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KATANA Zirconia Block is used for the fabrication of the ceramic restorations (frameworks, FCZ crowns, FCZ bridges (14Z L only), inlays, onlays and veneers).

The subject device, KATANA Zirconia Block is a pre-sintered zirconia block composed of yttrium stabilized zirconia, which is designed for CEREC milling systems. The subject device is meant to be end-user sintered after milling for the fabrication of dental restorations. KATANA Zirconia Block STML has 3 sizes (12Z, 14Z and 14Z L) and has 14 shade variations: (A1, A2, A3, A3.5, A4, B1, B2, B3, C1, C2, C3, D2, D3, NW). KATANA Zirconia Block ST has 1 size: (12Z) and has 1 shade variation: (CL). STML consists of 4 gradated shade layers and ST is mono color. They are classified as a Type II and Class 4a) material by ISO 6872.

This document describes the premarket notification for the KATANA Zirconia Block and demonstrates its substantial equivalence to previously cleared predicate and reference devices.

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

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

The document provides a table (Table 3-6-3) comparing the subject device (KATANA Zirconia Block (14Z L)), the predicate device (KATANA Zirconia Block (12Z, 14Z)), and the reference device (KATANA Zirconia Disc (ST, STML)) against requirements specified in ISO 6872:2015 (Dentistry — Ceramic materials — Part 1: Dental ceramics).

"COMPLIES" indicates that the test value was within the acceptable range to pass the testing in compliance with the requirements of ISO 6872:2015.

2. Sample sized 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 sizes used for the bench testing. It refers to a "comparative study performed according to ISO 6872:2015," which typically involves specific sample sizes dictated by the standard for each test. The data provenance (country of origin, retrospective/prospective) is not mentioned. However, the applicant is "Kuraray Noritake Dental Inc." in Japan, suggesting the testing was likely conducted by or for this Japanese company.

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 is a physical/mechanical properties test for a dental ceramic block, not a diagnostic medical device that requires expert interpretation. Therefore, there are no "experts" in the sense of medical professionals establishing a ground truth based on clinical evaluation. The ground truth for these tests is established by adhering to the standards and methods outlined in ISO 6872:2015. Visual inspections (e.g., for uniformity, absence of extraneous materials) would be performed by trained technicians or quality control personnel.

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

Since this is a bench testing scenario focusing on physical and chemical properties against a standard, an adjudication method for conflicting expert opinions (like 2+1 or 3+1) is not applicable. The compliance is determined by instrumental measurements and visual inspections against quantitative and qualitative criteria defined by ISO 6872:2015.

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

No MRMC comparative effectiveness study was performed. This device is a dental material (zirconia block) and not an AI-powered diagnostic tool requiring human reader assistance.

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

This is not an algorithm-based device. It is a physical dental material. Therefore, no standalone algorithm performance study was done. The performance evaluation is based on standard material testing methods.

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

The ground truth for this device's performance evaluation is established by international standards (ISO 6872:2015). The performance is measured against the pre-defined limits and specifications within this standard, rather than expert consensus on clinical cases, pathology, or outcomes data.

8. The sample size for the training set

This is not an AI/machine learning device; therefore, there is no "training set" in the computational sense. The material is manufactured and tested according to quality control procedures to meet the specified standards.

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

As there is no training set for an algorithm, this question is not applicable.

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KATANA Zirconia Block is used for the fabrication of the ceramic restorations (FCZ crowns, inlays, onlays and veneers).

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The provided text is a clearance letter from the FDA for a dental device, KATANA Zirconia Block, and indications for its use. It describes the regulatory classification and general controls applicable to the device. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other details requested in your prompt.

Therefore, I cannot provide the requested information based on the input text. The text does not describe a study or provide performance metrics for the device.

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