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Jplant is intended for use in partially or fully edentulous maxilla, in support of single of multiple-unit restorations including cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Jplant is for single stage surgical procedures. This system is intended for delayed loading.

Jplant is intended for use in partially or fully edentulous mandibles and maxilla, in support of single or multiple-unit restorations including cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Jplant is for single stage and two stage surgical procedures. This system is intended for delayed loading.

The Jplant is dental implant which is made of titanium alloy 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 patients chewing function. The fixture has the following sizes.

This document, a 510(k) summary for the Jplant endosseous dental implant, does not describe a study that proves the device meets specific acceptance criteria related to its performance in a clinical setting or against an AI-driven benchmark.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, not on proving device performance against detailed acceptance criteria in the manner of an AI/ML device study.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as they pertain to clinical or AI performance studies that were not conducted or described here.

Here's a breakdown of what can be extracted based on the provided text, indicating "Not Applicable (N/A)" for information that isn't present or relevant to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify performance-based acceptance criteria for a device, nor does it provide performance metrics in the way an AI/ML device would (e.g., sensitivity, specificity, accuracy). Instead, it establishes substantial equivalence to predicate devices based on design, materials, manufacturing, and intended use.

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

• N/A. The document does not describe a clinical test set or a dataset for performance evaluation. The "tests" mentioned are non-clinical (e.g., sterilization, shelf life, biocompatibility) and do not involve patient data in a "test set" context for device performance.

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)

• N/A. This information is not relevant to the type of non-clinical testing and substantial equivalence demonstration presented.

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

• N/A. No test set or expert adjudication process 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

• N/A. This device is an endosseous dental implant, not an AI/ML diagnostic or assistive device for human readers. No MRMC study was performed or is relevant.

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

• N/A. As above, this is not an AI/ML algorithm-driven device.

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

• N/A. For the non-clinical tests, "ground truth" would be the standard scientific methods and established procedures for evaluating materials, sterilization, and biocompatibility, as defined by the referenced ISO and ASTM standards. There is no "ground truth" related to clinical outcomes or expert consensus on findings as would be seen in an AI performance study.

8. The sample size for the training set

• N/A. There is no training set mentioned or implied for this mechanical implant device.

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

• N/A. There is no training set for this device.

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