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PreFace abutment, TI-Forms abutment, Titanium base 2nd generation, and Titanium base ASC Flex are intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. Abutment-level prosthetic components (Multi-unit Titanium Base, Multi-unit Titanium Cap, MedentiBASE Titanium Base) are intended for use as a support for multi-unit screw-retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.

All digitally designed abutments for use with PreFace abutment, TI-Forms abutment, Titanium base 2nd generation, Titanium base ASC Flex, Multi-unit Titanium Base, Multi-unit Titanium Cap, and MedentiBASE Titanium Base are intended to be sent to an FDA-registered Medentika validated milling center for manufacture or to be manufactured according to the digital dentistry workflow, which integrates multiple components: Scans from desktop and intra oral scanners, CAD and CAM software and milling machine with associated accessories.

Medentika abutments for the Nobel Biocare Nobel Active® 3.0 mm, Dentsply Sirona Astra Tech OsseoSpeed EV® 3.0 mm and TX® 3.0 mm, Straumann Bone Level 2.9 implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

The subject devices are Medentika CAD/CAM Abutments, which primarily expand the options for fabricating patient-specific final abutments from a "validated milling center" to a "digital dentistry workflow". This workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machines, and associated tooling and accessories. The devices include Titanium Base abutments, Titanium base ASC Flex abutments, and PreFace and TI-Form (blanks) abutments.

The abutments are made of titanium alloy (Ti-6Al-4V ELI). Titanium base abutments also include a zirconia superstructure. The specified zirconia materials for milling superstructures are Ivoclar Vivadent IPS e.max ZirCAD Prime, Ivoclar Vivadent IPS e.max ZirCAD Prime Esthetic, Amann Girrbach Zolid Bion, Amann Girrbach Zolid Gen-X, and Institut Straumann AG n!ce Zirkonia HT. The specified cement for bonding superstructures is Multilink Hybrid Abutment Cement from Ivoclar Vivadent AG.

Key design parameters for CAD/CAM zirconia superstructures (on Titanium base and Titanium base ASC Flex) include: minimum wall thickness of 0.5 mm, minimum cementable post height of 4.0 mm for single unit restorations, maximum gingival margin height of 5.0 mm, minimum gingival margin height of 0.5 mm, and maximum angulation of the final abutment of 30°.

PreFace and TI-Forms abutments (blanks) are used by dental laboratories to fabricate customized abutments from titanium alloy. Their design parameters include: minimum wall thickness of 0.4 mm, minimum cementable post height of 4.0 mm, maximum gingival margin height of 5.0 mm, minimum gingival margin height of 0.5 mm, and maximum angulation of 30°.

Prosthetic-level components (Multi-unit Titanium Base, Multi-unit Titanium Cap, MedentiBASE Titanium Base) are provided for use with previously cleared Medentika multi-unit abutments and MedentiBASE abutments.

All abutments are provided non-sterile with appropriate abutment screws. The screws attach the abutment to the implant or the prosthesis to the abutment.

The provided 510(k) clearance letter and summary describe a medical device, Medentika CAD/CAM Abutments, and its substantial equivalence to predicate devices based on non-clinical performance data. The document does not contain information about acceptance criteria or performance data for an AI/ML-based device, nor does it detail a clinical study involving human readers or expert consensus for ground truth.

Therefore, for the information requested in your prompt, I can only extract what is presented in the document, which pertains to the non-AI aspects of device acceptance and testing. Many of the points specifically refer to AI/MRMC studies, which are not applicable to this document.

Here's an analysis based on the provided text:

Device Description and Purpose:
The device is "Medentika CAD/CAM Abutments," which are dental implant abutments. The primary purpose of this submission is to expand the fabrication options for patient-specific final abutments from a "validated milling center" to a "digital dentistry workflow" that integrates CAD/CAM software and milling machines. It also adds new sizes and OEM compatibilities.

Study Type:
This is a pre-market notification (510(k)) submission seeking substantial equivalence to existing legally marketed devices. It relies heavily on non-clinical performance data to demonstrate that the new manufacturing workflow and expanded compatibilities do not raise new questions of safety or effectiveness.

Analysis of Requested Information (based on the provided document):

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

The document outlines various performance tests conducted to demonstrate substantial equivalence, but it does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance." Instead, it states that the tests demonstrate sufficient strength or ensure accuracy and reliability.

Here's a summary of the performance tests and their implied purpose:

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

• Sample Size for Test Set: The document does not specify numerical sample sizes for any of the non-clinical tests (e.g., how many abutments were mechanically tested, how many software validation tests were run). It simply states that "testing was conducted" or "validation was performed."
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of pre-market non-clinical testing for medical devices, these are typically prospective laboratory tests conducted by the manufacturer or accredited testing facilities. The manufacturer is Medentika® GmbH (Huegelsheim, Germany), suggesting the testing likely occurred in Germany or at internationally recognized labs.

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 for this device is established through engineering specifications, material standards (e.g., ASTM F136), and validated manufacturing processes, not through human expert consensus on diagnostic images.

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

This information is not applicable to the provided document, as it describes non-clinical engineering and manufacturing validation, not a multi-reader clinical study for AI.

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

This information is not applicable to the provided document. This device is a physical dental abutment and its associated CAD/CAM workflow, not an AI-based diagnostic tool that would require human reader studies. The document explicitly states: "No clinical data were included in this submission."

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

This information is not applicable to the provided document. While the device utilizes CAD/CAM software and milling machines, it is a physical product manufactured through a workflow, not a standalone AI algorithm whose performance needs to be assessed in isolation. The software functions as a design and manufacturing aid, not a diagnostic or decision-making algorithm.

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

The "ground truth" in this context refers to established engineering and material standards:

• Standards Compliance: Adherence to ISO standards (e.g., ISO 14801 for mechanical strength, ISO 10993 for biocompatibility, ISO 17665 for sterilization).
• Dimensional Accuracy: Verification against established design parameters and compatibility specifications for dental implants (e.g., OEM implant body and abutment dimensions).
• Material Specifications: Conformance to ASTM F136 for titanium alloy and specifications for zirconia and cement.
• Software Design Parameters: The "ground truth" for the CAD software validation is the pre-defined maximum and minimum design parameters that the software must enforce.

8. The sample size for the training set:

This information is not applicable to the provided document. The "device" in question is a physical dental abutment and its manufacturing workflow, not an AI/ML model that requires a training set. The CAD/CAM software itself is validated, not "trained" on a dataset in the AI sense.

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

This information is not applicable to the provided document for the same reasons as point 8.

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The Surcam Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The C Type 3.3mm diameter implants are indicated for use with only straight abutments.

Temporary cylinders must be used in a splinted restoration only and are not for single crown restorations.

The Surcam Dental Implant System consists of endosseous dental implants in conical and internal hex connections along with abutments, cover screws, healing caps and abutment systems for each connection type. Conical devices come in two platforms, NP and RP. Implants and abutments are made from ASTM F136 Ti6AL4V ELI. Multi-unit abutments are for multi-unit restorations only.

The provided text does not contain information about acceptance criteria or a study proving that an AI-powered device meets such criteria. The document is a 510(k) premarket notification for a medical device called the "Surcam Dental Implant System," which is a traditional dental implant system, not an AI device.

The document discusses:

• Device Name: Surcam Dental Implant System
• Indications for Use: Surgical and restorative applications for placement in the bone of the upper or lower jaw to support prosthetic devices (artificial teeth) to restore chewing function. It also indicates immediate loading when good primary stability is achieved.
• Device Description: Consists of endosseous dental implants (conical and internal hex connections), abutments, cover screws, healing caps, and abutment systems. Made from ASTM F136 Ti6AL4V ELI.
• Testing Summary: Dynamic fatigue testing (ISO 14801), surface cleanliness analysis, sterilization (ISO 11137-1 and 11137-2 for implants; ISO 17665-1 and -2 for abutments), material compliance (ASTM F136), endotoxin testing (USP 161), shelf life and package integrity testing (ASTM F1980, ASTM F1929, ASTM 2338, ASTM D3078, ISO 11607-1) for a shelf life of 5 years.
• MR Environment Condition: Non-clinical worst-case MRI review performed based on scientific rationale and published literature.
• Predicate and Reference Devices: Comparison with other legally marketed dental implant systems to establish substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets them, as the subject of this document is a conventional dental implant system.

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ICX-Implant System is indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. ICX- Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7.0 mm are indicated for delayed loading only.

ICX-Implant System CAD CAM abutments are intended for use with dental implants as a support for single unit or multiple unit prostheses in the maxilla of a partially or fully edentulous patient. All digitally designed abutments for use with ICX-Implant System CAD CAM abutments are intended to be manufactured at a medentis medical GmbH validated milling center.

The purpose of this submission is to obtain marketing clearance for an endosseous dental implant and abutment system. ICX-Implant System, from medentis medical GmbH. The ICX-Implant System includes a range of endosseous dental implants and prosthetic components. All implants have a selftapping apical thread with a tapered body and root-form designs with an internal hex implant/abutment connection. The implant body surface is blasted and acid-etched.

Abutments are available in multiple designs, including straight and angled abutments intended for single tooth and multi-unit restorations.

The provided text is a 510(k) summary for the "ICX-Implant System." This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to previously cleared devices rather than proving the device meets specific acceptance criteria through a standalone performance study.

Therefore, the document does not contain the detailed information required to fully answer all aspects of your request, especially regarding specific acceptance criteria for AI/algorithm performance, multi-reader multi-case studies, or detailed ground truth establishment for a test/training set in the context of an AI device.

The document does describe non-clinical performance data for the dental implant system itself (e.g., sterilization, biocompatibility, mechanical testing) to show its safety and effectiveness, but not for an AI component.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

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

• Missing: The document does not define "acceptance criteria" in the context of an AI/algorithm's performance (e.g., sensitivity, specificity, AUC). Instead, it discusses the substantial equivalence of the ICX-Implant System and its components to predicate devices based on technological characteristics, materials, and indications for use.
• The "Performance Data" section (Page 7) lists non-clinical tests performed, such as:
  • Validation of gamma irradiation sterilization to a sterility assurance level (SAL) of 10⁻⁶.
  • Bacterial endotoxin testing:

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Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm and TX 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika TiBase is intended for use with the Straumann® CARES® System. All digitally designed copings and/or crowns are intended to be sent to Straumann for manufacture at a validated milling center.
Medentika abutments for the Nobel Biocare Nobel Active®* 3.0mm, Dentsply Sirona Astra Tech OsseoSpeed EV®* 3.0mm and TX®* 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Medentika PreFace CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Medentika Preface is intended for use with the Straumann® CARES® System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann® CARES® validated milling center. The final patient matched form is a MedentiCAD abutment.
Medentika abutments for the Dentsply Sirona Astra Tech OsseoSpeed EV 3.0mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.
Multi-unit abutments are indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.

The Medentika abutments include abutments, abutment screws, caps, and bases which are labelled under a specific Medentika series and are compatible with a specified dental implant system. The abutments include sinqle-unit abutments intended for use with dental implants as a support for single or multiple tooth protheses in the maxilla or mandible of a partially or fully edentulous patient. The abutments also include multi-unit abutments indicated for use with dental implants as a support for multi-unit screw retained bridges and bars in the maxilla or mandible of a partially or fully edentulous patient.
The purpose of this premarket notification is to add additional abutments. The subject abutments include abutments compatible with additional dental implant systems forming a new Medentika series (the OT series). The subject abutments also include abutments compatible with new implant diameters in existing Medentika series (E, EV, F, and S). Lastly, the subject abutments include new abutment designs compatible with existing implant diameters in existing Medentika series (R).

This looks like a 510(k) Summary for a medical device (dental abutments), which means the document is about proving "substantial equivalence" to a predicate device, not about proving clinical effectiveness or performance against pre-defined acceptance criteria in the way one might for a novel AI/software medical device.

Therefore, the information requested in your bullet points (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) is not applicable to this type of regulatory submission because the device is a mechanical one, not an AI/software device. The data presented here is focused on demonstrating physical and mechanical compatibility and equivalence to previously cleared devices.

Here's why each point is not applicable and what information is provided:

1. A table of acceptance criteria and the reported device performance: This document doesn't provide a typical "acceptance criteria" table as would be seen for an AI/software device measuring diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating that the new abutments perform similarly to existing, cleared abutments through "dynamic fatigue testing" and "dimensional analysis and reverse engineering." The performance is implicitly "accepted" if these tests show equivalence to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No "test set" in the context of diagnostic performance is mentioned. The "testing" refers to non-clinical, physical testing (fatigue, dimensional analysis). There is no patient data involved in this type of submission for a mechanical device.

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, in the AI/software sense, is not established for this device. The "truth" is based on engineered specifications and physical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human adjudication of diagnostic output is 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 is not an AI-assisted device.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" is engineering specifications and physical measurements.

8. The sample size for the training set: Not applicable. There is no AI/machine learning component to "train."

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

What the document does provide regarding device performance and testing:

• Type of Testing:

  • Dynamic fatigue testing according to FDA guidance and ISO 14801 (Dentistry - implants dynamic loading test for endosseous dental implants).
  • Dimensional analysis and reverse engineering of the implant-to-abutment connection platform.
  • Sterilization validation (steam and gamma irradiation) referenced from K191123, ISO 17665-1, ISO/TS 17665-2, ISO 11137-1, ISO 11137-2.
  • Sterile packaging validation referenced from K191123, ISO 11607-1, ISO 11607-2.
  • Biocompatibility evaluations referenced from K142167, K170838, K191123, K150203, K061804 in accordance with ISO 10993-1.
  • MR testing referenced from K180564 in accordance with ASTM F2052-15, ASTM F2213-06 (2011), ASTM F2182-11a, and ASTM F2119-13.

• Conclusion: The tests demonstrated "implant to abutment compatibility" and "established substantial equivalency of the proposed device with predicate devices." This is the "proof" that the device meets the (implicit) acceptance of being substantially equivalent to existing, legally marketed devices.

In summary, this document is for a traditional mechanical medical device, and the regulatory pathway does not involve performance studies in the way you've outlined for AI/software-based devices.

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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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The BTI Interna Prosthetic Components are intended to function in the mandible or maxilla to support single and multiple-unit temporary or definitive restorations on the BTI Interna® Dental Implant System.

All digitally designed zirconia components for use with Aesthetic post abutments are to be sent to a BTI validated milling center for manufacture.

The purpose of this 510(k) is to expand the BTI product offering and include a variety of abutments compatible with the already cleared BTI Dental Implants. Subject device abutments include 15° Angled abutments, Transepithelial abutments, Temporary titanium abutments, Healing caps, Aesthetic post abutments and Screws. Aesthetic post abutments include Square abutments and Aesthetic interfaces for Transepithelials, as the bottom part of a two-piece abutment. A zirconia superstructure fabricated through CAD-CAM technology is the upper part of the two-piece abutment.

The subject 15º Angled Titanium abutments are designed to a BTI Interna Narrow implant, to hold single and multiple cement-retained restorations. The compatible BTI implants have been previously cleared in K211952. The abutments are offered with a 15º angulation and gingival heights of 3.0, 4.0, and 5.0 mm. They are manufactured in commercially pure titanium, with a TiN coating to enhance abutment aesthetic appearance.

The subject Temporary abutments are designed for single-unit screw-retained restorations on Transepithelial abutments are offered in prosthetic diameters of 3.5, 5.0 and 5.5 mm, with no angulation. They are manufactured from commercially pure titanium.

The subject Transepithelial abutments are designed for single-unit and multi-unit screw-retained restorations on previously cleared BTI implants. The compatible BTI implants have been previously cleared in K211952, K202825, K173257, and K151391. They are available in an engaging and a non-enqaging connection. They are offered in a prosthetic platform diameter of 3.5, 5.0 and 5.5 mm, and gingival heights ranging from 0.5 to 5.0 mm, with 0°, 17° and 30° angulation. They are manufactured from commercially pure titanium, with a TiN coating on abutment surface. The retention screw is provided with the abutment and is manufactured from titanium alloy with a DLC coating.

The subject Healing caps are designed to be connected to a Transepithelial abutment implant during the healing period, between Transepithelial placement and final dental restoration placement. These abutments are provided in prosthetic diameters of 3.5 and 5.0 mm. They are manufactured from commercially pure titanium and anodized.

The subject Aesthetic interfaces are two-piece abutments composed of a bottom half titanium component, and a patient-specific designed CAD-CAM zirconia superstructure as a top half component. The Aesthetic interfaces are to be attached to a Transepithelial abutment to hold single or multi-unit restorations. They are fabricated from commercially pure titanium, with a TiN coating to enhance abutment aesthetic appearance.

The design parameters for this top-half abutment fabrication are as follows:

• Minimum wall thickness: 0.4 mm -
• Minimum post height for single-unit restorations: 4.0 mm -
• Minimum gingival height: 0 mm in the zirconia superstructure -
• -Maximum gingival height: 6.0 mm
• -Maximum angulation: 0°

The subject Square abutments are two-piece abutments, composed of a bottom half titanium component, and a patient-specific designed CAD-CAM zirconia superstructure as a top half component. The Square abutments are to be attached to a BTI implant to hold single or multi-unit restorations. The compatible BTI implants have been previously cleared in K211952, K202825, K173257, and K151391. They are fabricated from commercially pure titanium, with a TiN coating to enhance abutment aesthetic appearance. The subject Square abutments are straight abutments (0%, and are provided in a variety of gingival heights ranging from 0.5 mm to 3.0 mm.

The design parameters for this top-half abutment fabrication are as follows:

• Minimum wall thickness: 0.4 mm -
• -Minimum post height for single-unit restorations: 4.0 mm
• Minimum qingival height: 0 mm in the zirconia superstructure -
• Maximum gingival height: 6.0 mm -

The zirconia superstructures for use with the subject Square abutments and Aesthetic Interfaces will be made at a BTI validated milling center and the material will conform to ISO 13356. The bonding cement recommended for the zirconia superstructure is Multilink Hybrid Abutment Cement (Ivoclar Vivadent AG), cleared in K130436.

The subject Screws are designed to attach Square abutments and Aesthetic Interfaces to the compatible BTI dental implant or Transepithelial abutment, respectively. The Screws are manufactured from titanium allov, with a DLC coating on screw thread. One subject Screw is also anodized for ease identification.

I am sorry, but the provided text does not contain the necessary information to describe the acceptance criteria and the study proving the device meets them, as it is a 510(k) summary for dental prosthetic components. This type of document focuses on demonstrating substantial equivalence to previously cleared devices rather than on performance studies with specific statistical acceptance criteria for a device involving AI or software.

The document discusses:

• Device Name: BTI Interna Prosthetic Components
• Regulatory Information: Class II device, product code NHA, regulation number 21 CFR 872.3630 (Endosseous Dental Implant Abutment).
• Indications for Use: To function in the mandible or maxilla to support single and multiple-unit temporary or definitive restorations on the BTI Interna® Dental Implant System. It also mentions that digitally designed zirconia components are to be sent to a BTI validated milling center for manufacture.
• Predicate Devices: Lists several predicate and reference devices, primarily other BTI Interna components and systems, and components from other manufacturers like AccelX Abutments and Medentika GmbH.
• Device Description: Detailed descriptions of various abutment types (15° Angled, Transepithelial, Temporary titanium, Healing caps, Aesthetic post abutments, and Screws), their materials (commercially pure titanium, zirconia), coatings (TiN, DLC), and design parameters (e.g., wall thickness, post height, gingival height, angulation).
• Performance Data (Non-clinical):
  • Moist heat sterilization validation.
  • Biocompatibility testing (ISO 10993-5 and ISO 10993-12).
  • Mechanical testing (ISO 14801).
  • Coating characterization.
  • Non-clinical worst-case MRI analysis.
  • Crucially, it explicitly states: "No clinical data were included in this submission."
• Technological Characteristics and Substantial Equivalence Discussion: A comparative analysis of the subject device with predicate and reference devices regarding indications for use, materials, surface treatment, restoration types, fixation methods, compatible implant platforms, dimensions (gingival height, angulation, prosthetic diameter), sterilization status, and packaging.

Why the requested information cannot be found in the provided text:

The request is for information typically found in the clinical study section of a submission for a device, especially those involving AI or software, where performance against a ground truth is evaluated. The provided document is a 510(k) summary for implant prosthetic components, which are mechanical devices, not AI/software. Therefore, concepts like "acceptance criteria" related to AI performance metrics (e.g., sensitivity, specificity), test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details are not applicable and not present in this document.

The "Performance Data" section in this document refers to non-clinical bench testing (sterilization, biocompatibility, mechanical strength, material characterization, and MRI compatibility) to demonstrate the physical and material properties of the dental components, and it explicitly states that no clinical data was included.

To answer your request, a different type of FDA submission document (e.g., one for an AI/ML-driven diagnostic or screening tool) would be required.

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The implant system is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

Anthogyr Multi-Unit prosthetic components directly or indirectly connected to the endosseous dental implants are indicated for use to provide support for multiple-unit prosthetic reconstructions such as bridges and bars. The final devices have the purpose of restoring chewing function. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase. The temporary restoration may not be placed into occlusion.

Temporary components have a maximum duration of usage of 180 days.

The OPMUN0-0 abutments are indicated for maxillary lateral and mandibular central/lateral incisors only.

The Anthogyr AXIOM® BL X3 implants are fully tapered dental bone level implants with external diameters of Ø3.4 mm, Ø4.6 mm, Ø5.2 mm, Ø5.8 mm and Ø6.4 mm and lengths of 6.5 mm, 8 mm, 10 mm, 12 mm, 16 mm, and 18 mm. The implants are manufactured from the Ti 6Al-4V ELI titanium-vanadium alloy material and are finished with BCP (Biphasic Calcium Phosphates) surface treatment. The abutment connection is identified as single conical connection.

The proposed Anthogyr Multi-Unit abutments for AXIOM® BL are dental abutments, which are intended to be screwed onto dental implants to provide support for prosthetic superstructures. Multi-Unit abutments can be used in combination with screw retrained multi-unit dental prosthetics, e.g., bars and bridges. Anthogyr Multi-Unit abutments for AXIOM® BL are very similar to the reference device Medentika Multi-Unit Abutments cleared in K191123.

Anthogyr Multi-Unit abutments for AXIOM® BL include straight and angled (18° and 30°) abutments, prosthetic screw and abutment carrier pin.

Anthoqyr Multi-Unit abutments are available as one-piece straight abutments, which have an integrated thread and can be screwed directly into the AXIOM® Bone Level implants, or as twoparts angled abutments, which can be screwed onto the AXIOM® Bone Level implant with the corresponding M1.6 screw.

Anthogyr Multi-Unit abutments for AXIOM® BL exist in two model types:

• Straight Multi-Unit abutments with various gingival heights and two platform diameters । (Ø 4.0 and Ø 4.8 mm)
• Angulated Multi-Unit abutments with various gingival heights and angulations.

Anthogyr Multi-Unit protective caps are placed to the Multi-Unit abutments and are intended to be used to protect the abutment and maintain, stabilize and form the soft tissue during the healing phase.

Anthogyr Multi-Unit temporary copings are compatible with the Multi-Unit abutments and are used for temporary restorations. The copings are placed on the Multi-Unit abutments to support temporary prosthetic superstructures. Temporary copings can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must not be placed into occlusion.

The Multi-Unit temporary copings can be adjusted by the dental technician to fit the oral situation and are fixed to a compatible Multi-Unit abutment by a M1.4 screw.

Anthogyr Flexibase for Multi-Unit abutments are compatible with the Multi-Unit abutments and are used for multiple-unit definitive restorations. The Flexibase are placed on Multi-Unit abutments to support definitive prosthetic superstructures. They are fixed to a compatible Multi-Unit abutment by a M1.4 screw.

The provided text describes a 510(k) summary for Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL. This document evaluates the substantial equivalence of new devices to existing legally marketed predicate devices, rather than establishing acceptance criteria and providing direct evidence of device performance against those criteria in a typical clinical study format.

Therefore, the requested information elements related to "acceptance criteria and reported device performance tabletop," "sample size for test set," "data provenance," "number of experts and qualifications," "adjudication method," "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are not applicable in the context of this 510(k) submission summary.

This document focuses on demonstrating that the new devices are substantially equivalent to predicate devices through comparisons of technological characteristics and performance testing (e.g., dynamic fatigue, biocompatibility, sterilization validation). The "acceptance criteria" here implicitly refer to demonstrating equivalence to the predicate devices and compliance with relevant standards and FDA guidance.

Here's an overview of the performance testing performed, interpreted as demonstrating compliance/equivalence rather than explicitly stated acceptance criteria with numerical performance targets:

1. Acceptance Criteria and Reported Device Performance:

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

• This information is not provided in the 510(k) summary. The summary refers to "tests were conducted" and "results were substantially equivalent," but actual sample sizes for mechanical, sterilization, or other tests are not detailed. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.

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

• Not applicable. This is a medical device, not an AI/software device requiring ground truth established by experts for a test set. The "ground truth" for non-AI devices is typically established through direct physical measurements, chemical analyses, and standardized test methodologies.

4. Adjudication Method for the Test Set:

• Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is not an AI/imaging device.

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

• Not applicable. This is not an AI/software device.

7. The Type of Ground Truth Used:

• For a traditional medical device like a dental implant, "ground truth" refers to established physical, chemical, and biological properties measured through standardized testing. Examples include:
  • Mechanical properties: Measured against international standards (e.g., ISO, ASTM) or FDA guidance for dental implants/abutments (e.g., fatigue strength, fracture resistance).
  • Biocompatibility: In vitro (e.g., cytotoxicity tests under ISO 10993-5) and in vivo tests (if new materials are introduced) against established biological safety profiles.
  • Sterilization efficacy: Measured by demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶ via methods compliant with ISO 11137-1 (radiation) or ISO 17665-1 (moist heat).
  • Material composition: Chemical analysis to confirm compliance with medical-grade specifications (e.g., Titanium-6Al-4V ELI conforming to ASTM F136).

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/software device that uses a "training set."

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

• Not applicable.

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Klockner Abutments are intended for use in dental implants to provide a support structure so that the edentulous or partially edentulous patients will regain their masticatory and aesthetic functions.

All digitally designed abutments for use with Klockner TiBase Abutments are intended to be sent to a SOADCO S.L. validated milling center for manufacture.

The abutments consist of healing abutments, temporary abutments, straight abutments, and an overdenture attachment system that consists of abutments, denture housings, and retention inserts, and TiBase abutments with screws.

This is a medical device 510(k) premarket notification for Klockner Abutments which are endosseous dental implant abutments. The submission aims to demonstrate substantial equivalence to previously cleared devices.

Here's the breakdown of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific performance targets (e.g., "must achieve X% accuracy"). Instead, it lists various non-clinical tests conducted to demonstrate substantial equivalence to predicate devices. The "reported device performance" is essentially that the device passed these tests in comparison to the predicate devices.

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

The document does not explicitly state a "sample size" in terms of number of patients or clinical cases for a test set, nor does it specify data provenance (country of origin, retrospective/prospective).

The studies mentioned are primarily non-clinical bench testing (e.g., sterilization, biocompatibility, mechanical testing, retention testing, coating characterization, MRI review). For these types of tests, "sample size" would refer to the number of devices or components tested, which is not detailed in this summary.

The "leveraged" data refers to studies performed on previously cleared predicate devices (K151194, K170022) and is therefore retrospective in relation to 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 typically relevant for studies involving human assessment or interpretation (e.g., imaging studies, clinical trials with expert review). Since the provided text describes primarily non-clinical bench testing, there is no mention of experts establishing ground truth in this context. The "truth" for these tests is based on objective measurements and compliance with recognized standards.

4. Adjudication Method for the Test Set

Again, this is applicable to studies with subjective assessments. As the studies are non-clinical bench tests, there is no adjudication method mentioned or applicable. Compliance is determined by objective measurements 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

No MRMC study was mentioned. This submission focuses on the substantial equivalence of a physical dental device (abutments) through non-clinical performance testing against established standards and predicates, not on AI-assisted diagnostic or interpretive tasks.

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

No standalone algorithm performance study was mentioned. The device is a physical dental implant component, not a software algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by:

• Established standards: e.g., ISO 17665-1, ISO 17665-2, ISO 10993-5, ISO 10993-10, ISO 10993-12, ISO 14801, ASTM F136, ISO 13356.
• FDA Guidance: e.g., "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," and "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."
• Performance of predicate devices: The subject device's performance is compared to that of previously cleared predicate devices (K151194, K170022, K222288, K191123, K220612) to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

There is no mention of a training set as this is not an AI/machine learning device. The studies described are non-clinical laboratory tests.

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

Since there is no training set mentioned, this question is not applicable.

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