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Heany Industries, Inc. "Luxisse +" is non-implantable Zirconia material intended for CAD/CAM fabrication of all ceramic dental restorations. The material is used for the manufacturing of inlays, veneers, single unit anterior and posterior crowns, and three unit anterior bridges.

Heany Industries Inc. "Luxisse +" is an all ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a block or disk shape. CAD/CAM fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of inlays, onlays, veneers, single unit posterior and anterior crowns, and three unit anterior bridges. The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer.

The provided text describes the "Luxisse +" device, a Zirconia material for CAD/CAM fabrication of all-ceramic dental restorations. The document is a 510(k) summary for premarket notification to the FDA, asserting substantial equivalence to a predicate device, "Heany Industries, Inc. Dental Zirconia" (K073314).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are derived from the consensus design standard ISO 6872:2008, "Dentistry - Ceramic Materials", and BS EN 1641:2004, "Dentistry, Medical Devices for Dentistry, Materials." The reported device performance is presented in "Table 2: Testing performed for the 'Luxisse + ' 510(k) Submission" and implicitly through the device comparison chart (Table 1) where specific values are listed.

Note: While "Luxisse +" met the requirements for flexural strength and fracture toughness as per ISO 6872:2008, its specific values are lower than those reported for the predicate device. The filing argues substantial equivalence based on meeting the standard rather than directly matching predicate values in these cases, stating "The formulations have not been changed in ways that may adversely impact device performance."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not explicitly state the sample size used for the non-clinical tests (e.g., number of specimens tested for flexural strength). It also does not mention the country of origin of the data or whether the tests were retrospective or prospective. It only states that "Non-clinical testing was performed in order to validate the design against the Company's specified design requirements... and to assure conformance with the consensus design standard ISO 6872:2008."

3. 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):

This information is not applicable as the described studies are non-clinical (material property testing) and do not involve human subject data or expert review for ground truth establishment. The ground truth is the predefined criteria/requirements of the ISO 6872:2008 standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable as the studies are non-clinical material property tests, not human subject studies requiring adjudication.

5. 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 information is not applicable. The device is a dental material, not an AI-powered diagnostic or assistive tool for human readers. There was no clinical testing performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable. The device is a dental material, not an algorithm. However, the non-clinical performance data can be considered a "standalone" evaluation of the material's properties against established standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the non-clinical performance evaluation is the predefined criteria and specifications outlined in the consensus design standards, specifically ISO 6872:2008 and BS EN 1641:2004. The testing assessed whether the material properties of "Luxisse +" conformed to these established standards for dental ceramic materials.

8. The sample size for the training set:

This information is not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

9. How the ground truth for the training set was established:

This information is not applicable for the same reason as #8.

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