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The permanent post-type implants of this system are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

The temporary implants are intended to provide immediate transitional splinting stability or fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. It is indicated for a maximum of one year.

The ZTI Implants System implants are post-type endosseous dental implants with design and manufacturing concepts, materials, surgical procedures, and intended uses quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device. The ZTI Implants system is most similar to the Straumann ITI Implants System which received concurrence of substantial equivalence from the Food and Drug Administration in premarket notification submission K-955281 and the ITI TE "" system in general. Like many commercial implants, the ZTI devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium)..

ZTI Implants also are available in coated form, either hydroxyapatite or titanium plasma spray, These devices are equivalent to various coated endosseous implants on the market, for example the Sabertech implants of Genentech, Inc., which were cleared under K-924112 and the Crystal-Seal Implants of Crystal Technology, cleared under K-980447.

This 510(k) summary for the ZTI Implants System does not contain the detailed information required to fill out the table and answer all the questions as it is a substantial equivalence submission, not a performance study report. The device is determined to be substantially equivalent to pre-amendment devices and other commercially available dental implants. Therefore, the submission relies on the established safety and effectiveness of its predicate devices rather than presenting a de novo study with specific acceptance criteria and performance data for this particular device based on new testing.

Here's what can be extracted and why certain information is missing:

Acceptance Criteria and Study for ZTI Implants System

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. No new test set data is presented for this specific device to determine performance against acceptance criteria.
• Data Provenance: Not applicable in the context of a de novo performance study. The submission refers to a general literature review ("Medline literature search produced over 700 review articles") of endosseous implants and a "Toronto 10-year study" on the Branemark implant technique, which are external to specific testing of the ZTI Implants System.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No new test set requiring expert ground truth establishment for this device is mentioned. The submission refers to a "Consensus Development Conference on Dental Implants [National Institutes of Health, Bethesda, MD, June 13-15, 1988]," indicating a general consensus in the field, not specific to this device's testing.

4. Adjudication method for the test set

• Not applicable. No test set requiring adjudication is described.

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

• Not applicable. This device is a dental implant, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

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

• Not applicable. This device is a physical dental implant, not an algorithm.

7. The type of ground truth used

• The ground truth relies on historical clinical evidence and consensus within the dental community regarding the performance of endosseous dental implants, especially titanium or titanium alloy, of similar design and materials. The submission cites established literature reviews, consensus conferences, and long-term studies (like the Toronto study on Branemark implants) as evidence of safety and effectiveness for this class of devices. It is not about a specific ground truth for an evaluation of this particular device.

8. The sample size for the training set

• Not applicable. This is a medical device (dental implant), not a machine learning model, so there is no "training set."

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

• Not applicable. As above, there is no training set.

Summary Explanation:

The K034067 submission is a 510(k) Premarket Notification, which seeks to demonstrate that the ZTI Implants System is substantially equivalent to legally marketed predicate devices. This regulatory pathway primarily relies on demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness as compared to a predicate device.

Therefore, the submission typically does not include new, independent clinical studies with specific acceptance criteria, performance metrics, or details about test and training sets. Instead, it references the established safety and efficacy of the predicate devices and the general scientific consensus in the field of dental implants. The "Clinical Discussion and Brief Literature Review" section serves to underpin the general safety and effectiveness of the type of device, not to report specific performance data for the ZTI Implants System itself.

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