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Dentis s-Clean SQ-SL Fixture 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. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Dentis s-Clean SQ-SL Fixture is two type as Mini and Regular according to the connection. Dentis s-Clean SQ-SL Fixture is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex.

The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching).

The dimensions of fixtures are as following:

Tolerance of dimension shall be within ± 1% range.

s-Clean SQ-SL Fixture is compatible with devices in K192688 and K210134 as below:

s-Clean SO-SL Fixture Mini is compatible with devices in K210080 as below:

Denis s-Clean SQ-SL Fixture is provided sterilized.

Dentis s-Clean SQ-SL Fixture is packaged with Cover screw that was cleared in FDA as K192688 and K210080.

This document is a 510(k) Summary for the Dentis s-Clean SQ-SL Fixture, a dental implant. It does not contain information about the acceptance criteria or a study proving the device meets those criteria from an AI/algorithm performance perspective. The document focuses on establishing substantial equivalence to predicate devices through non-clinical testing.

Therefore, I cannot provide the requested information regarding AI/algorithm acceptance criteria, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.

The "Non-Clinical Test Data" section describes engineering and biocompatibility tests conducted on the device, not an AI algorithm.

Non-Clinical Test Data Summary (from the document):

• Tests performed on the subject device: Fatigue Testing (ISO 14801:2016).
• Tests performed on predicate devices and leveraged for the subject device:
  • Sterilization Validation Test on Fixtures (ISO 11137-1,2,3 referenced in K192688).
  • Shelf-Life Test on Fixtures (ASTM F1980 referenced in K153639).
  • Biocompatibility testing on fixtures (ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 referenced in K153639).
  • Bacterial Endotoxin Test Report on Fixtures (ANSI/AAMI ST72:2011, USP , and USP referenced in K192688).
• Acceptance Criteria for these non-clinical tests: "met the criteria of the standards" (e.g., ISO 14801:2016 for fatigue).
• Study Design/Purpose: To demonstrate substantial equivalence to predicate devices.
• MR Environment Condition: A non-clinical worst-case MRI review was performed using scientific rationale and published literature to evaluate magnetic safety, addressing magnetically induced displacement force and torque.

This document describes a traditional medical device (dental implant) clearance process, not one involving Artificial Intelligence.

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The LW 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 LW Implant System is dedicated for two stage surgical procedures and is intended for delayed loading. Also, implants with diameters larger than 5mm are indicated for molar regions.

The LW Implant System consists of a fixture, cover screw, healing abutments, and abutment screw. The Fixture is made of CP Ti Grade 4(ASTM F67) with the surface treated by the SLA method. It has several design characteristics: internal hex connection, submerged type, tapered body, sided cutting edge. The Cover Screw and Healing Abutment are made of CP Ti Grade 4(ASTM F67) without any surface treatment. The Abutments consist of the LW Solid, LW Angled, LW Vis and LW Temporary Abutment, and LW Abutment Screw. The abutments have s-Line type and cuff type. The abutments are made of Ti-6AI-4V-ELI (ASTM F136).

The provided text is a 510(k) Summary for the LW Implant System. It outlines substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance data for this device. Therefore, a table of acceptance criteria and direct device performance is not explicitly available in the provided text in the way one would typically find for a new, de novo device or a clinical study.

The document focuses on demonstrating that the LW Implant System is "substantially equivalent" to already legally marketed predicate devices. This means that the device meets the same safety and effectiveness standards, often by showing it performs as well as, or better than, a known predicate device.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document doesn't present specific acceptance criteria and performance data in a dedicated table for the LW Implant System, as it's a 510(k) submission focused on substantial equivalence. Instead, it describes various non-clinical tests performed to demonstrate that the device meets established standards and performs comparably to predicate devices. The "acceptance criteria" are implied by adherence to relevant ISO and ASTM standards and FDA guidance documents, and the "reported device performance" is essentially that the device "met the acceptance criteria" or "demonstrated substantial equivalence."

Here's an interpretation of the implied acceptance criteria and the summary of reported 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 performed (e.g., how many devices were subjected to fatigue testing, or how many samples for biocompatibility). It references standards like ISO and ASTM, which inherently define sample size requirements, but the exact numbers are not reported in this summary.

Data Provenance: The tests are non-clinical (laboratory-based) and were conducted to support the safety and performance of the device against established standards and predicate device comparisons. The "country of origin of the data" is not explicitly stated for each test, but the applicant, Ossvis Co., Ltd., is based in the Republic of Korea. The data is retrospective in the sense that the tests were completed before this submission.

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

This information is not applicable to the provided document. The "ground truth" in this context is established through adherence to recognized international standards (ISO, ASTM) and national regulations (FDA guidance documents). These standards typically involve scientific and engineering principles, and the "experts" are the scientific and engineering professionals who developed these standards and those who conducted the tests in accordance with them. There is no mention of a ground truth established by a panel of clinical experts for a test set in a diagnostic or clinical performance study for this device.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of results by multiple readers (e.g., radiologists, pathologists) to establish a consensus ground truth. Since the reported studies are non-clinical performance and safety tests, a human adjudication method is not used. The "adjudication" is essentially the determination of whether the device passed the specified test according to the defined acceptance criteria in the relevant standards.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on non-clinical performance and safety to demonstrate substantial equivalence, not on the comparative effectiveness of human readers with or without AI assistance. This device is a physical dental implant system, not an AI/software as a medical device.

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

No, this is not applicable. This device is a physical medical device (dental implant system), not an algorithm or software. The concept of "standalone performance" without human-in-the-loop is relevant to AI/software applications, not to this type of medical device.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established scientific and engineering standards and regulatory guidance limits. For example:

• Sterility: Defined by ISO 11137 with an SAL of 10-6.
• Biocompatibility: Defined by ISO 10993 standards.
• Fatigue: Defined by ISO 14801.
• Bacterial Endotoxin: Defined by USP and .
• Surface Characteristics: Defined by FDA special controls guidance for dental implants.

The comparison is also made against the performance and characteristics of legally marketed predicate devices, implying that their established safety and effectiveness serve as a practical "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The LW Implant System is a physical medical device. The concept of a "training set" typically applies to machine learning algorithms where data is used to train a model.

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

This information is not applicable, as there is no "training set" for this physical medical device.

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Jplant is intended for use in partially or fully edentulous maxilla, in support of single of multiple-unit restorations including cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Jplant is for single stage surgical procedures. This system is intended for delayed loading.

Jplant is intended for use in partially or fully edentulous mandibles and maxilla, 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. Jplant is for single stage and two stage surgical procedures. This system is intended for delayed loading.

The Jplant is dental implant which is made of titanium alloy 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. The fixture has the following sizes.

This document, a 510(k) summary for the Jplant endosseous dental implant, does not describe a study that proves the device meets specific acceptance criteria related to its performance in a clinical setting or against an AI-driven benchmark.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, not on proving device performance against detailed acceptance criteria in the manner of an AI/ML device study.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as they pertain to clinical or AI performance studies that were not conducted or described here.

Here's a breakdown of what can be extracted based on the provided text, indicating "Not Applicable (N/A)" for information that isn't present or relevant to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify performance-based acceptance criteria for a device, nor does it provide performance metrics in the way an AI/ML device would (e.g., sensitivity, specificity, accuracy). Instead, it establishes substantial equivalence to predicate devices based on design, materials, manufacturing, and intended use.

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

• N/A. The document does not describe a clinical test set or a dataset for performance evaluation. The "tests" mentioned are non-clinical (e.g., sterilization, shelf life, biocompatibility) and do not involve patient data in a "test set" context for device performance.

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)

• N/A. This information is not relevant to the type of non-clinical testing and substantial equivalence demonstration presented.

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

• N/A. No test set or expert adjudication process is described.

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

• N/A. This device is an endosseous dental implant, not an AI/ML diagnostic or assistive device for human readers. No MRMC study was performed or is relevant.

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

• N/A. As above, this is not an AI/ML algorithm-driven device.

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

• N/A. For the non-clinical tests, "ground truth" would be the standard scientific methods and established procedures for evaluating materials, sterilization, and biocompatibility, as defined by the referenced ISO and ASTM standards. There is no "ground truth" related to clinical outcomes or expert consensus on findings as would be seen in an AI performance study.

8. The sample size for the training set

• N/A. There is no training set mentioned or implied for this mechanical implant device.

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

• N/A. There is no training set for this device.

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

This submission is to add new fixtures and abutments to the previously cleared device, Magicore System (K201981), Magicore II System (K201621), Magicore II System (K192197), and Magic UCLA Abutment System (K202418).
The fixtures and abutments in this system are below:

1. Fixture

• Magicore
• Magicore (Cutting Edge)

2. Abutment

• Magic Multiunit Abutment (Screw type - Hex, Non-Hex & Cemented type - Hex, Non-Hex)
• Magic Multiunit UCLA Cylinder
• Magic Multiunit Cap
• Magic Abutment (Screw type Hex, Non-Hex & Cemented type Hex, Non-Hex)
• Magic UCLA Cement Retained Type (Hex, Non-Hex)
• Magic Cylinder (Hex, Non-Hex, Post)
• Magic Multiunit Cylinder (Hex, Non-Hex, Post)
• Magicore Healing Cap
• Magicore Healing Cap Screw
• Cylinder Screw
  An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The Magicore System consists of dental implants, Abutments, cylinders, caps and screws for use in one or two-stage dental implant placement and restorations.
  The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the Magicore implant is treated with RBM (Resorbable Blasted media).

The provided text describes the regulatory submission for the Magicore System, an endosseous dental implant system, and its determination of substantial equivalence (SE) to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device performance study (e.g., accuracy, sensitivity, specificity, or clinical outcomes).

The document is a 510(k) summary for a dental implant system. The "acceptance criteria" here refers to demonstrating substantial equivalence to a predicate device, as required for FDA 510(k) clearance, rather than performance metrics of an AI model. The studies mentioned are primarily non-clinical (material, mechanical, sterilization, biocompatibility testing) and are leveraged from predicate devices or performed to show equivalence in basic structural and material properties. There is no mention of an AI/ML component in the Magicore System.

Therefore, I cannot provide the requested information about acceptance criteria for AI performance, sample sizes for AI test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the provided document.

The document discusses physical and material properties of a dental implant system, comparing them to legally marketed predicate devices to establish substantial equivalence.

However, if we were to interpret "acceptance criteria" in the context of this device's type (dental implants), it would refer to regulatory requirements and engineering performance specifications needed to demonstrate safety and effectiveness. Based on the provided text, here's what can be inferred about the "study" for this traditional medical device type regarding its acceptance for market clearance:

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

Since this is a 510(k) submission for a non-AI/ML dental implant device, the "acceptance criteria" are primarily related to substantial equivalence to predicate devices, material safety, mechanical performance, and sterility. The document outlines comparisons to predicate devices for various characteristics, implying these characteristics meeting equivalent or acceptable standards are the acceptance criteria.

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

• Sample Size: Not applicable in the context of an AI/ML test set. The document refers to non-clinical testing (e.g., sterilization, biocompatibility, fatigue, shelf-life). These tests typically involve a defined number of device units or material samples per standard requirements, not "patient data samples." Specific numbers of units tested are not detailed in this summary, but the tests themselves rely on established sample size methodologies for their respective standards.
• Data Provenance: Not applicable for patient data. The "data" provenance in this context refers to the source of non-clinical test reports, which are largely leveraged from previous 510(k) submissions for predicate devices by the same manufacturer (e.g., K201981, K201621, K192197, K202418, K152520, K173120). These are lab-based tests, not human study data.

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

• Not applicable. This pertains to establishing ground truth for AI model training/testing which is not relevant here. For dental implants, the "ground truth" for material, mechanical, and biological properties is established through adherence to recognized international standards (e.g., ASTM, ISO) and laboratory testing protocols.

4. Adjudication method for the test set:

• Not applicable. This refers to consensus methods for AI/ML ground truth, which is not relevant to this device's clearances.

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 type of study is relevant for diagnostic imaging AI. The document describes a physical dental implant.

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

• Not applicable. No AI algorithm is involved.

7. The type of ground truth used:

• For physical and material properties: The ground truth is based on established engineering principles, material science definitions, recognized industry standards (e.g., ASTM, ISO), and performance specifications determined through laboratory testing (e.g., mechanical strength, biocompatibility, sterility assurance levels).
• For substantial equivalence: The "ground truth" for the FDA's decision is the demonstration that the device's characteristics (intended use, design, materials, etc.) are as safe and effective as a legally marketed predicate device.

8. The sample size for the training set:

• Not applicable. There is no AI model to train.

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

• Not applicable. There is no AI model to train.

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s-Clean SQ-SL Implant System Regular 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. This system is dedicated for one- and two-stage surgical procedures. This system is intended for delayed loading.

This submission is to add new implants to the previously cleared device, s-Clean SQ-SL Implant System Regular (K192688). The newly added implant is "s-Clean SQ-SL Fixture with Ø5.2mm diameter".

The s-Clean SQ-SL Implant System Regular is composed of a fixture and cover screw. The s-Clean SQ-SL Fixture is a thread-type implant made of Commercial Pure Titanium Grade 4 according to ASTM F67 which is placed in the alveolar bone to replace the function of the missing tooth. This device has a connection between the upper prosthesis and the internal Hex.

The Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is the only part to be implanted into bone, to provide connection of prosthetic devices or other components of a dental implant set within the human body (mandibular or maxillary bone).

The document details a 510(k) premarket notification for the "s-Clean SQ-SL Implant System Regular" and relies on substantial equivalence to a predicate device (K192688) rather than presenting new clinical study data with acceptance criteria that would typically be associated with AI/ML device performance.

Therefore, the requested information elements related to AI/ML device performance, such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth, and training set details, are not applicable to this submission.

The acceptance criteria provided in the document pertain to the physical and material characteristics, manufacturing processes, and sterilization validation of the dental implant, demonstrating its equivalence to the predicate device.

Here's the information that can be extracted:

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

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

• Not Applicable. The submission leverages non-clinical test data from predicate devices (K192688 and K153639). No new clinical test set was used for the subject device to establish new performance metrics. The data provenance is implied to be from internal testing conducted by Dentis Co., Ltd. for the predicate devices.

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

• Not Applicable. No new clinical test set requiring expert ground truth was performed for this 510(k) submission.

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

• Not Applicable. No new clinical test set requiring adjudication was performed for this 510(k) submission.

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

• Not Applicable. This device is a dental implant, not an AI/ML diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant.

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

• Not Applicable. This device is a dental implant, not an AI/ML algorithm.

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

• Not Applicable. The "ground truth" here refers to the compliance with established international and national standards (e.g., ISO, ASTM, ANSI/AAMI, USP) for medical device materials, manufacturing, and sterilization, as demonstrated by the predicate devices.

8. The sample size for the training set:

• Not Applicable. This device is a dental implant, not an AI/ML device that requires a training set.

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

• Not Applicable. This device is a dental implant, not an AI/ML device.

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SD Abutment is intended for use in partially or fully edentulous maxilla, in support of single or multipleunit prosthetic restorations. SD Abutment is for single stage and two stage surgical procedures. This system is intended for delayed loading.

SD Abutment made of Ti-6A1-4V ELI alloy (ASTM F136) and/or Pure Titanium Gr4 (ASTM F67) is intended for use as an aid in single or multiple-unit prosthetic restorations. It consists of Healing Abutment, Solid Abutment, Dual Abutment, Dual Long Abutment, Angled Abutment (15° and 25°), Temporary Abutment and Abutment Screws. All abutments are supplied non-sterile and autoclaved by the end user.

This document, a 510(k) summary for the SD Abutment, details its substantial equivalence to previously marketed devices. It does not contain information about a study proving the device meets acceptance criteria derived from a performance study involving AI and human readers, nor does it provide a specific table of acceptance criteria with reported device performance.

The document primarily focuses on demonstrating that the SD Abutment is substantially equivalent to predicate devices based on design, materials, and intended use, rather than presenting a novel performance study against specific acceptance criteria. This is typical for a 510(k) submission for dental implant abutments, where the primary regulatory pathway is demonstrating substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested information from the provided text, as the document details a 510(k) submission for a dental implant abutment, not a performance study of a medical device involving AI, human readers, or specific performance metrics like those found in clinical studies for diagnostic or assistive AI tools.

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The Dentis Dental Implant System is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.

The Dentis Dental Implant System consists of three system, i-Clean System, s-Clean System, and e-Clean System. The purpose of this submission is to add various fixtures and abutment to the previously cleared device, K073486. Also, various set packing codes have been changed and it applies to the subject submission. Each system in the submission includes:

1. i-Clean System: Fixture (i-Clean Tapered Fixture/ i-Clean Straight Fixture / i-Clean Tapered II Fixture / i-Clean SAVE Fixture / i-Clean SAVE II Fixture), Abutment (i-Clean Cover Screw, i-Clean Closing Screw, i-Clean Solid Abutment, i-Clean Excellent Solid Abutment, i-Clean Healing Abutment, i-Clean Octa Abutment, i-Clean SynOcta Abutment, i-Clean InOcta Abutment, i-Clean Free Abutment, i-Clean Octa Healing Cap, i-Clean Gold UCLA, i-Clean Temporary Abutment, i-Clean Solid Healing Cap, i-Clean O-ring Abutment)
2. s-Clean System: Fixture (s-Clean Tapered Fixture/ s-Clean Straight Fixture / s-Clean SAVE Fixture / s-Clean SAVE II Fixture), Abutment (s-Clean Cover Screw, s-Clean Healing Abutment, s-Clean Free Healing Abutment, s-Clean Couple Abutment, s-Clean Free Abutment, s-Clean Sole Abutment, s-Clean Sub-Octa Abutment, s-Clean Gold UCLA Abutment, s-Clean Temporary Abutment, s-Clean Sole Healing cap, s-Clean O-Ring Abutment, s-Clean Abutment screw, s-Clean CCM UCLA Abutment)
3. e-Clean System: Fixture (e-Clean Tapered Fixture/ e-Clean Tapered II Fixture), Abutment (e-Clean Cover Screw, e-Clean Abutment Screw, e-Clean Mount Screw, e-Clean Healing Abutment ,e-Clean Cemented Abutment, e-Clean Gold UCLA Abutment, e-Clean Temporary Abutment(Ti), e-Clean O-Ring Abutment)
   The surface of the fixture has been treated with RBM (Resorbable Blasted media).

This document discusses the Dentis Dental Implant System and its substantial equivalence to previously cleared predicate devices. Since this is an unassisted device (a dental implant system), the concepts of "acceptance criteria for device performance," "test set," "training set," "experts for ground truth," "adjudication method," and "MRMC study" are not directly applicable in the way they would be for an AI/ML-driven device.

Instead, the "acceptance criteria" here relate to demonstrating that the new device (Dentis Dental Implant System with added fixtures and abutments) is as safe and effective as existing legally marketed devices. This is typically achieved through comparison to predicate devices and non-clinical testing.

Here's an interpretation of the requested information in the context of this unassisted medical device:

1. Table of Acceptance Criteria and the Reported Device Performance

For an unassisted device like this, "acceptance criteria" are not performance metrics in the sense of accuracy, sensitivity, or specificity. Instead, they are the criteria used to demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance. These typically involve demonstrating equivalence in:

• Intended Use: The purpose for which the device is used.
• Technological Characteristics: How the device achieves its intended purpose (e.g., design, materials, surface treatment, sterilization, packaging, shelf life).
• Performance Data: Non-clinical tests to confirm the device meets safety and functional requirements.

The reported device "performance" is therefore its adherence to these characteristics, demonstrating it is as safe and effective as the predicate.

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

• Sample Size: Not applicable in the context of an AI/ML device. For this unassisted medical device, "testing" refers to non-clinical bench testing (e.g., LAL, sterilization validation, shelf-life validation, biocompatibility) rather than a dataset for evaluating an algorithm's performance. The document doesn't specify the number of units or samples used for these non-clinical tests.
• Data Provenance: The non-clinical tests were performed by Dentis Co., Ltd. (South Korea) or leveraged from prior submissions for their predicate devices. The tests adhere to international standards (e.g., ISO, ASTM, USP). The country of origin for the device is South Korea.

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

• This concept is not applicable for this type of unassisted medical device. "Ground truth" established by experts is relevant for AI/ML diagnostic or prognostic devices where human experts define the correct diagnosis or outcome. For a dental implant system, the "ground truth" is typically defined by engineering specifications, material standards, and biological compatibility standards, evaluated through physical and chemical testing.

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

• This concept is not applicable as there is no test set in the AI/ML sense, and no human interpretation requiring adjudication.

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

• No MRMC study was done. This device is an implant system, not an AI-assisted diagnostic or interpretative tool that would involve human "readers."

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

• This is not applicable as this is not an algorithm or AI device.

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

• For this device, the "ground truth" is defined by established engineering and material standards, biological compatibility requirements (ISO 10993 series), and manufacturing process controls. The tests (e.g., LAL, sterilization, shelf life, biocompatibility) confirm that the device meets these pre-defined standards. There is no "ground truth" derived from expert consensus on medical images or patient outcomes data in the way an AI/ML device would use it.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so 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, so there is no "training set" or ground truth established for it.

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