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The DenQ Sub SLA Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

The DenQ Sub SLA Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. This implant system has internal hex connection, tapered with straight body and bone level that are similar to other commercial available products based on the intended use, technology used, the material composition employed and performance characteristics. This DenQ Sub SLA fixture of implant system is supplied sterile.

The DenQ Sub Abutments are device made of cp titanium grade 4 and titanium alloy intended for use as a Prosthetic restoration. It consists of Abutments(Healing, Solid, Cement, Angled, Temporary, Multi-unit Straight, Multi-unit Angled, Multi-unit Healing Cap, Multiunit Ti Cylinder, Multi-unit Temporary Cylinder and FreeMilling).

This document is a 510(k) Pre-market Notification for a dental implant system (DenQ Sub SLA Implant System). It aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than proving the device meets acceptance criteria through clinical or comparative effectiveness studies in the typical sense of a novel AI/software device.

Therefore, many of the requested elements (like MRMC studies, number of experts for ground truth, training set information for an AI device) are not applicable to a 510(k) submission for a physical dental implant system. The "acceptance criteria" here refers to demonstrating that the device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance testing and comparison of characteristics.

Here's a breakdown of the available information relevant to your request, adapting it to the context of this specific document:

1. Table of Acceptance Criteria (as demonstrated by testing) and Reported Device Performance:

For a physical device like a dental implant, "acceptance criteria" are the relevant ISO standards and material specifications that the device must meet to be considered safe and effective and substantially equivalent to a predicate. The "reported device performance" is the demonstration that these tests were passed.

2. Sample Size Used for the Test Set and Data Provenance:

This document is for a physical medical device, not an AI/software device that would typically have a "test set" of patient data. The "tests" here refer to laboratory and bench testing on the physical device components.

• Sample Size: Not specified for individual non-clinical tests (e.g., how many implants were subjected to fatigue testing). This information is typically detailed in the full test reports, which are summarized in the 510(k) submission.
• Data Provenance: Not applicable in the sense of patient data. The results are from in-vitro (laboratory) and bench testing of the devices themselves. The tests were performed "in accordance with ISO standards and US regulations." The manufacturer is located in the Republic of Korea.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable. This submission relies on engineering standards and laboratory measurements for its performance criteria, not expert interpretations of medical images or clinical data for ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. There is no "test set" requiring adjudication in the context of this type of submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done (and effect size):

• No. MRMC studies are typically for diagnostic AI devices assessing human reader performance. This is a physical dental implant.
• Summary of clinical testing: "No clinical testing was performed for this submission."

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

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

7. The Type of Ground Truth Used:

• The "ground truth" for the device's performance is established by engineering and material standards (e.g., ISO, ASTM, USP), and the physical measurements and observations derived from in-vitro and bench testing of the device's components (e.g., fatigue resistance, material properties, sterility).

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device, not an AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As above, no training set.

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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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CORE1 Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

CORE1 Implant System 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

CORE1 Fixture is a thread type implant made of CP Titanium Gr.4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic device or other components of a dental implant set with human body (mandibular or maxillary bone). Fixtures are provided after gamma sterilization as a set package including a cover screw or as a single fixture.

CORE1 Abutment intended for Single Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the crown. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows single prosthetic restorations to restore a patient's chewing function. Abutment Screw made of Ti-6AI-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Solid Abutment, Cement Abutment, Angled Abutment, Milling Abutment, Temporary Abutment, Solid Protect Cap, Cover Screw, Healing Abutment, Healing Abutment (Scan). Angled Abutment can select 15° and 25° angles for prosthetics, and Milling Abutment is up to 20° for hand milling only.

CORE1 Abutment intended for Multi-Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the bridge. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows multi prosthetic restorations to restore a patient's chewing function. Universal Plastic Cylinder is a burn-out device only used in the lab for casting and is not part of the final restoration. Abutment Screw made of Ti-6A1-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Universal Abutment, Universal Angled Abutment, Universal Ti Cylinder, Universal Temporary Cylinder, Universal Healing Cap. Universal Angled Abutment has angles of 17%30°.

The provided document is a 510(k) summary for the CORE1 Implant System, demonstrating its substantial equivalence to predicate devices. It focuses on physical and material characteristics and performance testing based on industry standards, rather than clinical study results involving human or expert evaluation for diagnostic accuracy.

Therefore, many of the requested details, such as those related to "acceptance criteria" for diagnostic accuracy, "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details" are not applicable or extractable from this document as it pertains to a dental implant system, not an AI/diagnostic device.

However, I can extract information related to the device's performance through non-clinical testing.

Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance:

The document doesn't define specific numerical "acceptance criteria" in a table format for diagnostic performance, as it's a dental implant. Instead, it describes performance through non-clinical testing against established ISO standards and FDA guidance for dental implants. The "acceptance" is demonstrated by meeting the requirements of these standards.

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

• Sample size: Not explicitly stated as a number of devices. The testing is based on performing the required tests as per relevant ISO standards. For fatigue testing, it states it was performed on "subject device and reference device K190837," implying at least one of each for the test, but typically these tests involve multiple samples to establish robustness and statistical significance as required by the standards.
• Data provenance: Not specified in terms of country of origin or whether it was retrospective/prospective. As this is non-clinical bench testing, the data is generated in a laboratory setting. The manufacturer, Cybermed Inc., is from the Republic of Korea.

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. This device is a dental implant, not a diagnostic device requiring expert review for "ground truth" establishment of medical conditions. The "ground truth" for performance is based on established engineering and materials science standards for dental implants.

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

Not applicable, as this is non-clinical bench testing against 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:

Not applicable. This is a dental implant, not an AI/diagnostic device.

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

Not applicable. This is a dental implant, not an AI/diagnostic device.

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

The "ground truth" for this device's performance is derived from compliance with international and national standards for medical device safety and performance, specifically for dental implants (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility, ISO 11137 for sterilization, USP for endotoxins).

8. The sample size for the training set:

Not applicable. This document does not describe a machine learning or AI algorithm, so there is no "training set."

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

Not applicable, as there is no "training set."

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URIS OMNI System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

URIS OMNI System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile. It consists of two implant lines, the OMNI and the OMNI Tapered, with corresponding cover screws, healing abutments and prosthetic abutments. The OMN Tapered implant has a tapered wall with a single thread design. The OMN is straight walled with smaller threading at the coronal end, and bigger threading at the apical end. Both implant lines have two platform sizes, Narrow (Ø 3.5 mm) and Regular (Ø 4.0 - Ø 6.5 mm). Both implant lines share the following diameters and lengths:

Ø 3.5 x 8.5, 10, 11.5, 13, 14.5mm (L) Ø 4.0 x 7. 8.5. 10. 11.5. 13. 14.5mm (L) Ø 4.5 x 7, 8.5, 10, 11.5, 13, 14.5mm (L) Ø 5.0 x 7, 8.5, 10, 11.5, 13, 14.5mm (L) Ø 5.5 x 7. 8.5. 10. 11.5. 13. 14.5mm (L) Ø 6.0 x 7, 8.5, 10mm (L) Ø 6.5 x 7, 8.5, 10mm (L).

URIS Prosthetic System is made of titanium alloy (Ti-6Al-4V ELI) intended for use as an aid in prosthetic restoration. It consists of Cover screw, Healing abutment-direct type, D-basis abutmentcemented type, Angled abutment, Milling abutment, Temporary abutment screw. The surface of cover screw and healing abutment are anodized in yellow and green.

The provided text is a 510(k) Summary for the URIS OMNI System, a dental implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical test data for mechanical properties and biocompatibility.

Crucially, this document explicitly states: "No clinical data were included in this submission."

Therefore, the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning human performance with or without AI, multi-reader multi-case studies, standalone algorithm performance, or ground truth derived from expert consensus, pathology, or outcomes data, cannot be found in this document.

The acceptance criteria mentioned in this 510(k) summary are for non-clinical tests to demonstrate the device's physical and biological properties.

Here's the relevant information that can be extracted, interpreting "acceptance criteria" in the context of this regulatory submission:

Acceptance Criteria and Device Performance (Non-Clinical)

The "acceptance criteria" for this submission are not expressed as performance metrics for an AI/CADe device, but rather as meeting established standards for dental implants and abutments. The "reported device performance" is a statement that the device met these criteria.

Since "No clinical data were included in this submission," the following requested information cannot be provided from this document:

2. Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to device performance in a clinical context.
8. The sample size for the training set: Not applicable (refers to AI/machine learning data, not present here).
9. How the ground truth for the training set was established: Not applicable.

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The s-Clean TiN Coating Abutments is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

The s-Clean TiN Coating Abutments are device made of pure titanium and titanium alloy intended for use as an aid in prosthetic restoration. The system consists of s-Clean TiN Half Coating Angled Abutment, s-Clean TiN Half and partial Coating Couple Abutment, s-Clean TiN Half Coating Free Abutment, s-Clean TiN Half Coating FreeMill Abutment, s-Clean TiN Half Coating MOA Abutment, s-Clean TiN Partial Sub-Octa Abutment, s-Clean TiN Partial Coating Sole Abutment, s-Clean DOA Ball Abutment, s-Clean DOA Snap Abutment, and s-Clean Sole Abutment Healing Cap. The surface of the abutments is partially or half TiN Coated by using PVD (Physical Vapor Deposition). The subject device is provided non-sterile and should be sterilized before use (End user sterilization).

This document is a 510(k) summary for a dental implant abutment, and as such, it focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets acceptance criteria through a standalone clinical study with detailed performance metrics.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission. The information provided heavily relies on non-clinical testing and comparison to predicates.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on meeting the requirements of specific international and FDA guidance standards for medical devices, particularly for dental abutments. The reported device performance is that these tests were met.

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

• Not Applicable (N/A) for clinical data. This submission relies on non-clinical (laboratory) testing, not a clinical test set with patient data.
• The non-clinical tests (biocompatibility, fatigue, sterilization) are laboratory-based and would use a sample size appropriate for those specific engineering and biological tests, but this detail is not provided. The data provenance for these tests would be internal laboratory testing by the manufacturer or a contracted lab.

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

• N/A. As mentioned, this is a non-clinical submission. Ground truth, in the context of clinical studies and expert consensus, is not relevant here. Decisions are made based on adherence to engineering and biocompatibility standards.

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

• N/A. No clinical test set requiring expert adjudication was conducted or 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

• N/A. This is a dental implant abutment, not an AI-powered diagnostic or assistive device. MRMC studies are not relevant here.

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

• N/A. This is a physical medical device (dental abutment), not an algorithm or AI system.

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

• For the non-clinical tests, the "ground truth" is defined by the validated and accepted international standards (e.g., ISO, ANSI/AAMI) for mechanical performance and biocompatibility. Passing these tests according to the established metrics within the standards constitutes meeting the "ground truth" of safety and performance.

8. The sample size for the training set

• N/A. There is no "training set" as this is not a machine learning or AI product.

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

• N/A. There is no "training set" as this is not a machine learning or AI product.

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