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Geo Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit cement-retained prosthesis in the mandible or maxilla. Geo Abutments are compatible with the following implants. All digitally designed custom abutments for use with Geo Abutments are to be sent to a GeoMedi Co. Ltd. validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for Geo Abutment from GeoMedi Co., Ltd. a line of titanium base abutments (identified as Multibase) and machinable blank abutments (identified as CMFit) to interface with compatible dental implants from four (4) manufacturers, and a total of seven (7) implant-abutment connections. The compatible implant body diameters range from 3.0 mm to 8.0 mm. The subject device prosthetic platform diameters range from 4.0 mm to 4.6 mm. All patient-specific abutments prepared from subject device Geo Abutment are to be manufactured at a GeoMedi validated milling center.

Geo Multibase abutments are two-piece abutments in which the Geo Multibase Abutment comprises the first part of the two-piece abutment and a patient-specific zirconia superstructure comprises the second part; the assembly becoming a final finished medical device after cementation of the superstructure on the subject device abutment. They are provided in straight designs, and two (2) connection types: for single unit prostheses (engaging connection) and for bridge or multi-unit prostheses (non-engaging connection). They are not intended for angulation correction, as the design parameters for the superstructure are restricted to straight abutments only.

These abutments are made of titanium alloy (Ti-6Al-4V) with a titanium nitride (TiN) coating on the coronal portion of the external surface, not including the implant-abutment interface.

The Geo Multibase abutment and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory or separately, for the clinician to bond together chairside, using the cement required in the labeling (3M ESPE RelyX Unicem bonding cement, cleared in K022476 as RelyX RMGIP).

All patient-specific custom zirconia superstructure fabrication is by prescription on the order of the clinician.

The design parameters for zirconia superstructures to be used with Geo Multibase abutments are:

• Minimum wall thickness – 0.5 mm
• Minimum cementable post height for single-unit restoration – 4.0 mm (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
• Minimum gingival height of the superstructure – 0 mm (Geo Multibase abutments have minimum gingival height of 1.0 mm)
• Maximum gingival height – 5.0 mm
• Maximum angle – 0° (straight only)

All zirconia copings (superstructures) for use with the subject device Geo Multibase abutment will be made at a GeoMedi Co., Ltd. validated milling center under FDA quality system regulations, and the material will conform to ISO 13356, Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

Geo CMFit abutments are cylindrical titanium alloy abutments designed to be used for fabrication of a one-piece, all titanium patient-specific abutment by a CAD/CAM process. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. Geo CMFit abutments are available in engaging and non-engaging connections.

All patient-specific abutment fabrication is by prescription on the order of the clinician. The design parameters for all CMFit patient-specific abutments are:

• Minimum wall thickness – 0.65 mm
• Minimum cementable post height for single-unit restoration – 4.0 mm (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
• Minimum gingival height – 0.5 mm
• Maximum gingival height – 5.0 mm
• Maximum angle – 30°

Manufacture of the Geo Abutment CMFIT patient-specific abutment is to be performed at an GeoMedi Co., Ltd. validated milling center.

The provided text is a 510(k) clearance letter for a dental implant abutment, not an AI/ML medical device where performance characteristics like sensitivity, specificity, or reader studies are typically discussed.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through:

• Indications for Use (IFU) comparison: Showing that the intended use of the Geo Abutment is the same as already cleared devices (supporting prosthetic devices in edentulous patients, compatible with various implants).
• Technological characteristics comparison: Detailing similarities in design, materials (titanium alloy, TiN coating, zirconia for superstructures), manufacturing processes (CAD/CAM, milling center), mechanical properties, and sterilization methods.
• Non-clinical performance data: This section lists types of tests conducted (e.g., mechanical testing per ISO 14801, shear/tension testing per ASTM F1044/F1147, sterilization validation per ISO 17665-1/2, biocompatibility per ISO 10993-5/12) to ensure the device meets safety and performance standards equivalent to the predicate. However, it does not provide acceptance criteria or specific numerical results from these tests. It only states that these tests were done to "demonstrate that the subject devices... have sufficient strength for the intended use" and "characterize the mechanical properties."

Therefore, based on the provided document, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This detailed information is typically part of the test reports submitted to the FDA, but not usually summarized in the publicly available 510(k) clearance letter or summary in this level of detail (i.e., the specific pass/fail thresholds and the measured values for each test). The document only states what was tested and the conclusion that it demonstrated "sufficient strength."
2. Sample sizes used for the test set and the data provenance: This information is not present in the 510(k) summary. These details would be in the specific test protocols and reports.
3. Number of experts used to establish the ground truth... and their qualifications: This is not applicable as this is a physical device, not an AI/ML diagnostic aid requiring human expert annotation for ground truth.
4. Adjudication method for the test set: Not applicable for this type of device.
5. MRMC comparative effectiveness study: Not applicable for a physical dental abutment. This is typically for AI/ML diagnostic devices.
6. Standalone (algorithm only without human-in-the-loop performance): Not applicable for a physical device.
7. The type of ground truth used: For a physical device like a dental abutment, "ground truth" relates to material properties, mechanical strength, dimensional accuracy, and biocompatibility, as demonstrated through engineering tests and material characterization, not clinical outcomes or expert consensus in an AI sense. The document refers to ISO and ASTM standards, which define the test methods and what constitutes acceptable performance (the "ground truth" for material and mechanical properties).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document demonstrates substantial equivalence for a physical dental device through comparison to predicate devices and adherence to established engineering and material standards, rather than through clinical study formats typically seen for AI/ML diagnostic tools.

To answer your question, if this were an AI/ML device document, the "acceptance criteria" and "reported device performance" would typically be found in sections describing performance metrics like:

• Sensitivity, Specificity, Accuracy
• Area Under the Receiver Operating Characteristic (ROC) Curve (AUC)
• Positive Predictive Value (PPV), Negative Predictive Value (NPV)
• F-score or Dice coefficient (for segmentation tasks)
• Comparison to a "clinical standard of care" or "expert performance."

And the "study that proves the device meets the acceptance criteria" would be a clinical validation study (often a retrospective or prospective reader study or a standalone algorithm performance study) with clearly defined ground truth, reader qualifications, and statistical analysis. None of these elements are present because the device is a physical dental abutment.

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MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function.

All digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen validated milling center for manufacture

The MegaGen Dental Implant Abutment includes several components: Healing Abutment, Temporary Cylinder, EZ Post Abutment, EZ Post Cylinder, CCM Abutment, Gold Abutment, Octa Abutment, ZrGEN Abutment, TiGEN Abutment, AXA Abutment (Straight and Angled Types), and Abutment Screw. These components are made of materials such as Ti-6Al-4V-ELI, POM, Co-Cr-Mo alloy, and gold alloy, and are offered with machined or anodized surfaces. Some components are supplied sterile, while others are non-sterile and require sterilization by the user. They are intended for single use. The device provides prosthetic support for dental restorations on endosseous dental implants.

The provided text is a 510(k) summary for the MegaGen Dental Implant Abutment, seeking clearance based on substantial equivalence to predicate devices. It does not contain information about a study that proves the device meets specific acceptance criteria in terms of clinical performance, diagnostic accuracy, or effectiveness with human readers.

Instead, the document details a comparison of the subject device (MegaGen Dental Implant Abutment) with various predicate and reference devices, focusing on technical characteristics, materials, and design. The "acceptance criteria" referred to in the document are primarily related to meeting the characteristics of the predicate devices and demonstrating that any differences do not affect the fundamental function or safety of the device. The "study" that "proves" the device meets these criteria is a non-clinical testing summary, including biocompatibility, sterilization validation, accelerated shelf-life, pyrogen/endotoxin testing, performance testing (ISO 14801), and MR compatibility.

Therefore, many of the requested fields cannot be answered directly from the provided text as they pertain to clinical or diagnostic performance studies involving human subjects or AI algorithms, which are not described here.

Here's a breakdown of the information that can be extracted, and where the requested information is not available:

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

The document does not explicitly present a table of acceptance criteria with corresponding device performance for each component in a consolidated manner. Instead, it discusses "similarities" and "differences" compared to predicate/reference devices, and states that "test results met the pre-set criteria" for performance testing (ISO 14801) and that biocompatibility and sterilization have been validated.

Below is a summarized representation of the comparison for one component (Healing Abutment) as an example, to illustrate the type of comparison presented in the document. The "acceptance criteria" are implied by the characteristics of the predicate/reference devices, and "reported device performance" refers to the subject device's characteristics or the outcome of non-clinical tests.

Example for Healing Abutment:

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

• Test Set Sample Size: Not specified for any clinical or diagnostic evaluation. The evaluations are primarily non-clinical. For performance testing (ISO 14801), the sample size for individual tests like fatigue is not mentioned within this summary, only that tests were performed.
• Data Provenance: Not applicable in the context of clinical/diagnostic data. For non-clinical tests like biocompatibility and sterilization, previous 510(k) submissions (e.g., K110955, K123988, K210161, K220562, E220672, K230618) from MegaGen Implant Co., Ltd. are leveraged. The tests were performed according to international standards (ISO, ASTM, USP).

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

Not applicable. The ground truth for this type of medical device (dental implant abutment) is established by engineering specifications, material properties, and performance under rigorous bench testing conditions, compared to predicate devices. There is no mention of expert consensus for diagnostic ground truth.

4. Adjudication method for the test set

Not applicable. No expert adjudication process for diagnostic imaging or clinical outcomes is 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

Not applicable. This device is a dental implant abutment, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence is based on:

• Comparison to legally marketed predicate devices (their established safety and effectiveness).
• Compliance with recognized international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11137 for sterilization, ASTM F1980 for shelf-life, ISO 14801 for performance/fatigue testing, and FDA guidance documents for MR compatibility).
• Confirmation through non-clinical bench testing that the device's physical and mechanical properties meet predefined criteria, demonstrating that any differences from predicate devices do not raise new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable. This pertains to AI algorithms.

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ALLONUS Tech Prosthetic is intended for use with dental implants as a support for single or multiple-unit prosthetic restorations in the maxilla or mandible of partially or fully edentulous patient. It is including; cemented retained, screw-retained, or overdenture restorations.

It is compatible with the following systems:

• · Astra OsseoSpeed EV(K130999) 3.0
• · Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
• Tapered Internal Implants (K071638) (K143022) 3.4. 3.8. 4.6. 5.8 mm
• · BioHorizons Laser-Lok Implant System (K093321) 3.0 mm
• · Conelog Screw-Line (K113779) 3.3, 3.8, 4.3, 5.0 mm
• Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) mm (Mini. Regular)
• · Megagen AnyRidge Internal Implant System (K140091) 4.0, 4.4, 4.9, 5.4 (3.1)
• · Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
• · Nobel Active 3.0 (K102436) 3.0
• · Nobel Active Internal Connection Implant (K071370) NP RP
• · Nobelactive Wide Platform (Wp) (K133731) WP
• Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.5, 5.5, 6.5 (RB, WB)
• · Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC)
• · Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC)
• · Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9)
• (Ti-base only) Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.7(4.5), 6.0(5.7)

All digitally designed abutments and/or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture.

ALLONUS Tech Prosthetic is made of titanium alloy (Ti-6AI-4V ELI, ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank abutment, Ti-Base Abutment, and Multi-unit Abutment and Components (Multi-unit Healing Cap, Multi-unit Temporary cylinder, Multi-unit Ti-cylinder).

Pre-Milled Blank has a pre-manufactured implant interface connection interface with a customizable cylindrical area-by CAD/CAM- above the implant-abutment interface.

Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured component of the abutment that will be used to support a CAD/CAM-designed zirconia superstructure (the second part of the two-piece abutment) that composes the final abutment.

Multi-unit Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Multi-unit Abutment includes abutments and components (Multi-unit Healing Cap, Multi-unit Temporary cylinder, Multi-unit Ti-cylinder). Multi-unit Abutment - are provided in various gingival cuff height ranging from 1 to 6 mm.

All digitally designed abutments and/or coping for use with the abutments are intended to be sent to a ALLONUS Tech-validated milling center for manufacture.

The provided text is a 510(k) Summary for the ALLONUS Tech Prosthetic, which is an endosseous dental implant abutment. It details the device's technical characteristics and compares it to predicate devices to establish substantial equivalence, rather than describing a study that proves the device meets specific acceptance criteria for a new and novel performance claim.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this type of submission. The information provided primarily focuses on demonstrating equivalence through comparison to existing legally marketed devices, material properties, and standard performance tests for similar devices.

However, I can extract the relevant information that is available from the document for each type of device within the ALLONUS Tech Prosthetic family: Pre-Milled Blank, Ti Base, Multi-Unit Abutment, Multi-Unit Healing Cap, Multi-Unit Temporary Cylinder, and Multi-Unit Ti-Cylinder.

General Information on Acceptance Criteria and Studies for ALLONUS Tech Prosthetic (as inferred from the 510(k) Summary):

The ALLONUS Tech Prosthetic is claiming substantial equivalence to predicate devices, meaning it does not need to establish new performance criteria but rather demonstrate that it is as safe and effective as existing legally marketed devices. The "acceptance criteria" here are largely implied by the performance of the predicate devices and the relevant ISO standards for dental implant abutments. The studies performed are non-clinical bench tests.

1. Table of Acceptance Criteria (Inferred from Comparison) and Reported Device Performance:

The document presents comparisons to predicate devices to establish substantial equivalence rather than explicit acceptance criteria and corresponding performance metrics for novel claims. However, the design limits of the subject devices are compared to the design limits of the predicate devices, which act as de facto acceptance criteria in the context of substantial equivalence. The device's performance is demonstrated by meeting the standards in non-clinical testing.

Here's a generalized table summarizing this approach:

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

• Test Set Sample Size:
  • The document does not specify the exact sample sizes used for the non-clinical bench tests (fatigue, sterilization, biocompatibility, or dimensional analysis). It only states that tests were performed "for the subject device" and "of the worst-case scenario through fatigue testing."
• Data Provenance:
  • The 510(k) submission is from ALLONUS Tech Co., LTD. in the REPUBLIC OF KOREA. This implies the testing was likely conducted in or overseen by this entity.
  • The studies were non-clinical bench tests, not clinical studies involving human patients. Therefore, terms like "retrospective" or "prospective" clinical dataProvenance are not applicable here.

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

• This information is not provided in the 510(k) Summary. For non-clinical bench testing, "ground truth" is typically established by recognized international standards (e.g., ISO, ASTM) and engineering principles, rather than expert consensus on clinical cases.
• The document mentions "Dimensional analysis and reverse engineering... were performed" and "assessment of maximum and minimum dimensions... along with cross-sectional images." This suggests engineering expertise, but specific numbers or qualifications of experts are not stated.

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

• This is not applicable as the studies were non-clinical bench tests. Adjudication methods like 2+1 (two readers plus one adjudicator) are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies in expert interpretations of patient data.

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, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is relevant for diagnostic AI devices that assist human interpretation of medical images or data. The ALLONUS Tech Prosthetic is a physical medical device (dental implant abutment), not an AI diagnostic tool.

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

• No, a standalone (algorithm-only) performance study was not done. This question is also typically relevant for AI/software as a medical device (SaMD). The ALLONUS Tech Prosthetic is a physical device that integrates with human dental procedures.

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

• For the non-clinical tests (fatigue, sterilization, biocompatibility), the "ground truth" is adherence to recognized international standards (ISO, ASTM) and established engineering specifications.
• For implant-to-abutment compatibility, the "ground truth" was based on dimensional analysis and reverse engineering of OEM implant bodies, abutments, and screws, comparing the subject device's design to established OEM specifications.

8. The sample size for the training set:

• This is not applicable. "Training set" refers to data used to train machine learning algorithms. The ALLONUS Tech Prosthetic is a physical medical device, not an AI/ML algorithm.

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

• This is not applicable as there is no training set for a physical medical device.

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The Highness Implant System is designed to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (crowns, bridges, and overdentures) in partially or fully edentulous individuals. It is used to the restore the patient's chewing function. Implants with diameter less than ø5.5mm are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated to the molar region and are indicated for delayed loading.

The Multi-Unit Abutments are intended for multi-unit restorations only and can be used up to 25 degrees when connecting cylinder.

The Highness Implant System is a titanium-metal dental implant designed to be surgically placed in the bone of the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

The Highness Implant System consists of fixtures and abutments.

The fixture is made of pure titanium metal and is supplied sterile (gamma irradiated). The surface is SLA, sandblasted (using 425-180-micron MCD apatitic abrasive, which is a granular, multi-phase calcium phosphate composed primarily of hydroxyapatite and tricalcium phosphate), large grit, acid-etched (solution of hydrochloric acid and nitric acid), treated.

The abutments are made of Ti-6Al-4V ELI titanium alloy (ASTM F136). It consists of a Cemented Abutment, Angled Abutment, Solid Abutment, Temporary Abutment, and Multi-Unit Abutment Screw & Abutment Screw, which are intended for use as an aid in single- or multiple-unit prosthetic restorations, and the Multi-Unit Abutment and Multi-Angled Abutment, which are intended for use only as aids in multiple-unit prosthetic restorations. In addition, Cover Screws and Healing Abutments are prefabricated prosthetic components that connect directly to endosseous dental implants and are indicated as temporary components to allow for soft tissue healing. All abutments are supplied non-sterile and individually packaged in FDA cleared wraps and/or pouches. The abutments should be sterilized prior to use by the end-user. And temporary abutments are intended to be used 6 months.

The abutments are compatible with both HS - I and HS - VII implant bodies.

This document, K240383, is a 510(k) Premarket Notification for the Highness Implant System. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study proving the device meets specific acceptance criteria related to clinical performance or AI/software.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets such criteria in the context of clinical effectiveness, AI performance, or human reader improvement. This document is a regulatory submission for a medical device (dental implants) and, as explicitly stated in Section X, it does not include data from clinical tests.

Therefore, I cannot provide answers to most of your requested points as they pertain to clinical studies, AI performance, or multi-reader multi-case studies, which are not present in this regulatory submission.

However, I can extract information related to non-clinical testing which demonstrates the device meets certain performance standards (acceptance criteria) for the device itself, not for an AI component or clinical outcomes.

Here's what can be extracted from the document regarding non-clinical performance:

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

The document provides performance data in relation to industry standards and guidance, which serve as the acceptance criteria for these non-clinical tests.

Points that cannot be addressed from the document:

• 2. Sample sized used for the test set and the data provenance: Not applicable for non-clinical tests in the context of user evaluation or clinical effectiveness. The numbers of devices tested for fatigue, biocompatibility, and sterilization validation are not specified, only that the tests were performed "in accordance with" standards. Data provenance (country, retrospective/prospective) is typically for clinical data, which is absent.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this refers to establishing ground truth for perception/interpretation tasks, or clinical endpoints, neither of which are part of this 510(k) submission.
• 4. Adjudication method: 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, as there's no AI component or clinical study.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for non-clinical material and mechanical tests. The "ground truth" here is the physical and material properties meeting specified engineering and biological standards.
• 8. The sample size for the training set: Not applicable, no AI/training set.
• 9. How the ground truth for the training set was established: Not applicable, no AI/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 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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MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patients chewing function. All digitally designed abutments for use with ZrGEN Abutment are intended to be sent to a MegaGen validated milling center for manufacture.

The submission includes descriptions for the following devices: Scan Healing Abutment, Temporary Abutment, Temporary Cylinder, Comfort Cap, Healing Cap, Healing Cap Screw, Milling Abutment, EZ Post Abutment/Extra EZ Post Abutment, EZ Post Cylinder, ZrGEN Abutment, Multi-unit Abutment, Multi-unit Angled Abutment, AXA Abutment (Straight), AXA Abutment (Angled), Abutment Screw, Cylinder Screw, and Crown Screw. Each description details the intended use, material, surface treatment, sterilization, single use status, dimensions, and compatible implant systems.

The provided document, a 510(k) premarket notification from MegaGen Implant Co., Ltd. for their "MegaGen Dental Implant Abutment" device, focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving that the device meets specific acceptance criteria through a standalone study.

For medical devices, especially those going through the 510(k) pathway, acceptance criteria are typically based on showing that the new device performs as safely and effectively as a legally marketed predicate device. The "study" proving this is primarily a non-clinical performance testing (bench testing) and a comparison to predicate devices. Clinical studies are often not required for 510(k) submissions, as explicitly stated in this document ("No clinical studies are submitted.").

Therefore, the acceptance criteria are implicitly defined by the performance characteristics of the predicate devices and general standards (like ISO 14801 for dental implants) as outlined in the "Summary of Non-Clinical Testing" section. The device performance is demonstrated through a comparative analysis to these predicates and the results of the bench testing.

Here's a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission, the "acceptance criteria" for the subject device are fundamentally its demonstration of substantial equivalence to predicate devices, meaning it performs as safely and effectively. The "reported device performance" is a direct comparison to the predicate devices and adherence to relevant standards.

The document provides extensive comparison tables for each component of the MegaGen Dental Implant Abutment system against its predicate and reference devices. Below is a representative excerpt from these tables, focusing on a few key components to illustrate the comparison:

Example: Scan Healing Abutment

Summary of Device Performance (Based on "Substantial Equivalence Discussion" sections for all components):

The subject device is deemed substantially equivalent to its predicate/reference devices across all listed components (Scan Healing Abutment, Temporary Abutment, Temporary Cylinder, Comfort Cap, Healing Cap, Healing Cap Screw, Milling Abutment, EZ Post Abutment/Extra EZ Post Abutment, EZ Post Cylinder, ZrGEN Abutment, Multi-unit Abutment, Multi-unit Angled Abutment, AXA Abutment (Straight), AXA Abutment (Angled), Abutment Screw, Cylinder Screw, Crown Screw).

Any identified differences in characteristics (e.g., specific dimensions like diameter, gingival height, post height, total length, or surface treatment for some components) are explicitly discussed and concluded not to affect substantial equivalence. This is often supported by arguing that the differences are minor, fall within the range of cleared devices, allow for more precise treatment, or are supported by bench testing (e.g., fatigue tests for worst-case scenarios).

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

The document does not detail specific sample sizes for test sets in the context of clinical data, as no clinical studies were submitted.

For non-clinical testing (bench tests), the document states:

• "The bench tests have been performed in accordance with 'ISO 14801' and the recommendations of 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment' to evaluate the performance of the subject devices and the test results met the pre-set criteria."
• For ZrGEN Abutment, AXA Abutment (Angled type), and other potentially "worst-case" scenarios, fatigue tests were conducted to demonstrate performance and stability.

The data provenance is pre-market non-clinical testing data generated by the manufacturer. The country of origin for the manufacturing and testing is Republic of Korea (MegaGen Implant Co., Ltd. is based in Daegu, Republic of Korea). The data is prospective in the sense that it was specifically generated for this 510(k) submission to demonstrate equivalence.

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

This information is not applicable (N/A) as no clinical studies were conducted or submitted. For non-clinical bench testing, "ground truth" is established by adherence to recognized standards (like ISO 14801) and established testing methodologies, not typically by expert consensus of medical professionals on a test set.

4. Adjudication Method for the Test Set

This information is N/A as no clinical studies with human readers or image interpretation were conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement

This information is N/A as no clinical studies were conducted, and certainly no MRMC studies involving human readers, as this is a physical dental implant component, not an AI or imaging device that would typically involve human-in-the-loop performance evaluation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is N/A as the device is a physical dental implant abutment, not a software algorithm.

7. The Type of Ground Truth Used

For the purpose of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is:

• Performance specifications derived from legally marketed predicate devices.
• Adherence to recognized international standards (e.g., ISO 14801 for mechanical properties, ISO 10993-1 for biocompatibility, ISO 11137 for sterilization) for manufacturing and material properties.
• Results of non-clinical bench testing to confirm physical and mechanical performance characteristics.

There is no "expert consensus," "pathology," or "outcomes data" in the typical sense of a clinical study since none were performed.

8. The Sample Size for the Training Set

This information is N/A. The device is a physical product, not an AI/ML model that requires a "training set."

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

This information is N/A as there is no training set for a physical device.

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The ARi ExCon Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

• Delayed loading

• Immediate loading when good primary stability is achieved and with appropriate occlusal loading.

For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.

The ARi ExCon Implant is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be placed in the maxillary or mandibular areas to restore masticatory function.
The Abutments are prosthetic components directly or indirectly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation, allows single & multiple prosthetic restorations.

The provided text is an FDA 510(k) premarket notification summary for the "ARi ExCon Implant System." It details various components of the dental implant system (implants, cover screws, healing abutments, etc.) and compares them to predicate and reference devices to demonstrate substantial equivalence.

However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/human-in-the-loop performance study, such as an MRMC study. The "Performance test" section on page 25-26 only mentions fatigue testing according to ISO 14801 and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment" to evaluate the performance of subject devices (implant components), and that test results met pre-set criteria. This is a mechanical performance test, not a clinical or human-reader study.

Therefore, I cannot fulfill the request for information regarding:

1. A table of acceptance criteria and reported device performance (in the context of AI/human performance).
2. Sample size for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (clinical/AI performance).
8. Training set sample size.
9. How training set ground truth was established.

The document primarily focuses on demonstrating substantial equivalence of the dental implant components through material comparisons and mechanical bench testing to predicate and reference devices, not on the performance of a medical AI device or human-in-the-loop performance with AI assistance.

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-Healing Abutment, Cover Screw (previously cleared per K210826) MegaGen Prosthetics are intended for use as an aid in prosthetic rehabilitation.
-Multi-unit Abutment, Multi-unit Angled Abutment (previously cleared per K203808) The Multi-unit Abutment, Multi-unit Angled Abutment is intended to be surgically placed in the maxillary or mandbular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals.
-AnyOne External Implant System (previously cleared per K203554) The AnyOne External Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading, Larger implants are dedicated for the molar region and are indicated for delayed loading.
-AnyOne Onestage Implant System (previously cleared per K210161) The AnyOne Onestage Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols: -Delayed loading. -Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.
-Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment (previously cleared per K192614) Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment is intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. Intended for fully edentulous jaw retaining a tissue supported overdenture. The abutments in combination with endosseous implants are used as the foundation for anchoring tooth replacements in either jaw. The attachments are used in fixed overdenture restorations that can be attached with a snap-in system.
-ST Internal Implant System (previously cleared per K192347) The ST Internal Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
-AnyRidge Octa 1 Implant System (previously cleared per K182448) The AnyRidge Octa 1 Implant System is intended to be surgically placed in the maxillary or mandibular arches for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing situations and with the clinical protocols: - Delayed loading. - Immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region.

• Advanced Intermezzo Implant System (previously cleared per K191127) Advanced Intermezzo Implant Systems is threaded one-piece implants designed for orthodontic onestage surgical procedures in upper and lower jaw to provide a means of prosthetic attachment to restore a patient's chewing function. Advanced Intermezzo Implant System consists of single-stage, root-form dental implants. The system is designed to provide immediate provisional implant to provide temporary support for prosthetic devices during the healing phase of permanent root form implants. Depends on a patient's quality of bone condition, Advanced Intermezzo Fixtures are to be removed within six to ten weeks after the surgery. The system is intended for immediate placement in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations.
  -MiNi Internal Implant System (previously cleared per K150537) The MiNi Internal Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols: - The intended use for the 3.0 mm diameter MiNi implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. - Immediate placement in extraction situations with a partially or completely healed alveolar ridge. - It is intended for delayed loading.
  -XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM (previously cleared per K140091) The Xpeed AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than 06.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
  -ANYONE™ INTERNAL IMPLANT SYSTEM (previously cleared per K123988) The AnyOne™ Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
  -XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM (previously cleared per K123870) The Xpeed®AnyRidge®Intemal Implant System is intended to be surgically placed in the maxillaryor mandbular molar areas for the purpose providing prosthetic support for dental restorations(Crown, bridges, and overdentures) in partially or filly edentulous individuals. It is used to restore a patient's chewing function. Smaller implants (less than Ø6.0mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

Not Found

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is primarily an FDA 510(k) clearance letter for the "MegaGen Dental Implant Systems Portfolio - MR Conditional." It lists various implant systems and their indications for use, many of which were previously cleared.

The letter focuses on regulatory approval, substantial equivalence, and compliance with general controls and other FDA regulations for medical devices. It does not include details on specific performance metrics, clinical studies, sample sizes, ground truth establishment, or expert evaluations that would be necessary to answer your request.

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The TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.

For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.

The TiGEN Abutment is machined with the final prosthetic in accordance with the intraoral structure. It is machined by using dental CAD/CAM technology in accordance with customized patient's information in MegaGen-validated milling center. The TiGEN Abutment is made of Ti-6Al-4V ELI alloy. And It is provided with abutment screw. All TiGEN Abutment is provided non-sterile. The milled TiGEN Abutment must be sterilized by users prior to use.

The ZrGEN Abutment is a two-piece abutment composed of the stock titanium base cemented together with the zirconia top-half to complete the final finished device. This abutment is to be used only with implants placed straight. It is made of Ti-6Al-4V ELI alloy. It is provided with abutment screw. All ZrGEN Abutment is provided non-sterile. Therefore, the ZrGEN Abutment must be sterilized by users prior to use after the cementation of the Zirconia top-half.

The Scan Healing Abutment designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile for the final prosthesis. And they have the added design feature to be scannable an intraoral impression by digital scanner. The Scan Healing Abutment is provided with abutment screw and is provided gamma-sterile.

The provided text is a 510(k) summary for a medical device submission to the FDA. It primarily focuses on demonstrating substantial equivalence to predicate devices based on comparisons of indications for use, design, materials, and non-clinical testing. It explicitly states that no clinical studies were submitted (Section 9). Therefore, the document does not contain information about acceptance criteria for device performance as would be demonstrated by a study with ground truth data.

However, it does describe the non-clinical tests performed to support substantial equivalence. Here's a breakdown of what the document provides regarding tests and an explanation for the absence of other requested information:

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

Since no clinical studies with performance metrics like sensitivity, specificity, accuracy, or effect sizes were performed, a table of acceptance criteria for diagnostic performance cannot be extracted from this document. The document describes non-clinical testing for safety and mechanical integrity.

However, the document does mention criteria for these non-clinical tests:

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

This information is not applicable as no clinical studies with human test sets were conducted or referenced. The non-clinical tests involved physical samples of the devices. For example, fatigue testing was performed on "worst-case TiGEN Abutment and compatible implant fixture constructs" but the specific number of samples is not provided. Data provenance for non-clinical lab tests is typically the manufacturing facility or a contracted lab, but specific details are not in this summary.

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 is not applicable as no clinical studies with ground truth established by experts were conducted.

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

This is not applicable as no clinical studies requiring expert adjudication were conducted.

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 is not applicable as this device is a dental abutment and not an AI-powered diagnostic device. No MRMC study was performed.

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

This is not applicable as this device is a dental abutment and not an algorithm.

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

For the non-clinical tests:

• Sterilization Validation: Ground truth is achieving the specified Sterility Assurance Level (SAL), verified through standard microbiological testing methods (e.g., bioburden and sterility testing).
• Pyrogen and Endotoxin Test: Ground truth is meeting the specified endotoxin limit, verified through standard endotoxin testing (e.g., LAL test).
• Biocompatibility: Ground truth is compliance with ISO 10993 series through tests like cytotoxicity, sensitization, irritation, etc., performed in a lab setting.
• Fatigue Testing: Ground truth is the device (abutment-implant construct) withstanding specified dynamic loading for a certain number of cycles without failure, as defined by ISO 14801.
• Accelerated Shelf Life Test: Ground truth is the maintenance of device properties over the projected shelf life, extrapolated from accelerated aging test data per ASTM F1980.
• MR Compatibility: Ground truth is the device behaving predictably and safely in an MRI environment, based on physics principles and empirical measurements of magnetic displacement and torque.

8. The sample size for the training set

This is not applicable as no machine learning or AI algorithm development was involved.

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

This is not applicable as no machine learning or AI algorithm development was involved.

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MegaGen Prosthetics are intended for use as an aid in prosthetic rehabilitation.

The Healing Abutment is designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile before a final restoration is placed. The Scan Healing Abutment Screw is used to connect the Healing Abutment to the endosseous implant. The Healing Abutments are several types depending on the anatomic location. There are Incisor Type, Canine Type, Molar Type, Special type suitable for the patient's oral environment. The Cover Screw is used for protecting the inner structure of a fixture, and exposed fixture platform after fixture placement. It is used for submerged type surgery. It is sterilized using gamma irradiation during manufacturing process. It is single use devices.

The provided text is a 510(k) Summary for the MegaGen Implant Co., Ltd.'s Healing Abutment and Cover Screw. This document is a regulatory submission to the FDA demonstrating substantial equivalence to legally marketed predicate devices, not a study reporting on specific acceptance criteria and performance data in the traditional sense of a clinical trial or performance study against pre-defined metrics.

Therefore, the information required for topics like acceptance criteria, reported device performance (with quantifiable metrics), sample sizes for test sets, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, and training set details are not explicitly present or applicable in the provided regulatory summary.

Here's an analysis of what can be extracted and what is explicitly not available based on your request:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the document. The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, meaning it argues that the new device is as safe and effective as a device already on the market. It does not typically present a table of quantitative acceptance criteria and then report the device's performance against those specific criteria with numerical results.

Instead, the document details physical and material similarities to predicate devices and states that non-clinical testing data "support demonstrating substantial equivalence."

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

• Sample size for test set: Not explicitly stated with numerical values. For the "Precision Fit Test," it mentions that "the test was conducted by selecting randomly among the subject devices in each Implant System." It does not specify the number of devices tested.
• Data provenance: Not specified. The non-clinical tests mention adherence to international standards (ISO, ASTM, USP) but do not detail the origin of the test data (e.g., country where testing was conducted, whether it was retrospective or 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 information is not applicable/not provided. The document is about physical dental devices (healing abutments and cover screws) and their material/mechanical properties, not an AI or diagnostic device that requires expert-established ground truth from medical images or patient data. The non-clinical tests relate to biocompatibility, surface treatment, pyrogen/endotoxin, sterilization, shelf life, and precision fit, which are typically assessed through laboratory tests against established standards.

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

This information is not applicable/not provided for the same reasons as #3. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not described here.

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 information is not applicable/not provided. This document pertains to physical dental devices, not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant.

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

This information is not applicable/not provided. This document pertains to physical dental devices, not an algorithm or AI system.

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

This information is not applicable/not provided in the context of the device's non-clinical testing. The "ground truth" for non-clinical tests (like biocompatibility, sterility, material properties) is typically defined by reference standards (e.g., ISO, ASTM specifications, USP limits for endotoxin) rather than expert consensus on clinical cases or pathology.

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical medical device, not a machine learning algorithm that requires a training set.

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

This information is not applicable/not provided for the same reason as #8.

In summary, the provided document is a regulatory submission (510(k) Summary) demonstrating substantial equivalence for physical dental devices. It focuses on comparing the new device to existing predicate devices based on design, materials, manufacturing processes, and non-clinical performance (biocompatibility, sterility, etc.), rather than reporting on a clinical or performance study with detailed acceptance criteria, quantitative performance metrics, and specific study designs typical for AI or diagnostic devices.

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