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The Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation.

All digitally designed abutments for use with Warantec Custom Abutments are intended to be sent to a Warantec-validated milling center for manufacture.

Warantec Custom Abutments are used for cement-retained crowns and bridges using customized abutment considering based on the patient's mouth using CAD/CAM system. That is customized abutment considering shape of the final prosthesis based on the patient's mouth model using CAD/CAM system during the manufacturing. The Warantec Custom Abutment are made of Ti-6A1-4V ELI (ASTM F136). These devices are supplied non-sterile and autoclaved by the end user and intended for single use only. Warantec Custom Abutments are compatible with IU Implant System.

I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and the study that proves the device meets the acceptance criteria in the format you specified.

The document is a 510(k) summary for a dental abutment, primarily focusing on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use. It lists non-clinical testing data such as:

• Steam sterilization validation
• Biocompatibility of the material
• Fatigue testing according to ISO 14801:2016 and FDA Special Controls Guidance Document.
• Non-clinical worst-case MRI review.

However, it does not provide specific acceptance criteria values for these tests or reported device performance against those criteria in a tabular format. It also explicitly states: "No clinical data were included in this submission."

Therefore, I cannot extract details like:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set or data provenance.
• Number of experts or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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The Warantec dental abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation.

The IU Implant System Abutment is a dental implant superstructure made of titanium alloy. It is an abutment used to support or maintain the restoration after the implantation of the fixture in the oral cavity. The abutments are provided non-sterile and should be sterilized before use.

This document is a 510(k) summary for the IU Implant System Abutment, a dental implant superstructure. It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence. However, it does not contain the specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics such as sensitivity, specificity, accuracy, or effect size for AI assistance. The document focuses on showing the device's substantial equivalence to existing predicate devices based on design, materials, and non-clinical testing.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a breakdown of what can and cannot be provided based on the input:

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria are implicitly related to demonstrating substantial equivalence to predicate devices through comparisons of material, design, intended use, and non-clinical testing results (fatigue, biocompatibility, sterilization, MRI safety).
• Reported Device Performance: Performance is reported in terms of meeting specific standards and showing substantial equivalence in non-clinical tests, rather than clinical performance metrics.

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

• Not applicable for performance metrics. The "tests" mentioned are non-clinical (sterilization, biocompatibility, fatigue, MRI review). These typically involve a specific number of samples for mechanical or material testing, but not a "test set" from patients or images.
• Data Provenance: The submission is from Warantec Co., Ltd. in the Republic of Korea. The testing itself (e.g., ISO standards) does not specify "data provenance" in the way clinical studies would.

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

• Not applicable. This information is relevant for clinical studies or studies using expert readers for image interpretation, which were not conducted for this submission ("No clinical data were included in this submission.").

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

• Not applicable. This relates to clinical or expert-read studies, which were not performed.

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

• No, an MRMC comparative effectiveness study was not done. This is a dental implant abutment, not an AI-powered diagnostic device. The submission explicitly states, "No clinical data were included in this submission."

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

• Not applicable. This is not an AI algorithm; it's a physical medical device.

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

• For the non-clinical tests:
  • Sterilization: Ground truth is defined by the objective measurement of sterility (SAL) and adherence to ISO standards.
  • Biocompatibility: Ground truth is established by chemical composition and biological response testing, adhering to material standards (ASTM F136) and prior submissions.
  • Fatigue: Ground truth is based on physical endurance under simulated physiological loads according to ISO standards.
  • MRI Safety: Ground truth is based on existing scientific literature and physics principles related to magnetic forces and materials.

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable. No training set was used.

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The IU Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

The IU Implant System is an integrated system of endosseous dental implants with corresponding various abutments (cover screw, two piece abutment, solid abutment, abutment screw, ball abutment, retained abutment, temporary abutment, and multi abutment). The IU Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. There are two types of Fixtures, triangular screw threads design and square screw threads design. The IU Implant System includes the each fixtures is available in various diameters (lengths) 3.6 mm (8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 4.1 mm, 4.6 mm, 5.1 mm, 5.6 mm, 6.1 mm (7.5 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) of triangular screw threads design and 4.3 mm, 4.8 mm, 5.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 6.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm) of square screw threads design according to the anatomical situation. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. Abutment is device made of titanium alloy and it is intended for use to make permanent prostheses and/or temporary prosthesis. The abutments are provided non-sterile and should be sterilized before use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the IU Implant System, extracted from the 510(k) summary:

The provided document (K172345) is a 510(k) Summary for a new medical device, the IU Implant System. In 510(k) submissions, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to establish new safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating equivalence to established standards and predicate devices, largely through non-clinical testing.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the IU Implant System are implicitly set by the standards and characteristics of the identified predicate and reference devices, as well as relevant ISO standards. The "performance" being demonstrated is that the subject device meets these established benchmarks, thereby showing substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance

Study Details

Given this is a 510(k) submission, the "study" that proves the device meets the acceptance criteria is primarily a non-clinical comparative testing and documentation of material/design equivalence to predicate devices and recognized standards.

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

• Test Set Sample Size: Not explicitly stated in terms of a "test set" as one might refer to it in a clinical study. The non-clinical tests (biocompatibility, sterilization, shelf-life) would typically involve a sample of the manufactured device components. The exact number of samples for each specific test (e.g., cytotoxicity, sensitization, mechanical flexural strength) is not detailed in this summary.
• Data Provenance: The biocompatibility testing was conducted according to International Standard ISO 7405:2008 and ISO 10993-1:2009/AC:2010. Sterilization testing followed ISO 11137-1/2/3 and ISO 17665-1/2. Shelf-life testing followed ASTM F1980. Risk analysis followed ISO 14971. This indicates testing against internationally recognized standards. The country of origin of the data generation isn't specified beyond the device manufacturer being WARANTEC Co., Ltd. from Korea. This is a retrospective analysis of non-clinical design and safety data against known standards and predicate devices.

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

• This is not applicable in the context of this 510(k) submission. "Ground truth" in this scenario is established by adherence to recognized international standards (ISO, ASTM) and demonstrative equivalence to predicate devices, rather than expert consensus on a test set (e.g., interpretation of medical images). The experts involved would be those who conducted the laboratory tests and certified compliance with the standards (e.g., microbiologists, material scientists, toxicologists), but their number and specific qualifications are not detailed in this summary.

3. Adjudication method for the test set:

• Not applicable. There is no "adjudication method" in the sense of reconciling divergent expert opinions on test data. Compliance with each standard (e.g., passing a cytotoxicity test, achieving a certain SAL) is a binary outcome based on pre-defined criteria within the standard itself.

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, an MRMC comparative effectiveness study was not done. This device is an endosseous dental implant system, not an AI-powered diagnostic or assistive tool for human readers. This type of study is irrelevant for this device.

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

• No, this is not an AI algorithm. This question is not applicable.

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

• The "ground truth" for this P(re-market) N(otification) is
  • Compliance with recognized international standards for biocompatibility (ISO 10993, ISO 7405), sterilization (ISO 11137, ISO 17665), shelf-life (ASTM F1980), and risk management (ISO 14971).
  • Substantial equivalence to predicate devices in terms of intended use, materials, design, and manufacturing processes, which implicitly means the predicate devices' established safety and effectiveness serve as the benchmark.

7. The sample size for the training set:

• Not applicable. There is no "training set" in the context of a 510(k) submission for this type of device. The information refers to the manufacturing and testing of physical medical devices and their components, not machine learning models.

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

• Not applicable. As stated, there is no training set for this type of device.

Summary of the "Study" (Non-Clinical Evidence):

The "study" presented is a collection of non-clinical tests and comparisons to establish substantial equivalence. It confirms:

• The IU Implant System has the same intended use as the primary predicate device (Luna Dental Implant System / SHINHUNG MST Co., Ltd. / K123155).
• Its technological characteristics (design, dimensions, material, surface treatment, connection, sterilization method) are similar to or identical to the predicate and reference devices.
• It meets all relevant biocompatibility standards (ISO 7405, ISO 10993-1) through specific lab tests (Cytotoxicity, Sensitization, Oral irritation, Systemic Toxicity, Genotoxicity, Implantation, Endotoxin).
• Its sterilization process achieves the required sterility assurance level (SAL 10^-6) validated by ISO standards.
• It has demonstrated shelf-life stability through accelerated aging testing (ASTM F1980).
• A risk analysis was conducted according to ISO 14971, finding all risks acceptable.

Key Point from the Submission: "No clinical data were included in this submission." This explicitly states that the substantial equivalence determination relies entirely on non-clinical data and comparison to legally marketed predicate devices, as is common for many Class II medical devices in the 510(k) process.

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ONEPLANT is designed for use in dental implant Surgery. These are intended for use in partially or fully edentulous mandibles and maxillae to support for single or multiple-unit restorations such as cemented retained, screw retained, or over denture restorations and terminal or intermediate abutment support for fixed bridgework.

Dental implant systems are devices made of a material such as titanium intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices such as artificial teeth, and to restore the patients chewing function. Dental implant system consists of Fixture, Abutment and Implant surgical instruments.

This 510(k) summary (K081748) for the ONEPLANT Dental Implant System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically associated with AI/ML-driven medical devices.

Instead, this submission is for a traditional medical device (dental implants) and focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This means the manufacturer is showing that their new device is as safe and effective as devices already on the market, by comparing its materials, design, intended use, and functional characteristics.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this document. I will fill in what can be gleaned from the provided text, and explicitly state when information is not available or not relevant for this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of an AI/ML device performance study. This submission is for a physical medical device (dental implants). The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to predicate devices in terms of materials, design, and intended use. The "reported device performance" refers to the characteristics that allow it to be considered equivalent, rather than quantitative performance metrics from a clinical trial.

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

Not applicable. This submission does not involve a "test set" in the context of an AI/ML device or a clinical performance study with patient data. It is a comparison of product specifications and materials.

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

Not applicable. No ground truth was established by experts from a test set. The comparison is based on the technical specifications of the devices themselves.

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

Not applicable. No adjudication method for a test set was used.

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 not an AI/ML device, and no MRMC study was performed.

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

Not applicable. This is not an AI/ML device.

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

Not applicable as there is no "ground truth" derived from patient data or clinical outcomes in this substantial equivalence submission. The "ground truth" for the comparison is the established characteristics and performance of the predicate devices based on their prior clearances and regulatory compliance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no training set.

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

Not applicable. This is not an AI/ML device; there is no training set or associated ground truth establishment.

Summary regarding K081748:

This 510(k) submission for the ONEPLANT Dental Implant System is a substantial equivalence submission for a traditional medical device (dental implants). It is not for an AI/ML device and therefore does not include or require the types of performance studies and data analyses that would be found in a submission for an AI/ML product. The "study" proving the device meets acceptance criteria is the comparison table demonstrating that the ONEPLANT system has similar design, materials, and intended use as the legally marketed predicate devices (DENTIUM and Osstem Implant systems). The conclusion explicitly states: "In all respects, the Oneplant Dental Implant components are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. This device is substantially equivalent in design, material, intended use and function to the products on the table above."

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