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Custom Titanium Abutments are customizable devices intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

• Custom Titanium Abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements.
• Custom Titanium Abutment for short (8mm) 3.7mmD implants: Indicated for tooth replacement of mandibular and maxillary central and lateral incisors.
  Custom Legacy Titanium Abutments are compatible at the implant-level with Legacy2, Legacy3, Legacy4, simplyLegacy2 and simplyLegacy3 implants, excluding 6mm length implants.
  Custom InterActive Titanium Abutments are compatible at the implant-level with InterActive, SimplyInterActive and SwishActive implants, excluding 6mm length implants.

The Custom Legacy Titanium Abutments and Custom InterActive Titanium Abutments (collectively the "Custom Titanium Abutments") are one-piece hex type engaging abutments comprised of Titanium 6AL-4V ELI, which serve as a final abutment upon which a prosthetic dental restoration will be fitted.
The Custom Legacy Abutments are offered in 3.0mm, 3.5mm, and 5.7mm diameters that correspond to the platform diameters of the Legacy Implant System; the Custom InterActive Abutments are offered in 3.0mm and 3.4mm diameters that correspond to the InterActive Implant System. The devices are supplied with fixation screws that are placed through the abutment to secure it to the implant's reciprocal hex platform. The Custom Abutments are provided with a large amount of modifiable material to accommodate the digital workflow used for device customization. Customization of the final abutment is performed in Implant Direct's Custom Direct laboratory under Implant Direct's manufacturing control, where the devices are milled to meet individual patient specifications. The digital workflow uses the following additional devices:

• 3Shape Abutment Design Software (K151455)
• Dental System Control Panel
• Dental Designer
• Lab Scanner (3Shape D700 and 3Shape Scan-it Restoration Dental System (510(k)-exempt, Product Code NOF)
• Intra-oral scanners
• 3M True Definition Scanner (K122467)
• Itero Scanner Software (K131101)
  The Custom Abutments are patient-specific and may be modified within the following parameters:
• Maximum angle of 30° from the axis of the implant
• Minimum wall thickness of 0.4mm
• Minimum post height of 4mm
  The Custom Abutments are available using either a Design-and-Mill or Mill-only digital workflow. With the Design-and-Mill process flow, the patient's dentition information (impression or intraoral scan) is sent to Implant Direct. Implant Direct will design an abutment and forward the design to the end user for approval prior to manufacturing. With the Mill-only process flow, the end user uses intra-oral scanners and lab scanners to design the abutment using the 3Shape software. The abutment design file (.stl) is sent to Implant Direct for manufacturing.
  The Custom Abutments are single-use and supplied non-sterilization by the end user. They are externally-communicating devices which come in permanent contact (>30 days) with a patient's tissue/bone.

This document is related to a 510(k) premarket notification for dental implant abutments, which are physical medical devices, not AI/software-based devices. Therefore, the concepts of "acceptance criteria for an AI model," "study proving the device meets acceptance criteria" (in the context of algorithm performance), "test set," "training set," "ground truth establishment," "experts," "adjudication," and "MRMC studies" are not applicable here.

The document discusses performance data for the physical dental abutments, but this refers to traditional engineering and biological testing, not AI model validation.

Here's a breakdown of why your desired information isn't present in this document:

• Device Type: The device is "Custom Legacy and Custom InterActive Titanium Abutments," which are physical, custom-milled dental prosthetics. They are not AI algorithms.
• Study Purpose: The studies mentioned (Biocompatibility, Fatigue Testing, Steam Sterilization, Software Verification and Validation) are engineering and biological tests designed to ensure the physical device is safe and performs its mechanical function, and that the design software adheres to specified parameters. They are not studies to evaluate the diagnostic or predictive performance of an AI model.

However, I can extract information related to the device's technical specifications and how its engineering performance was validated:

Acceptance Criteria and Device Performance (in a physical device context):

The document details various non-clinical tests performed to support the device's safety and performance, acting as "acceptance criteria" for a physical medical device. The "reported device performance" is that the device passed these tests, indicating it performs as intended and is substantially equivalent to predicate devices.

Table of "Acceptance Criteria" and "Reported Device Performance" (adapted for a physical device K192218):

Regarding the other points, as they pertain to AI/ML, they are not applicable to this physical device submission:

1. Sample size for the test set and data provenance: Not applicable. This document refers to the number of physical abutment samples tested for biocompatibility and fatigue, not a test set for an AI model.
2. Number of experts and qualifications for ground truth: Not applicable. Ground truth for an AI model's performance on medical images is irrelevant for this physical device.
3. Adjudication method: Not applicable.
4. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is for evaluating changes in human reader performance with AI assistance, which is not relevant here.
5. Standalone (algorithm only) performance: Not applicable. The device itself is a physical object; there's no "algorithm-only" performance to evaluate in this context. The software mentioned (3Shape Abutment Designer) is a design tool, not a diagnostic or predictive AI.
6. Type of ground truth used: Not applicable. Ground truth for AI (e.g., pathology, outcomes) is not relevant for testing the mechanical and biological properties of a dental abutment.
7. Sample size for the training set: Not applicable. There is no AI training set for this physical device.
8. How the ground truth for the training set was established: Not applicable.

In summary, this document thoroughly covers the engineering and biological validation required for a Class II physical medical device, demonstrating its substantial equivalence to predicate devices through well-defined tests, but it does not contain information about AI model validation.

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