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The Longeviti ClearFit™ cranial Implant is designed and manufactured individually for each adult patient to correct bony voids and/or defects of the cranium.

The Longeviti ClearFit Implant is patient specific, implantable prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implant is manufactured from polymethyl methacrylate materials and are designed using the patient's CT scan data. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners. An identical backup implant may be supplied as a courtesy to the surgeon, according to custom, but is not required. The typical maximum single plate size does not exceed a total surface area of 411 cm2 and should have a nominal thickness of 4mm, not to exceed 5mm, to ensure physical integrity. Perfusion holes (also known as drainage holes) are available upon surgeon request at the time of ordering. Perfusion holes are 2mm in diameter and spaced at least 10mm apart.

I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and study proving device performance for an AI/CADe device. The document is a 510(k) premarket notification letter and summary for a cranial implant (Longeviti ClearFit Cranial Implant), which is a physical medical device, not an AI or CADe product.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance (for an AI/CADe).
2. Sample sizes or data provenance for a test set.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method for a test set.
5. Information about MRMC comparative effectiveness studies or effect sizes for human readers.
6. Stand-alone performance data for an algorithm.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document explicitly states: "No new performance testing was required to determine substantial equivalence because the manufacturing and materials are identical to those described in K191210. The only additional testing for this submission was the addition of the acoustic property testing to support the labeling change." This indicates that the device's performance was not evaluated through the types of studies typically conducted for AI/CADe systems.

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