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Anker Dental Implant System is 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. It is intended for delayed loading.

Anker Dental Implant System consists of fixture, abutment (healing abutment, fixed abutment, dual abutment, angle abutment, o-ring abutment, temporary abutment) and cover screw. Fixture is made of pure titanium (grade IV) and its surface was treated by SLA (Sand-blasted, Large grit, Acid-etched) process. Diameters of fixtures are including 3.4 to 5.0 mm and lengthes are including 7.0 to 15.0 mm. Most abutments are made of titanium alloy and their diameters are including 4.0 to 7.0 mm. Temporary abutment is made of SUS316 stainless steel instead of titanium alloy. All products are sterilized as finished products.

The Anker Dental Implant System is a medical device and its acceptance criteria are based on non-clinical testing to demonstrate substantial equivalence to predicate devices. No clinical study or human-in-the-loop performance study has been conducted for this device.

Here's a breakdown of the requested information:

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

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

This information is not provided in the given text. The text states that "Non-clinical test was used to support the decision of safety and effectiveness," but does not specify sample sizes for these tests or the data provenance. These are laboratory/benchtop tests, not human subject studies.

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 the acceptance criteria were established through non-clinical laboratory testing, not human expert evaluations.

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

This information is not applicable as the acceptance criteria were established through non-clinical laboratory testing.

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

No, an MRMC comparative effectiveness study was not conducted. The document explicitly states "Non-clinical test was used to support the decision of safety and effectiveness" and "Clinical Testing: Non-clinical test was used to support the decision of safety and effectiveness," indicating that no clinical studies with human participants were performed. This device is not an AI-assisted diagnostic tool, so comparison with human readers is not relevant.

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

No, a standalone algorithm-only performance study was not done as this device is a physical dental implant system, not a software algorithm. The "standalone" concept applies to AI/software performance in isolation, which is not applicable here.

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

The "ground truth" for the non-clinical tests was based on internationally recognized testing standards (e.g., ISO, ASTM, OECD guidelines). The device's performance was compared against the requirements and specifications outlined in these standards.

8. The sample size for the training set

This information is not applicable as there was no training set for an algorithm. The evidence presented is for a physical medical device and its material and mechanical properties.

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

This information is not applicable as there was no training set for an algorithm.

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