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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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PreXolid CAD/CAM Abutments are intended for use on endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in the prosthetic rehabilitation.

The subject patient-specific abutment, PreXolid CAD/CAM Abutment used in fabricating fully patient-specific abutments made of Ti-6A1-4V ELI, conforming to ASTM Standard F136. Each patient-specific abutment is individually prescribed by the clinician.

The subject devices are available in diameters ranging from 5.0mm. The subject device is provided with an abutment screw.

PreXolid CAD/CAM Abutments are compatible with XPEED AnyRidge Internal Implant System (K12231).

The allowable ranges of design parameters after CAD/CAM patient-matching are as follows:

Minimum wall thickness(mm): 0.45
Maximum angulation(°): 25
Minimum gingival collar height(mm): 2.00
Maximum gingival collar height(mm): 5.00
Minimum gingival collar(ø): 4.00
Maximum gingival collar(ø): 9.50 , 11.50
Minimum post height (mm): 4.00
Maximum post height (mm): 6.00

The subject abutments are provided non-sterile and are intended to be sterilized by the clinician.

Materials:
Pre-milled abutments and screws are fabricated from Ti-6A1-4V ELI, conforming to ASTM Standard F136.

The provided text includes information about the PreXolid CAD/CAM Abutments, but it does not contain acceptance criteria or study results for a device that is typically evaluated using acceptance criteria such as sensitivity, specificity, or AUC. This document is a 510(k) premarket notification for a dental abutment, focusing on establishing substantial equivalence to a predicate device.

The "acceptance criteria" presented are primarily standards that the device adheres to, and the "study" involves non-clinical testing to demonstrate compliance with these standards and substantial equivalence, rather than a clinical performance study with defined performance metrics like those for diagnostic or AI/ML devices.

Here's an breakdown of the information that is available based on the typical categories you requested, and where the requested information is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table is not present. The document focuses on compliance with engineering and biocompatibility standards, and a comparison table of technical characteristics with a predicate device.

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

• Sample Size for Test Set: The document mentions "worst-case scenario" samples for fatigue testing (smallest diameter with maximum angulation) and reverse engineering. However, specific numbers of units tested are not provided.
• Data Provenance: The tests are described as non-clinical, conducted in accordance with ISO standards and FDA guidance. No information on country of origin for data or if it was retrospective/prospective is applicable or provided, as these are material and mechanical tests.

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

This is not applicable as the "ground truth" for this type of device (dental abutment) is established by engineering and material property standards, not by expert interpretation of images or clinical data.

4. Adjudication method for the test set

This is not applicable as the "test set" involves physical and material tests, not subjective interpretations requiring adjudication.

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. This device is a dental abutment, not an AI/ML-driven diagnostic or image analysis tool. No human reader studies are mentioned.

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 dental abutment, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on established engineering standards, material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI), and the compliance of mechanical properties (fatigue strength, dimensional accuracy) with these standards. Substantial equivalence is also a key "ground truth" to the predicate device K220562.

8. The sample size for the training set

This is not applicable. 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 is not applicable for the same reason as point 8.

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8plant 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Implant bodies with a diameter of 5mm or more are intended to be used in the molar region.

8plant Implant System consists of SF Fixtures, Cover Screw, Abutment, and Abutment Screw.

1. 8plant Implant System (SF Fixtures and Cover Screw)
   This titanium dental implant features a SLA (Sandblasted with Large-grit and Acid-etched) surface with the alveolar bone and is designed to support single or multiple-unit restorations in partially or fully edentulous patients. It is secured to the upper structure using an internal hex fastening system.
2. 8plant Abutment System (Abutment and Abutment Screw)
   8plant Abutment System is compatible with the SF Fixtures. 8plant Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. The 8plant Abutment System consists of the following; Healing Abutment, Rigid Abutment, Locator Abutment, Transfer Abutment, Angled Abutment, Temporary Abutment, Abutment Screw.

The provided document describes a 510(k) premarket notification for the "8plant Implant System." This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria with reported device performance.

Therefore, the requested information for acceptance criteria and a study proving the device meets them, including specific details like sample sizes, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, and training set sample size/ground truth establishment, is not available in this document.

The document primarily highlights:

• Substantial Equivalence Comparison: The core of the submission is a comparison of the subject device (8plant Implant System) to a primary predicate device (ZENEX Implant System) and several reference devices. This comparison is presented in tables detailing similarities and differences in intended use, structure, dimensions, material, surface treatment, and sterilization methods for various components (fixture, cover screw, abutments, abutment screw).
• Non-clinical Testing: The document lists bench tests conducted to "verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device." These tests were performed to ensure compliance with standards relevant to dental implants:
  • Mechanical Performance: Fatigue testing (ISO 14801:2016).
  • Surface Analysis: Utilizing EDS and SEM evaluations for SLA treated surfaces.
  • Sterilization, Shelf-life, and Packaging: Gamma sterilization validation (ISO 11137 series), End User Sterilization Validation (ISO 11138-1, ISO 17665 series, ISO 11737 series), and real-time aging tests (ASTM F88, ASTM F1929).
  • MR Environment Condition: Non-clinical worst-case MR review based on scientific rationale and published literature.
  • Bacterial Endotoxin: Testing to ensure endotoxin levels are below 0.5 EU/mL (USP ).
  • Biocompatibility: Evaluations according to ISO 10993-1 and ISO 10993-12.

The document concludes that the "results of the below tests have met the standards and demonstrated the substantial equivalence with the predicate device." However, it does not provide specific numerical acceptance criteria or detailed performance data from these tests. It simply states that the device 'met the standards' or 'demonstrated substantial equivalence.'

Without a dedicated clinical study or further non-clinical performance data with explicit acceptance criteria and corresponding results, it's impossible to fill out the table and provide the in-depth study information requested.

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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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· Smaller Implant (Widest Thread Diameter: Ø4.0mm ~Ø5.0mm)

The smaller Implant 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 Implant (Widest Thread Diameter: Ø5.6mm ~Ø7.0mm)

The larger Implant 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. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:

• Delaved loading

Bone Chamber Implant is a dental implant 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 arches for smaller implants and in the maxillary or mandibular molar areas for larger implants. The fixture offers two connection types: 2.8 and 3.3 diameter. Also Bone Chamber Implant is characterized by having a chamber on the external surface.

This appears to be a 510(k) summary for a dental implant, "Bone Chamber Implant," seeking substantial equivalence to existing predicate devices. Consequently, the document describes non-clinical bench testing to demonstrate equivalence, rather than clinical trials with human subjects. Therefore, many of the requested items related to clinical study design (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) will not be applicable and the acceptance criteria will be based on engineering performance standards.

Here's an analysis based on the provided text:

Key Takeaway: The device's acceptance criteria and proven performance are primarily based on demonstrating mechanical equivalence to predicate devices through bench testing, specifically fatigue testing, following ISO and FDA guidance. No clinical studies were performed.

Acceptance Criteria and Reported Device Performance

Since this is a submission for substantial equivalence based on non-clinical testing, the "acceptance criteria" are the ability of the device to meet the specified performance standards in the referenced guidance documents and ISO standards, and to perform comparably to the predicate devices. The "reported device performance" is that the device met these criteria.

Study Details (Non-Clinical Bench Testing)

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

   • Sample Size: Not explicitly stated as a numerical count for each test (e.g., number of implants tested for fatigue). The document states "the performance test on the subject and predicate device have been performed in consideration of the worst case according to 'ISO 14801' and 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment'." For regulatory submissions like 510(k), compliance with the standards' requirements for sample size is assumed.
   • Data Provenance: The studies were non-clinical bench tests, not involving human data. The company is MegaGen Implant Co., Ltd., located in Daegu, South Korea. The testing was conducted internally or by a contracted lab to meet international and FDA standards.

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

   • Not Applicable. This was non-clinical bench testing of physical properties, not an assessment requiring expert clinical judgment or ground truth determination (like image interpretation). The "ground truth" here is the physical measurement against a standard.

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

   • Not Applicable. This refers to clinical adjudication, which is not relevant for bench testing.

4. 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. No MRMC study was done, as this is a physical dental implant, not an AI software or imaging device that human readers would interpret.

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

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

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

   • Engineering Standards and Specifications. The "ground truth" for non-clinical testing refers to the established requirements and thresholds defined by international standards (e.g., ISO 14801) and FDA guidance documents for medical device performance (e.g., fatigue strength, biocompatibility, sterilization efficacy). The device's performance is compared against these quantitative and qualitative criteria.

7. The sample size for the training set:

   • Not Applicable. This refers to the training of an algorithm or AI model. This device is a physical product.

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

   • Not Applicable. As above, this refers to algorithm training.

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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 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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The ST Internal Implant System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. The ST Internal Implant System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The ST Internal Implant System are made with Grade 4 titanium and surface treatment is done with SLA (Sand-blasted, Large grit, Acid-etched). The systems consist of one-stage and two-stage root form dental implants, associated with abutment systems, which provide the dentist with screw and cement retained restoration options. The devices covered by this system are ST internal implant, screw and abutment. The implants in this system are provided in lengths from 7.0-15.0 and in diameters from 3.7-5.1. The 3.7 diameter implant is not provided in the 7.0 length. The ST implants have two types, one is mini and the other is regular. The mini type diameters of ST implants are 3.7 mm and the lengths are 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm. The regular type diameters of ST implants are 4.2 mm, 4.6 mm, and 5.1 mm, and the lengths are 7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm. EZ Post abutments, solid abutments, Cylinder abutments, angled abutments, mount screws, cover screws, abutment screws and fixture mounts are included in the system.

The provided text describes a 510(k) premarket notification for a medical device, the "ST Internal Implant System." The approval is based on a determination of substantial equivalence to existing predicate devices, rather than a de novo clinical study with specific acceptance criteria based on human performance.

Therefore, many of the requested details about acceptance criteria, study design with human readers, and ground truth establishment (especially for AI or image analysis devices) are not applicable (N/A) to this 510(k) submission. The performance testing focuses on mechanical and biological properties of the dental implant itself, not on an algorithm's ability to interpret data.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, but does not provide a specific table of quantitative acceptance criteria for all performance parameters and their corresponding reported values in a standardized format. Instead, it states:

• Sterilization Test: "leveraged from own K132992 predicate" - implies meeting standards leveraged from prior approval.
• Shelf Life Test: "leveraged from own K132992 and K152787 predicate" - implies meeting standards leveraged from prior approval.
• Biocompatibility testing:
  • Cytotoxicity Test
  • Intracutaneous Reactivity Test
  • Maximization Sensitization Test
  • Systemic Injection Test (Intravenous Injection)
  • Pyrogen Test
  • "All the test results demonstrate that ST Internal Implant System meets the requirements of its pre-defined acceptance criteria and intended use." (General statement, no specific values given).
• 90-Day Bone Implantation Study: Listed as performed.
• Fatigue test:
  • Acceptance Criteria Statement: "A fatigue test is required to evaluate the stability of implant system in oral cavity. The fatigue testing has been conducted on the proposed device in accordance with ISO 14801."
  • Reported Performance: "Test results comply with ISO14801." (No specific numerical values or pass/fail thresholds are explicitly provided in the document, only a statement of compliance).
• SLA surface treatment (cleaning validation and SEM/EDX analysis):
  • Acceptance Criteria Statement: "to verify that any particles or chemicals used to remove particles have been washed from the surface."
  • Reported Performance: "The SEM/EDX analysis verifies that there were no elements besides titanium found on the surface of the implant."

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

• Sample Size for Test Set: Not specified for any of the non-clinical tests (e.g., number of implants tested for fatigue). These are typically lab-based tests, not human data.
• Data Provenance: The device manufacturer, T-Plus Implant Tech. Co., Ltd., is located in Taiwan. The tests are "non-clinical testing," implying laboratory or animal studies, not human data from a specific country.
• Retrospective or Prospective: N/A for these non-clinical tests.

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

• N/A. The testing described is for the physical and biological properties of a dental implant, not for an algorithm where expert radiologist ground truth would be established. The ground truth for mechanical and biocompatibility tests are defined industry standards (e.g., ISO 14801) and established laboratory protocols.

4. Adjudication Method for the Test Set

• N/A. Not relevant for non-clinical, lab-based performance tests of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, N/A. This type of study is relevant for diagnostic imaging AI systems and not for a dental implant's mechanical or biological performance.

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

• N/A. The device is a dental implant, not an algorithm.

7. The Type of Ground Truth Used

• For mechanical testing (e.g., fatigue), the ground truth is compliance with international standards (ISO 14801).
• For biocompatibility, the ground truth is compliance with established biological safety requirements (e.g., ISO 10993 series through tests like cytotoxicity, sensitization, implantation, etc.).
• For surface analysis, the ground truth is the absence of foreign elements as determined by analytical techniques like SEM/EDX.

8. The Sample Size for the Training Set

• N/A. This device does not involve machine learning or AI, so there is no "training set."

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

• N/A. As there is no training set for an algorithm, this question is not applicable.

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