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SMARTbuilder System is a metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.

SB Anchor is used for connecting with Healing abutment or Cover Cap on the top of the SB Anchor to fix the SMARTbuilder that is predicated 510(K), K120951, K130840. The SB Anchor has the same material, indication for use, technological characteristics and similar design as the predicate device, Height in the SMARTbuilder System. The SB Anchor is designed for use with NT Fixture connection (K081078) and TS SA Fixture connection (K121995).

This document is a 510(k) premarket notification for a dental device called "SB Anchor." It asserts substantial equivalence to a predicate device, the "SMARTbuilder System." The document does not describe a study involving an AI/CADe device or its performance criteria/results.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device conformance for an AI-based system. The provided text is a regulatory submission for a conventional medical device (an endosseous dental implant abutment).

Specifically, the document states:

• "No clinical studies are submitted" (Page 5, Section 8). This explicitly indicates that no clinical performance data for the device, including any related to AI or a study demonstrating its meeting of acceptance criteria, is present.
• The entire document revolves around demonstrating substantial equivalence to a predicate device based on material, indication for use, and technological characteristics of a physical implant component, not a software algorithm.

Based on the provided text, the following information is not available:

1. A table of acceptance criteria and the reported device performance: Not applicable as this is not an AI/CADe device and no performance study is described.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
6. If a standalone performance (algorithm only without human-in-the-loop performance) was done: No.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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