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The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

The LOTA SLA Dental Implant system and LOTA HA Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy, which confirms to ASTM F136, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. All diameters are available with all lengths. The implants are used with the following abutments. The Shouldered Abutments and the Shouldered Hex Abutments have internal connection structure, and they adopt locking taper connection. They restore fixed crown and bridge restorations. The Shouldered Removal Abutment uses screw and locking taper connection to be connected with the fixture. It has the same intended use as the other abutments. All the abutments are not intended for angulation.

This document is a 510(k) premarket notification for the LOTA SLA Dental Implant System and LOTA HA Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study that proves the device meets specific performance acceptance criteria for a new and innovative AI/software functionality.

Therefore, many of the requested items (e.g., sample size for training/test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth for AI, effect size of human reader improvement with AI) are not applicable or extractable from this document as it pertains to a medical device (dental implant system), not an AI/Software as a Medical Device (SaMD).

However, I can extract information related to the non-clinical testing performed to establish substantial equivalence for this physical device.

Summary of Acceptance Criteria and Proving the Device Meets Them (Based on the Provided Document which is for a Physical Medical Device - Dental Implant System)

This 510(k) submission establishes substantial equivalence for the LOTA SLA Dental Implant System and LOTA HA Dental Implant System to legally marketed predicate devices. The "acceptance criteria" here are not about software performance metrics but rather about demonstrating that the new device shares fundamental scientific technology, materials, design, and performance characteristics with existing devices, and that any differences do not raise new questions of safety or effectiveness. The "study" largely refers to non-clinical testing and comparison to predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding AI/Software specific criteria (not applicable for this document):

The provided document is a 510(k) premarket notification for a physical medical device (dental implants). It is not for a software or AI device. Therefore, the specific questions related to AI/Software performance, test sets, ground truth establishment by experts, MRMC studies, or standalone algorithm performance are not detailed or relevant in this context.

If this were an AI/Software as a Medical Device (SaMD) submission, these sections would be crucial. Since it's for a physical implant, the "acceptance criteria" are based on material properties, design, manufacturing processes, intended use equivalence to predicates, and standard biological and physical testing.

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The KJ ZIRCONIA Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. It is for delayed loading.

KJ ZIRCONIA Implant System is a dental implant system made of ZIRCONIA intended to be surgically placed in the bone of the upper or lower jaw arches. It is one piece type implant which the implant and the abutment are manufactured as one piece. It offers two types: BL type and BS type, and the difference is only in the length of the abutment part.

This document is a 510(k) Premarket Notification from the FDA for a dental implant system. It primarily focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting performance data from a clinical or algorithm-based study for an AI/ML device. Therefore, it does not contain the information needed to answer your request about acceptance criteria and study proving performance for an AI/ML device.

Here's why the document doesn't provide the requested information:

• Device Type: The "KJ ZIRCONIA Implant System" is a physical medical device (a dental implant), not an AI/ML software device.
• Regulatory Pathway: A 510(k) submission for this type of device typically demonstrates equivalency to existing predicate devices based on design, materials, and intended use, supported by non-clinical testing (e.g., sterilization, biocompatibility, mechanical properties). It does not usually involve clinical performance studies in the way an AI/ML diagnostic or prognostic device would.
• Absence of AI/ML Specifics: There is no mention of algorithms, machine learning models, test sets, ground truth establishment by experts, or MRMC studies, which are all pertinent to evaluating AI/ML product performance.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set details) from this document as it pertains to an AI/ML device.

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The J2A SLA Dental 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, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The J2A SLA Dental Implant System is for single and two stage surgical procedures. The system is intended for delayed loading.

The J2A SLA Dental Implant System is internal hexagon type dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the system has been treated with SLA (sandblasted, Large- grit, Acid-etched).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each non-clinical test conducted (e.g., number of implants tested for SEM, cytotoxicity, etc.). The study is a retrospective comparison to a predicate device (J2A Dental Implant System, J2C Dental Implant System, K150060) and aims to demonstrate substantial equivalence to this already marketed device. The data provenance would be from internal testing conducted by KJ Meditech Co., Ltd.

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

The document does not describe an expert-based ground truth establishment for the non-clinical tests. These tests (e.g., SEM analysis, cytotoxicity, sterilization validation) inherently have objective, measurable endpoints determined by established scientific methods and standards, rather than expert interpretation of images or clinical outcomes.

4. Adjudication method for the test set

Not applicable, as the tests are objective and do not involve human interpretation or adjudication for ground truth.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this type of device (dental implant). This submission focuses on the safety and performance of the physical implant itself, not on an AI-driven diagnostic or assistive tool for human readers.

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 performed, nor is it applicable. This device is a physical dental implant, not a software algorithm.

7. The type of ground truth used

The ground truth for the non-clinical tests is established by objective measurements and adherence to international standards (e.g., ISO, ASTM, USP). For instance:

• Pathology/Histology (indirectly): Cytotoxicity and intracutaneous reactivity tests assess biological responses at a cellular and tissue level, often involving microscopic examination by trained professionals, but the 'truth' is defined by the biological reaction severity against established criteria.
• Physical/Chemical Standards: SEM, EDS, and physical integrity tests (seal, dye penetration) are based on direct physical and chemical measurements against defined specifications.
• Microbiological Standards: Sterilization and microbial challenge tests are based on established microbiological methods to confirm the absence or reduction of microorganisms.
• Analytical Standards: Endotoxin testing follows a defined analytical method to quantify endotoxin levels against a specified limit.

8. The sample size for the training set

Not applicable. This submission is for a physical medical device (dental implant), not a machine learning or AI-based system that requires a "training set."

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

Not applicable. As a physical medical device, there is no "training set" or need to establish ground truth in the context of machine learning.

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The KJ Mini Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 2.0mm, 2.5mm, and 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The KJ Mini Implant System is intended for single use only. It is for delayed loading.

KJ Mini Implant System is a dental implant system made of Titanium 6AL 4V ELI Gt.23 alloy intended to be surgically placed in the bone of the upper or lower jaw arches. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the fixture part has been treated with R.B.M. The KJ Mini Implant System offers the following implants with various sizes.

The document provided is a 510(k) premarket notification for the KJ Mini Implant System. It presents information to demonstrate substantial equivalence to predicate devices, rather than detailing a study focused on specific performance acceptance criteria for an AI or imaging device. Therefore, a direct answer to the request to describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/imaging device performance cannot be fully provided from the given text.

The document discusses non-clinical testing for the dental implant system itself, which primarily focuses on manufacturing and material standards rather than diagnostic performance metrics.

Below is an attempt to structure an answer based on the available information, highlighting what is not present in the document.

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

This document does not provide a table of acceptance criteria or reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) that would be typical for an AI-powered diagnostic device. Instead, it compares the new device (KJ Mini Implant System) to predicate devices based on design, materials, indications for use, and technological characteristics to demonstrate substantial equivalence.

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

This information is not available in the provided document. The document describes non-clinical testing for sterilization and shelf-life, which are laboratory tests, not clinical studies with test sets of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not available in the provided document. As the device is a dental implant, not an AI/imaging diagnostic tool, the concept of "ground truth for a test set" established by experts in the context of diagnostic performance metrics does not apply to the information presented.

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

This information is not available in the provided document. Adjudication methods are relevant for clinical studies assessing diagnostic accuracy, which are not detailed here.

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

This information is not available in the provided document. The device is a dental implant, not an AI-assisted diagnostic tool, so MRMC studies or human-in-the-loop performance metrics are not applicable to this submission.

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

This information is not available in the provided document. The device is a dental implant, and therefore, standalone algorithm performance is not relevant.

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

This information is not available in the provided document. The concept of ground truth in the context of diagnostic accuracy is not discussed. For a dental implant, "ground truth" would more likely refer to successful integration, absence of complications, or restoration of masticatory function, which would be assessed in clinical trials. However, the provided document focuses on premarket notification for substantial equivalence based on material and physical characteristics.

8. The sample size for the training set

This information is not available in the provided document. Training sets are applicable to machine learning algorithms, which are not part of this dental implant device.

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

This information is not available in the provided document, for the same reasons as #8.

Summary of Non-Clinical Testing (from the document):

The provided document describes the following non-clinical tests for the KJ Mini Implant System to demonstrate safety and effectiveness for its intended use, focusing on material and physical properties, not diagnostic performance:

• Sterilization Validation Testing:
  • According to ISO 11137-1 & ISO 11137-2 for implants (gamma sterilization).
  • According to ISO 17665-1 & ISO 17665-2 for abutments.
• Three-year shelf-life testing: According to ASTM F1980.
• Chemical and SEM Analysis: (Details not provided in the summary).

The document concludes that based on the similarities in intended use, operating principle, basic design, material, and surface treatment to predicate devices, the KJ Mini Implant System is substantially equivalent. This implies that if the predicate devices meet performance and safety criteria, the new device, being substantially equivalent, would also meet them. However, specific acceptance criteria for these tests and their detailed results are not explicitly enumerated in this 510(k) summary.

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The I2A Dental Implant System and I2C Dental Implant System are 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. The 12A Dental Implant System and J2C Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

The J2A Dental Implant System and J2C Dental Implant System are internal hexagon type dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with R.B.M (Resorbable Blast Media).

The provided document is a 510(k) summary for the J2A Dental Implant System and J2C Dental Implant System. It presents a comparison to predicate devices to establish substantial equivalence, rather than a study proving performance against acceptance criteria in the context of an AI/software as a medical device (SaMD).

Therefore, I cannot extract information related to:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
6. Standalone algorithm performance.
7. Type of ground truth for test set.
8. Sample size for training set.
9. Ground truth establishment for training set.

The document discusses non-clinical testing which was conducted to demonstrate substantial equivalence, but not a study of the device's performance against specific clinical acceptance criteria in the way an AI/SaMD would be evaluated. It states:

Non-Clinical Testing:

• Risk analysis was conducted according to ISO14971 to demonstrate that modifications to the company's own predicate, Hero II Dental Implant System (K121047), are substantially equivalent.
• Modifications evaluated include:
  • Fixture thread design change.
  • Fixture size addition.
  • Coating area expansion for one-piece type abutments.
  • Abutment size addition.
• Additional predicate devices of similar design and dimensions were identified to determine substantial equivalence.
• Based on the risk analysis, the shelf-life, sterilization, biocompatibility, and performance testing of the predicate, Hero II Dental Implant System (K121047), is applicable to the subject device.

Conclusion on Substantial Equivalence:
The document concludes that the J2A Dental Implant system and the J2C Dental Implant system are substantially equivalent to the predicate devices because they:

• Have the same intended use.
• Use the same operating principle.
• Incorporate the same basic design.
• Incorporate the same material and surface treatment.

This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance metrics from a clinical study against specific acceptance criteria.

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KJ External 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. KJ External Implant System is for stage surgical procedures. It is intended for delayed loading.

The KJ External Implant System is a dental implant system made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the implants has been treated with R.B.M (Resorbable Blast Media).

This document is a 510(k) premarket notification summary for the KJ External Implant System, a dental implant device. It establishes substantial equivalence to predicate devices, but it does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes for training/test sets, expert qualifications, etc.) that would typically be found in a study proving a device meets acceptance criteria for an AI/algorithm-based medical device.

The information provided relates to the physical and material properties of a dental implant, not to an algorithm's performance. Therefore, I cannot extract the requested information as it is not present in the provided text.

Here's why and what kind of information is provided:

Why the requested information is not present:

• Device Type: The KJ External Implant System is a physical medical device (a dental implant), not a software or AI-based device. The detailed requests about acceptance criteria, performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies are primarily relevant for evaluating the performance of algorithms or diagnostic imaging devices where subjective interpretation or computational accuracy is key.
• 510(k) Summary Purpose: A 510(k) summary aims to demonstrate "substantial equivalence" to a legally marketed predicate device. This often involves comparing intended use, technological characteristics, materials, and non-clinical performance (like sterilization, shelf life, and material composition for physical devices). It rarely includes detailed clinical trial data or algorithm validation studies unless the device itself is a diagnostic algorithm or introduces novel performance claims requiring such studies.

What is provided in the document (and why it's different from your request):

• Device Description: It describes the physical characteristics of the dental implant, including its material (Titanium 6AL 4V ELI alloy), surface treatment (R.B.M), and available sizes (diameters and lengths).
• Intended Use/Indications for Use: For use in partially or fully edentulous mandibles and maxillae, supporting various restorations, and intended for delayed loading.
• Predicate Devices: The document identifies predicate devices (US SYSTEM by Osstem Implant Co., Ltd. (K062030) and Hero II/IS Dental Implant System by KJ Meditech Co., Ltd. (K121047)) to which the new device is compared for substantial equivalence.
• Non-Clinical Testing: This section mentions tests performed to demonstrate safety and performance for a physical implant:
  • Sterilization validation (ISO 11137, ISO 11737-1 & -2, ISO 17665-1 & -2)
  • 3-year shelf-life validation (accelerating testing)
  • Chemical and SEM image analyses for residual RBM treatment (on fixtures)

Therefore, an actual table of acceptance criteria and the requested study details for an AI/algorithm device cannot be constructed from this document.

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J2I 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 interminal or intermediate abuments upport for fixed bridgework. J21 Implant System is for single and two stage surgical procedures. It in intended for delating.

The J2I Implant System is a dental implant system made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implant may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the system has been treated with R.B.M (Resorbable Blast Media).

This document describes the J2I Implant System, a dental implant device, but it lacks the specific information requested about acceptance criteria and a study proving those criteria are met, especially in the context of AI/ML performance.

The provided text is a 510(k) summary for a dental implant system. It focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices that are similar to devices already legally marketed. This process primarily involves comparing design, materials, indications for use, and performance characteristics to a previously cleared device.

Here's a breakdown of why the requested information is not present and what is included instead:

• Acceptance Criteria and Reported Device Performance (Table): This document does not specify quantitative acceptance criteria (e.g., specific thresholds for success, failure rates, or clinical outcomes) for the J2I Implant System itself. Its performance is implicitly deemed acceptable by virtue of its substantial equivalence to the predicate device, which would have had its own performance data reviewed for its original clearance. The document lists the material (Ti 6Al 4V ELI, ASTM F136) and various sizes (Platform Dia, Diameter, Length) of the implant.

• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document describes non-clinical testing for sterilization, shelf-life, and surface analysis (chemical and SEM image analysis). It does not describe a clinical study in the way one would for evaluating the performance of an AI/ML diagnostic or prognostic device.

  • Sample size for test set and data provenance: Not applicable in the context of an AI/ML study; the non-clinical tests likely used specific batches of implants for verification.
  • Number of experts and qualifications, Adjudication method: Not applicable as there's no diagnostic or interpretative task involving human experts.
  • MRMC comparative effectiveness study: Not applicable. This device is a physical implant, not an AI/ML system assisting human readers.
  • Standalone (algorithm only) performance: Not applicable.
  • Type of ground truth: For the non-clinical testing, the "ground truth" would be the specifications and standards (e.g., ISO 11137 for sterilization, ASTM F136 for material). This is not the type of ground truth (e.g., pathology, expert consensus) typically associated with AI/ML performance studies.
  • Sample size for training set, how ground truth for training set was established: Not applicable, as this is not an AI/ML device relying on a trained model.

What is provided in the document:

• Non-Clinical Testing:

  • Sterilization validation testing per ISO 11137, ISO 11737-1 & ISO 11737-2 (gamma) and ISO 17665-1 and ISO 17665-2 (steam).
  • Three years of shelf life validated through accelerated testing.
  • Chemical and SEM image analyses performed to verify no residual after RBM treatment.

• Basis for Substantial Equivalence: The document asserts that the J2I Implant System is substantially equivalent to the SS SYSTEM by OSSTEM IMPLANT CO., LTD (K062051) and Hero II Dental Implant System, IS Dental Implant System by KJ Meditech Co., Ltd. (K121047). The similarities highlighted are:

  • Same intended use.
  • Similar fundamental scientific technology (threaded, root form implants of titanium with RBM roughened surfaces).
  • Same internal octagon abutment connection system.
  • Similar body shape design (straight walled neck and tapered body).
  • Same operating principle.
  • Same basic design.
  • Same material and surface treatment.

• Differences noted: Body shape, cutting edge design, and taper angle, which are deemed minor and not raising new questions of safety or effectiveness.

In summary, this document is a regulatory submission for a physical medical device (dental implant) and demonstrates substantial equivalence based on engineering and material characteristics, and non-clinical laboratory testing. It does not contain the kind of AI/ML device performance study details you've requested.

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The Hero I Dental 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, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Hero I Dental Implant System is for single and two stage surgical procedures. The system is intended for delayed loading.

The Hero I Dental Implant System is made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implant may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition an performance characteristics. The surface of the system has been treated with R.B.M (Resorbable Blast Media).

This submission (K121098) is for the Hero I Dental Implant System. It's a 510(k) summary, which means the manufacturer is asserting substantial equivalence to previously cleared devices, not necessarily demonstrating "meets acceptance criteria" through a comprehensive study with specific performance metrics.

The provided document does not contain information about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Data provenance or ground truth establishment for a study related to acceptance criteria.
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.

The document primarily focuses on establishing substantial equivalence based on similarities in intended use, technology, materials, and design to predicate devices. It states that "no new question of safety or effectiveness has been raised" when compared to the predicate devices.

Therefore, I cannot fulfill your request for this input, as the information required is not present in the provided text.

This 510(k) summary is analogous to an application stating "my new car is substantially equivalent to existing cars because it has four wheels, an engine, and seats, and therefore meets the same basic safety standards." It doesn't include details of crash test performance (acceptance criteria and reported performance) that would typically be found in a study demonstrating such.

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The Hero II Dental Implant System and the IS Dental Implant System are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Hero II Dental Implant System and the IS Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

The Hero II Dental Implant system and the IS Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with R.B.M (Resorbable Blast Media).

The provided document does not contain acceptance criteria or study data for device performance in a clinical context.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence of the Hero II Dental Implant System and the IS Dental Implant System to a predicate device (GS FIXTURE SYSTEM by OSSTEM IMPLANT CO., LTD (K072896)). Substantial equivalence is primarily proven through similarities in:

• Intended Use: Both the subject and predicate devices are dental implant systems used in the jaw for missing teeth, supporting various types of restorations, and for single or two-stage surgical procedures with delayed loading.
• Technological Characteristics: Both are threaded, root form implants made of titanium with RBM roughened surfaces and share the same internal hexagon abutment connection system. They are also bone-level implants with similar body shapes.
• Materials and Surface Treatment: Made of commercially pure titanium with RBM surface treatment.
• Sizes: Similar size ranges for fixtures and abutments.
• Sterilization Method: Gamma irradiation for fixtures.

Non-Clinical Testing:

The document mentions non-clinical testing performed to support safety and shelf life, which includes:

• Sterilization Validation: In accordance with ISO 11737-1 & ISO 11737-2 for gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization.
• Shelf Life Validation: Three-year shelf life validated through accelerating testing.
• Chemical and SEM image analyses: To verify no residual after RBM treatment on the fixtures.

Therefore, I cannot provide the requested information in the table format or answer the questions related to clinical study design, sample sizes, ground truth establishment, or expert involvement, as these details are not present in the provided 510(k) summary. The 510(k) process for substantial equivalence typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical trials if sufficient evidence of technological similarity and non-clinical performance (like material properties, biomechanical characteristics, sterilization) exists.

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The Kerator is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The Kerator is made from Titanium grade Ti-6AI-4V ELI (meets ASTM Standard F-136) and compatible with several fixtures made by other manufactures.

Here's an analysis of the provided 510(k) summary, focusing on acceptance criteria and supporting studies:

Assessment of Acceptance Criteria and Study Details for Kerator

Based on the provided 510(k) summary for the "Kerator" device (K112787), the primary acceptance criteria and supporting studies are focused on demonstrating substantial equivalence to predicate devices, rather than establishing novel safety and effectiveness through clinical trials with specific performance metrics. This is typical for Class II medical devices seeking 510(k) clearance.

The summary emphasizes design, material, function, and intended use equivalence. The key non-clinical tests performed relate to the physical characteristics and functional compatibility of the device.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for an abutment, the "acceptance criteria" are predominantly related to matching the design, materials, and functional characteristics of the predicate device, or meeting established engineering standards for such components. The performance is assessed against these equivalences.

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

• Sample Size for Test Set: Not explicitly stated in terms of a number of physical units tested. The documentation mentions that a "reverse engineering analysis was conducted" and "the retention test has been carried out." These imply a limited number of samples were tested to demonstrate equivalence, but the precise count is not provided.
• Data Provenance: The studies are non-clinical, involving laboratory testing of the device itself.
  • Country of Origin: The manufacturer is in South Korea (KJ Meditech Co., Ltd.), so the tests were likely conducted in South Korea or by a contracted lab.
  • Retrospective or Prospective: These non-clinical tests were conducted prospectively as part of the 510(k) submission process to assess the newly manufactured Kerator devices.

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

N/A. This is a non-clinical 510(k) for an implant abutment. There is no ground truth, expert consensus, or human interpretation involved in the engineering performance tests (reverse engineering for size/tolerance, or retention strength). The "ground truth" is established by direct physical measurement and engineering principles compared against established specifications of the predicate devices.

4. Adjudication Method for the Test Set

N/A. As mentioned above, there's no human interpretation or ground truth to adjudicate. The "adjudication" is essentially the comparison of physical measurements and test results against the specifications of the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. These studies are typically conducted for AI-driven diagnostic or medical image analysis devices to evaluate how human performance (e.g., diagnostic accuracy) is affected by AI assistance. The Kerator is a physical dental implant abutment, not a diagnostic or AI-enabled device.

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

No. This is N/A. The Kerator is a physical medical device (an abutment), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

The "ground truth" in this context is the engineering specifications and demonstrated performance characteristics of the legally marketed predicate devices.

• For design and sizing, the ground truth is the established dimensions and tolerances of the predicate devices and compatible fixtures.
• For material equivalence, the ground truth is the specified ASTM standards and material compositions of the predicate devices.
• For retention performance, the ground truth is the expected or established retention ability of commercially available, similar abutment systems, against which the Kerator's performance is implicitly (or explicitly, if thresholds were defined internally) compared.

8. The Sample Size for the Training Set

N/A. This is a physical device, not an AI or machine learning model. There is no "training set."

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

N/A. There is no training set or ground truth for a training set for this type of device.

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