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IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.

IPD Dental Implant Abutments is a dental implant abutment system composed of dental abutments and screws intended to be placed into dental implants to provide support for dental prosthetic restorations. Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants svstems. IPD Dental Implant Abutments includes the following categories of dental abutment designs: -Titanium base (Interface) abutments; -Multi-unit abutments; -Overdenture abutments (PSD). The system also includes the corresponding Titanium Screws, which were included in previous premarket notifications. The devices are intended to attach the prosthesis to the dental implant. Specifically: - Ti Screw: Used during restoration fabrication. - TiN Screw: Used in finished restorations, with TiN coating. - TPA Screw: Used in finished angulated restorations, with TiN coating. The metallic components of the subject abutments and screws are made of titanium alloy conforming to ISO 5832-3 "Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy". The purpose of this submission is to expand IPD Dental Implant Abutments cleared under K240570: . To expand IPD's abutment designs (Multi-unit and Overdenture abutments), as well as to expand the range of angulations available for certain compatible Ti Bases (Interfaces). IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems: (List of compatible implant systems provided in tables). The zirconia superstructures for use with the Ti Base (Interface) are only intended to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. Ti Base (Interface) abutments are attached (screw-retained) to the implant and cemented to the zirconia superstructure. The Ti Base is a two-piece abutment composed of the titanium component, as the bottom-half, and the zirconia superstructure, as the top-half. It consists of a pre-manufactured prosthetic component in Titanium alloy per ISO 5832-3, as well as the supporting digital library file for FDA-cleared design software (3Shape Abutment Designer™ Software, cleared under K151455) which enables the design of a patient-specific superstructure by the laboratory/clinician and which will be manufactured in FDA-cleared Zirconia (e.g., DD Bio Z, K142987) according to digital dentistry workflow at the point of care, or at a dental laboratory. The design and fabrication of the zirconia superstructure for Ti Base (Interface) will be conducted using a digital dentistry workflow requiring the use of the following equipment, software and materials: Scanner: 3D Scanner D850. Design Software: 3Shape Abutment Designer Software, K151455. Zirconia Material: DD Bio Z, K142987. Milling machine/Brand: Dental Concept System Model: DC1 Milling System Cement: Multilink® Automix, K123397. Ti Base (Interface) abutment design parameters for the zirconia superstructure are defined as follows: Minimum gingival height: 1.5 mm Minimum wall thickness: 0.43 mm Minimum post height for single-unit restorations: 4.75 mm (1) Maximum gingival height: 6.0 mm Maximum angulation of the final abutment 30° (2) Note 1: Post height is the length above the abutment collar. Note 2: In Table 2 it has been specifically referred to the angulation depending on the dental implant system and platform. The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient.

The provided text is a 510(k) summary for a dental implant abutment system, primarily focusing on proving substantial equivalence to previously cleared predicate devices. It does not present a study with acceptance criteria and reported device performance in the manner typically expected for AI/Machine Learning (AI/ML) medical devices, or a multi-reader multi-case (MRMC) comparative effectiveness study.

The "device" in this context is a physical dental implant abutment, not an AI/ML algorithm. Therefore, the questions related to AI/ML specific criteria (such as training sets, ground truth establishment for AI, human reader improvement with AI assistance, or standalone algorithm performance) are not applicable to this submission.

However, I can extract the relevant information regarding the acceptance criteria and the "study" (bench testing in this case) that proves the device meets those criteria, as described in the provided document.

Acceptance Criteria and Device Performance for IPD Dental Implant Abutments

This submission is for a physical medical device, IPD Dental Implant Abutments, and demonstrates substantial equivalence to predicate devices through a combination of design characteristics and non-clinical performance (bench) testing. The "acceptance criteria" are implied by the standards and guidance associated with dental implants, and the "performance" is demonstrated through compliance with these standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a physical device and not an AI/ML algorithm, the "acceptance criteria" are derived from relevant ISO standards and FDA guidance for endosseous dental implant abutments. The "reported device performance" is the demonstration of compliance with these standards through specific non-clinical tests.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify exact numerical sample sizes for each bench test conducted (e.g., number of abutments tested for fatigue). It generally refers to "worst-case configurations and combinations" being tested. For biocompatibility, it states "all patient-contacting surfaces" were tested.
• Data Provenance: The tests are non-clinical bench tests, not patient data trials. The studies were performed to support a 510(k) submission to the FDA for a device manufactured by IMPLANT PROTESIS DENTAL 2004, S.L., located in Premià de Dalt (Barcelona), Spain. The data is thus internal company testing. It is inherently "prospective" in the sense that the tests were designed and conducted to meet regulatory requirements for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable in the context of an AI/ML device. For this physical device, "ground truth" is established by relevant international standards (e.g., ISO 14801, ISO 10993, ISO 17665-1) and internal design specifications, verified through engineering bench tests rather than expert interpretation of images/data for AI. Expertise would come from engineers, material scientists, and quality assurance professionals performing and reviewing the tests. The document does not specify the number or specific qualifications of individuals involved in the execution or review of these bench tests, beyond implying adherence to recognized standards.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically for clinical studies or radiology readings where multiple experts independently review data and discrepancies are resolved. For bench testing of a physical device, the "adjudication" is compliance with predetermined test protocols and acceptance criteria outlined in the relevant ISO standards and internal specifications, often involving quantitative measurements.

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 MRMC study was done, and it is not applicable for this physical device. This type of study is relevant for AI/ML diagnostic or assistive devices, not for dental implant abutments. The submission explicitly states: "No clinical testing was performed, the determination of substantial equivalence is supported by non-clinical testing."

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

• Not applicable. This question pertains to AI/ML algorithms. The device is a physical dental implant abutment, not an algorithm.

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

• For this physical device, the "ground truth" for performance evaluation is defined by established engineering standards (e.g., ISO 14801 for mechanical fatigue, ISO 10993 for biocompatibility) and validated design specifications, rather than clinical outcomes or expert consensus on clinical data. Compliance with these quantitative and qualitative standards serves as the ground truth.

8. The sample size for the training set:

• Not applicable. This question refers to AI/ML models. The "training" for this device would refer to its design and manufacturing processes, not a data set for machine learning.

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

• Not applicable. As above, this pertains to AI/ML models. For a physical medical device, the design is based on engineering principles and regulatory requirements, not a "training set ground truth" in the AI sense. The "ground truth" for design validation comes from international standards, material properties, and biomechanical principles.

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