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The Icon Implant System is intended for use in either partially or fully edentulous mandibles and maxillae in the following areas:

• Support of fixed (cemented) restorations utilizing multiple abutments;
• Support of fixed detachable (screw retained) prosthetics utilizing multiple abutments;
• Overdenture retention by means of a ball overdenture attachment, o-ring attachment, dalla bona, or hader bar;
• Terminal or intermediate abutment support for fixed bridgework;
• Free standing restorations without involvement of adjacent dentition when the external hex is engaged.

The Bio Science Technologies, Inc.'s Icon Implant System consists of a screw implant and a cover screw which are contained within a titanium (CP) canister. An actual implant is provided for the Reviewer. The implant and cover screw are nearly identical to the Branemark System® Mk II Self-Tapping Fixture (K945398) manufactured by Nobelpharma USA, Inc.

The Bio Science Technologies, Inc.'s Icon Implant System gained 510(k) clearance by demonstrating substantial equivalence to the legally marketed predicate device, the Branemark System® Mk II Self-Tapping Fixture (K945398). The submission relies on a comparison of characteristics rather than a study with acceptance criteria and measured performance.

Here's an analysis of the provided information, addressing your points:

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

Since this is a substantial equivalence submission, there aren't explicit "acceptance criteria" in terms of performance metrics with thresholds, nor is there "reported device performance" in the traditional sense of a study measuring clinical outcomes. Instead, the "acceptance criterion" is a demonstration of substantial equivalence to a predicate device.

Conclusion on Equivalence: The submission asserts substantial equivalence based on the similarities in intended use, design principles, material (both commercially-pure titanium), and similar surgical/healing protocols. Differences in grades of titanium (grade 1 vs. 3 or 4) and ranges of diameters/lengths were presented as minor differences that do not raise new questions of safety or effectiveness.

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

There was no test set as described for performance evaluation. This submission is a comparison to a predicate device. The data provenance is a description of the proposed device and a comparison to the predicate device's specifications.

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. No ground truth was established by experts for a test set in this context. The "ground truth" for the comparison was the specifications and intended use of the predicate device, which was already cleared by the FDA.

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

Not applicable. No test set was used requiring adjudication.

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 a medical device (dental implant), not a diagnostic AI system, and no MRMC study was conducted.

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

Not applicable. This is a medical device (dental implant), not an algorithm.

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

The "ground truth" for this 510(k) submission is the pre-existing FDA clearance of the predicate device, Branemark System® Mk II Self-Tapping Fixture (K945398), and its established specifications and clinical performance, against which the new device is compared for substantial equivalence.

8. The sample size for the training set

Not applicable. No "training set" was used as this is not an AI/machine learning device.

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

Not applicable. The concept of a "training set" and its ground truth establishment is not relevant to this type of device clearance.

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