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The Vericore Abutment is intended for use as an accessory to an endosseous implant to support a prosthetic device in a partially or completely endentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The abutment is placed over the implant and is mounted on to the implant with an abutment screw.

This device is compatible with the following manufacturers' implant systems: Nobel Biocare, Southern Hexed, 3i, 3i Certain, Zimmer, Endopore, Nobel Replace, Southern Trilobe, Astra and Straumann.

This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.

Angled abutments and narrow diameter implants are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

The Devices covered in this submission are abutments which are placed on the dental implant to provide support for a prosthetic restoration.

Vericore Abutments are made from Titanium grade Ti-6Al-4V. The abutment screws and are made from Titanium grade Ti-6A1-4V. The abutment is made to be placed over the implant and is mounted on to the implant with an abutment screw. The abutments are compatible with the following implant systems: Zimmer - Narrow, Regular, Wide Nobel Biocare - Narrow, Regular, Wide 3i - Regular Hexed 3i Certain - Narrow, Regular, Wide Southern Hexed - Narrow, Regular, Wide Endopore -- Narrow, Regular and 5mm Nobel Replace- Narrow, Regular, Wide and 6mm Southern Trilock - Narrow, Regular and Wide Astra - Narrow and Regular Straumann - Narrow, Regular and Wide

Here's a breakdown of the acceptance criteria and study information for the Vericore Custom Abutment in Titanium, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

The provided document describes a premarket notification (510(k)) for a medical device, which primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific acceptance criteria in the way a new drug or novel medical device might. Therefore, some of the requested categories are not directly applicable in the traditional sense of a clinical trial or AI performance study.

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

• Sample Size: Not specified for the fatigue testing. It refers to "the worst case scenario for each connection platform style." This implies a selection of representative abutment designs for testing, but not a large statistical sample of patient data.
• Data Provenance: Not specified. The testing was described as "conducted according to ISO 14801," an international standard, suggesting it was laboratory-based testing rather than data from human patients.

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. The "ground truth" here is based on engineering and materials science principles and international standards (ISO 14801) for mechanical performance, not expert human interpretation of medical data.

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

• Not applicable. This type of adjudication is relevant for human-interpreted medical image or diagnostic studies, not for the mechanical testing described.

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 abutment) and the submission details mechanical performance testing, not an AI-assisted diagnostic or interpretation tool.

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

• Not applicable. This device is a physical medical implant component, not an algorithm.

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

• The "ground truth" for the performance evaluation derives from established engineering principles, materials science specifications (Titanium grade Ti-6Al-4V), and an international standard for mechanical testing (ISO 14801). Compliance with these standards and comparison to a predicate device's measured performance serves as the basis for evaluation.

8. The sample size for the training set

• Not applicable. There is no concept of a "training set" in the context of this type of medical device submission.

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

• Not applicable. As there's no training set, this question is not relevant.

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