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CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CAMLOG® SCREW-LINE and CAMLOG® ROOT-LINE implants in the maxilla and mandible for the purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with CAMLOG® CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.

CAM Titanium Blanks are intended for the fabrication of abutments and healing caps on CONELOG® SCREW-LINE implants in the maxilla and mandible for the purpose of supporting single ooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with CONELOG® CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.

CAM Titanium Blanks are intended for the fabrication of abutments and healing caps/gingiva former on iSy® implants in the maxilla and mandible for the purpose of supporting single or multiple tooth prostheses of a partially or fully edentulous patient. Digitally designed abutments fabricated with CAD/CAM techniques for use with iSy CAM Titanium Blanks are intended to be sent to a CAMLOG validated milling center for manufacture.

CAM Titanium Blanks are abutments with a prefabricated, precision interface (implant/abutment connection) and a screw channel suitable for the respective implant system. CAM Titanium Blanks are to be used by a CAMLOG validated milling center with CAD/CAM technology to fabricate a final finished customized abutment made of titanium alloy. Each patient-specific abutment is individually prescribed by the clinician as a temporary, permanent, single, or multi-unit abutment. Computer-aided manufacturing (CAM) techniques are used to process the cylinder portion above the implant connection into an individual abutment or healing cap/gingiva former design. The healing cap/gingival former is temporary and used during healing. Permanent abutments have straight and angled designs that can be used for crowns, bridges or overdentures.

CAM Titanium Blanks are available for CAMLOG SCREW-LINE and ROOT-LINE implants fitting five implant diameters (3.3. 3.8. 4.3. 5.0. 6.0 mm), for CONELOG SCREW-LINE implants fitting four implant diameters (3.3. 3.8, 4.3, 5.0 mm), and for the iSy implants with one connection fitting three implant diameters (3.8, 4.4, 5.0 mm).

This document is a 510(k) summary for the "CAM Titanium Blanks" dental device, which is related to endosseous dental implant abutments. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting a performance study with specific acceptance criteria and detailed quantitative results.

Therefore, much of the requested information regarding acceptance criteria and performance study specifics for an AI/ML device (like sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable or present in this regulatory submission.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide specific quantitative acceptance criteria or corresponding reported device performance values in the way one might see for an AI/ML diagnostic or predictive device (e.g., sensitivity, specificity, AUC thresholds). Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence through:

• Non-clinical testing: This includes sterilization validation, biological evaluation, and mechanical testing. The acceptance here is successful completion according to the referenced standards.
• Comparison of Indications for Use: The claim is that the indications are "substantially equivalent."
• Comparison of Technological Characteristics: The claim is that the characteristics are "similar" or "substantially equivalent."

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

• This document is for a mechanical dental device (titanium blanks for abutments), not an AI/ML-driven device that typically uses test sets of data.
• The "test set" here refers to the actual physical devices subjected to non-clinical tests. The sample sizes for these specific non-clinical tests (sterilization, biological, MR, mechanical) are not explicitly stated in this summary, but would be defined by the relevant ISO/ASTM standards referenced.
• Data provenance (country of origin, retrospective/prospective) is not applicable in the context of this summary for a mechanical device.

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 as this is a mechanical device, not an AI/ML device relying on expert-labeled ground truth data. The "ground truth" for mechanical properties would be derived from standard test methods and measurements, not expert consensus on interpretations.

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

• Not applicable. This is a mechanical device.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic tools that assist human readers, which this device is not.

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

• Not applicable. This is a mechanical device, not an algorithm.

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

• The "ground truth" for demonstrating the safety and effectiveness of this mechanical dental device is based on established engineering standards and material properties testing. For example, the "ground truth" for mechanical strength is whether the device withstands specified forces according to ISO 14801. The "ground truth" for biocompatibility is conformance to ISO 10993-1.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI/ML device trained on data.

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

• Not applicable.

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