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The ISO Abutment is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla. The ISO Abutment is compatible with the following fixtures.

The ISO Abutment is to be placed into the dental implant to provide support for a prosthetic restoration. The ISO Abutment is made from Titanium grade Ti-6AI-4V ELI (meets ASTM Standard F-136) and compatible with several fixtures made by 3rd party implant manufactures.

This 510(k) clearance letter details the regulatory approval for the ISO Abutment, an endosseous dental implant abutment. It establishes its substantial equivalence to a predicate device based on similar indications for use, technological characteristics, materials, design, and sterilization methods.

However, the provided document does not contain information related to software, artificial intelligence (AI), diagnostic accuracy studies, or clinical performance data typically associated with acceptance criteria tables, sample sizes for medical imaging datasets, expert adjudication, or MRMC studies. The device itself is a physical dental implant component, not an AI-powered diagnostic tool.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance (as these would be mechanical and biocompatibility tests, not diagnostic accuracy metrics)
• Sample sizes used for the test set and data provenance (not applicable for this type of device)
• Number of experts used to establish ground truth and qualifications (not applicable)
• Adjudication method (not applicable)
• MRMC comparative effectiveness study (not applicable)
• Standalone (algorithm-only) performance (not applicable)
• Type of ground truth used (e.g., pathology, outcomes data - not applicable for this device beyond engineering/material testing)
• Sample size for the training set (not applicable)
• How the ground truth for the training set was established (not applicable)

The "Non-clinical Tests" section (Page 13) describes the types of studies performed for a physical device, which include:

• Sterilization validation testing (ISO 17665-1 & 2)
• Biocompatibility tests (ISO 10993-5, -10, -11, -3, -33) including:
  • Cytotoxicity
  • Oral mucosa irritation
  • Skin sensitization
  • Acute systemic toxicity
  • Subchronic systemic toxicity
  • Bacterial reverse mutation
• Reverse engineering analysis of OEM implant body, abutment, and fixation screw (for compatibility verification)
• TiN coating tests (F1044, F1147, F1160)
• Non-clinical worst-case MRI review (using scientific evidence and published literature) to assess magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119).

These tests establish the physical, mechanical, and biological safety and compatibility of the dental abutment, rather than the diagnostic performance of an AI system.

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s-Clean Link Abutment Narrow is intended for use with dental implant as a support for single or multiple tooth prostheses in mandibular central and lateral incisors and maxillary lateral incisors.

s-Clean Link Abutment Narrow is intended for use with the s-Clean OneQ-SL Narrow Fixture according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment Narrow are intended to be manufactured at a Dentis validated milling center.

The s-Clean Link Abutment Narrow is intended to provide support for customized prosthetic restorations such as crowns and bridges. The s-Clean Link Abutment is composed of a two-piece abutment that is a link abutment at the bottom and a coping (CAD/CAM patient specific superstructure) as the top-half. The submission also includes an abutment fixation screw. The s-Clean Link Abutment are pre-manufactured (stock) abutments, made from a titanium alloy conforming to ASTM F136.

The top half of the s-Clean link abutment composed of zirconia is referenced from our previously cleared K222913 submission.

s-Clean Abutment Screw is made of Ti-6Al-4V ELI (ASTM F136) and cleared in K161244.

The diameters of s-Clean Link Abutment Narrow are 4.0 and 4.5mm.

s-Clean Link Abutment Narrow is provided non-sterile and must be sterilized after the cementation of the patientspecific superstructure on the Link Abutment Narrow.

Accessing the provided text, there is no information about an AI/ML device, its acceptance criteria, or a study proving that it meets those criteria. The document describes a traditional medical device, specifically a dental implant abutment (s-Clean Link Abutment Narrow), and its 510(k) clearance process.

Therefore, I cannot provide the requested information. The text does not contain details regarding:

1. A table of acceptance criteria and reported device performance for an AI/ML device.
2. Sample sizes or data provenance for an AI/ML test set.
3. The number or qualifications of experts for establishing ground truth for an AI/ML device.
4. Adjudication methods for an AI/ML test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study for AI assistance.
6. Stand-alone performance of an AI algorithm.
7. The type of ground truth used for an AI/ML device.
8. The sample size for an AI/ML training set.
9. How ground truth for an AI/ML training set was established.

The document focuses on non-clinical testing for equivalence to a predicate device, material testing, sterilization validation, biocompatibility, and MRI compatibility for a physical dental implant component.

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The Dentis s-Clean Abutment Mini 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.

Dentis s-Clean Abutment Mini is composed of Abutments are made of Ti-6AI-4V ELI according to ASTM F136 and Cobalt-28Chromium-6Molybdenum Alloy ASTM F1537. The s-Clean O-Ring Abutment s-Line and s-Clean TiN Half Coating Sub-Octa Abutment is screw assembled design but s-Clean CCM UCLA Abutment s-Line is screw separation design. The s-Clean TiN Half Coating Sub-Octa Abutment is always to be combined with a casting abutment (e.g., Gold Cylinder) or burn-out plastic sleeve for single-unit loading. The minimum post height of s-Clean TiN Half Coating Sub-Octa Abutment when combined with casting abutment (e.g., Gold Cylinder) or burn-out plastic sleeve for single-unit loading is 4mm. The minimum post height of s-Clean CCM UCLA Abutment s-Line for single-unit loading is 4mm. The Subject device is compatible with implants cleared in K210080. Compatible fixture diameters are Ø5.8. 6.8 and Ø7.8 and lengths are 7.5. 9.5, 11.4 and 11.5mm. Compatible fixture, K210080, has dual screw-joint (structured with Upper and Lower screw joint) and a hex anti-rotation design connection. As explained in K210080, there are two-screw-joint features, 1.6M screw (Lower part) or 2.0M Screw (Upper Part) for diverse screw connection with other abutments. s-Clean O-Ring Abutment s-Line and s-Clean TiN Half Coating Sub-Octa Abutment have Upper M2.0 Screw and s-Clean CCM UCLA Abutment s-Line has Lower M1.6 screw. When dividing screw assemble design, screw assembled one-piece abutment is connected with upper screw and screw separated twopiece abutment is connected with lower screw.

The Dentis s-Clean Abutment Mini is an endosseous dental implant system, and the provided document is a 510(k) summary for its FDA clearance. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing a standalone study with specific acceptance criteria and performance data for the subject device itself. Therefore, much of the requested information regarding acceptance criteria, performance data, sample sizes, expert ground truth, and specific study types (MRMC, standalone) as typically described for AI/ML device evaluations is not applicable or available in this kind of regulatory submission.

Instead, the document asserts substantial equivalence based on:

1. Similarities in intended use, materials, and product specifications with predicate devices.
2. Leveraging non-clinical testing data from predicate devices for biocompatibility and sterilization, as the materials and manufacturing processes are considered equivalent.
3. Scientific rationale and literature review for MRI safety, rather than new testing.

Here's a breakdown of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the context of specific performance metrics for the Dentis s-Clean Abutment Mini against defined acceptance criteria. The regulatory approval is based on demonstrating that the device is substantially equivalent to predicate devices already on the market, implying that it meets the accepted safety and effectiveness standards without necessarily requiring new, specific performance studies for this particular submission.

The document highlights the following characteristics of the subject devices (Dentis s-Clean Abutment Mini: s-Clean O-Ring Abutment s-Line, s-Clean TiN Half Coating Sub-Octa Abutment, and s-Clean CCM UCLA Abutment s-Line) and compares them to predicate devices:

2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This document does not describe a new clinical or non-clinical test set specifically for the Dentis s-Clean Abutment Mini for performance evaluation against acceptance criteria. The approach relies on substantial equivalence to predicate devices and leveraging existing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No specific "test set" with expert-established ground truth is described for this submission, as it focuses on demonstrating equivalence rather than proving new performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. As there's no defined test set for performance, adjudication methods are not relevant 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
Not applicable. This device is a physical dental implant abutment, not an AI/ML diagnostic or assistive software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical component, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided. No new ground truth data was established for performance evaluation of the subject device in this submission. The "ground truth" for the clearance is the established safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set
Not applicable. This device is a physical product, not an AI/ML model that requires training data.

9. How the ground truth for the training set was established
Not applicable. This device is a physical product, not an AI/ML model that requires training data.

Summary of the Study (Compliance with Standards and Leveraged Data):

The "study" described in this 510(k) submission is primarily a non-clinical review and comparison to predicate devices, leveraging previously established data and scientific rationale.

• Biocompatibility Testing: Performed for predicate devices and "leveraged for the subject device" because the materials (Ti-6Al-4V ELI and Cobalt-28Chromium-6Molybdenum Alloy) and manufacturing processes are substantially equivalent. Tests were conducted according to ISO 10993-1:2009.
• End User Sterilization Validation Test Report: Performed for predicate devices (K210080 for Ti-6Al-4V, K161244 for Cobalt-28Chrominum-6Molybdenum, and K171027 for Ti-6Al-4V with TiN Coating) and "leveraged for the subject device." Tests were conducted according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1. The report also mentions a test article for Cobalt-27Chrominum-6Molybdenum that was the "largest surface area among the devices that have the same manufacturing process and material," likely representing a worst-case scenario.
• Fatigue Testing: Not performed for the subject device itself, as it does not include angled abutments. This decision is based on FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," which states fatigue testing is not necessary for systems without angled abutments.
• Surface Modification Information: Not tested or provided for the subject device because it was "provided in the predicate devices and can be leveraged for the subject device," implying similar surface characteristics.
• MR Environment Condition: A non-clinical worst-case MRI review was performed. This involved evaluating the device's components (materials) against scientific rationale and published literature (e.g., Woods, Terry O., et al., 2019) to assess magnetically induced displacement force and torque. The FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" was referenced.
• Clinical Testing: This was explicitly stated as "not necessary to establish substantial equivalency of the device."

In conclusion, this regulatory submission focuses on demonstrating substantial equivalence through a rigorous comparison of the subject device's features (materials, dimensions, intended use, sterilization, surface treatment) to already-cleared predicate devices, coupled with leveraging existing non-clinical test data and scientific literature for safety aspects. It is not a performance study in the sense of establishing new acceptance criteria and demonstrating achievement through new testing specific to the subject device alone.

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CORE1 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, 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.

CORE1 Implant System 3.3mm diameter implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

CORE1 Fixture is a thread type implant made of CP Titanium Gr.4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic device or other components of a dental implant set with human body (mandibular or maxillary bone). Fixtures are provided after gamma sterilization as a set package including a cover screw or as a single fixture.

CORE1 Abutment intended for Single Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the crown. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows single prosthetic restorations to restore a patient's chewing function. Abutment Screw made of Ti-6AI-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Solid Abutment, Cement Abutment, Angled Abutment, Milling Abutment, Temporary Abutment, Solid Protect Cap, Cover Screw, Healing Abutment, Healing Abutment (Scan). Angled Abutment can select 15° and 25° angles for prosthetics, and Milling Abutment is up to 20° for hand milling only.

CORE1 Abutment intended for Multi-Unit restorations is a superstructure of a dental implant system and connecting elements between the dental implant and the bridge. It is to made of Ti-6A1-4V ELI (ASTM F136), and intended to be placed on the fixture allows multi prosthetic restorations to restore a patient's chewing function. Universal Plastic Cylinder is a burn-out device only used in the lab for casting and is not part of the final restoration. Abutment Screw made of Ti-6A1-ELI (ASTM F136) is used to connect and fix the abutment to the fixture. The contained various abutments and accessories in the system are Universal Abutment, Universal Angled Abutment, Universal Ti Cylinder, Universal Temporary Cylinder, Universal Healing Cap. Universal Angled Abutment has angles of 17%30°.

The provided document is a 510(k) summary for the CORE1 Implant System, demonstrating its substantial equivalence to predicate devices. It focuses on physical and material characteristics and performance testing based on industry standards, rather than clinical study results involving human or expert evaluation for diagnostic accuracy.

Therefore, many of the requested details, such as those related to "acceptance criteria" for diagnostic accuracy, "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details" are not applicable or extractable from this document as it pertains to a dental implant system, not an AI/diagnostic device.

However, I can extract information related to the device's performance through non-clinical testing.

Here's a breakdown of the relevant information provided:

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

The document doesn't define specific numerical "acceptance criteria" in a table format for diagnostic performance, as it's a dental implant. Instead, it describes performance through non-clinical testing against established ISO standards and FDA guidance for dental implants. The "acceptance" is demonstrated by meeting the requirements of these standards.

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

• Sample size: Not explicitly stated as a number of devices. The testing is based on performing the required tests as per relevant ISO standards. For fatigue testing, it states it was performed on "subject device and reference device K190837," implying at least one of each for the test, but typically these tests involve multiple samples to establish robustness and statistical significance as required by the standards.
• Data provenance: Not specified in terms of country of origin or whether it was retrospective/prospective. As this is non-clinical bench testing, the data is generated in a laboratory setting. The manufacturer, Cybermed Inc., is from the Republic of Korea.

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 device is a dental implant, not a diagnostic device requiring expert review for "ground truth" establishment of medical conditions. The "ground truth" for performance is based on established engineering and materials science standards for dental implants.

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

Not applicable, as this is non-clinical bench testing against established standards.

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

Not applicable. This is a dental implant, not an AI/diagnostic device.

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

Not applicable. This is a dental implant, not an AI/diagnostic device.

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

The "ground truth" for this device's performance is derived from compliance with international and national standards for medical device safety and performance, specifically for dental implants (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility, ISO 11137 for sterilization, USP for endotoxins).

8. The sample size for the training set:

Not applicable. This document does not describe a machine learning or AI algorithm, so there is no "training set."

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

Not applicable, as there is no "training set."

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The IS-III active System S-narrow Type is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

The IS-III active System S-narrow Type is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

IS-III active System_S-Narrow System is composed of IS-III active S-Narrow Type fixtures and Abutments. IS-III active Fixture S-Narrow Type is a thread type implant made of Titanium ELI according to ASTM F136 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.

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

The Fixture's diameters are 3.2 mm and the lengths are 8.5/10.0/11.5/ 13.0/ 15.0 mm. Tolerance of dimension shall be within ± 1% range.

IS-III active System S-Narrow Type Abutments are composed as below: IS Cover Screw, IS Healing Abutment, IS Cemented Abutment, IS Temporary Abutment and IS Abutment Screw

This document is a 510(k) Premarket Notification from the FDA, asserting the substantial equivalence of the Neobiotech IS-III active System S-narrow Type dental implant system to legally marketed predicate devices.

This document describes a premarket notification for a dental implant system. It does NOT contain information about an AI/ML-driven medical device or a study involving human-in-the-loop performance, expert consensus, or ground truth establishment for a test set.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as this document does not pertain to such a device or study.

The provided document focuses on:

• Device Description: What the dental implant system is composed of (fixtures, abutments, screws), materials used (Titanium ELI), dimensions, and surface treatments.
• Indications for Use: Where and how the device is intended to be used in dental procedures.
• Substantial Equivalence Comparison: A detailed comparison of the subject device (IS-III active System S-narrow Type) with various predicate devices (both primary and reference predicates) across technological characteristics such as device name, classification, materials, design, dimensions, surface treatment, sterilization, and principle of operation.
• Non-Clinical Testing Data: A list of performance tests conducted on the subject device (e.g., sterilization validation, shelf life, bacterial endotoxin) and tests leveraged from predicate devices (e.g., biocompatibility testing). The conclusion states that these tests met the criteria of the standards and demonstrated substantial equivalence.

Without information on an AI/ML component or a clinical study that evaluates its performance against acceptance criteria using a human-in-the-loop or standalone approach, I cannot fulfill the request for the specific points listed.

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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 CCM Abutment System is intended to replace missing teeth to restore chewing function. The CCM Abutment System can be placed in support of single or multiple-unit restorations including, cement retained, 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.

CCM Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. CCM Abutment System consists of UCLA Abutment and titanium abutment screws. All subject abutments are intended to be cast at zero angulations and placed on dental implant bodies which do not require angle correction.

This document is a 510(k) Premarket Notification from the FDA, asserting "substantial equivalence" of the CCM Abutment System to previously marketed devices. These types of documents focus on comparing a new device to existing ones to demonstrate similar safety and effectiveness, rather than presenting a detailed study proving the new device meets specific, pre-defined quantitative acceptance criteria through clinical trials or standalone performance evaluations (especially relevant for AI/ML devices). This document describes a dental implant abutment system, which is a physical device, not an AI/ML-driven medical device. Therefore, the information typically requested for AI/ML device performance, such as sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not applicable to this document.

The document primarily relies on non-clinical data to demonstrate substantial equivalence, focusing on materials, design, indications for use, and manufacturing processes compared to predicate devices.

Here's the information that can be extracted relevant to acceptance and performance for this physical device, framed in the context of "substantial equivalence" rather than "meeting acceptance criteria" in the way an AI/ML device would:

Acceptance Criteria and Device Performance (for a physical dental abutment system)

The "acceptance criteria" here are implicitly tied to demonstrating substantial equivalence to legally marketed predicate devices. The performance is assessed through non-clinical testing and comparison of attributes.

Since this is a 510(k) for a physical dental abutment, the "acceptance criteria" are not quantitative performance metrics in the same way they would be for an AI/ML device. Instead, they are about demonstrating that the device is as safe and effective as predicate devices.

Table of "Acceptance Criteria" (Implicit for 510(k)) and Reported Device Performance:

Study Details (as applicable to a physical device 510(k) submission):

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

   • Not applicable in the context of an AI/ML device. This document does not refer to a "test set" of patient data for algorithm evaluation.
   • For the non-clinical tests (biocompatibility, galvanic reaction), the "sample size" would refer to the number of physical device units tested according to the respective ISO/ASTM standards. These details are not provided in this summary but would be part of the full submission. The provenance is internal lab testing for a new device.

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

   • Not applicable. "Ground truth" in this context is implicitly established by the standards themselves (e.g., ISO 10993 specifications for biocompatibility) and engineering principles for mechanical functionality. Human expert consensus on a test set of images or data is not a component of this submission.

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

   • Not applicable. This refers to a process for resolving discrepancies in expert labeling or diagnoses, which is not relevant for this physical device testing.

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

   • Not applicable. This is a study design for evaluating diagnostic AI, not a physical dental device.

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

   • Not applicable. This pertains to AI/ML software.

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

   • For the non-clinical tests, the "ground truth" is defined by the specific criteria and methodologies outlined in the referenced international standards (e.g., ISO 10993 for biocompatibility, ISO 17665 for sterilization). For galvanic reaction, it's based on "corrosion potential" and "couple potential" as assessed per FDA guidance for dental implants.

7. The sample size for the training set:

   • Not applicable. This is for AI/ML model development.

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

   • Not applicable. This is for AI/ML model development.

In summary, this document is a regulatory communication for a Class II physical medical device, not an AI/ML-driven diagnostic tool. As such, the requested details related to AI/ML study design and performance criteria are not present because they are not relevant to the type of device and submission being reviewed. The "study" proving the device meets "acceptance criteria" is the set of non-clinical bench tests and comparisons performed against established predicate devices and international standards, demonstrating "substantial equivalence."

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The s-Clean TiN Coating Abutments is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root 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 s-Clean TiN Coating Abutments are device made of pure titanium and titanium alloy intended for use as an aid in prosthetic restoration. The system consists of s-Clean TiN Half Coating Angled Abutment, s-Clean TiN Half and partial Coating Couple Abutment, s-Clean TiN Half Coating Free Abutment, s-Clean TiN Half Coating FreeMill Abutment, s-Clean TiN Half Coating MOA Abutment, s-Clean TiN Partial Sub-Octa Abutment, s-Clean TiN Partial Coating Sole Abutment, s-Clean DOA Ball Abutment, s-Clean DOA Snap Abutment, and s-Clean Sole Abutment Healing Cap. The surface of the abutments is partially or half TiN Coated by using PVD (Physical Vapor Deposition). The subject device is provided non-sterile and should be sterilized before use (End user sterilization).

This document is a 510(k) summary for a dental implant abutment, and as such, it focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets acceptance criteria through a standalone clinical study with detailed performance metrics.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of submission. The information provided heavily relies on non-clinical testing and comparison to predicates.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on meeting the requirements of specific international and FDA guidance standards for medical devices, particularly for dental abutments. The reported device performance is that these tests were met.

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

• Not Applicable (N/A) for clinical data. This submission relies on non-clinical (laboratory) testing, not a clinical test set with patient data.
• The non-clinical tests (biocompatibility, fatigue, sterilization) are laboratory-based and would use a sample size appropriate for those specific engineering and biological tests, but this detail is not provided. The data provenance for these tests would be internal laboratory testing by the manufacturer or a contracted lab.

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

• N/A. As mentioned, this is a non-clinical submission. Ground truth, in the context of clinical studies and expert consensus, is not relevant here. Decisions are made based on adherence to engineering and biocompatibility standards.

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

• N/A. No clinical test set requiring expert adjudication was conducted or 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 is a dental implant abutment, not an AI-powered diagnostic or assistive device. MRMC studies are not relevant here.

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

• N/A. This is a physical medical device (dental abutment), not an algorithm or AI system.

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

• For the non-clinical tests, the "ground truth" is defined by the validated and accepted international standards (e.g., ISO, ANSI/AAMI) for mechanical performance and biocompatibility. Passing these tests according to the established metrics within the standards constitutes meeting the "ground truth" of safety and performance.

8. The sample size for the training set

• N/A. There is no "training set" as this is not a machine learning or AI product.

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

• N/A. There is no "training set" as this is not a machine learning or AI product.

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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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