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Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Keystone® Dental PrimaConnex® Implant System, Neodent® GM Implant System, Straumann® BLX Implant System, Implant Direct® Legacy® Implant System, Implant Direct® InterActive® Implant System, Implant Direct® RePlant® Implant System. The products are made from titanium alloy Ti-6A1-4V ELI, which meets ASTM F136-13(2021), Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). They include Inclusive® Titanium Abutment Blanks intended to be used to fabricate one-piece, all-titanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH and 6mmH intended to be used for support of fabricated crowns/bridges or a zirconia coping to complete the two-piece abutment. The zirconium coping intended for use with the Inclusive® Titanium Abutments are made from zirconium oxide ceramic, conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top-half which when cemented together (Shofu MonoCem K020481) constitutes the final finished abutment. Each patient-specific abutment is prescribed by a clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft Inc. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use.

Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136-13(2021) and used in conjunction with the OEM Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® multi-unit abutments. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multiunit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.

The provided document is a 510(k) Summary for a dental device (Inclusive® Titanium Abutments). It details the device's technical characteristics and claims substantial equivalence to a predicate device based on non-clinical testing. However, it does not include specific quantitative acceptance criteria or detailed results of a study designed to compare the device performance against such criteria.

The document discusses "performance data" in general terms, referring to several non-clinical tests (Biocompatibility, Mechanical Properties, Sterilization Validation, Shelf Life and Packaging Validation, and Use in MR Environment). It states that these tests were performed to "demonstrate substantial equivalence" and to "address questions related to substantial equivalence based on the differences in technical specifications," but it doesn't present the data in a way that allows for filling out the requested table of acceptance criteria and reported performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 regarding sample size, data provenance, expert involvement, adjudication, MRMC studies, or training set details, as this information is not present in the provided text.

The document explicitly states:

• "Non-clinical testing data are submitted to demonstrate substantial equivalence. No clinical data was included in this submission."

This indicates that clinical trials with human subjects, which would typically involve expert ground truth establishment and detailed performance metrics comparing against specific acceptance criteria, were not part of this submission for substantial equivalence.

The "Mechanical Properties" section mentions:

• "Static load and fatigue testing of the implant/abutment assembly was considered according to the FDA Guidance Document, Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments and ISO 14801:2016 standard with the worst-case scenario. The fatigue limit data demonstrated that the subject device has sufficient strength for its intended use."

This implies that there were performance targets based on ISO 14801:2016 for fatigue strength, but the specific acceptance critiera (e.g., minimum fatigue strength in Newtons) and the actual reported performance values are not provided in this summary. It only states that the device "has sufficient strength."

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Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Compatible Implant System: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic®

Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Neoss® ProActive® Narrow Implant System, Neoss® ProActive® Standard Implant System, MIS® SEVEN® Implant System, and Zimmer® Eztetic® Implant System. The products are made from titanium alloy Ti-6A1-4V ELI, which meets ASTM standard F136. They include Inclusive® Titanium Abutment Blanks intended to be used to fabricate one-piece, all-titanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH intended to be used for support of fabricated crowns/bridges or a zirconia coping to complete the two-piece abutment. Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top-half which when cemented together (Shofu MonoCem K020481) constitutes the final finished abutment. Each patient-specific abutment is prescribed by a clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft Inc. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use.

Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6A1-4V ELI conforming to ASTM F136 and used in conjunction with the Neoss® ProActive® Standard and MIS® SEVEN® multi-unit abutment. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multi-unit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.

This document is a 510(k) premarket notification for Inclusive® Titanium Abutments. It describes the device, its intended use, and provides a comparison to a predicate device to demonstrate substantial equivalence, rather than standalone performance criteria. Therefore, the information typically requested in your prompt regarding acceptance criteria and a study proving device meeting those criteria (especially for AI/software devices) is not directly applicable to this submission.

This is a submission for a physical medical device (dental abutments), and the "acceptance criteria" here refer to demonstrating substantial equivalence to a legally marketed predicate device, rather than the performance metrics of a diagnostic or AI algorithm.

However, I can extract the relevant information regarding the performance data and the aspects that were tested to demonstrate substantial equivalence, which serves a similar purpose in this context:

Summary of Performance Data (to demonstrate Substantial Equivalence):

Additional Information based on the provided text:

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

   • Biocompatibility: The text does not specify a separate "test set" sample size for dedicated biocompatibility testing on this specific device, as it leverages existing data. It states, "additional biocompatibility testing was not conducted" due to identical materials, manufacturing, and facility as the predicate (K191222) and reference device (K160979). Cytotoxicity testing (ISO 10993-5) was referenced from K160979.
   • Mechanical Properties: The document states that static load and fatigue testing was performed "with the worst-case scenario." It does not specify the number of samples tested for this specific submission, but it would have been a sufficient number to meet the requirements of ISO 14801:2016. Data provenance is implied to be internal testing by Prismatik Dentalcraft, Inc.
   • Sterilization: No sample size is specified, as "additional sterilization was not conducted" for this submission due to identical materials, manufacturing, and parameters as predicate and reference devices. Validation was referenced from K083192 and K160979.
   • Packaging: "A packaging validation according to ASTM D4169-16 was conducted" but no specific sample size is mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a physical device submission relying on established engineering standards and material properties, not an AI or diagnostic device that requires expert-established ground truth for its performance assessment.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device submission for dental abutments.

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 pertains to AI/software performance, not a physical dental implant component.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This pertains to AI/software performance.

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

   • "Ground truth" in this context is based on established engineering standards (e.g., ISO 14801:2016 for dynamic loading, ISO 10993-1 for biocompatibility, ISO 17665-1/2 for sterilization, ASTM D4169-16 for packaging), material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI), and dimensional analysis / reverse engineering for compatibility with OEM implant systems. Biocompatibility also referenced cytotoxicity testing (ISO 10993-5) from a previous submission.

7. The sample size for the training set: Not applicable. This is not an AI/machine learning device.

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

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Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Compatible Implant Systems: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1

Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Straumann® Bone Level SC Implant System, BioHorizons® Tapered Internal Implant System and MIS® C1 Implant System. The products are made from titanium alloy Ti-6Al-4V ELI, which meets ASTM standard F136. They include Inclusive® Titanium Abutment Blanks intended to fabricate one-piece, alltitanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH and 6mmH intended to be used for support of fabricated crowns/bridges or zirconia copings. Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top half. Each patient-specific abutment is prescribed by a clinician and manufactured by Prismatik Dentalcraft, Inc. or a qualified validated milling center. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use.

Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136 and used in conjunction with the OEM BioHorizons® Tapered Internal and OEM MIS® C1 multi-unit abutment. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multi-unit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.

The provided text describes a medical device called "Inclusive® Titanium Abutments" and details its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered medical device.

The document is a 510(k) summary for a dental implant abutment, which is a physical component, not a software device or an AI/ML powered device. The "performance data" section focuses on physical and material properties (Biocompatibility Evaluation, Mechanical Properties, Sterilization Validation, Shelf Life and Packaging Validation, Use in MR Environment) to demonstrate substantial equivalence to a predicate device, as opposed to functional performance metrics for an AI/ML algorithm.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Specifically, the following information is not available:

1. A table of acceptance criteria and the reported device performance (for an AI/ML device): The document discusses performance related to physical properties and material compatibility, not AI/ML metrics.
2. Sample size used for the test set and the data provenance: Not applicable to this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable in the AI/ML sense. "Ground truth" here relates to established standards for material science and dental mechanics.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations.

All digitally designed abutments for use with Inclusive Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Compatible Implant System: Dentsply Implants Astra Tech Implant System® EV

Inclusive® Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV, which are the subject of this submission, are designed and fabricated to be compatible exclusively with Dentsply Implants Astra Tech Implant System EV, and have a prefabricated, precision interface (implant/abutment connection) compatible with the primary predicate device connection. The proposed product line includes stock abutments and abutments intended for fabrication of patient-specific custom abutments using CAD/CAM technology. Each patient-specific abutment is individually prescribed by the clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft.

The subject devices are manufactured from titanium alloy conforming to ASTM F136, and have a taper followed by a keyway connection feature that prevents rotation of the abutment. The abutments are compatible exclusively with the Astra Tech OsseoSpeed EV implant line (cleared under K120414) in the following diameters: 3.0S, 3.6S, 4.2S, 4.2C, 4.8S, 4.8C, 5.4S mm. The subject device includes the following components: Titanium Abutment Blanks, intended to fabricate all-titanium, patientspecific abutments using CAD/CAM technology; Titanium Abutment 4.5mmH and Titanium Abutment 6mmH, intended to be used for support of CAD/CAM fabricated crowns/bridges or zirconia copings; Titanium Esthetic Abutments, prefabricated abutments intended to be connected directly to an endosseous implant for retention of a prosthesis in straight and 15° angled designs; and Titanium Screws, indicated for the temporary or long-term retention of the abutments to the compatible dental implant fixtures. All subject device components are provided non-sterile.

Titanium Abutment 4.5mmH are two-piece abutments. The crowns/bridges or zirconia copings produced at the validated milling center compose the second part of the two piece abutment.

The provided text describes the 510(k) premarket notification for Inclusive® Titanium Abutments compatible with Dentsply Implants Astra Tech Implant System® EV. This document is a regulatory submission for a dental device, not an AI/ML medical device. Therefore, the information requested in your prompt regarding acceptance criteria and study proving performance for an AI/ML device (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this document.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical performance data.

Here's an analysis based on the information that is available in the document:

Device Type: Dental Implant Abutment (Hardware, not Software/AI)

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

Since this is a hardware device submission, the "acceptance criteria" are related to mechanical, material, and biological compatibility, and "performance" refers to demonstrating equivalence to a predicate device through non-clinical testing.

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

• Test Set Sample Size: Not explicitly stated as "sample size" in the context of statistical testing for AI/ML. For mechanical testing, it would refer to the number of abutments tested, which is not detailed in the summary (e.g., "Worst-case constructs were subjected to static compression and compression fatigue testing.").
• Data Provenance: The studies are non-clinical, likely conducted in a lab environment rather than on human patients. The document does not specify a country of origin for the testing data, beyond the manufacturer being in Irvine, CA, USA.
• Retrospective/Prospective: Not applicable, as this refers to non-clinical lab testing of a hardware device.

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

• Not Applicable. This is a hardware device not requiring human interpretation of medical images or data for "ground truth" establishment in the AI/ML sense. The "ground truth" here is adherence to engineering specifications and performance standards, validated by accredited testing methods.

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

• Not Applicable. No human adjudication process is described or implied for the performance validation of this hardware device.

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 hardware device; no human reader or AI assistance is involved in its use or evaluation for regulatory purposes. 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:

• Not Applicable. There is no algorithm for standalone performance. This device is a physical component used in dental procedures.

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

• For Hardware Devices: The "ground truth" is defined by established engineering and material standards, validated through laboratory tests:
  • Mechanical Integrity: Conformance to ISO 14801 (static compression and fatigue limits).
  • Biocompatibility: Conformance to ISO 10993 series.
  • Sterilization: Conformance to ISO 17665-1.
  • Dimensional Accuracy: Verified through reverse engineering and dimensional analysis against OEM specifications.

8. The sample size for the training set:

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

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

• Not Applicable. As above, no training set for an AI/ML algorithm is involved.

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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 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.

The subject device includes two CAD/CAM abutment designs, the Medentika TiBase and the Medentika PreFace. The TiBase is a two-piece abutment used as a base when fabricating a zirconia superstructure and the PreFace is an abutment used in fabricating a full patient-specific abutment in titanium alloy. Both abutment designs are provided non-sterile and are intended to be sterilized by the clinician. Medentika Preface Abutment is available in diameters 3.0 mm to 7.0 mm. Medentika TiBase Abutment is available in diameters 3.25 mm to 7.0 mm. The specific diameters for each Series coordinate with the compatible implant systems and sizes listed below.

TiBase is available in two post designs. TiBase Generation 1 has a conically shaped post that is 4.0 mm high and TiBase Generation 2 has a parallel walled post shape that is 5.5 mm high. PreFace is available in one cylinder height of 20 mm. The maximum angle for abutments fabricated using TiBase or PreFace is 30°, the maximum gingival height is 6 mm and the minimum post height is 4 mm.

Medentika CAD/CAM Abutments are compatible with eleven dental implant systems. Each Medentika abutment series has a precision implant/abutment interface corresponding to the implant system predicate for that series.

The provided document is a 510(k) premarket notification for Medentika CAD/CAM Abutments, asserting substantial equivalence to legally marketed predicate devices. It does not describe a study involving an AI/ML powered device, nor does it detail acceptance criteria related to such a device's performance. Instead, it focuses on non-clinical testing to demonstrate safety and effectiveness for a dental abutment. Therefore, I cannot extract the requested information regarding acceptance criteria, study design for AI/ML performance, ground truth establishment, or human-in-the-loop studies from this document.

The "Performance Data" section (Page 6/7) explicitly states the types of non-clinical testing conducted:

• Engineering analysis and dimensional analysis: To determine compatibility with original manufacturers' components.
• Static and dynamic compression-bending testing: According to ISO 14801 (Dentistry – Implants – Dynamic fatigue test for endosseous dental implants).
• Sterilization testing: According to ISO 17665-1 and ISO 17665-2 to demonstrate an SAL of 10^-6.
• Biocompatibility testing: For cytotoxicity according to ISO 10993-5.

The acceptance criteria would be the successful completion of these tests in accordance with the specified ISO standards and demonstrating compatibility and performance comparable to the predicate devices. However, the document does not list the quantitative acceptance criteria or the specific numerical results obtained for each test (e.g., specific fatigue life, or precise dimensional tolerances met).

In summary, the document does not contain the information required to answer the prompt as it pertains to AI/ML device performance. The device is a physical medical device (dental abutments), and the review is for substantial equivalence based on physical and mechanical properties, not an AI/ML algorithm.

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