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The Cresco Ti® Implant Concept is intended a) for implantation into the fully edentulous ridge for the support of a dental prosthesis; b) for implantation into the partially edentulous ridge for support of a dental prosthesis; c) for single toolh implantation use.

The proposed system which is the subject of this Special 510(k) Notification, is a modification to the existing Cresco Ti implant concept, which has been previously cleared by the FDA under 510(k) Number K981052 on December 18, 2001. This exaced includes a single non-sterile package containing all components necessary for the laboratory work and the prosthetic work to produce bridge supports and related accessories which are compatible with non-Cresco Ti endosseous implants. Modifications have been made to apply the same concept as that used for the Cresco . Hourient system to other inplant interfaces other than those included on page 134 of the original 510(k) Notification K980152. Additional bridge supports are included in this 510(k) Notification which are designed to fit a broader range of implant interfaces. In addition, the Cresco concept can also be used for other metals or metal alloys in addition to Titanium (e.g. procious metal, Co-Cr),

The Cresco Ti® Implant Concept K042354 submission describes a modification to an existing dental implant system. The document focuses on demonstrating substantial equivalence to a predicate device (K981052) and does not contain detailed information on acceptance criteria for device performance as would be found in a clinical study report for an AI/ML medical device.

Therefore, many of your specific questions regarding acceptance criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, cannot be directly answered from the provided text. The document describes a traditional medical device modification, not an AI/ML system.

However, I can extract information related to the non-clinical and clinical tests mentioned, which serve as evidence for device performance.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a device modification, the "acceptance criteria" are not reported as numerical performance metrics, but rather as showing that the modified device performs similarly to or better than the predicate, especially regarding mechanical integrity and compatibility.

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

• Sample Size: Not explicitly stated. The document refers to "in vitro testing" and "clinical testing" generally, without providing specific numbers of tests or subjects.
• Data Provenance: Not explicitly stated. The "Clinical Test Results" section vaguely mentions "long-term validity of the concept," but gives no details on the study's origin or type (retrospective/prospective).

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)

• Not applicable as this is not an AI/ML device or a study involving expert readers for ground truth establishment.

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

• Not applicable.

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 is not an AI-assisted device.

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

• Not applicable. This is a physical dental implant system.

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

• For non-clinical tests, the "ground truth" would be established by engineering standards and measurement accuracy (e.g., successful retention during fatigue testing, specific torque values achieved).
• For clinical tests, the ground truth for "long-term validity" would likely be patient outcomes, such as implant survival rates, lack of complications, and successful integration, assessed over time, but no specifics are provided.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable.

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