(257 days)
The Merete Locking Bone Plate System III can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes.
The Merete Locking Bone Plate System III consists of contoured, anatomically shaped locking bone plates in various sizes and different curvatures for the fixation with Merete 3.0 and 3.5 mm locking screws and 3.0 mm cannulated compression screws. Before placing the screws, plates can be fixed temporarily with K-Wires. Plates, screws and K-Wires of the Merete Locking Bone Plate System III are made of Ti-6Al-4V ELI Alloy for Surgical Implant Applications (ASTM F136, ISO 5832-3). K-Wires are additionally made of CrNiMo Stainless Steel for Surgical Implants (ASTM F138, ISO 5832-1).
The information provided describes the Merete Locking Bone Plate System III, a medical device for bone fixation. The document focuses on the regulatory submission to the FDA (510(k)) and the mechanical testing conducted to demonstrate its safety and effectiveness.
Here's a breakdown of the requested information based on the provided text, primarily drawing from the "Mechanical testing" section:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria in a table format. However, it does mention the types of mechanical tests performed and the general outcome.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device meets mechanical properties necessary for intended use. | Dynamic 4-point bending fatigue test (per ASTM F382-2003 and ISO 9585): "All tests considered the worst case scenario for the system and were passed successfully." This suggests the device demonstrated sufficient fatigue resistance under simulated loading conditions to withstand the stresses encountered in vivo without failure for the expected service life. |
| Device performs as well as or better than predicate devices from a mechanical standpoint. | Screw torsion test (per ASTM F543 and ISO 6475): "All tests considered the worst case scenario for the system and were passed successfully." This indicates the screws' torsional strength and resistance to breakage met the required standards and were comparable to or better than predicate devices. |
| Device meets design requirements based on engineering principles. | Engineering rationale: "All tests considered the worst case scenario for the system and were passed successfully." This implies that theoretical calculations and design considerations were validated through physical testing, confirming the structural integrity and functional performance of the system under various conditions, including "worst-case scenarios." |
2. Sample Size Used for the Test Set and the Data Provenance
The provided text does not specify the sample size used for the mechanical tests.
The data provenance is from nonclinical mechanical testing conducted by Merete Medical GmbH. This is an in-vitro (laboratory) study, not human or animal data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to the provided information. The "ground truth" for this device's performance is established through objective mechanical testing against international standards (ASTM and ISO), not through expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments. Mechanical tests follow predefined protocols and objective measurements.
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
This question is not applicable. The device is a bone plate system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the Merete Locking Bone Plate System III is established through objective mechanical measurements against established international standards (ASTM F382-2003, ISO 9585, ASTM F543, ISO 6475). The successful completion of these tests under "worst-case scenarios" serves as the ground truth for its mechanical integrity and functional performance.
8. The Sample Size for the Training Set
This question is not applicable. Mechanical testing of a physical device does not involve "training sets" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. As stated above, there is no "training set" in the context of this device's testing.
§ 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.