(287 days)
The Versalock Rib and Sternum Plates System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternal reconstructive surgical procedures, rib and sternum fractures, fusions and osteotomies.
The Versalock Rib and Sternum Plates System is indicated for the stabilization and rigid fixation of chest wall fractures, including sternal reconstruction processes, trauma and/or planned osteotomies. The physical principle is based on rigid fixation, where the screws have a specific thread profile in their head, which, when fixed, allows the surgeon to fix it with a variable angle of ±15° in the threaded hole of the plate. The system also allows fixation with non-threaded head screws when the surgeon so desires. The devices are presented in Titanium Alloy according to the standard ASTM F136 and Pure Titanium According to ASTM F67.
This document describes a 510(k) premarket notification for the "Versalock Rib and Sternum Plates System". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a novel, high-risk device.
Therefore, the sections of your request related to "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample sizes used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for the training set was established" are not directly applicable in the context of this 510(k) submission for a metallic bone fixation appliance.
Instead, the submission relies on demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical performance testing to recognized consensus standards.
Here's a breakdown of the relevant information from the provided text, addressing your questions where possible within the context of a 510(k) submission for this type of device:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of acceptance criteria and reported device performance in the manner typically seen for clinical diagnostic studies or novel performance claims. For a 510(k) for a metallic bone fixation device, "acceptance criteria" are generally met by demonstrating that the device's mechanical properties are comparable to or meet the requirements of established ASTM standards, which are considered sufficient to ensure safety and effectiveness for its intended use, similar to predicate devices.
The "reported device performance" is indicated by its successful testing against these standards, implying it met the performance expectations set forth by those standards.
| Performance Characteristic | Standard Tested Against | Reported Outcome / "Acceptance" |
|---|---|---|
| Torsional Properties | ASTM F543 | Tested successfully |
| Driving Torque | ASTM F543 | Tested successfully |
| Axial Pullout Strength | ASTM F543 | Tested successfully |
| Single Cycle Bending (Static) | ASTM F382 | Tested successfully |
| Bending Fatigue Test | ASTM F382 | Tested successfully |
| Lateral Distraction, Longitudinal and Transversal Shear | (No specific ASTM number listed, but implied as part of mechanical testing) | Tested successfully |
| Pyrogenicity | USP | Device meets pyrogen limit specifications |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact number of samples used for each mechanical test. This level of detail is typically found in the full test reports, not in the 510(k) summary. However, recognized consensus standards like ASTM F543 and F382 usually dictate the minimum number of samples required for robust testing.
- Data Provenance: The testing was "non-clinical" and performed against recognized consensus standards (ASTM F543, ASTM F382, USP ). This implies laboratory-based mechanical and biological (pyrogen) testing. The country of origin of the data is not explicitly stated, but the manufacturer is based in Brazil, suggesting the testing could have occurred there or by a certified lab elsewhere. The data is prospective in the sense that these tests were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. For mechanical and biological performance testing of a bone fixation device, "experts" in the sense of establishing clinical ground truth (like radiologists reading images) are not applicable. The "ground truth" for this device is its physical and material properties, assessed by engineering and laboratory methods against established standards.
4. Adjudication method for the test set
N/A. Adjudication methods (like 2+1 reader consensus) are relevant for clinical studies, particularly in image interpretation or diagnostic pathways. This submission relies on objective mechanical and biological test results.
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
N/A. This is a medical device for physical fixation, not an AI/software device or a diagnostic tool requiring human reader interpretation. No MRMC study was conducted or is relevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device is not an algorithm or AI. It is a physical implant.
7. The type of ground truth used
The "ground truth" for this device, in the context of its 510(k) submission, is established through:
* Mechanical properties: Measured values obtained from testing according to ASTM F543 and ASTM F382, which serve as objective standards for bone fixation devices.
* Material composition: Conformance to ASTM F136 (Titanium Alloy) and ASTM F67 (Pure Titanium).
* Biocompatibility/Sterility related: Meeting pyrogen limit specifications per USP .
* Substantial Equivalence: Comparison to the design, materials, and intended use of legally marketed predicate devices (K161590, K161896).
8. The sample size for the training set
N/A. This is not an AI/machine learning device, so there is no training set in that context. If "training set" is meant as in "samples used for development and iterative testing," that information is not provided in the summary.
9. How the ground truth for the training set was established
N/A. Not applicable for this type of device and submission.
§ 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.