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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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The BLUEDIAMOND IMPLANT 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:

• Delaved loading
• Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
  For the BLUEDIAMOND IMPLANTS with a Thread Length of 5mm,
  It is indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks.
  It is specifically recommended for:
• Fixed partial dentures/splinted units (one implant per unit)
• Pontic cases in combination with at least one longer implant
• Fully edentulous cases with at least one 5 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants

The BLUEDIAMOND IMPLANT is a dental implant body 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.
It has different thread lengths depending on the diameter and length. The Implanted length of the device is the length that is implanted into the bone, including the length from the thread to the shoulder, which is the non-threaded part.
The Gingival (Cuff) area of the device has grooves; the bottom of the grooves indicate the implantable length.
The BLUEDIAMOND IMPLANT is consisted of the following components.
BLUEDIAMOND IMPLANT Cuff Type: The BLUEDIAMOND IMPLANT is a dental implant body 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.
Material: CP Ti Grade 4 of ASTM F67
Dimension (mm):

• Normal Thread Ø 4.0 x 9.0, 11.0, 13.0, 15.0 (7.0, 9.0); Ø 4.4 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 4.7 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0)
• Deep Thread Ø 4.4 x 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 4.8 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0); Ø 5.1 x 7.0, 9.0, 11.0, 13.0, 15.0 (5.0, 7.0, 9.0)
  Diameter X Total Length (Thread Length):
• Normal Thread Ø 4.0: 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.4: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.7: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
• Deep Thread Ø 4.4: 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 4.8: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0); Ø 5.1: 7.0, 8.0, 9.0, 10.0, 11.0 (1.0, 2.0)
  Implanted Length (Thread to Shoulder Height): 2.0, 3.0, 4.0
  Gingival (Cuff) Height: Not Found

The BLUEDIAMOND IMPLANTs are compatible to abutments of The BLUEDIAMOND IMPLANT System from K182448, K192614, K210161, K203808, K233450.

The provided text is an FDA 510(k) summary for a dental implant device (BLUEDIAMOND IMPLANT). It focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML medical device. Therefore, it does NOT contain the specific information required to answer your prompt, such as:

• Acceptance Criteria for AI/ML Performance: The document does not describe performance metrics like sensitivity, specificity, AUC, or other measures typically used for AI/ML models. Instead, it focuses on physical and material properties, and mechanical performance (fatigue, pull-out).
• Study Proving Device Meets Acceptance Criteria for AI/ML: No AI model training, validation, or testing is described. The "performance test" section refers to fatigue tests and pull-out tests, which are engineering tests for the physical implant, not for an AI algorithm.
• Sample Sizes for Test Set (AI/ML): Not applicable, as there's no AI/ML test set.
• Data Provenance (AI/ML): Not applicable.
• Number of Experts/Qualifications (AI/ML Ground Truth): Not applicable.
• Adjudication Method (AI/ML Ground Truth): Not applicable.
• MRMC Study (AI/ML): Not applicable.
• Standalone Performance (AI/ML): Not applicable.
• Type of Ground Truth (AI/ML): Not applicable.
• Sample Size for Training Set (AI/ML): Not applicable.
• How Ground Truth for Training Set was Established (AI/ML): Not applicable.

The document primarily discusses:

• Device Description: Material (CP Ti Grade 4), surface treatment (S.L.A), dimensions, components.
• Indications for Use: Placement in maxillary/mandibular molar areas for prosthetic support, delayed and immediate loading protocols, specific recommendations for 5mm thread length implants.
• Substantial Equivalence: Comparison of the BLUEDIAMOND IMPLANT to a primary predicate device (ARi ExCon Implant System) and several reference devices based on design, dimensions, material, surface treatment, sterilization, shelf life, and features.
• Non-Clinical Testing: Biocompatibility, pyrogen/endotoxin testing, sterilization validation, shelf life, modified surface treatment evaluation, and performance test (fatigue test in accordance with ISO 14801, and pull-out testing), and MR compatibility.

In summary, the provided text describes a physical dental implant device and its regulatory submission to the FDA, not an AI/ML-driven medical device. Therefore, it does not contain the information requested about AI acceptance criteria, performance studies, or ground truth establishment.

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Indications for use Bilimplant® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.

Bilimplant Abutments and Prosthetic parts are intended for use with Implants in the maxillary and / or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients.

The Bilimplant® dental implants and abutments, which are models within the Proimtech Implant and Abutment system, are intended for oral implantation to provide a support structure for connected prosthetic devices.

Bone Level Implant: Thanks to its design features, it is placed completely at the bone level. It is produced to be applied in different bone types and different regions (anterior and posterior) in the lower and upper jaw. Since it is at the bone level, it can be used for more aesthetic results, especially in the front areas of the jaws (in the areas on the smile line).

Tissue Level Implant: The Tissue Level Implant has a 2.3 mm machined collar. It can be used in posterior applications in the upper and lower jaw where there are no aesthetic concerns, in different bone types and especially in cases with high gingival amount in order to facilitate prosthetic stages.

Straight Abutments: It is the superstructure part that supports fixed partial dentures manufacture on a straight implant. It is used in single member or bridge cemented restorations. Cement retained abutments have a different gingival height of 1-5 mm, diameters of 3.5, 4.5, 6 mm depending on the platform diameters.

Healing Caps: Following the second surgery of the gingiva in two-stage surgical procedures, and after the placement of the implant in single-stage surgeries, it is screwed into the implant body and protects the internal structure of the implant. It is not used to support a prosthetic superstructure. It is used for transgingival healing and shaping of soft tissue during the healing process of soft tissue. There are two different designs for healing caps in dental implant systems. These are manufactured to be compatible with tissue level and bone level implants.

Abutment Screws: Connects and fixes the abutment and implant body.

This is a 510(k) premarket notification for a medical device family consisting of Proimtech Dental Body Implants, Abutments, Healing Caps, and Abutment Screws. The provided document is an FDA clearance letter and a 510(k) Summary, which details the device's characteristics and its substantial equivalence to previously cleared devices.

The document does not describe a study proving the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as it is a medical device clearance for physical devices, not a diagnostic or AI-powered device.

Therefore, I cannot provide information on acceptance criteria and a study proving the device meets them in the context of diagnostic performance. The studies mentioned are related to material properties, sterilization, biocompatibility, and packaging, which are standard for dental implants.

However, I can extract the information provided regarding the testing and characterization of the device components, which serve as evidence for their safety and effectiveness in achieving substantial equivalence.

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

Since this is a physical medical device (dental implants and associated components) and not an AI/diagnostic device, the concept of "acceptance criteria" and "reported device performance" typically refers to engineering performance (e.g., strength, durability, biocompatibility) rather than diagnostic metrics. The document describes several tests conducted to ensure the device's fundamental characteristics are met:

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

The document does not specify sample sizes for these tests (e.g., how many implants were tested for sterilization or biocompatibility). This level of detail is typically found in the full test reports, not the 510(k) summary.

• Data provenance: The testing was conducted as part of the regulatory submission process for a manufacturer in Turkey (Proimtech Saglik Urunleri Anonim Sirketi, Istanbul, Turkey). The studies are non-clinical (laboratory-based) as explicitly stated: "No clinical data were included in this submission." The testing would be considered prospective in the sense that it was performed specifically for this submission.

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

This question is not applicable to the type of device and studies described. "Ground truth" and "experts" in this context typically refer to diagnostic interpretation in AI or clinical studies. For physical device testing (material, sterilization, biocompatibility), the "ground truth" is established by adherence to international standards (e.g., ISO, ASTM, USP) and the results are interpreted by qualified laboratory personnel, not by a panel of medical experts establishing a "ground truth" for a diagnosis.

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

This is not applicable for non-clinical, laboratory-based testing of physical medical device properties. Adjudication methods are typically used in clinical trials or diagnostic performance studies to resolve discrepancies in expert opinions or outcomes.

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. MRMC studies are used to evaluate the interpretive performance of readers (e.g., radiologists) with and without assistance from an AI device for diagnostic tasks. The Proimtech Dental Body Implant system is a physical dental implant and prosthetic components, not a diagnostic AI system.

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

This is not applicable. The device is a physical medical implant, not an algorithm or AI.

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

As explained in point 3, the concept of "ground truth" in the context of diagnostic devices is not applicable here. For the non-clinical tests conducted, the "ground truth" is defined by the objective measurement criteria and specifications outlined in the referenced international standards (e.g., ISO 11137 for sterilization, ISO 10993 for biocompatibility) and scientific analytical methods (e.g., SEM/EDS for surface characterization). Compliance with these standards is the "ground truth" for the device's physical and biological properties.

8. The sample size for the training set

This is not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a training set.

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

This is not applicable, as there is no training set for a machine learning model.

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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 NB 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, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. NB Implant System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.

An endosseous dental implant is a device made of a material such as Pure titanium (Conforming to ASTM F67) which will be placed in the alveolar bone to replace the function of the missing tooth. The NB Implant System consists of dental implants, abutments for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is internal hex and morse taper bevel. The surface of the fixture 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 devices or other components of a dental implant set with human body (mandibular or maxillary bone). The Scan Healing Abutments are designed to aid in soft tissue contouring the healing period after implant placement, creating an emergence profile for the final prosthesis. They have the added design feature of machined marking for identification when taking an abutment level impression or an intraoral scan/digital impression. Identification information is captured in the intraoral scan or model scan.

Here's a breakdown of the acceptance criteria and study information for the NB Implant System, based on the provided text. It's important to note that this document is a 510(k) summary for a dental implant system, which primarily relies on substantial equivalence to predicate devices and existing testing, rather than a de novo AI/software device that would have explicit AI performance acceptance criteria.

Therefore, the "acceptance criteria" here are related to demonstrating substantial equivalence for a medical device (dental implant), focusing on material safety, sterilization, and mechanical characteristics, rather than specific performance metrics for an AI algorithm. The study described is primarily non-clinical testing to support this equivalence.

Device Name: NB Implant System
Regulation Number: 21 CFR 872.3640 (Endosseous Dental Implant)
Product Code: DZE, NHA

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a physical dental implant system, the "acceptance criteria" are focused on demonstrating a device that is as safe and effective as a legally marketed predicate. Performance is demonstrated through non-clinical testing and comparison to predicates.

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

• Sample Size: The document does not specify exact sample sizes for the non-clinical tests (biocompatibility, sterilization, shelf-life, MRI). It refers to the tests being performed "in accordance with" relevant ISO and ASTM standards, which would dictate minimum sample sizes for each specific test type.
• Data Provenance: All data referenced appears to be from non-clinical (laboratory/bench) testing. The document heavily relies on previously submitted data (K213506, K173374, K182448) from ARUM DENTISTRY Co., Ltd. and other manufacturers. The company's address is in Daejeon, Republic of Korea, suggesting the testing was likely conducted in Korea or by contract labs following international standards. The data is retrospective in the sense that it relies on previously generated and accepted data for predicate devices and earlier versions/components.

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

Not applicable. This is a submission for a physical medical device (dental implant), not an AI/software device that requires expert-established ground truth for a test set of images or clinical data. The ground truth for device safety and performance relies on physical measurements, material properties, and established laboratory testing protocols (e.g., ISO, ASTM standards).

4. Adjudication Method for the Test Set

Not applicable. No human adjudication of results is described, as the studies are non-clinical tests (e.g., sterilization reports, material testing).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted image interpretation or diagnostic devices, not for physical dental implants.

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

Not applicable. This device is a physical dental implant system, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established through:

• Standardized Non-Clinical Testing: Adherence to established international standards (ISO, ASTM) for biocompatibility, sterilization, shelf-life, and material properties.
• Predicate Device Data: The safety and effectiveness of previously cleared, substantially equivalent predicate devices.
• Scientific Rationale/Literature: For MRI safety, peer-reviewed literature and scientific rationale are cited.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI system that requires a "training set."

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

Not applicable. (See #8)

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The BLUEDIAMOND IMPLANT System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.

The BLUEDIAMOND 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 surgically placed in the maxillary or mandibular molar areas. The fixture offers two types: Normal Thread Type and Deep Thread Type. As the name indicates the Deep Thread Type has slightly deeper threads than the Normal Thread Type.

The Abutment Screw is used for securing the abutment to the endosseous implant. It is made of Ti-6AL-4V ELI.

I am sorry, but the provided text is a 510(k) Premarket Notification from the FDA for a dental implant system. This document is a regulatory submission for a medical device and does not contain information about studies proving that a device meets specific acceptance criteria in the context of an AI/ML-enabled medical device.

The document describes:

• The device (BLUEDIAMOND IMPLANT and Abutment Screw)
• Its intended use (dental restorations)
• Comparison with predicate devices for substantial equivalence (materials, design, sterilization, etc.)
• Non-clinical testing performed (biocompatibility, surface treatment, pyrogen/endotoxin, sterilization, shelf life, performance tests based on ISO standards)
• A statement that no clinical studies were submitted.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance (in the context of an AI/ML device): The document reports performance testing to ISO standards for dental implants (e.g., fatigue testing for mechanical properties) but does not provide acceptance criteria and reported performance in the manner requested for an AI/ML device (e.g., sensitivity, specificity thresholds).
2. Sample size used for the test set and data provenance: Not applicable as no AI/ML study is reported.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information: Not applicable.
6. Standalone (algorithm-only) performance: Not applicable.
7. Type of ground truth used: Not applicable in the context of AI/ML. The device's "ground truth" for regulatory purposes relies on engineering and material standards.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document discusses non-clinical performance tests for mechanical properties (e.g., fatigue test according to "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant Abutment") to demonstrate substantial equivalence to predicate devices, but this is distinct from the type of performance data requested for an AI/ML-driven device.

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The IBS System is intended to replace missing teeth to restore chewing function. The IBS System can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

The fixtures and abutments in this system are below:

1. Fixture

• Magicore (RBM)
• Magicore (RBM Cutting Edge)
• Magicore II (SLA) .
• Magicore II (SLA Cutting Edge)

2. Abutment

• Magic Angled Abutment (Screw type _Hex, Non-Hex) ●
• Magic Motion
• Magic Motion Housing ●
• Magic Abutment (Screw type Hex, Non-Hex & Cement type Hex, Non-Hex) ●
• Magic Multiunit Abutment (Cement type Hex, Non-Hex)
• Magic Multiunit Cap .
  An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The implant-abutment connection is tight and precise fitting with internal hex, non-hex and Morse taper bevel. The surface of the Magicore implant is treated with RBM (Resorbable Blasted media) and Magicore II implants are treated with SLA(sand-blasted, large-grit, acid-etched).

The provided text is a 510(k) summary for the IBS System, an endosseous dental implant. It focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance data against acceptance criteria from a study on the IBS System itself. Therefore, I cannot extract the full details you requested regarding acceptance criteria and the study that proves the device meets them.

The document primarily shows a comparison of technological characteristics between the subject device (IBS System) and various predicate and reference devices. The "SE Discussion" (Substantial Equivalence Discussion) sections explain why the differences are not considered to affect safety and effectiveness, thus supporting the claim of substantial equivalence.

However, I can extract the following information based on the provided text, particularly from the "Non-Clinical Data" section, which outlines the types of tests performed and the standards met:

Inferred Acceptance Criteria and Reported Device Performance (Summary based on tests performed for substantial equivalence):

Further Breakdown of Requested Information (where available):

1. A table of acceptance criteria and the reported device performance: See table above. It's important to note that these are inferred from the standards cited as being met for establishing substantial equivalence, not explicit performance metrics from a comparative study of the new device against specific performance criteria.

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

   • Sample Size: Not specified in the provided text for any of the non-clinical tests (e.g., number of abutments for sterilization, number of implants for fatigue testing, number of participants for human factors).
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The manufacturer is InnoBioSurg Co., Ltd. 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 document describes non-clinical engineering and biological tests, not studies involving human expert assessment for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. As above, this is for non-clinical testing.

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 an endosseous dental implant, not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

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

   • For Sterilization: Ground truth is defined by the demonstrated sterility assurance level (SAL) of 10^-6, verified by biological indicators and physical parameters outlined in the referenced ISO and AAMI standards.
   • For Biocompatibility: Ground truth is established by the cellular responses and tissue reactions observed in tests, interpreted against the criteria of the ISO 10993 series.
   • For Fatigue Testing: Ground truth is the material's resistance to fracture under cyclic loading, compared to the ISO 14801:2016 standard.
   • For Surface Modification: Ground truth involves microscopic and chemical analysis (e.g., surface roughness, composition analysis, SEM imaging) against established benchmarks or predicate device characteristics.

8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established: Not applicable.

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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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