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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 systems. IPD Dental Implant Abutments submission includes the following categories of dental abutment designs: Healing abutments; Temporary abutments; Cementing titanium abutments; Titanium base (interface) abutments; The system also includes the corresponding Titanium Screws intended to attach the prosthesis to the dental implant. All 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".

I am sorry, but based on the text provided, I cannot fulfill your request. The document describes the FDA's clearance of a dental implant abutment system and its substantial equivalence to predicate devices, but it does not contain information about the acceptance criteria or results of a study (especially a clinical study with elements like sample size, ground truth, expert adjudication, MRMC studies, or standalone performance) in the context of typical AI/medical device performance evaluation.

The "Performance Data" section mentions bench testing, sterilization validation, cytotoxicity testing, reverse engineering, dimensional analysis, validation of digital workflow, static and dynamic fatigue testing, and a non-clinical worst-case MRI review. While these are performance tests, they are not presented as typical acceptance criteria for an AI/CADe device's diagnostic performance and the study details (sample sizes, ground truth establishment, expert qualifications, etc.) required by your prompt are absent for these tests.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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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 systems.

IPD Dental Implant Abutments submission includes the following categories of dental abutment designs:

• Healing abutments; -
• -Temporary abutments;
• Cementing titanium abutments; -
• -Titanium base (interface) abutments;

The system also includes the corresponding Titanium Screws 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.

All 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".

Unfortunately, the provided text does not contain information about acceptance criteria or a study that proves a device meets those criteria, as typically found in a clinical trial report or a performance study summary.

The document is an FDA 510(k) Premarket Notification letter for IPD Dental Implant Abutments. This type of document aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, rather than proving its performance against specific acceptance criteria through a clinical or algorithmic study.

While it mentions "bench testing to determine fulfillment of design and performance requirements" and "Static and dynamic fatigue testing...in accordance with ISO 14801," these are engineering performance tests for mechanical properties and material compatibility, not studies that would involve:

• Acceptance criteria for clinical or diagnostic performance (e.g., sensitivity, specificity, accuracy for a diagnostic device; efficacy for a therapeutic one).
• Sample sizes for a test set of data (e.g., patient cases/images).
• Experts establishing ground truth for a diagnostic or AI-assisted task.
• Multi-reader multi-case (MRMC) studies or human reader performance.
• Standalone algorithm performance.
• Ground truth types like pathology or outcomes data.
• Training set sample size or ground truth establishment for a machine learning model.

The "performance data" section primarily discusses:

• Sterilization validation.
• Biocompatibility testing (cytotoxicity, skin sensitization, irritation).
• Reverse engineering and dimensional analysis for compatibility.
• Validation of the digital workflow and software system to ensure that design and manufacturing of the top half was within the specified design parameters. (This is about engineering design parameters, not clinical acceptance of a diagnostic tool).
• Static and dynamic fatigue testing (mechanical strength).
• Modified Surfaces Information.

Therefore, I cannot extract the requested information from this document because it is not present. This document is focused on establishing substantial equivalence based on material, design, and manufacturing processes, supported by bench engineering tests, rather than a clinical or AI performance study with acceptance criteria for diagnostic or clinical outcomes.

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