weil osteotomies. Osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand. Pins and wires are indicated for pelvic, small and long bone fracture fixation."
The document lists several predicate devices (e.g., Smith & Nephew 6.5mm and 8.0mm Cannulated Screws K060736, Synthes 2.4mm Cannulated Screw K012945, Synthes 3.0mm Cannulated Screw K962823, Synthes 3.0mm Headless Compression Screw K050636, DePuy FRS Screw K062352, Smith & Nephew K-Wires (Pre-amendment device), PERI-LOC Periarticular Locked Plating System VLP Plates/Screws K071563, Smith & Nephew Locking Bone Plate System Periarticular Plates K033669). The FDA's clearance letter confirms a "substantial equivalence" determination. |
| Mechanical Performance: Components capable of withstanding expected in vivo loading without failure. | "A review of the mechanical testing data indicates that the implant components of the VLP FOOT Plating, Screws and Accessories are equivalent to devices currently used clinically and are capable of withstanding expected in vivo loading without failure." |
| Safety: No new questions of safety raised by differences from predicate devices. | The FDA's substantial equivalence determination implies that no new questions of safety were raised. |
| Effectiveness: No new questions of effectiveness raised by differences from predicate devices. | The FDA's substantial equivalence determination implies that no new questions of effectiveness were raised. |
**Note:** For 510(k) submissions, the primary "acceptance criterion" is generally "substantial equivalence" to a legally marketed predicate device. This is demonstrated by showing similar intended use, technological characteristics (including materials and performance), and addressing any differences that might exist.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "Mechanical Testing Data" but does not specify sample sizes for testing (e.g., number of implants tested), data provenance (country of origin), or whether the mechanical testing was retrospective or prospective in the sense of clinical studies. It refers to testing on the "implant components." This type of submission relies heavily on bench testing for mechanical properties, not typically clinical trials with patient populations as a "test set."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This document does not describe a clinical study involving human patients, therefore, there is no "test set" in the context of expert-evaluated clinical data for which ground truth would be established by experts like radiologists. The mechanical testing data would be evaluated by engineers or materials scientists. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this submission does not detail a clinical study requiring expert adjudication of patient data for a test set. -
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 a 510(k) for an orthopedic implant and does not involve AI or human readers evaluating images or cases. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a 510(k) for an orthopedic implant and does not involve an algorithm or AI. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the mechanical testing, the "ground truth" would be established by engineering standards and specifications for implant strength, fatigue life, and other mechanical properties, as well as comparison to the performance of predicate devices. This is typically done through laboratory measurements and calculations, not pathological or clinical outcomes data in the context of a 510(k) for this type of device. -
The sample size for the training set:
Not applicable. The concept of a "training set" is relevant for machine learning algorithms. This submission is for an orthopedic implant. The design and manufacturing processes are informed by existing biomechanical knowledge, material science, and the performance of predicate devices. -
How the ground truth for the training set was established:
Not applicable, for the reasons stated above.
In summary:
The provided 510(k) documentation focuses on demonstrating substantial equivalence of the VLP FOOT Plating, Screw System and Accessories to existing legally marketed predicate devices, primarily through mechanical testing data and comparison of intended use, design features, operational principles, and material composition. It does not describe a clinical study with human subjects, a test set of patient data, or the use of AI/algorithms that would require expert review or ground truth establishment in the ways typically associated with AI/software medical devices. Mechanical acceptance criteria are met by demonstrating the device can "withstand expected in vivo loading without failure" and is "equivalent to devices currently used clinically."
§ 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.