(147 days)
The Mondeal® CONTOUR HO System is intended to be used for the internal fixation of small bones including the hand and foot.
Dorted Desert from Hand Osteosynthesis System consists of titanium plates with shapes and sizes designed for internal fixation of small bones including the hand and foot, and screws of varying lengths from 4 to 23 mm and 1.2 , 1.7, and 2.3 mm in diameter, supplied nonsterile packaged together in either tempered plastic or stainless steel trays suitable for recommended steam sterilisation, and also individually for single implantable use. The plates include straight, "T" shaped and condylar configurations. Manual reusable surgical instruments are supplied to facilitate implantation
This submission does not contain the information required to complete the request. The provided text is a 510(k) summary for a medical device (Mondeal® CONTOUR HO System), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study design with performance metrics.
Here's a breakdown of why the information is missing and what would typically be expected for each point:
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Acceptance Criteria and Reported Device Performance: This type of submission usually focuses on material equivalence and mechanical testing that mimics physiological loads, rather than clinical performance metrics (like sensitivity, specificity, accuracy) that would apply to diagnostic devices or devices with measurable clinical outcomes. The document states "overall performance characteristics," but does not list specific numerical acceptance criteria or performance results (e.g., in terms of strength, fatigue life, or clinical success rates).
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Sample Size for Test Set and Data Provenance: Not applicable. As this is a mechanical fixation device, the "test set" would refer to the materials and constructs tested. The provided document doesn't specify the number of samples used in any mechanical tests, nor does it mention any clinical data or its provenance.
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Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth, in the context of clinical studies, refers to the definitive determination of a condition or outcome. For a device like a bone fixation system, clinical trials might establish ground truth through imaging follow-ups, surgical assessment, or patient outcomes, but this is not covered in a 510(k) summary focused on substantial equivalence.
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Adjudication Method: Not applicable for this type of submission. Adjudication methods (like 2+1 or 3+1) are typically used in studies where human readers are interpreting images or clinical data, which is not the focus here.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. MRMC studies are used to evaluate the performance of diagnostic imaging devices or algorithms with and without AI assistance, comparing human reader performance. This device is a surgical implant, not a diagnostic tool.
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Standalone Performance Study: Not applicable. "Standalone performance" usually refers to the algorithm-only performance of an AI-powered diagnostic device. For a surgical implant, performance is assessed through mechanical testing and, in some cases, clinical follow-up. This document doesn't detail such studies.
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Type of Ground Truth Used: Not applicable in the context of clinical "ground truth" for a diagnostic device. For an implant, "ground truth" might pertain to the success of the fixation in a mechanical test (e.g., did it fail at a certain load?) or clinical outcome measures in a trial. This document does not elaborate on these.
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Sample Size for Training Set: Not applicable. This device is a mechanical implant, not an AI or machine learning system that requires training data.
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How Ground Truth for Training Set was Established: Not applicable, as there is no training set for this type of device.
In summary, the provided 510(k) summary is designed to demonstrate substantial equivalence based on material properties, design, and intended use compared to a predicate device, rather than providing detailed clinical study results with acceptance criteria and performance metrics typically associated with diagnostic or AI-powered devices.
§ 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.