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Microdent Ektos Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Ektos Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Small diameter implants are indicated only for replacement of central and lateral incisors in the maxilla and mandible.

Microdent Ektos Implant System is comprised of dental implants and prosthetic components. Microdent Ektos dental implants are internal connection endosseous implants machined in titanium that can be used with deferred load or immediate load techniques. The implant is designed to be inserted at crestal level. Microdent Ektos Implant is recommended to be placed at crestal bone level. The implant has an internal hexagonal connection. Microdent Ektos Implants are provided with blasted surface. The implants are supplied sterile and the abutments are provided non-sterile. The system also contains Microdent Ektos abutments made of Ti-6AL 4-V-ELI alloy. The abutments Conical, Multi-function (supplied with the implant) and Mini Capitel are used for cemented and screw-retained restorations. The following Cover Screws are provided to protect the inner configuration of the implant and are supplied sterile with the implant. Healing abutment to shape the soft tissue during the healing phase. The Retention Screws are used for securing the abutments to the implant. Overdenture retention consists of a titanium alloy socket that attached to a threaded post for use with titanium endosseous implants having an internal threaded socket. Both devices have a plastic component that has a shape on one and that mate into the titanium socket, while the other end with metal cap is attached to the denture.

The provided text describes the Microdent Ektos Implant System, a dental implant device, and its comparison to predicate devices to establish substantial equivalence for regulatory approval. The document outlines acceptance criteria related to design, materials, sterilization, and performance, primarily through adherence to ISO standards and bench testing.

Here's an analysis of the requested information based on the provided text:

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

The document does not present a formal table of "acceptance criteria" against "reported device performance" in a quantitative sense as might be expected for an AI device. Instead, it describes compliance with recognized standards and successful bench testing. The acceptance criteria for the Microdent Ektos Implant System are largely based on demonstrating substantial equivalence to predicate devices (Legacy System Dental Implants – K073033 and Microdent Genius Implant System – K141188) and compliance with specific ISO standards. The "reported device performance" is the confirmation that these standards have been met through non-clinical testing.

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

The document focuses on non-clinical bench testing. It does not provide information about a "test set" in the context of clinical data or its provenance. For fatigue testing, multiple samples (implants) would be tested to ISO 14801, but the exact sample sizes are not specified for each test. The testing was performed by Implant Microdent Systems, located in Spain.

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. The device is a physical dental implant system, not an AI or diagnostic device that requires expert-established ground truth for a test set. The "ground truth" here is defined by engineering standards and material science, not clinical expert consensus on diagnostic outcomes.

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

Not applicable. This concept is relevant for clinical studies, especially those involving human interpretation or expert review, which were not part of this submission.

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 device, and no MRMC studies were conducted.

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

Not applicable. This is not an AI device or software algorithm. Performance was evaluated through non-clinical bench testing, which is 'standalone' in the sense of the device itself being tested, but not in the context of an algorithm.

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

The "ground truth" for the device's performance, as demonstrated in this submission, is based on:

• Engineering standards: Primarily ISO standards (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility, ISO 11137 for sterilization).
• Material specifications: Compliance with recognized material standards like ISO 5832-2 and ISO 5832-3.
• Benchmarking equivalence: Demonstrating that the device's characteristics and performance are substantially equivalent to already legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

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

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