(28 days)
Distal Humerus Plates are indicated for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension. Olecranon Plates are indicated for intra-articular or extra-articular fractures of the proximal ulna, osteotomies, and nonunions. Longer plates may be used for proximal ulna fractures with diaphyseal extension.
The VariAx™ Elbow System is intended for fracture fixation of long bones. The subject and predicate devices are made from Titanium alloy (Ti-6Al-4V) and Commercially pure titanium.
This 510(k) summary describes a modification to the indications for use of the VariAx Elbow System, which is a bone plate and screw system. The submission does not involve a medical device that uses AI or machine learning, and therefore the concepts of acceptance criteria, device performance, ground truth, training sets, or expert adjudication as typically applied to AI/ML devices are not relevant here.
The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K073557) rather than providing performance data against specific acceptance criteria for a new or significantly modified device.
Here's a breakdown of why the requested information cannot be provided based on the given text:
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A table of acceptance criteria and the reported device performance: Not applicable. This submission is for changing the indications for use of an existing device type, not for a device with a performance metric that would be assessed against specific acceptance criteria in the context of an AI/ML study. The device itself (bone plates and screws) is a mechanical fixation device, not a diagnostic or prognostic system with performance metrics like accuracy, sensitivity, or specificity.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of an AI/ML algorithm or a study designed to evaluate performance metrics. The substantial equivalence argument relies on the inherent properties of the device materials and design, not on clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. There is no "ground truth" to establish for this type of submission, as it's not evaluating the output of an algorithm against a known correct answer.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or related adjudication process is described or relevant.
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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: Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool. No human reader studies are mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is established or used for this type of submission.
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The sample size for the training set: Not applicable. There is no training set for an AI/ML algorithm.
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How the ground truth for the training set was established: Not applicable. No ground truth for a training set.
Summary of the Study (Substantial Equivalence Justification):
The "study" in this context is a substantive equivalence justification, a regulatory pathway for medical devices that are similar to legally marketed predicate devices.
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Acceptance Criteria (for regulatory clearance): The acceptance criterion for this submission is demonstrating that the modified VariAx Elbow System is substantially equivalent to its predicate device (K073527) for the new indications for use. This involves showing that the modifications do not raise new questions of safety and effectiveness.
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Reported Device Performance (as presented):
- Intended Use: The revised intended use is for fracture fixation of long bones, specifically for "Distal Humerus Plates for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions" and "Olecranon Plates for intra-articular or extra-articular fractures of the proximal ulna, osteotomies, and nonunions."
- Basis for Equivalence:
- No design changes: "No mechanical testing was needed to demonstrate substantial equivalence of the subject components since no design changes were made to the system."
- Identical manufacturing methods, packaging, and sterilization.
- Identical materials: Both predicate and subject devices are made from Titanium alloy (Ti-6Al-4V) and Commercially pure titanium.
- Identical mechanical & functional properties: "The mechanical & functional properties of the subject VariAx Elbow System are identical to the predicate device VariAx Elbow System K073527."
In essence, the "study" proving the device meets the "acceptance criteria" (of substantial equivalence) is the assertion and demonstration that the physical device itself is unchanged from a previously cleared device, only its stated indications for use are being clarified and expanded. Therefore, the performance characteristics are assumed to be identical to the predicate device.
§ 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.