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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, screws, as well as other dental abutment accessories, 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 includes the following categories of dental abutment designs:

• Titanium base (Interface) abutments (INC3D);
• Multi-Unit abutments (MUA);
• Overdenture Abutments (PSD);
• Temporary Abutments (PP);
• Healing Abutments (TC).

The system also includes the use of the corresponding screws intended to attach the prosthesis to the dental implant. Specifically:

• Ti Screw (TT): Used during restoration fabrication.
• TiN Screw (TTN): Used in finished restorations, with TiN coating.
• TPA Screw (TPA): 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 "Implant 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 offerings with:
• New IPD's compatible dental implant systems,
• New angulations available abutment-category specific.
• New in-house TiN coating.

IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems:
(Table 2. Summary of IPD abutments categories with compatibilized OEM Implant/Abutment Systems with specific reference to maximum angulation specifically included in this submission. provided in original text)

Ti Base (Interface) abutments are attached (screw-retained) to the implant/abutment 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)

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 FDA 510(k) clearance letter pertains to IPD Dental Implant Abutments, a medical device, not an AI/ML-driven software product. Therefore, the information requested regarding acceptance criteria and study data for an AI/ML device (e.g., sample size for test/training sets, expert ground truthing, MRMC studies, standalone performance) is not applicable to this document.

The document describes the device, its intended use, comparison to predicate devices, and the non-clinical performance testing conducted to demonstrate substantial equivalence. These tests are physical and chemical in nature, not related to the performance of an AI/ML algorithm.

Here's a breakdown of why an AI/ML-focused response is not possible, based on the provided text:

• Device Type: The device is "IPD Dental Implant Abutments," which are physical components used in dentistry (titanium alloy abutments, screws, designed for zirconia superstructures). It is not software, a diagnostic imaging tool, or an AI/ML algorithm.
• Purpose of Submission: The submission aims to expand compatibility with new dental implant systems and include new angulations and in-house TiN coating. This is a modification of a physical medical device, not a new AI/ML development.
• Performance Data (Section VII): This section explicitly lists non-clinical performance testing such as:
  • Sterilization validation (ISO 17665-1)
  • Biocompatibility testing (Cytotoxicity, Sensitization, Irritation per ISO 10993)
  • Reverse engineering and dimensional analysis for compatibility
  • Validation of the digital workflow and software system (but this refers to the CAD/CAM software used to design the physical abutments, not an AI/ML diagnostic tool)
  • Static and dynamic fatigue testing (ISO 14801)
  • Modified Surfaces Information
  • MRI safety review

Conclusion:

The provided document describes a 510(k) clearance for a physical dental implant component. It does not contain any information about the acceptance criteria or study design for an AI/ML driven medical device. Therefore, a table of acceptance criteria and reported device performance related to AI/ML, sample sizes for test/training sets, details on expert ground truthing, MRMC studies, or standalone performance of an algorithm cannot be extracted from this 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 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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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 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.

This is a Premarket Notification (510(k)) summary for the IPD Dental Implant Abutments. This document does not describe a study proving the device meets acceptance criteria as would be found in a clinical trial for a novel AI device with specific performance metrics. Instead, it demonstrates substantial equivalence to predicate devices based on bench testing and engineering analysis.

Here's an breakdown of the information provided, tailored to your request, but emphasizing that this is not a typical AI/ML performance study:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for dental abutments, the "acceptance criteria" are not reported as specific performance metrics (like sensitivity/specificity for an AI model), but rather as compliance with recognized standards and demonstration of substantial equivalence to predicate devices. The "reported device performance" refers to successful completion of various non-clinical tests.

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

• Sample Size for Test Set: Not applicable in the context of human data or AI model test sets. The "test set" here refers to the physical samples of the IPD Dental Implant Abutments (and their components, potentially in various configurations) that were subjected to the specified bench and biocompatibility tests. The exact number of physical abutments, screws, or zirconia superstructures tested for each specific criterion is not detailed in this summary but would be found in the full test reports.
• Data Provenance: Not applicable in the context of country of origin for patient data. The tests were performed on the manufactured device components. The materials are specified (e.g., Titanium alloy conforming to ISO 5832-3).

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

Not applicable. "Ground truth" in this context would generally refer to expert-derived labels for clinical data, which is not part of this 510(k) submission. The "truth" for the performance tests is established by adherence to recognized international standards (e.g., ISO, FDA Guidance) and objective measurements from engineering or biological tests.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among human readers or expert labelers of clinical data, which is not relevant here. The evaluation criteria for the bench tests are objective and defined by established standards.

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. This device is a dental implant abutment, not an AI software. Therefore, MRMC studies and AI assistance effect sizes are not relevant to this submission.

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

No. This is a physical medical device (dental abutments), not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by:

• Compliance with international standards (e.g., ISO 14801 for fatigue testing, ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization).
• Engineering specifications and dimensional analysis to ensure compatibility with other specified dental implant systems.
• Validated digital dentistry workflow parameters (e.g., minimum gingival height, wall thickness, post height, angulation for zirconia superstructures), which are based on established dental prosthetic principles.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. No training set is used for this physical device.

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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.

Ask a specific question about this device

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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