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The Mistral one stage screw-type dental implant is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

The Mistral is a one stage, screw-type, internal octagon dental implant and is provided in the following range of dimensions:

• Diameters: 3.75. 4.10 and 4.80 mm
• Length: 8, 10, 11.50, 13 and 16 mm
  All implants are manufactured from medical grade 5 pure titanium, which meets requirements of standard ASTM F136.
  The required surface roughness and microgeometry of the implants is achieved by blasting sand particles and acid etching. Blasted surfaces archive more bone contact with the implant surface.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria for the "Mistral one stage screw-type dental implant."

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria.

The key points from the provided text are:

• Predicate Device: One stage implant from MIS Dental Implant System (K040807).
• Description of Device: Mistral is a one-stage, screw-type, internal octagon dental implant made from medical grade 5 pure titanium with a sand-blasted and acid-etched surface.
• Indications for Use: Placement in the upper or lower jaw to support prosthetic devices for restoring chewing function.
• Substantial Equivalence: The device is considered substantially equivalent to the predicate device because it has the same intended use and equivalent performance characteristics.
• Conclusion: No additional concerns regarding safety and effectiveness were identified, leading to substantial equivalence.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth was established for the training set.

This information is typically found in design validation reports or detailed performance studies, which are not part of this 510(k) summary document.

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