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TSV BellaTek® Express and BellaTek® Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained.

All digitally designed superstructures and/or hybrid abutment crowns for use with TSV BellaTek Express or BellaTek Flex Abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.

The TSV BellaTek Express Abutment and BellaTek Flex Abutment (subject devices) are Titanium-base type abutments to be used as the apical part of two-piece abutments. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. All digitally designed superstructures manufactured in zirconia conform to ISO 13356:2015 and ISO 6872:2015. Biomet 3i recommends the use of Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436) to affix the zirconia superstructure and/or hybrid abutment crown to the Certain BellaTek Express and BellaTek Flex abutments. TSV BellaTek Express Abutment and BellaTek Flex Abutment are intended to be used with Zimmer Dental's Tapered Screw-Vent, Screw-Vent and Trabecular Metal dental implants for single and multi-unit restorations. The subject device abutments are available in hexed (single-unit) and non-hexed (multi-unit) configurations. They are available in pre-defined platform diameters, emergence profiles and heights to accommodate varying patient anatomies. They are machined from Titanium Alloy. They are intended for single use only. The device is packaged in a sealed nylon bag and sold non-sterile.

The TSV Titanium ASC screw used with the subject device is also machined from Titanium Alloy and anodized pink. The device is packaged individually in a sealed nylon bag and sold sterile. When the TSV BellaTek Express or BellaTek Flex Abutment is placed on the corresponding implant, the retaining screw will mate with the internal thread feature of the dental implant to hold the abutment in place.

The provided document is a 510(k) summary for a medical device (dental abutments) and does not describe a study involving an algorithm or AI. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and performance of an AI/algorithm-based device.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through a comparison of design, function, materials, indications for use, and non-clinical testing.

Here's a breakdown of the available information relevant to product acceptance, though it's for a physical medical device, not an algorithm:

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

The document primarily demonstrates substantial equivalence through comparisons with predicate devices and adherence to relevant standards. It doesn't present a table of specific performance acceptance criteria in the way one would for an AI model's metrics (e.g., sensitivity, specificity).

Instead, "performance" here refers to the physical and biological characteristics of the dental abutment and its components:

Regarding the other points you requested (2 through 9), they are not applicable as this document discusses a physical medical device, not an AI/algorithm:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device. The "tests" mentioned are non-clinical (e.g., sterilization, biocompatibility, packaging), not an evaluation of an algorithm on a dataset.
• 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. Ground truth, in the context of expert review, is not relevant to the non-clinical testing performed for dental abutments.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 document explicitly states, "No clinical data was included in this submission."
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a physical device's performance relies on adherence to material specifications, engineering standards, and biological compatibility.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory submission for a physical medical device, not an AI or algorithm. Therefore, the specific details you requested regarding AI model evaluation are not present.

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