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The Multi-unit Abutment, Multi-unit Angled Abutment is intended to the maxillary or mandbular arches for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals.

The Multi-unit Abutment, Multi-unit Angled Abutment of a dental implant system to provide support for prosthetic restorations. It is attached to the implants and intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore patient's chewing function. The Multi-unit Abutment, Multi-unit Angled Abutment consists of straight & angled abutments and prosthetic components in varying sizes for single & multiple unit screw retained restorations.

Here's an analysis of the provided text regarding the acceptance criteria and study for the dental device:

Acceptance Criteria and Device Performance for MegaGen Implant Co. Ltd.'s Multi-unit Abutment, Multi-unit Angled Abutment (K203808)

This submission is a 510(k) premarket notification for dental implant abutments. The primary method of demonstrating acceptance and substantial equivalence is through comparison to predicate devices and performance testing according to established international standards (ISO 14801) and FDA guidance documents. There is no AI component or related acceptance criteria described in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical thresholds within the document, as the submission focuses on demonstrating substantial equivalence to existing predicate devices. The performance is assessed by confirming that the subject device meets the requirements of relevant standards, implying that its performance is comparable to or better than the predicate devices.

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

The document does not explicitly state the sample sizes used for the non-clinical performance (bench) testing. Similarly, the data provenance (e.g., country of origin, retrospective/prospective) for these tests is not specified beyond indicating they were performed in accordance with international standards. Given it's a Korean manufacturer, the testing likely occurred in Korea or at facilities that adhere to these international standards.

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

This section is not applicable as the device is a dental implant abutment, and the document describes a 510(k) submission based on substantial equivalence and non-clinical bench testing. There is no mention of a "ground truth" derived from expert consensus on patient cases for evaluation in the context of diagnostic or interpretive performance.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert readers independently assess cases and discrepancies are resolved. The submission relies on bench testing and comparison to predicates, not clinical interpretation studies.

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 involves human readers interpreting cases, often with and without AI assistance, to measure diagnostic performance. The submission pertains to a physical dental device (abutments) and does not involve AI or human-in-the-loop performance evaluation.

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

No, a standalone (algorithm only) performance study was not done. This concept is specific to AI/CADe (Computer-Assisted Detection/Diagnosis) devices. The submitted device is a mechanical component, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically defined for diagnostic or AI studies (expert consensus, pathology, outcomes data) does not apply here. For this device, the "ground truth" for demonstrating acceptance is adherence to engineering specifications, material standards, and performance benchmarks established by international standards (ISO 14801) and FDA guidance documents. The acceptable performance of the predicate devices acts as the benchmark.

8. The Sample Size for the Training Set

Not applicable. The device is a physical product (dental implant abutment). There is no "training set" in the context of machine learning or AI algorithms for this type of submission.

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

Not applicable. As there is no training set for an AI algorithm, there is no ground truth to be established for it.

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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 External Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients and consists of fixtures and abutments. The dental implants which used in conjunction with other prosthesis restore the lost chewing ability and improve the appearance. AnyOne External Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity. Dental prosthesis is a superstructure of a dental implant system and connecting elements between the dental implant and the crown. It is made of Ti-6A1-4V ELI, Gold alloy, CCM alloy and intended to be placed on the fixture allows single & multiple prosthetic restore a patient's chewing function.

Here's a breakdown of the acceptance criteria and study information for the AnyOne External Implant System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission details the equivalence to predicate devices rather than explicit, stand-alone acceptance criteria with specific numerical thresholds for each component. However, the core acceptance criteria revolve around demonstrating substantial equivalence to existing, legally marketed devices (predicates and reference devices). The reported performance across all components is that they met the pre-set criteria for the conducted tests.

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

The document does not explicitly state the numerical sample size for the test set used in the performance bench tests (static compression-strength and fatigue tests). It mentions "test was performed on the subject device and predicate device" and "representative specimen".

• Sample Size (Test Set): Not explicitly stated as a numerical value for each test (e.g., how many implants were tested for fatigue). It generally refers to "the subject device and predicate device" and "representative specimen" in singular form, implying at least one of each worst-case scenario. However, for a regulatory submission of this nature, multiple samples would typically be tested to establish statistical confidence, even if not explicitly detailed in this summary.
• Data Provenance: The study is non-clinical bench testing. The country of origin of the data is not specified, but the applicant and correspondent are located in the Republic of Korea. The tests are prospective as they were conducted specifically for this submission to demonstrate substantial equivalence.

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

This is not applicable as the studies are non-clinical bench tests (physical properties, biocompatibility, sterilization, etc.). Ground truth in this context is established by adherence to recognized international standards (ISO, ASTM, USP) and FDA guidance documents. There is no mention of human experts interpreting test results for "ground truth" in the way it might apply to a clinical study involving medical image analysis, for example.

4. Adjudication Method for the Test Set

This is not applicable for non-clinical bench testing. Passing or failing criteria are determined by adherence to established engineering and material science standards (e.g., force applied, number of cycles, endotoxin concentration limits).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a submission for a dental implant system involving physical components. MRMC studies are typically performed for AI/CAD systems that assist human readers in tasks like medical image interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. As above, this is for a physical medical device. There is no algorithm involved.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on:

• Standardized Test Methods: Adherence to international standards such as ISO 14801 for mechanical testing, ISO 10993-1 for biocompatibility, ISO 11137 and ISO 17665-1, 2 for sterilization, ASTM F1980 for shelf life, and USP 39 for endotoxin testing.
• Predicate Device Comparison: Substantial equivalence is established by demonstrating that the subject device's performance, materials, and design are comparable to legally marketed predicate and reference devices. The predicate devices themselves serve as a form of "ground truth" for acceptable performance and safety within their intended use.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning algorithm.

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

Not applicable. See point 8.

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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 stuations 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.

AnyOne Onestage Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients and consists of fixtures and abutments. The dental implants which used in conjunction with other prosthesis restore the lost chewing ability and improve the appearance.

AnyOne Onestage Fixture is a substructure of a dental implant system made of CP Ti Grade 4 with the . surface treated by SLA method. It is placed in the anterior or posterior site of maxillary or mandibular jawbone considering bone quality and bone quantity. The fixtures have Octa connection, and various cuff height with consideration for soft tissue level (gingival height). These fixtures can be used the one-stage and two-stage surgical procedure. This device is a tissue level implant.

Dental prosthesis is an abutment of a dental implant system and connecting elements between the dental implant and the restoration. The abutment is fixed to the implant and is permanently or temporary in contact with the gum in the surgical cavity. These abutments are made of alloy and POM, and intended to be placed on the fixture allows single & multiple prosthetic restorations to restore a patient's chewing function.

The proposed AnyOne Onestage Implant System is consisted of the following components: Fixture Products (AnyOne Onestage Fixture), Closing Screw & Cover Screw & Healing Abutment (Closing Screw, Cover Screw, Healing Abutment), Fixture Level Prosthesis (Multi Post, Multi Post Cap, EZ Post Abutment, Angled Abutment, Gold Abutment, CCM Abutment, Multi Post Screw, Abutment Screw), Abutment Level Prosthesis (Solid Abutment, Solid Cap, Solid Post Abutment, Solid Post Cap, Octa Abutment, Healing Cap, Temporary Cylinder, EZ Post Cylinder, Gold Cylinder, CCM Cylinder, Abutment Screw), Overdenture Prosthesis (Meg-Loc Abutment, Meg-Ball Abutment, Meg-Magnet Abutment, Magnet, Meg-Rhein Abutment).

The provided text does not describe an AI/ML device but rather a dental implant system. Therefore, details regarding AI/ML device performance, such as acceptance criteria, test set sample size, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or training set specifics, are not applicable and not present in the document.

The document focuses on demonstrating the substantial equivalence of the "AnyOne Onestage Implant System" to predicate devices, primarily through comparison of design, materials, indications for use, and mechanical performance testing (biocompatibility, surface treatment, endotoxin, sterilization, and static/fatigue tests).

Acceptance Criteria and Device Performance (Not Applicable for AI/ML):

Since this is a non-AI/ML device, the concept of "acceptance criteria" as it relates to algorithm performance (e.g., sensitivity, specificity, AUC) and "reported device performance" in that context is not relevant. Instead, the document demonstrates that the new device meets established standards and is equivalent to legally marketed predicate devices through various non-clinical tests.

However, if we interpret "acceptance criteria" as the criteria for demonstrating substantial equivalence for this medical device (dental implant system) and "reported device performance" as the results of the non-clinical tests, we can extract details regarding the physical property tests performed. The acceptance criterion for these tests is that the device must meet "pre-set criteria" according to ISO 14801 and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment," and the reported performance is simply that the test results "met the pre-set criteria."

Summary of Non-Clinical Testing Performance for Dental Implant System:

Further details as requested (adapted for a non-AI/ML device):

2. Sample size used for the test set and the data provenance:
   The document focuses on non-clinical (bench) testing. For the physical properties (static compression-strength and fatigue tests), representative specimens were selected "under the consideration of worst case." The exact number of samples tested for each component is not explicitly stated in this summary, but it would have been part of the full testing report. The provenance of the "data" would be the internal testing laboratories of MegaGen Implant Co., Ltd. (Republic of Korea). The tests are prospective in the sense that they are specifically conducted to support this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical tests is established by standardized testing protocols (e.g., ISO 14801) and engineering measurements, not human expert consensus.

4. Adjudication method for the test set: Not applicable for physical property testing. Test results are objectively measured against predefined standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a dental implant system (physical device), not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used:
   For physical properties (static compression-strength and fatigue), the "ground truth" is based on the performance requirements specified in international standards (ISO 14801) and FDA guidance documents ("Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutment"). For biocompatibility and sterilization, it's adherence to ISO standards (ISO 10993-1, ISO 11137, ISO 17665-1, 2) and ASTM standards (ASTM F1980), as well as USP for endotoxin.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

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

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The Zuga™ Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges, and overdentures. The Zuga™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Zuga™ Dental Implant System includes endosseous dental implants, sealing caps, healing caps, dental implant abutments, and fixation screws in a variety of sizes to accommodate differing patient anatomy. Implantation is suitable for one-or two-stage procedures. Endosseous implants are bone level, self-tapping, root-form, threaded. The threaded surface is blasted, then passivated. Sizematched anterior and posterior abutments are offered. Thes are fastened to the implant using a fixation screw. Sealing caps and healing caps provide protection to the abutment connection threads during endosseous and gingival healing. The implants are provided sterile, the remaining components must be sterilized prior to use.

The provided text describes a 510(k) premarket notification for the Zuga™ Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving that the device meets a set of specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or accuracy, as would be common for AI-driven diagnostic devices.

Therefore, the document does not contain the information requested regarding acceptance criteria in terms of performance metrics for an AI/ML device, nor does it detail a study proving the device meets such criteria with respect to AI performance.

Instead, the "Performance Data" section ([15]) focuses on biological and mechanical compatibility/safety testing, which is standard for medical devices like dental implants. These tests are designed to show that the physical device itself is safe and performs as intended, not to evaluate an AI algorithm's diagnostic or predictive capabilities.

Here's an breakdown of the information present and what's missing, based on the prompt's requirements:

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

• Present: The document lists various tests performed and their outcomes which act as "acceptance criteria" for a physical medical device. These are:
  • Static fatigue tests and dynamic fatigue tests (per ISO 14801 and FDA Guidance): "The results show that the Zuga™ Dental Implant System has sufficient mechanical strength for the intended clinical application."
  • Cytotoxicity testing (per ISO 10993-5 and USP ): "The results showed that the Zuga™ Dental Implant System received a passing score and is thus acceptable for clinical application."
  • Sterility tests (per ISO 10993, ISO 11137-1, 11137-2, ISO 17665-1, 17665-2): "yielded no difference in performance between the Zuga™ Dental Implant System and the predicate device."
  • LAL (Limulus Amebocyte Lysate) bacterial endotoxin tests (per ISO 10993 and USP , ): "yielded a EU/Device value that was less than the established acceptance criteria of 20 EU/Device".
  • Shelf life tests (per ISO 11607): "established the shelf life to be five years provided the sterile seal is not breached."
• Missing (for an AI/ML device context): Specific performance metrics like sensitivity, specificity, accuracy, AUC, FROC, etc., and their corresponding acceptance thresholds.

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

• Present: For LAL tests, it states: "The sampling plan consists of selecting 3% of the batch up to a maximum of 10 samples to be pooled for testing."
• Missing (for an AI/ML device context): Sample size for a "test set" of patient data (e.g., medical images, clinical records) for an AI algorithm. Data provenance (country of origin, retrospective/prospective) is not applicable or mentioned for these physical/biological tests.

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

• Missing: This information is not relevant to the mechanical/biological testing of a physical implant. It would be crucial for an AI/ML device based on clinical data.

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

• Missing: Not applicable to the presented data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Missing: Not applicable. This device is a physical dental implant, not an AI-assisted diagnostic tool.

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

• Missing: Not applicable.

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

• Present (for physical device tests): The "ground truth" here is adherence to international standards (ISO, ASTM) and USP guidelines for mechanical strength, biocompatibility, sterilization, and endotoxin levels.
• Missing (for an AI/ML device context): Clinical ground truth established by experts or pathology for diagnostic purposes.

8. The sample size for the training set:

• Missing: Not applicable, as this is not an AI/ML device.

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

• Missing: Not applicable.

In summary: The provided document is an FDA 510(k) clearance letter for a physical dental implant system. Its "acceptance criteria" and "performance data" relate to the mechanical, chemical, and biological safety and efficacy of the implant itself, demonstrated through adherence to various international and US standards. It contains no information relevant to the development, testing, or performance of an AI/ML device.

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The ST Internal Fixture 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 Fixture System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The ST Internal Fixtures are made with Grade 4 titanium. 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 submission are ST internal fixture, screw and abutment. The diameters of ST internal fixtures are 3.5 mm, 4.0 mm, 4.5 mm, and 5.0 mm, and the lengths are 7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm.

The applicant, T-Plus Implant Tech. Co., Ltd., is seeking 510(k) clearance for their ST Internal Fixture System. The device is a dental implant system intended for placement in the upper or lower jaw to support prosthetic devices and restore chewing function, for both two-stage and single-stage surgical procedures. It is also intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The submission aims to demonstrate substantial equivalence to two predicate devices: the Ti Star Implant System (K132992), also from T-Plus Implant Tech. Co., Ltd., and the ExFeel Dental Implant System (K052369) from MegaGen Co., Ltd.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document provides details on non-clinical testing. For the performance tests conducted, such as "Fatigue test" and "RBM surface coating," specific sample sizes are not explicitly stated in the provided text. The data provenance is derived from these non-clinical tests performed on the "proposed device." There is no indication of clinical data, so discussions of country of origin or retrospective/prospective studies are not applicable to the testing mentioned.

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

This information is not applicable as the provided document details non-clinical laboratory testing, not studies involving human subjects or expert assessment for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the provided document details non-clinical laboratory testing, not studies involving human subjects or expert assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No additional clinical testing was necessary for a determination of substantial equivalence."

6. Standalone (Algorithm Only) Performance:

This information is not applicable as the device is a physical medical implant, not an algorithm or software. The "performance testing" described refers to the physical properties of the implant.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is established by adherence to recognized international standards (e.g., ISO 14801) and scientific methods (e.g., cleaning validation, SEM/EDX analysis). For biocompatibility and sterilization, it is implied that the predicate devices had established ground truth based on their respective testing protocols and regulatory approvals.

8. Sample Size for the Training Set:

This information is not applicable as the document describes a medical device seeking substantial equivalence based on non-clinical testing, not a machine learning model that requires a training set.

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

This information is not applicable as there is no training set for the described device.

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The A Plus Internal Fixture 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. It is intended for delayed loading.

The A Plus internal fixtures are made with Grade 4 titanium. 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 submission are A Plus internal fixture, screw, abutment and some accessories. The diameters of A Plus internal fixtures are 3.4 mm, 3.8 mm, 4.3 mm, 4.8 mm, and 5.3 mm, and the lengths are 8 mm, 10 mm, 12 mm, and 14 mm.

This document describes a 510(k) premarket notification for a medical device called the "A Plus Internal Fixture System," which is an endosseous dental implant. The core of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical effectiveness through extensive studies as might be required for a novel device. Therefore, the information provided focuses on non-clinical performance and design similarity rather than complex clinical trial data or AI performance metrics.

Based on the provided text, the device itself is an endosseous dental implant, not an AI-powered diagnostic or assistive tool. Consequently, questions related to AI performance, human reader improvement with AI assistance, expert consensus for ground truth establishment in a diagnostic context, and training/test set sample sizes for algorithms are not applicable to this submission.

Here's an analysis based on the information provided, addressing the relevant points and noting the non-applicability of others:

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

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

• Sample Size for Test Set: Not specified for any of the non-clinical tests. For mechanical and material tests like fatigue and surface analysis, samples of the physical device components are tested according to the relevant ISO standards, but a "test set" in the context of clinical or AI validation is not applicable here.
• Data Provenance: The device manufacturer is T-Plus Implant Tech. Co., Ltd. in New Taipei City, Taiwan. The non-clinical testing was performed either directly by the manufacturer or by a contracted lab, with the results provided as part of the 510(k) submission. No information on the country of origin of "data" in a patient or imaging context is relevant or provided. The studies are not clinical human studies; they are bench tests.

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. "Ground truth" established by experts is relevant for diagnostic devices, especially those using AI, where a human expert's interpretation (e.g., radiologist's reading) is compared to the device's output. For an endosseous dental implant, "ground truth" is established by engineering specifications, material science standards, and the results of physical and chemical tests (e.g., measuring forces, observing material degradation, analyzing surface composition).

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

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or multi-reader studies to resolve discrepancies among expert readers when establishing a "ground truth" for a diagnostic task. The tests performed for this dental implant are non-clinical bench tests (e.g., fatigue, biocompatibility), where results are determined by objective measurements against predefined standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This question is not applicable. The "A Plus Internal Fixture System" is a physical dental implant, not an AI-powered diagnostic or assistive device. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was performed or is relevant to its substantial equivalence determination.

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

• This question is not applicable. The device is an endosseous dental implant, not an algorithm. There is no "standalone algorithm" performance to report.

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

• The "ground truth" for this device's performance is based on established engineering standards, material specifications, and regulatory requirements. For example, for the fatigue test, the "ground truth" is that the implant must withstand a certain number of load cycles at a specified force as per ISO 14801. For biocompatibility, the "ground truth" is that the materials must not elicit adverse biological reactions as defined by ISO 10993 series for medical devices. For surface coating, the "ground truth" is the absence of residual particles.

8. The sample size for the training set

• This question is not applicable. There is no "training set" for this type of device, as it is not a machine learning or AI-based system.

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

• This question is not applicable. As there is no training set, there is no ground truth to be established for it.

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EBI Dental Implant System is intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

An endosseous dental implant is a device made of a material such as Pure Titanium Grade 4 and Titanium alloy (Ti-6A1-4V ELI). EBI Implant system has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placement. EBI Implant systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The EBI External Implant System has an external connection.

The surface of the system has been treated with RBM (Resorbable Blasted media).

The Fixture diameters are 3.25, 3.3, 3.75, 4, 4.1, 4.8, 5, 5.5, 6, 6.5, 7mm and lengths are 7, 8, 8.1, 8.5, 9, 9.6, 10, 11, 11.5, 12, 12.6, 13, 14, 14.6, 15mm in this system.

The contained various abutments and accessories in the system are cover screw, healing abutment, cemented abutment, temporary abutment, healing cap, impression coping, analog, fixture mount, Ti-screw, angled abutment, impression guide pin, gold UCLA abutment and locator.

Fixtures and abutments are packaged separately. The Fixtures are supplied sterile and the abutments and accessories are provided non-sterile. The abutments and accessories should be sterilized before use.

The EBI External Implant System is a dental implant system. The provided document is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices rather than proving specific acceptance criteria with detailed studies in the manner typically seen for novel AI/software devices. Therefore, the information typically requested for AI/software-based devices regarding acceptance criteria, ground truth, sample sizes, and expert adjudication for performance studies is not directly applicable or available in this document.

However, based on the provided text, we can glean information about the performance testing conducted and how it demonstrates "safety and effectiveness" in the context of a dental implant.

Here's an analysis based on the available information:

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

The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or F1-score, as would be expected for a diagnostic or AI-driven decision support system. Instead, for a dental implant, performance is assessed through bench testing demonstrating structural integrity and compliance with recognized standards.

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

The document doesn't provide specific sample sizes for the fatigue testing in terms of the number of tested devices. It only states that "Fatigue Testing was performed in accordance with ISO 14801:2007." ISO 14801 specifies test methods for dental implants, which would inherently include a defined number of samples to ensure statistical validity, but this detail is not explicitly stated in the 510(k) summary.

Data Provenance: The testing was conducted by EBI Inc., a South Korean company.

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 in the context of this device and testing. The "ground truth" for a dental implant's mechanical performance is defined by adherence to engineering standards and material specifications, not expert consensus on an image or diagnosis.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in clinical performance studies, typically for diagnostic devices. Mechanical bench testing of an implant does not involve such human-based 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

Not applicable. This is a medical device (dental implant), not an AI or software-assisted diagnostic system. Therefore, MRMC studies examining human reader performance with or without AI are not relevant.

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

Not applicable. There is no algorithm. The device is a physical dental implant.

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

The "ground truth" for the performance of the EBI External Implant System is based on established engineering and material standards, specifically:

• ISO 14801:2007 for fatigue testing of dental implants.
• ASTM F67 for unalloyed titanium (CP Titanium Grade 4) used in dental implants.
• ASTM F136 for wrought titanium-6aluminum-4vanadium alloy (Ti-6Al-4V ELI) for surgical implant applications.
• General device safety and effectiveness principles outlined in FDA's Class II special controls guidance document for root-form endosseous dental implants and abutments.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a learning algorithm or AI/ML device.

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

Not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply.

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