(90 days)
The EVOLVE® Radial Plate is indicated for fixation of unstable radius fractures in which closed reduction is not suitable.
The EVOLVE® Radial Plate system consists of plates, cortical screws, and locking screws. The design features of the plates and locking screws of the EVOLVE® Radial Plate system are summarized below:
Plates
- Manufactured from stainless steel
- Offered in two lengths: Short and Long .
- Cupped head with varying arch to accommodate patient's anatomy .
- Compression slots compress fracture as screw is tightened to facilitate uniting a fracture .
- Threaded screw holcs in the head portion accept locking screws for stable plate/screw . construct
- Cortical screw holes located in head and shaft .
Cortical Screws
- Manufactured from stainless stecl .
- Available in two diameters: 2.7mm and 1.8mm in varying lengths ranging from 3.0mm to . 40.0mm in 2mm increments
- Identical to cortical screws previously submitted and cleared under the LOCON-T® . Distal Radial Plating System
Locking Screws
- Manufactured from stainless steel
- Available in lengths from 14mm to 28mm in 2mm increments .
- Threads on the screw mate to threads in the screw holes to fix the screw to the plate . reducing the likelihood of screw loosening and improving the screw to plate stability of the system
The provided document is a 510(k) summary for the EVOLVE® Radial Plate. It is a premarket notification for a medical device seeking clearance from the FDA, asserting substantial equivalence to previously cleared devices. This type of document does not typically contain detailed information about a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study report would.
Instead, the document focuses on:
- Identification of the device and its intended use.
- Description of the device components and materials.
- Demonstration of substantial equivalence to predicate devices, which is how clearance is sought under the 510(k) pathway. This means the device is considered as safe and effective as a legally marketed device (predicate device).
Therefore, I cannot provide the specific details requested regarding acceptance criteria and a study that proves the device meets those criteria, as these are generally not part of a 510(k) submission in the format you've requested. The 'study' in this context is the comparison to existing devices for substantial equivalence.
However, I can extract the available relevant information:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria and reported device performance in terms of specific metrics like sensitivity, specificity, or similar performance indicators for a diagnostic device. For a bone fixation plate, acceptance criteria would typically relate to mechanical strength, biocompatibility, and sterilization, which are established through adherence to standards and material testing, not usually presented in a 510(k) summary with numerical performance values for this type of device. The primary "performance" reported is its substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance:
Not applicable. This is not a study with a test set of data. The "testing" involved demonstrating material properties and design similarity to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not a study assessing diagnostic accuracy or clinical outcomes where expert ground truth would be established.
4. Adjudication method for the test set:
Not applicable.
5. 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 bone fixation plate, not an AI-powered diagnostic device, so MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used:
Not applicable in the typical sense of a diagnostic or therapeutic study. The "ground truth" for a 510(k) for a bone plate is the established safety and effectiveness of the predicate device(s) through their own regulatory clearances.
8. The sample size for the training set:
Not applicable.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what the document does provide regarding "acceptance" and "proof":
The "acceptance criteria" for the EVOLVE® Radial Plate under the 510(k) pathway are primarily met by demonstrating substantial equivalence to legally marketed predicate devices.
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Acceptance Criteria (Implicit via Substantial Equivalence): The device (EVOLVE® Radial Plate) must be as safe and effective as the predicate device(s). This is achieved by having:
- Similar indications for use.
- Similar technological characteristics (materials, design features, mechanical properties).
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Study/Proof that the device meets acceptance criteria:
The document states: "The safety and effectiveness of the EVOLVE® Radial Head Plate are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."This means the "study" is a compilation of information and data (likely including mechanical testing, material specifications, biocompatibility reports, etc., though not detailed in this summary) that shows the EVOLVE® Radial Plate is comparable to existing, legally marketed devices (such as the LOCON-T® Distal Radial Plating System mentioned for cortical screws).
In essence, the entire 510(k) submission serves as the "study" to demonstrate that the device meets the regulatory acceptance criterion of substantial equivalence, thereby proving its safety and effectiveness for its intended use.
§ 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.