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EK DIGITAL ABUTMENTS are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

EK DIGITAL ABUTMENTS are digitally designed patient specific abutments manufactured from titanium Alloy (Ti-6AI-4V ELI) and titanium alloy + zirconia. The EK Hybrid abutments are a two-piece abutment consisting of a pre-manufactured titanium base (ASTM F136) and a CAD/CAM patient-matched mesostructure component (ISO 6872) and PANAVIA F 2.0 (K032455) cement is used to attach the two structures. They are intended only for use with HIOSSEN EK dental implants to provide support for customized prosthetic restorations. EK DIGITAL ABUTMENTS are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. Each EK DIGITAL ABUTMENT is individually prescribed by the clinician.

The provided text is a 510(k) Summary for the EK Digital Abutments and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria, especially in the context of an AI/ML powered device. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, manufacturing processes, and mechanical testing.

However, I can extract the information that is present concerning performance and testing:

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

The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics. It indicates that the device's mechanical properties were evaluated against the ISO 14801 standard.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "The worst case implant and titanium abutments" were chosen for the mechanical fatigue tests. It does not specify the exact number of samples or details on data provenance (country of origin, retrospective/prospective).

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)

This section is not applicable as the study described is a mechanical fatigue test of a physical device, not an AI/ML powered device relying on expert-established ground truth.

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

This section is 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

This section is not applicable. The device is a physical dental abutment, not an AI/ML diagnostic tool.

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

This section is not applicable.

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

For the mechanical fatigue testing, the "ground truth" is defined by the physical failure of the samples under controlled load and cycling conditions, as specified by the ISO 14801 standard. This is a physical, objective measurement rather than an expert interpretation or pathology.

8. The sample size for the training set

This section is not applicable as there is no mention of a training set, indicating this is not an AI/ML device.

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

This section is not applicable as there is no mention of a training set.

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The S-Plant Dental Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller S-Plant Dental Implants (03.4, 3.6, 3.8, 4.2, 4.7, 5.2 mm) 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 is achieved with appropriate occlusal loading. The larger S-Plant Dental Implants (06.0, 7.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

Dual abutments are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Healing abutments are used to make a natural soft tissue shape before setting and removing cover screw after osseointegration. Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete.

The S-Plant Dental Implant System is comprised of dental implants, superstructures, instruments for prosthetics and surgical instruments. The S-Plant Dental Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions. There are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations.

The S-Plant Dental Implant System fixtures are made of commercial pure titanium, grade 4 (ASTM F67) which have a S.L.A (Sand blasted large grit acid etched) treated surface and supplied sterile (gamma radiation). These fixtures can be used one stage surgery method or two stage surgery method. And that are surgically inserted into the upper and/or lower jawbone. The fixtures replace tooth roots providing a stable foundation for restorations. Geometrically, the implant is screw type. An abutment is connected to the implant through a tapered joint.

The Abutment made of Ti-6AL-4V ELI alloy (ASTM F136) is intended for use as an aid in single or multiple-unit prosthetic restorations. It consists of Healing Abutment, and Abutment Screws. All abutments are supplied non-sterile and autoclaved by the end user.

The Cover Screw made of Ti-6Al-4V ELI alloy (ASTM F136), is an essential component in dental implant procedures. This device safeguards the internal threads of dental implant fixtures during the healing phase, ensuring a sterile environment for successful osseointegration.

This document describes a 510(k) premarket notification for the S-Plant Dental Implant System, which is a Class II medical device. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices. However, it does not contain information typically found in a study demonstrating the device meets acceptance criteria related to clinical performance or AI models.

The provided text solely focuses on establishing substantial equivalence based on comparisons to predicate and reference devices regarding design, materials, indications for use, and non-clinical testing (biocompatibility, sterilization, surface modification, and MRI compatibility). There is no mention of an AI component, human-in-the-loop performance, or specific performance metrics like sensitivity, specificity, or AUC against a clinical ground truth for the S-Plant Dental Implant System itself.

Therefore, I cannot fulfill your request for the following information as it is not present in the provided document:

• A table of acceptance criteria and the reported device performance (for clinical performance/AI).
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method.
• Multi Reader Multi Case (MRMC) comparative effectiveness study results or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical evaluation.
• Sample size for the training set.
• How the ground truth for the training set was established.

The provided text is a 510(k) summary for a dental implant system, which is a physical device, and not an AI/software device. The "acceptance criteria" discussed are related to regulatory conformance and manufacturing standards, not clinical performance metrics in the context of an AI study.

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The S-Plant Dental Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller S-Plant Dental Implants (03.4, 3.6, 3.8, 4.2, 4.7, 5.2 mm) 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 is achieved with appropriate occlusal loading. The larger S-Plant Dental Implants (Ø6.0, 7.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

Dual abutments are intended for use with a dental implant to prosthetic restorations such as crowns, bridges, or overdentures. Healing abutments are used to make a natural soft tissue shape before setting up prosthetics and removing cover screw after osseointegration. Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete.

The S-Plant Dental Implant System is comprised of dental implants, superstructures, instruments for prosthetics and surgical instruments. The S-Plant Dental Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations.

The S-Plant Dental Implant System fixtures are made of commercial pure titanium, grade 4 (ASTM F67) which have a S.L.A (Sand blasted large grit acid etched) treated surface and supplied sterile (gamma radiation). These fixtures can be used one stage surgery method or two stage surgery method. And that are surgically inserted into the upper and/or lower jawbone. The fixtures replace tooth roots providing a stable foundation for restorations. Geometrically, the implant is screw tvpe. An abutment is connected to the implant through a tapered joint.

The Abutment made of Ti-6AL-4V ELI alloy (ASTM F136) is intended for use as an aid in single or multiple-unit prosthetic restorations. It consists of Healing Abutment, Dual Abutment, and Abutment Screws. All abutments are supplied non-sterile and autoclaved by the end user.

The Cover Screw made of Ti-6Al-4V ELI alloy (ASTM F136), is an essential component in dental implant procedures. This device safeguards the internal threads of dental implant fixtures during the healing phase, ensuring a sterile environment for successful osseointegration.

The provided text describes the regulatory clearance of the S-Plant Dental Implant System and its components (Fixture, Dual Abutment, Healing Abutment, Abutment Screw, Cover Screw) by demonstrating substantial equivalence to predicate and reference devices. The acceptance criteria and the study that proves the device meets these criteria are primarily based on non-clinical testing and comparison with existing, legally marketed devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the FDA's "substantial equivalence" framework, meaning the device must perform as safely and effectively as legally marketed predicate devices without raising new questions of safety or effectiveness. The reported device performance is demonstrated by comparing its design, materials, intended use, and technological characteristics to the predicate and reference devices, and by non-clinical testing that meets established industry standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The information provided does not describe a clinical study with a test set of patient data. Instead, it details non-clinical testing (bench testing, biocompatibility testing, sterilization validation, shelf-life determination, and MRI safety assessment) and a comparative analysis of the device's characteristics against predicate and reference devices.

• Sample Size for Test Set: Not applicable in the context of patient data. The "test set" refers to samples of the device components used for various laboratory tests (e.g., material samples for biocompatibility, sterility test units, accelerated aging samples, MRI phantom testing). The specific number of samples for each non-clinical test is not detailed in this summary but would be found in the full submission.
• Data Provenance: The studies are non-clinical (laboratory/bench testing) and therefore do not involve patient data from specific countries or have a retrospective/prospective nature in the typical clinical sense. The tests were conducted by the manufacturer (IDIS Co., Ltd. in Republic of Korea) or their designated testing facilities to demonstrate compliance with international standards (ISO, ASTM, ANSI/AAMI) as required for FDA clearance.

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

Not applicable. This is not a study involving expert readers interpreting medical images or clinical outcomes. Ground truth for non-clinical tests is established by adhering to defined scientific methodologies and international standards for material science, biomechanics, and biocompatibility.

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

Not applicable. There is no adjudication method described as this is not a study involving human interpretation of data for ground truth establishment.

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 submission does not involve an AI-enabled device or MRMC studies.

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

Not applicable. This submission does not pertain to an algorithm or AI device.

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

The "ground truth" for the substantial equivalence determination and non-clinical testing is based on:

• Established Industry Standards and Regulations: ISO 7405, ISO 10993 standards (biocompatibility), ISO 11137-1/2, ANSI/AAMI ST79 (sterilization), ASTM F1980 (shelf life), ASTM F67, ASTM F136 (materials), and FDA guidance documents (e.g., "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment").
• Predicate and Reference Device Specifications: The detailed characteristics (materials, dimensions, surface treatment, intended use) of the legally marketed predicate and reference devices serve as the benchmark for comparison to claim substantial equivalence.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

Not applicable, as no training set is described.

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