(55 days)
The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies.
The System is intended for fractures and fracture dislocations, osteotomies and nonunions of the proximal humerus, particularly in osteopenic bone.
The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone.
The EBI OptiLock Upper Extremity Plating System is an internal fixation device used to provide surgeons with bone plates that are capable of using locking screws for better stability and non-locking screws for compression. Threaded slots are also available for non-locking screws to hold the plate to the bone while adjusting the plate along the length of the bone. The shapes of the plates are pre-contoured to the shape of the bone and the holes on the plate are threaded in such a way as to permit surgeons a choice of locking or non-locking screws. Instruments allow minimum incision during surgery.
The provided text is a 510(k) summary for the EBI® OptiLock Upper Extremity Plating System, an internal fixation device. This type of submission focuses on demonstrating substantial equivalence to predicate devices, not on proving device performance through clinical studies with acceptance criteria in the way a diagnostic AI/ML device submission would.
Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance is not present in this document. This is because the device is a mechanical surgical implant, not a diagnostic imaging or AI algorithm, and its approval pathway does not typically require the types of performance studies listed in the prompt.
Here's how to interpret the provided document in the context of your questions:
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Acceptance Criteria and Reported Device Performance: This document does not describe performance criteria or reported performance results in the way a diagnostic device would (e.g., sensitivity, specificity thresholds). For an internal fixation device like this, acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices regarding intended use, materials, and function. This is typically supported by engineering testing (e.g., mechanical strength, fatigue testing, biocompatibility) rather than clinical performance metrics in humans. These engineering tests would have their own internal acceptance criteria, but they are not detailed in this 510(k) summary.
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Study Proving Device Meets Acceptance Criteria: The "study" here is the 510(k) submission itself, where the manufacturer provides information and data to demonstrate substantial equivalence to predicate devices. This involves comparing the technological characteristics of the new device to existing, legally marketed devices.
Let's address the specific points you requested, noting where information is not applicable or provided:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance metrics in this summary. The overarching acceptance criterion for the 510(k) process is "substantial equivalence" to predicate devices in intended use, materials, and function.
- Reported Device Performance: Not reported in clinical performance terms. The document asserts that "There are no significant differences between the EBI® OptiLock Upper Extremity Plating System and other currently marketed internal fixation systems. It is substantially equivalent to the predicate devices in regard to intended use, materials, and function." This implies that the device performs equivalently to the predicates, based on engineering data, but no specific performance numbers are given.
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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. This submission does not involve clinical "test sets" in the context of diagnostic performance evaluation.
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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. Ground truth for diagnostic performance is not relevant here.
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Adjudication method (e.g., 2+1, 3+1, none) 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: Not applicable. This is not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device lies in established engineering standards (e.g., ASTM standards for materials) and the performance characteristics of the predicate devices. The claim of substantial equivalence is the cornerstone, supported by comparison of design, materials, and intended use.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires training data.
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How the ground truth for the training set was established: Not applicable.
In summary: The K0624994 submission for the EBI® OptiLock Upper Extremity Plating System is a product of traditional medical device regulation focused on mechanical and material equivalence to existing devices, not on the performance criteria or study methodologies typically associated with diagnostic AI/ML products.
§ 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.