(41 days)
APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
APTUS Ulna Shortening 2.5 system consists of titanium locking plates. The plates are secured using previously cleared titanium screws (K103332 and K051567), both locking and nonlocking. This submission includes additional lengths of non-locking screws. Plates have a low overall height, rounded edges, polished surfaces and incorporate TriLock Technology with use of TriLock (locking) screws. All plates are made from unalloyed titanium conforming to ASTM F67, and all screws are made from titanium alloy conforming to ASTM F136.
This is a medical device 510(k) summary, not a study describing AI/algorithm performance. Therefore, most of the requested information about acceptance criteria, study design, and AI model specifics is not applicable.
The document describes the APTUS® Ulna Shortening 2.5 system, which consists of titanium locking plates and screws used for ulna fractures and osteotomies. The approval is based on demonstrating substantial equivalence to existing, legally marketed predicate devices, not on proving performance against specific acceptance criteria in a clinical or AI-based study.
Here's a breakdown of what can be extracted and why other parts are not applicable:
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A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense. This is not an AI/algorithm study with performance metrics like sensitivity, specificity, etc.
- The "acceptance criteria" here relate to demonstrating substantial equivalence (SE) to predicate devices. The "reported device performance" refers to the data provided to support this equivalence.
- Acceptance Criteria for Substantial Equivalence (implied):
- Same intended use.
- Same technological characteristics (or differences don't raise new safety/efficacy issues).
- Same or similar materials.
- Similar design characteristics.
- Same range of physical dimensions.
- Compatible with screws from predicate devices.
- Same packaging and sterilization methods.
- Performance data (dimensional analysis, engineering analysis, dynamic mechanical testing) to support equivalence.
- Reported Device Performance: "Performance data provided to demonstrate substantial equivalence included detailed dimensional analysis of the subject and predicate device designs, engineering analysis and dynamic mechanical testing of the subject and predicate plate designs." No specific metrics (e.g., strength in Newtons) are provided in this summary.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is not a study that uses a "test set" of patient data in the context of an algorithm or clinical trial. The "testing" refers to mechanical and engineering tests of the device components. Details on the sample sizes for these mechanical tests are not provided in this summary.
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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" in the context of medical device approval for equivalence generally refers to engineering specifications, material properties, and established medical standards. There is no mention of experts establishing a "ground truth" for a test set in the way an AI algorithm would require.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method is used as this is not a study involving human reader interpretation of data.
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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 hardware device (bone plate and screws), not an AI-assisted diagnostic or therapeutic tool. Therefore, no MRMC study with AI assistance was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable in the AI/clinical study sense. The "ground truth" for this device's approval is based on established engineering principles, material science standards (ASTM F67, ASTM F136), and regulatory requirements for demonstrating substantial equivalence to predicate devices that have a history of safe and effective use.
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The sample size for the training set
- Not Applicable. This is a hardware device; there is no "training set" in the context of an AI algorithm.
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How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.