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"Zibone Zirconia Blocks" are intended for CAD/CAM fabrication of full ceramic dental restorations such as copings, crowns, inlays, onlays, veneers, and bridges of 3 or less units.

"Zibone Zirconia Blocks" are made from partially sintered zirconium oxide. The devices are to be CNC machined to construct dental restorations and substructures such as crowns and bridges with the aid of CAD/CAM technology.

The devices are in cylinder forms with a constant diameter of 98mm and variety of heights from 12 to 20 mm, and in rectangular bar forms with various lengths and widths with the height of 16mm.

This document is a 510(k) Premarket Notification from the FDA to Coho Technology Co., Ltd. regarding their "Zibone Zirconia Blocks." The core of the document confirms that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices.

The document does not describe a study involving an AI/software device or a diagnostic device, or a study that evaluates human reader performance. Instead, it pertains to a dental material (zirconia blocks) and focuses on demonstrating its physical, chemical, and mechanical equivalence to a predicate device, along with biocompatibility.

Therefore, most of the requested information about acceptance criteria, study design for AI/human reader performance, sample sizes for test/training sets, expert involvement, and ground truth establishment is not applicable or cannot be extracted from this document.

However, I can extract the relevant information regarding the device's conformity to standards and the tests performed to establish its equivalence.

Here's the relevant information based on the provided text:

Acceptance Criteria and Device Performance (for a Dental Material, not an AI Device):

The acceptance criteria here are based on meeting the specifications of an international standard for dental ceramics and demonstrating biocompatibility.

• Cytotoxicity per ISO 10993-5 and ISO 10993-11
• Sensitization and irritation per ISO 10993-10
• Pyrogen tests per ISO 10993-11 and USP 151
  Results: "favorable biocompatibility results" |
  | Substantial Equivalence to Predicate Device (K100145) | "Based on similar chemical composition, intended use, technological characteristics, physical properties testing, and favorable biocompatibility results, Zibone Zirconia Blocks are substantially equivalent to the predicate device." Key similarities highlighted: Same major chemical component (ZrO2), similar indications for use, similar method of fabrication (CAD/CAM Systems), similar types of restorations, and same device forming process (Press CIP). Differences in percentages of chemical composition were noted but deemed equivalent based on ISO 6872 testing. |

Information NOT Applicable to this Document (as it's not an AI/Software/Diagnostic Device Study):

1. Sample sizes used for the test set and the data provenance: Not applicable. This document refers to bench testing of physical materials, not a digital dataset or patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a material's physical properties is established through standardized laboratory testing, not expert consensus on images.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is relevant for diagnostic studies, not material testing.
4. 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: Not applicable. This is for AI-assisted diagnostic device studies.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" here is the established specifications and performance parameters outlined by ISO 6872:2008 and other biocompatibility standards (e.g., ISO 10993 series, USP 151), validated through laboratory bench testing.
7. The sample size for the training set: Not applicable. This is for machine learning models.
8. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory approval for a dental material based on its physical, chemical, and mechanical properties and biocompatibility, not a performance study for an AI-powered diagnostic tool.

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Zibone one-piece ceramic dental implants are indicated for implantation into the upper or lower jaw to replace missing teeth. They are indicated for (delayed or immediate) loading once primary stability has been achieved.

Zibone ® Ceramic (Zirconia) Dental Implants are threaded; root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices. The implants are manufactured from yttrium stabilized zirconium oxide bioceramics material conforming to ISO 13356-2008: Implants for surgery-ceramic materials based on yttria-stablized tetragonal ziconia (Y-TZP). The implant has a one-piece design (both implant and abutment), which simplifies the surgical procedures.

The implants are single use devices and are delivered in sterile condition have been sterilized with moisture heat. Zibone ceramic dental implants are also subjected to a sandblasting process that is used to impart the surface of the devices to enhance the osseointegration process.

Zibone dental implants are offered in three diameters (3.6mm, 4mm and 5mm) and 5 insertion lengths (8mm, 10mm, 11.5mm, 13mm and 14.5mm) for different teeth. The general rule is to select largest and longest implant size that the indication permits.

The provided text is a 510(k) summary for the Zibone Ceramic Dental Implant System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the way one might find for an AI/CADe device.

Therefore, many of the requested sections about acceptance criteria, study design, and performance metrics (especially those pertaining to AI/CADe systems like sensitivity, specificity, reader studies, etc.) are not applicable to this type of submission.

Here's a breakdown based on the information provided:

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

Note: The document states "The following were reviewed to support the performance of Zibone Summary of 8. Ceramic Dental Implant System: Fatigue test to ISO 14801, Nonclinical Testing: Sterilization validation, Shelf life testing, Surface analysis & Biocompatibility testing." It does not provide specific numerical acceptance criteria or performance values for each of these tests, but concludes they support performance and substantial equivalence.

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 no clinical studies with test sets are reported for this 510(k) submission. The testing conducted was bench testing.

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 no clinical studies requiring ground truth by experts are reported.

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

This information is not applicable as no clinical studies requiring adjudication are reported.

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 as no MRMC study or AI components are described. This device is a physical dental implant, not an AI/CADe system.

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

This information is not applicable as this is a physical medical device, not an algorithm.

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

This information is not applicable as no clinical studies requiring ground truth are reported. Performance was evaluated through non-clinical (bench) testing against established standards (e.g., ISO 14801) and material properties.

8. The sample size for the training set

This information is not applicable as no training set (for an algorithm) is mentioned or relevant to this physical device submission.

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

This information is not applicable as no training set or ground truth in that context is mentioned or relevant.

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