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The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially or fully edentulous jaws for the purpose of restoring function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.

The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:

• · Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
• · BioHorizons Multi Unit Abutment, 4.8mm, max 30°
  • · CONELOG® Implant System
• · Biomet 3 i Multi Unit Abutments, 4.8mm, max 30°
  • · TSXTM Implants
  • · Tapered Screw-Vent Implant
• · DESS Dental Multi Unit Abutments, 3.4-5.7 mm, 0°
  • · 3i OSSEOTITE®
  • · Astra Tech OsseoSpeed™
  • · Neodent Grand Morse
  • NobelReplace® Trilobe
  • · NobelReplace® Conical
  • · Nobel Brånemark System®
  • · Straumann BLX Implants
• · DESS Dental Multi Unit Abutments. Angled. 3.4-6.5 mm, max 30°
  • · NobelActive® NobelParallel Conical
  • Straumann® Bone Level
  • · Zimmer Screw Vent® and Tapered Screw-Vent®
• · Dentium SuperLine® Abutments, 4.5-5.5 mm, max30°
• · Genesis ACTIVE™ Multi-Unit Abutments, 4.8mm, max 30°
• · Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
• KDG Abutments, 4.8mm, max 30°
• · Keystone Multi Unit Abutment, 4.8mm, 0°
• · Medentika Multi Unit Abutments, 4.8mm, max 30°
  • · EV Series Dentsply® Implants Astratech Osseospeed®
  • · F Series Nobel Biocare NobelActive® NobelReplace® Conical
  • · H Series Biomet 3i Certain®
  • L Series Straumann Bone Level
  • · N Series Straumann Soft tissue Level
  • · R Series Zimmer Dental Tapered Screwvent®
• Medentika Multi Unit Abutments, 4.8mm, 0°
  • E Series Nobel Biocare Replace™ Select
  • · I Series Biomet 3i Osseotite®
  • K Series Nobel Biocare™ Branemark
  • · S Series Astra Tech OsseoSpeedTM
  • · T Series Dentsply Friadent® Frialit/Xive®
• · MegaGen Multi Unit Abutments, 4.8mm, max 30°
• · Xpeed® AnyRidge® Internal Implant System
• AnyOne® Internal Implant System
• AnyRidge® Octa 1 Implant System
• AnyOne® External Implant System
• AnyRidge® Octa 1 Implant System
• AnyOne® Internal Implant System
• Rescue Internal Implant System
• MIS Multi-unit Abutments, 4.8mm
  • · C1 Conical Connection Implant System, max 30°
  • · V3 Conical Connection Implant System, max 30°
  • · Internal Hex Implant System, max 30°
  • · Conical Connection, max 30°
• · Neodent GM Mini Conical Abutment, 4.8 mm, max 30°
• · Nobel Biocare™ Brånemark Multi Unit Abutment, 4.8 mm, max 17°
• · Nobel Biocare™ Multi Unit Abutment Plus, 4.8 mm, max 30°
• · Nobel Biocare™ Multi Unit Abutment, 4.8 mm, max 30°
• Nobel Biocare™ Multi Unit Abutments for Straumann and Astra Tech System, 4.8 mm, max 30°
• Nobel Biocare™ Multi Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, 4.8 mm, max 30°
• · Nobel Biocare Xeal Abutments, 4.8 mm, max 30°
• · OSSTEM Multi Unit Abutment, 4.8mm, max 30°
  • SS SA Fixture Implants
  • SA Implant System
  • · ET US SSS Prosthetic System
• · Paltop Multi Unit Abutment, 5.0 mm, max 17°
• · Southern Compact Conical Abutments, 4.8 mm
  • MAX Implant System, 0°
  • · Provata Implant System, max 30°
  • · Deep Conical (DC) Implants, 0°
  • · Piccolo Implants, 0°
  • · External Hex Implants, max 30°
• Straumann® BLX Screw Retained Abutment, 4.6 mm, max 30°
• · Straumann® Screw Retained Abutment, 4.6 mm, max 30°
• · Zimmer Angled Tapered Abutments, 4.5 mm, max 30°

The Osteon Precision Milled Suprastructures (also referred to as superstructures) are metallic dental restorative devices that are intended to be attached by screw retention to dental implant abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function. These suprastructures attach to dental implant abutments using the prosthetic screws from the original equipment manufacturers (OEM) and are used to support the final multi-unit restoration.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's dental impression. The suprastructure is manufactured with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical.

Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence are categorized as Type A and Type B.

• Type A: Intended to act as a supporting structure to facilitate the attachment of a removable dental prosthesis and include Primary Bar and Nexus Removable Bar.
• . Type B: Intended to act as a supporting structure to facilitate the attachment of a fixed dental prosthesis and include Melbourne Bar and Nexus Fixed Bar (including Nexus Hybrid, Nexus Bridge, Micro Nexus, and Nexus Wraparound).

The provided FDA 510(k) summary (K233083) describes the acceptance criteria and study for the Osteon Precision Milled Suprastructure.

1. Table of Acceptance Criteria and Reported Device Performance

This submission is a 510(k) for an expansion of an existing device (K221019) to add compatibility with new OEM abutment systems and introduce three new Type B Nexus Fixed Bars. The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate devices in terms of intended use, technological characteristics, and material composition.

The tables below synthesize the design specifications (acceptance criteria) and the device's performance (reported as meeting these specifications) by demonstrating substantial equivalence to predicate devices.

Table 1: Comparison of General Characteristics and Materials (summarized for clarity)

Table 2: Design Specifications (Acceptance Criteria vs. Reported Performance)

*Note for Suprastructure Height: The Minimum Suprastructure Height for the Micro Nexus Bar (a new Type B bar in the subject device) is 2.5 mm, which is within the stated range of 3*-22 mm, where * indicates variability for this new bar.
**Note for Suprastructure Width: The Minimum Suprastructure Width for the Micro Nexus Bar (a new Type B bar in the subject device) is 2.5 mm, which is within the stated range of 3.4**-12 mm, where ** indicates variability for this new bar.

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

The submission is a 510(k) for an expansion of an existing device (K221019). The "study" proving the device meets acceptance criteria primarily relies on non-clinical data and demonstration of substantial equivalence to predicate devices.

• Test set/Sample size: The document does not describe a "test set" in the traditional sense of a clinical or imaging study with a defined sample size for statistical analysis. Instead, it relies on:
  • Reverse engineering analysis of OEM abutments and OEM abutment screws: This was done to confirm compatibility. The sample size for this analysis is not explicitly stated but would involve the specific OEM abutments listed for compatibility with the subject device.
  • Fatigue testing: The document states, "Fatigue testing was not performed since the Subject devices are abutment-borne and are not intended to compensate for angulation in excess of the maximum angulation of OEM angled abutments..." This indicates that engineering analysis and design specifications, rather than physical fatigue testing, were used to demonstrate performance in this regard.
• Data provenance: Not directly applicable as there isn't a "test set" from patients. The data relies on engineering analysis, existing predicate device data, and compliance with standards.

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

Not applicable. This is not a study requiring expert readers to establish ground truth. Substantial equivalence claims are based on engineering, material, and design comparisons to legally marketed devices.

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

Not applicable. There is no "test set" or diagnostic performance study that would require an adjudication method.

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 suprastructure, not an AI-powered diagnostic tool.

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

Not applicable. This device is a physical dental suprastructure, not an algorithm.

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

The "ground truth" equivalent for this submission is the established safety and effectiveness of the primary predicate device (K221019) and various reference devices, supported by:

• Compliance with recognized standards: Biocompatibility (ISO 10993-5, ISO 10993-12), sterilization validation (ANSI/AAMI/ISO 17665-1, ANSI/AAMI/ISO 17665-2, ANSI/AAMI/ISO 14937).
• Material specifications: Conformance to ASTM F136 for titanium alloy.
• Engineering analysis and design specifications: Comparison of design features to predicate devices and confirmation of compatibility through reverse engineering.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As above, there is no training set for this device.

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IH Implant System is device made of titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained restorations and terminal or interminal abutment support for fixed bridgework. IH Implant System is for stage surgical procedures. It is intended for delayed loading.

IH Implant System is device made of titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained restorations and terminal or interminal abutment support for fixed bridgework. IH Implant System is for stage surgical procedures. It is intended for delayed loading. The system includes IH2 SLA Fixtures, IH Healing Abutments, IH Cement Abutments, and IH Multi-unit Abutments. The fixtures are endosseous threaded implants with a surface treatment of sand blasting and acid etching. The abutments are premanufactured and connect directly to the implant. The materials used are Pure Titanium Grade 4 (ASTMF67-06) and Titanium Alloy (ASTM F 136).

The provided text is a 510(k) Summary for the "IH Implant System." It describes the device and its claimed substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for device performance or a study proving it meets those criteria, nor does it include details like sample sizes for test sets, data provenance, ground truth establishment, or multi-reader multi-case study results.

This document focuses on demonstrating that the new IH Implant System is safe and effective as existing legally marketed dental implant systems. The "Substantial Equivalence Review" section details how various components of the IH Implant System are similar to previously cleared devices.

The "Summary of non-clinical testing" section lists various types of tests performed to support substantial equivalence, such as:

• Endotoxin testing (USP and )
• Biological Evaluation (ISO 10993-1, Cytotoxicity Testing ISO 10993-5)
• Fatigue Testing (ISO 14801:2016)
• Gamma sterilization validation (ISO 11137-1 and ISO 11137-2)
• End User Sterilization Validation (ANSI/AAMI ST79, ISO 17665-2, ISO 11737-1, ISO 11737-2, ISO 11138-1 and ISO 11138-3)
• Shelf Life Test (ASTM F1140, ASTM F1929, ASTM F2096, ASTM F1980 and ISO 11607)
• Worst-case MRI review

However, it does not provide the specific acceptance criteria for these tests, nor does it report the quantitative results or performance metrics that would typically be described in the context of an "acceptance criteria and study" table. The document concludes that "The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate devices," implying that the device passed these tests relative to the predicate, but the specific performance data is not disclosed here.

Therefore, I cannot provide the requested table and detailed information based on the provided text. The document is a regulatory submission for substantial equivalence, not a clinical or performance study report with specific acceptance criteria and detailed device performance outcomes.

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URIS OMNI Narrow System is indicated for use in the treatment of missing maxillary lateral incisors or the mandbular central and lateral incisors, in support of single or multiple-unit restorations including: cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

The URIS OMNI Prosthetic abutments are intended for use with URIS OMNI dental implants to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

All digitally designed abutments and/or coping for use with URIS OMNI Prosthetic abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

URIS OMNI Narrow System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile. It consists of two implant lines, the OMNI Straight and the OMNI Tapered, with corresponding cover screws, healing abutments and prosthetic abutments. The OMNI Tapered implant has a tapered wall with a single thread design. The OMNI Straight implant has straight wall with smaller threading at the coronal end, and bigger threading at the apical end. Both implant lines have Narrow (Ø 3.15 mm) platform sizes. Both implant lines share the following diameters and lengths.

Ø 3.15 x 10, 11.5, 13, 14.5mm (L)

URIS Prosthetic System is made of titanium alloy (Ti-6Al-4V ELI) intended for use as an aid in prosthetic restoration. It consists of Ball Abutment, Retainer, T LOC Straight Abutment, T Loc Titanium Cap, Multi-Unit Straight Abutment, Multi-Unit Angled Abutment, Multi-Unit Healing Cap, Multi-Unit Ti Cylinder, Multi-unit temporary cylinder, Multi-Unit Cylinder screw, URIS DS, URIS Base. No additional angulation is to be included in the when using a coping or cylinder (i.e., Multi-unit Ti Cylinder, Multi-unit Temporary Cylinder, Multi-unit Base) with any of the Multi-unit Abutments.

URIS Base consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. URIS Base is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

URIS DS abutment as a patient matched titanium abutment compatible with both URIS OMNI System (K172100) and URIS OMNI Narrow System (subject).

The provided document is a 510(k) Summary for a dental implant system. It discusses the substantial equivalence of the "URIS OMNI Narrow System & Prosthetic" to predicate devices based on non-clinical testing. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of human reader performance or a standalone algorithm performance for AI/ML-driven devices.

The document states: "No clinical data were included in this submission." and focuses on demonstrating substantial equivalence through comparisons of technological characteristics and non-clinical test data.

Therefore, I cannot provide the requested information for an AI/ML device related to acceptance criteria, detailed study design, sample sizes, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies, as these types of studies are not discussed in this 510(k) summary for this device.

The "acceptance criteria" presented in this document are primarily related to the successful completion and results of non-clinical tests to demonstrate equivalence to predicate devices. These are not performance metrics for an AI/ML algorithm.

Here's an analysis of what is provided regarding acceptance criteria in the context of this traditional medical device:

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

The document implicitly defines acceptance criteria by listing the standards to which tests were performed and stating that "the results have met the criteria of the standards." The "reported device performance" is that it successfully met these standards, thereby demonstrating substantial equivalence.

2. Sample size used for the test set and the data provenance:
Not applicable for this type of non-clinical, non-AI device study. The document refers to testing on the device itself (e.g., fatigue testing, sterilization testing, biocompatibility).

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. Ground truth as typically understood for AI/ML performance is not relevant here. The "ground truth" for these tests would be the accepted parameters and methods defined by the referenced ISO/ASTM standards and FDA guidance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a human reader or AI performance study.

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. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is not an AI/ML device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable in the context of AI/ML device performance. For the described non-clinical tests, the "ground truth" is defined by the specific parameters and requirements of the referenced ISO/ASTM standards. For example, for biocompatibility, the ground truth is whether the materials meet the criteria specified in ISO 10993-1.

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

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.

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The US SA 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as bridges, or overdenture.

The US SA 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. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. The US Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration.

The provided text describes a 510(k) premarket notification for the "US SA Implant System," a dental implant device. The document focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than establishing acceptance criteria or reporting performance from a clinical study for a new device on its own merits against specific criteria.

Therefore, many of the requested details about acceptance criteria, specific device performance numbers, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not directly applicable or available in this type of submission document.

However, I can extract information related to the non-clinical testing performed to support the substantial equivalence claim.

Here's a breakdown of the information that can be gleaned from the document based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document in the format of specific numerical acceptance criteria and corresponding device performance metrics. The document instead focuses on demonstrating substantial equivalence through comparison of materials, design, indications for use, and non-clinical testing results against predicate devices. The fatigue testing was conducted according to a guidance document, implying the device met the requirements outlined in that guidance, but specific numerical thresholds and results are not detailed.

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

• Test set sample size: Not specified. The document states "fatigue testing was conducted." The number of devices or iterations in this testing is not mentioned.
• Data provenance: The testing was conducted by the manufacturer, OSSTEM IMPLANT Co., Ltd., likely in a laboratory setting. The country of origin for this specific testing is implied to be Republic of Korea, where the company is based. The nature of the testing is non-clinical (laboratory).

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

• Not applicable. This relates to clinical studies and human interpretation of data. The submission focuses on non-clinical engineering testing (fatigue, sterilization).

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

• Not applicable. This relates to clinical studies and human interpretation of data.

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

• No, an MRMC study was not done. This type of study is for comparing human performance, often in diagnostic imaging, with and without AI. This submission is for a dental implant, which is a physical device, and does not involve AI.

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

• Not applicable. This device is a physical dental implant, not an algorithm or AI system.

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

• For the fatigue testing, the "ground truth" would be the engineering standards and requirements for mechanical strength and durability of dental implants, aligned with ISO standards and FDA guidance. The determination of "success" or "failure" would be based on whether the device passed these mechanical tests without fracture or significant deformation.
• For sterilization validation, the "ground truth" is established by adherence to recognized international standards (ISO 11137 series for gamma sterilization and ISO 17665 series for steam sterilization), demonstrating acceptable sterility assurance levels.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is a physical device, not an AI model or a system that requires machine learning training.

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

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

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

• Fatigue testing: Conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment." This testing confirms the mechanical strength and durability of the implant and abutment components. The document indicates that a fatigue test was specifically performed for the US Multi Angled Abutment due to differences in connection structure and shape compared to a predicate, to confirm its strength.
• Gamma Sterilization Validation: Performed with the Fixture System according to ISO 11137-1, ISO 11137-2, and ISO 11137-3.
• Steam Sterilization Validation: Provided according to ISO 17665-1 and ISO 17665-2.
• Biocompatibility and Surface Coating Characterization: The document states that the subject devices are made of the same materials, manufacturing process, chemical composition, and body contact as predicate devices (TS Fixture System, K121995 and Multi Angled Abutment, K123755), thus demonstrating substantial equivalence in these areas.

In conclusion, this 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, indications for use, and adherence to recognized non-clinical testing standards (fatigue, sterilization) rather than presenting a clinical study with detailed acceptance criteria and performance statistics for a completely novel device.

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IH Implant System is device made of titanium and titanium alloy indicated for in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained or screw retained restorations and terminal abutment support for fixed bridgework. IH Implant System is for single and two stage surgical procedures. It is intended for delayed loading.

IH2 SLA Fixture is dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SLA (Sandblasted, Large grit and Acid etched) treated. IH2 SLA Fixture has a various diameters 3.7 to 5.1 mm (3.7, 4.2, 4.6 and 5.1mm) and lengths 8.5 to 15mm (8.5, 10, 11.5, 13 and 15mm).

IH Prosthetic System is device made of titanium alloy, CCM alloy and POM intended for use as an aid in prosthetic restoration. It consists of Abutments (Healing Abutment, Solid Abutment, Cement Abutment, Angled Abutment, Temporary Abutment, Multi-unit Abutment and FreeMilling Abutment), Solid Protect Cap, Abutment Screws, Healing Cap, Cylinders (CCM Cylinder, Temporary Cylinder, Plastic Cylinder) and Cylinder Screws. Its surfaces are partially TiN coated or uncoated. IH Prosthetic System is supplied non-sterile and should be sterilized before use. It has a various diameters, gingival heights, heights and angles.

The provided text describes information for a 510(k) premarket notification for the "IH Implant System" by Sewon Medix Inc. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets acceptance criteria through a traditional clinical study with reported performance metrics.

Therefore, many of the requested elements for a study proving device acceptance against specific criteria are not explicitly present in the provided text. The document details bench testing, specifically fatigue testing and biocompatibility, to show equivalence.

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

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this 510(k) pertains to demonstrating that the new device is as safe and effective as a legally marketed predicate device. For the non-clinical testing performed, the acceptance criteria are generally "in compliance with" or "similar to" established standards and predicate device characteristics, rather than specific performance thresholds.

Table 1: Acceptance Criteria and Reported Device Performance (Non-Clinical Equivalence)

Study Details (as far as available in the text)

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

   • The document does not specify a "test set" in the context of a clinical study or human performance evaluation.
   • For biocompatibility and fatigue testing, the sample sizes are not explicitly stated. These are typically bench tests performed on a representative number of devices.
   • Data provenance: For Fatigue Testing, it was "conducted according to... ISO 14801:2007 Dentistry - Fatigue test for endosseous dental implants with the worst case scenario." For Biocompatibility, it states "Testing including biocompatibility has been performed to demonstrate that the devices comply with the applicable international and US regulations." The text does not provide country of origin or whether it was retrospective/prospective data, as these are non-clinical lab tests.

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

   • Not applicable. This document describes non-clinical bench testing for substantial equivalence, not a study requiring human expert ground truth.

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

   • Not applicable. This is not a study requiring adjudication of expert interpretations.

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 not an AI-assisted device or an MRMC study.

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

   • Not applicable. This is a physical dental implant system, not an algorithm.

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

   • Not applicable in the sense of clinical ground truth. For non-clinical tests (biocompatibility, fatigue, surface roughness), the "ground truth" or reference is established by international standards (e.g., ISO 14801, ASTM F67-06), regulatory guidance, and the characteristics of the legally marketed predicate devices.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" as it is a physical medical device, not an AI/machine learning product.

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

   • Not applicable for the same reason mentioned above.

In summary: The provided 510(k) focuses on demonstrating substantial equivalence of a physical dental implant system through non-clinical laboratory testing. It does not present a clinical study with human subjects, associated acceptance criteria as performance metrics, or the human-involved "ground truth" and reader performance details common in studies for diagnostic devices or AI algorithms. The "acceptance criteria" here refer to meeting established safety and performance standards via bench testing to show similarity to predicate devices.

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The IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant 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.

An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The IBS Implant System is consists of dental implants, abutments, 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 system has been treated with RBM (Resorbable Blasted media) to increase junction strength by increasing the area of bone-implant interface.

There are 2 types of fixtures in this system, NR Fix and Magic FC. The NR Fix has diameters in 3.5mm and lengths in 9, 10, 11, 12, 13, 14 mm. The Magic FC has diameters in 4. 4.5. 5.0. 5.5. 6.0. 6.5mm and lengths in 7. 9. 11, 13. 15 mm.

The contained various abutments and accessories in the system are Magic Screw retained type Abutment & protect cap, Healing Abutment, Angled Abutment (hexa, non hexa), Pair Abutment (non hexa), Solid Abutment & Solid abutment cap, Magic abutcoping (transfer type, pick up type), Multiunit abutment, UCLA abutment.

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

The provided text describes a 510(k) premarket notification for the IBS Implant System, primarily focusing on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for device performance. As such, much of the requested information regarding specific acceptance criteria, detailed study parameters, ground truth establishment, sample sizes, and expert qualifications for performance evaluation (especially for AI/standalone algorithm performance) is not available in this document.

The document primarily discusses non-clinical data to support substantial equivalence.

Here's an attempt to extract the available information based on your request, followed by acknowledgments of what is missing:

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

The document does not explicitly state acceptance criteria in terms of numerical performance thresholds (e.g., specific accuracy, sensitivity, specificity, or success rates) for the device. Instead, the reported "performance" is demonstrated through compliance with recognized standards and successful non-clinical testing to show substantial equivalence.

Missing Information (Not available in the provided text):

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

• The document mentions "non-clinical tests" and "fatigue test" but does not detail the sample sizes (e.g., number of implant samples tested) or data provenance (e.g., from which specific test batches or labs). No human or clinical data is mentioned, so no information on retrospective/prospective human data.

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

• Not applicable as no human-expert-evaluated test set is described. The "ground truth" for the non-clinical tests would be the established performance metrics or compliance standards.

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

• Not applicable as no human-expert evaluation/adjudication 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

• No MRMC or AI-assisted study is mentioned. This filing is for a physical dental implant system, not an AI software device.

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

• Not applicable; this is not an AI algorithm.

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

• For the non-clinical tests (sterilization, fatigue, surface analysis), the "ground truth" would be established by the specifications of the relevant ISO and ASTM standards and the results obtained from laboratory testing (e.g., successful biological indicator kill for sterilization, passing cycles for fatigue).

8. The sample size for the training set

• Not applicable; this is not an AI algorithm.

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

• Not applicable; this is not an AI algorithm.

Summary of what the document confirms:

The IBS Implant System received 510(k) clearance by demonstrating substantial equivalence to existing predicate devices. This was supported by:

• Matching intended use.
• Identical material composition (Ti-6AL-4V Eli conforming to ASTM F-136).
• Compliance with non-clinical testing standards including ISO 11137-1:2006, ISO 11137-2:2009 for sterilization validation, and ISO 14801:2007 for fatigue testing.
• Similar surface treatment (R.B.M.).
• A general statement of being "designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments."

The review process focused on these points to confirm that the new device does not raise new questions of safety and effectiveness compared to the already marketed predicate devices.

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