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KATANA Zirconia ONE For IMPLANT is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

For the SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

KATANA Zirconia ONE For IMPLANT is used in combination with the TiBase and Sirona Dental CAD/CAM System. KATANA Zirconia ONE For IMPLANT cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

Compatible implant systems and TiBase are as follows.

The KATANA Zirconia ONE For IMPLANT mesostructure material (conforming to ISO 6872:2015) is a pre-sintered zirconia block to be used as the ceramic mesostructure component of a two-piece titanium base abutment. KATANA Zirconia ONE For IMPLANT is compatible with the specified TiBase and the CAD/CAM component of the Sirona Dental CAD/CAM system (K193408, K200191) as identified in the Indications for Use. This device is further processed by the trained professional to make individually designed mesostructure that are milled into the desired shape of a hybrid abutment or hybrid abutment crown.

The Zirconia block has identical composition as our own previously cleared reference device, KATANA Zirconia Block (K190436) under product code "EIH".

The mesostructure material of KATANA Zirconia ONE For IMPLANT is available in shades, A1, A2, A3, A3.5, B1, B2, C1, C2, D2 and NW for flexibility and application variety to meet individual patient needs. The mesostructure material of KATANA Zirconia ONE For IMPLANT is available with one block size and two sizes of access hole, which is small (S) and large (L).

The abutment must be sterilized after the cementation of the CAD/CAM patient matched mesostructure on the pre-manufactured titanium base component. PANAVIA SA Cement Universal (K183537) is used as the cement to set the mesostructure material to TiBase when the mesostructure material of the subject device set to TiBase prior to sterilization.

Dentsply Sirona has issued a letter of authorization indicating that the subject mesostructure material of the subject device can be selected in combination with the CAD/CAM system. Kuraray Noritake Dental and Dentsply Sirona have a business agreement for adding this new material to the Sirona CAD/CAM system. Kuraray Noritake Dental has worked with Dentsply Sirona to implement their new material into the Sirona CAD/CAM system libraries.

KATANA Zirconia ONE For IMPLANT which is the subject of this premarket notification consists of:

• Sirona Dental CAD/CAM System with CEREC Chairside Software or with inLab Software
• Sirona TiBase
• . KATANA Zirconia ONE mesostructured blocks

The provided text is a 510(k) summary for a dental device, specifically a zirconia block for implant mesostructures. It details the device's indications for use, design, material composition, and technical characteristics, comparing it to predicate and reference devices.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific "test set" sample size for a clinical study. The performance evaluation relied on non-clinical testing and comparison to predicate devices, referencing international standards and scientific literature.

• Data Provenance: The document does not specify a country of origin for any data beyond the manufacturer being in Japan. The studies are non-clinical, involving material testing and compatibility assessments. There is no mention of retrospective or prospective data as no human clinical testing was performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. No human clinical testing was performed, and thus no expert ground truth was established for a clinical test set. The ground truth for material properties and performance would be derived from adherence to international standards and non-clinical testing protocols.

4. Adjudication Method for the Test Set

Not applicable. As no clinical test set requiring human interpretation or adjudication was used, this information is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of the subject device."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is not an AI algorithm. It is a physical dental material (zirconia block) used in a CAD/CAM system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The performance is related to the material's physical and mechanical properties, its compatibility with the CAD/CAM system, and its ability to meet structural requirements when fabricated into an abutment.

7. The Type of Ground Truth Used

The ground truth for this device is based on:

• International Standards: Adherence to established ISO standards for ceramic dental materials (ISO 6872:2015) and dynamic fatigue testing for dental implants (ISO 14801:2016).
• Material Composition: Verification of identical chemical composition to a previously cleared reference device (KATANA Zirconia Block, K190436).
• Biocompatibility Standards: Evaluation against ISO 10993 series and ISO 7405.
• Engineering Design Parameters: Validation against specified design parameters for abutment post height, angulation, wall thickness, diameter, and gingival height, consistent with CAD/CAM system requirements and FDA recommendations.
• Compatibility: Confirmation of functional compatibility with the predicate CAD/CAM system (Dentsply Sirona) and associated TiBase components through a business agreement and technical specifications.

8. The Sample Size for the Training Set

Not applicable. This device is a physical material, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are dental prosthetics placed onto a dental implant or screw retained abutment, to provide support for dental prosthetic restorations. The Base Abutments and Adhesive Sleeves include: Titanium bases/sleeves with a pre-machined implant connection or screw retained abutment connection on which the CAD/CAM designed upper structure may be fitted to complete a two-piece dental abutment. The Base Abutments and Adhesive Sleeves include an abutment/sleeve screw for fixation to the underlying implant/screw retained abutment. These dental prosthetics may be used for single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with AB Dental Implants with internal connection and screw retained connections for standard and narrow platforms.

All digitally designed abutments and/or copings for use with AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are intended to be sent to AB Dental validated milling center for manufacture.

A.B. Dental Devices® CADCAM Products consists of; Base Abutments and Adhesive Sleeves which are used with Standard Platform (Internal Hex connection) implants, Narrow Platform implants and Screw retained (P64 and P14/P16 MultiUnit) abutments.

Base Abutments (standard or narrow platform) and Adhesive Sleeves (screw retained abutment platform) are prefabricated abutments/sleeves made to be used as final abutments/ sleeves that will be used as adhesive connection (cement retained) of the prosthetic restoration on implant platform or on Multiunit platforms.

The design and manufacturing of the patient-specific abutments take consideration the shape of the final prosthesis based on the patient's intra-oral scanning using the manufacturing. All digitally designed abutments and/or copings for use with AB Dental CAD/CAM Base Abutments and Adhesive Sleeves are intended to be sent to AB Dental validated milling center for manufacture.

This submission adds the following Base Abutments and Adhesive sleeves:

Ti Base Anti-Rotational Abutments (Standard or Narrow platforms) - Base Abutment
Ti Base Rotational Abutments (Standard or Narrow platforms) - Base Abutment
P64 Ti Conical Adhesive Sleeve - Adhesive Sleeve
Ti Straight Adhesive Sleeves - Adhesive Sleeve

Base Abutments;
The titanium bases are used as part of a two-piece abutment, where the base is premanufactured from titanium alloy (Ti-6Al-4V ELI) and the top half is a CAD/CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment.

Raw material Zirconium blanks
Dental Direkt Zirconia Blanks by Dental Direkt GmbH, cleared under K183569

Dental Cement
PANAVIA SA Cement Universal by Kuraray Noritake Dental Inc., cleared under K183537

Adhesive Sleeves
The adhesive sleeves are all Rotational (non-engage) for bridges restoration.

The adhesive sleeves are made of Titanium alloy (Ti-6Al-4V ELI) and will be installed on straight or angular screw-retained abutments.

The Multiunit (screw retained abutments already cleared devices) are P14/P16 platform: The below listed devices are previously cleared items that the sleeves are intended to be used with:
P14-3,17-1, P14-3,17-3, P14-3,30-1, P14-3,30-3, P14-3.75,17-1, P14-3.75,17-3, P14-3.75,30-1, P14-3.75,30-3, P16-3.75,1, P16-3.75,2, P16-3.75,3, P16-3.75,4, P16-3.75,5, P64-3,1, P64-3,17-0.5, P64-3,17-2, P64-3,2, P64-3,3, P64-3,30-0.5, P64-3,30-2, P64-3.75,1, P64-3.75,2, P64-3.75,3, P64-3.75,4, P64-3.75,5, P64-3.75,17-0.5, P64-3.75,17-2, P64-3.75,17-3, P64-3.75,30-0.5, P64-3.75,30-2, P64-3.75.30-3

The provided document is a 510(k) Summary for a dental device, not an AI/ML device. Therefore, it does not contain information related to AI/ML acceptance criteria or studies proving device performance from an AI/ML perspective.

However, I can extract the acceptance criteria and performance data for the dental device as presented in the document:

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

The document does not explicitly state "acceptance criteria" for the device in the typical sense of numerical thresholds for metrics like accuracy, sensitivity, or specificity. Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device through comparison of technological characteristics and non-clinical performance data.

The "acceptance criteria" are implied by the comparison to the predicate device and the successful completion of various non-clinical tests. The "reported device performance" refers to the results of these non-clinical tests.

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

This information is not applicable as this is a 510(k) submission for a non-AI/ML dental device. The "test set" refers to physical samples for engineering and biological testing, not a dataset of patient information. The provenance of the manufacturing is Israel (A.B. Dental Devices Ltd., 19 Hayalomim St., Ashdod 7761117 Israel) and the testing labs are mentioned (e.g. Nelson Lab).

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 not applicable. "Ground truth" in the context of AI/ML refers to accurately labeled data against which an algorithm's performance is measured. For this dental device, "ground truth" would be established by validated engineering specifications, material properties, and regulatory standards. The experts involved would be engineers, material scientists, and regulatory affairs specialists. No specific number or qualifications are mentioned for establishing these in the document itself, beyond stating that an "Engineering analysis" was performed.

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

This is not applicable. Adjudication methods are typically used in clinical studies involving interpretation by multiple human readers. For the non-clinical tests described, the results are derived from physical measurements and laboratory procedures, not interpretations subject to 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 is not applicable. The device is a dental prosthetic and does not involve AI or human interpretation.

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

This is not applicable. The device is a dental prosthetic and does not involve an algorithm.

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

For the non-clinical tests, the "ground truth" is based on:

• Established engineering specifications and material properties: For design comparisons (e.g., material, dimensions, angulation).
• Validated laboratory testing standards: For cytotoxicity (ISO 10993-5), fatigue (ISO 14801), sterilization (ANSI/AAMI/ISO 17665, ISO 11138), and MRI compatibility (various ASTM standards).
• Predicate device characteristics: The predicate device K181580 serves as a benchmark for demonstrating substantial equivalence.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device.

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

This is not applicable as this is not an AI/ML device.

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