(63 days)
The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.
The Dorsal, Lateral and Ulna Plating System consists of Titanium alloy plates utilizing non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr for bone fixation and the management of fractures, revisions, fusions and reconstructive surgeries. They can be provided in a pre-packaged sterile kit with accompanying single use instrumentation, individually packaged sterile units or non-sterile for further steam sterilization prior to use. Offered in left and right configurations, with the exception of the Ulna plate that is bilateral, the plates are for use with existing 2.2mm pegs and 2.7mm locking and non-locking screws and multidirectional fasteners.
This submission does not include information about AI/ML device performance or a study demonstrating that a device meets acceptance criteria related to AI/ML performance. Instead, it is a 510(k) summary for a "Dorsal, Lateral and Ulna Plating System," which is a metallic bone fixation appliance.
The document discusses preclinical data to demonstrate substantial equivalence to predicate devices, focusing on mechanical properties of the physical implant. Therefore, the questions related to AI/ML performance, ground truth, experts, sample sizes for test/training sets, and MRMC studies are not applicable to this submission.
Here's a breakdown of the relevant information provided:
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Table of acceptance criteria and reported device performance:
- Acceptance Criteria (Implied): Substantial equivalence to predicate devices in:
- Design
- Dimensions
- Material
- Performance (axial load construct testing, evaluation of galvanic corrosion potential, multidirectional screw capability).
- Reported Device Performance:
- The Dorsal, Lateral and Ulna Plating System's technological characteristics are "similar to the predicate devices including design, dimensions and material."
- Demonstrated with preclinical data including:
- Axial load construct testing
- Evaluation of galvanic corrosion potential
- Multidirectional screw capability
- Acceptance Criteria (Implied): Substantial equivalence to predicate devices in:
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Sample size used for the test set and the data provenance: Not applicable. This involves preclinical (benchtop) testing of a physical device, not a data-driven AI/ML model.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant's mechanical properties is typically established through standardized engineering tests, not expert consensus on medical images or patient data.
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Adjudication method for the test set: Not applicable.
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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: No, this is not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI/ML device.
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The type of ground truth used: For the physical device, the "ground truth" for demonstrating substantial equivalence is established through standardized engineering tests and material evaluations. This is based on objective measurements of mechanical performance and material properties.
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The sample size for the training set: Not applicable. There is no training set for an AI/ML model.
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How the ground truth for the training set was established: Not applicable.
§ 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.