(90 days)
The SBi ArtFIX is intended for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
The SBi ArtFIX System consists of compression screws that are used for internal fixation. ArtFIX is a cannulated, fully threaded, headless compression screw based on a conical design. The ArtFIX screw has a cutting tip and three thread configurations along its length.
This looks like an FDA 510(k) premarket notification for a medical device called "SBi ArtFIX," which is a bone fixation screw. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study as would be seen for a novel AI/software medical device.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, as it's not a performance study report for an AI device.
Let's break down why the requested information isn't present in this document and what each point asks for:
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A table of acceptance criteria and the reported device performance: This would typically be a table outlining specific metrics (e.g., sensitivity, specificity, accuracy for an AI device, or mechanical strength thresholds for a physical device) and the study results demonstrating the device met those pre-defined thresholds. The provided 510(k) summary for SBi ArtFIX focuses on substantial equivalence based on design, materials, and intended use, not performance against acceptance criteria.
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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): This refers to the characteristics of the dataset used to evaluate an AI model's performance. Since SBi ArtFIX is a physical bone screw and not an AI/software device, there is no "test set" in this context.
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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): Ground truth is crucial for evaluating AI performance. For a physical device like a screw, there isn't "ground truth" established by experts in the same way as for diagnostic imaging.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: This describes how discrepancies in expert opinions were resolved when establishing ground truth for an AI device. Not applicable here.
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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: This is specifically for evaluating the impact of AI assistance on human performance, a concept entirely unrelated to a bone fixation screw.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This describes an AI device's performance without human interaction. Not applicable for a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As mentioned, "ground truth" for a physical screw isn't defined by these methods. Performance for such devices would be based on mechanical testing (e.g., fatigue, torsion, pull-out strength) and clinical outcomes in predicate device equivalency, not expert consensus on data.
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The sample size for the training set: Refers to the dataset used to train an AI model. Not applicable for a physical device.
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How the ground truth for the training set was established: Similar to point 8, not applicable for a physical device.
In summary, the provided document is a 510(k) clearance letter for a bone fixation screw, which establishes substantial equivalence to a predicate device based on design, materials, and intended use, not through a performance study that measures against specific acceptance criteria for an AI or software device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.