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TDS Abutment for Friadent Xive is 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.

This device is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Internal Connect Type; Astra: Osseospeed Implant, Osseospeed TX Implant; BioHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok® 3.0 implant system; Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active Implant.

TDS Abutment for Friadent Xive are titanium and ceramic-titanium abutments designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutment for Friadent Xive is compatible with the following implant systems which have an internal hex with flat-to-flat dimensions of 1.78mm or greater: Firadent: FRIALIT Implant, XiVA Implant; 3i: Internal Connect Type; Astra: Osseospeed Implant, Osseospeed TX Implant; BirHorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System, Laser-lok 3.0 implant system; Lifecore: Lifecore RENOVA™ Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System; Osstem: GS System; Nobel Biocare: Active Impalnt.

The provided document describes the K103339 510(k) Premarket Notification for the "TDS Abutment for Friadent Xive." This device is a dental implant abutment.

Here's an analysis of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Study: The primary study conducted was non-clinical testing focusing on mechanical strength and compatibility.

The document does not suggest an AI/ML device. Therefore, the following points are not applicable to the provided information.

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

Not applicable, as this is a mechanical medical device, not an AI/ML device, and no clinical data (test set) is described in the provided summary. The testing was non-clinical.

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 this is a mechanical medical device, not an AI/ML device. Ground truth, in the context of expert consensus for medical imaging, is not relevant here. The "ground truth" for mechanical performance is established by standardized testing protocols (ISO 14801).

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

Not applicable, as this is a mechanical medical device, not an AI/ML device with a human-adjudicated test set.

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, as this is a mechanical medical device and not related to AI assistance for human readers.

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

Not applicable, as this is a mechanical medical device and not an algorithm.

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

For the mechanical strength testing, the "ground truth" or the success criteria would be defined by the acceptance limits specified in the ISO 14801 Dentistry - Fatigue test for endosseous dental implants standard. For compatibility testing, the "ground truth" is appropriate fit based on measured dimensions, tolerances, and rotation parameters. This is a technical standard-based ground truth.

8. The sample size for the training set

Not applicable, as this is a mechanical medical device and not an AI/ML device that requires a training set.

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

Not applicable, as this is a mechanical medical device and not an AI/ML device.

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TDS Precision Dental Bars are indicated for use with dental implants as a prosthetic framework to support and/or retain removable or fixed dental prostheses in the treatment of partially or totally edentulous jaws to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.

TDS Precision Dental Bars are prosthetic frameworks and made of machined titanium, zirconia-titanium, and zirconia materials. They are connected with dental implants utilizing the TDS screw which is made of Ti-6A1-4V ELI (Extra Low Interstitial) alloy. TDS Precision Dental Bars are fabricated individually following instructions to each patient and serve to support and/or retain fixed dental prosthesis or removable dental prosthesis. They are compatible with dental implants manufactured by NobelBiocare, Camlog, BIOMET 3i, Zimmer, Lifecore, Astra, BioHorizons, Straumann, Dentsply Friadent, and Osstem.

Here's an analysis of the provided text regarding the acceptance criteria and study for the TDS Precision Dental Bar:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the numerical sample size for the mechanical and compatibility testing. It refers to "a worst-case scenario" for fatigue testing.
• Data Provenance: The study was conducted by Pou Yu Biotechnology Co., Ltd. in Taiwan. The text does not specify if the data is retrospective or prospective, but given it's a pre-market notification for a new device, the testing would generally be prospective in nature, specifically for the purpose of demonstrating device performance.

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

• The document does not mention the use of experts to establish a "ground truth" in the traditional sense of medical image analysis or diagnostic studies. The evaluation is based on objective engineering and mechanical testing standards (ISO 14801) and physical assessments of fit. Therefore, this information is not applicable in this context.

4. Adjudication Method for the Test Set

• This is not applicable as the study involves mechanical and compatibility testing against defined engineering standards and physical measurements, not interpretation by human experts that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human interpretation is involved. The TDS Precision Dental Bar is a prosthetic device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Yes, the described testing is fundamentally a standalone evaluation of the device's physical and mechanical properties. There is no "human-in-the-loop" component as the device is a physical prosthetic, not a diagnostic algorithm. The tests (fatigue, compatibility) assess the device itself.

7. Type of Ground Truth Used

• The "ground truth" in this context is established by engineering standards and physical measurements.
  • For mechanical strength: Compliance with performance requirements of ISO 14801 Dentistry - Fatigue test for endosseous dental implants.
  • For compatibility and fit: Dimensional, tolerance, and rotation parameters with specified implant systems.

8. Sample Size for the Training Set

• This concept is not applicable here. The TDS Precision Dental Bar is a manufactured component whose performance is assessed through physical testing, not a "training set" for an algorithm or AI model.

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

• Not applicable as there is no "training set" in the context of this device's evaluation.

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TDS Zirconia Abutment for Nobel Biocare Branemark is 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.
This device is compatible with the following implant systems which have an external hex with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare: Branemark System® Mk III Groovy, Branemark System® Mk III Shorty, Branemark System® Zygoma, NobelSpeedy Groovy, NobelSpeedy Shorty; 3i: Nano Tite External Hex Connection Implants, Full OSSEOTITE External Hex Connection Implants, OSSEOTITE External Hex Connection Implant; BioHorizons: Maestro - External Hex Implants; Lifecore: Restore External Hex Implant Systems.

TDS Zirconia Abutment for Nobel Biocare Branemark are zirconia abutments made of yttria-stabilized zircona (Y-TZP) designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Zirconia Abutment for Nobel Biocare Branemark is compatible with the following implant systems which have an external hex with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.

This looks like a 510(k) premarket notification for a dental implant abutment, not a study describing the acceptance criteria or performance of an AI medical device. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting clinical study data for an AI algorithm.

Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and AI performance metrics cannot be extracted from this document.

Here's an assessment based on the provided text:

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

   • Not applicable. This document is for a physical medical device (dental abutment), not an AI algorithm. It focuses on demonstrating substantial equivalence to a predicate device, not performance against specific clinical acceptance criteria in a study.

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

   • Not applicable. No test set or clinical data is presented for performance evaluation.

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. No ground truth establishment for a test set is discussed.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 device.

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

   • Not applicable. This is not an AI device.

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

   • Not applicable. No ground truth is discussed in the context of an AI algorithm evaluation.

8. The sample size for the training set

   • Not applicable. This is not an AI device that requires a training set.

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

   • Not applicable.

In summary, the provided document is a regulatory submission for a dental implant abutment, a physical medical device. It does not contain information about AI algorithm performance, clinical studies, acceptance criteria, or ground truth establishment as would be relevant for an AI-based medical device.

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TDS Titanium Abutment for Nobel Biocare Branemark is 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.

This device is compatible with the following implant systems which have an external hex with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare: Branemark System® Mk III Groovy, Branemark System® Mk III Shorty, Branemark System® Zygoma, NobelSpeedy Groovy, NobelSpeedy Shorty; 3i: Nano Tite External Hex Connection Implants, Full OSSEOTITE External Hex Connection Implants, OSSEOTITE External Hex Connection Implant; BioHorizons: Maestro - External Hex Implants; Lifecore: Restore External Hex Implant Systems.

TDS Titanium Abutment for Nobel Biocare Branemark are titanium abutments made of Ti-6A1-4V ELI titanium designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is also made of Ti-6A1-4V ELI titanium and is used to secure the abutment to the implant. In combination with the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Titanium Abutment for Nobel Biocare Branemark is compatible with the following implant systems which have an external hex with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.

The provided text is a 510(k) summary for a dental implant abutment, not a description of a device that uses AI or machine learning. Therefore, the questions about acceptance criteria, study details, and performance metrics for an AI/ML device cannot be answered from the provided text.

The document states that the device is "substantially equivalent in indications and design principles to predicate devices." This substantial equivalence is the primary "acceptance criterion" described, implying that its performance is implicitly accepted if it is similar to already approved predicate devices. No specific quantitative performance metrics or studies proving those metrics are provided.

Here's an attempted breakdown based on the information available, emphasizing what is not present:

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

   • Acceptance Criteria: The primary acceptance criterion for the 510(k) pathway is demonstrating "substantial equivalence" to a legally marketed predicate device. This means the device has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, the differences do not raise new questions of safety and effectiveness.
   • Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity, AUC) are reported for the TDS Titanium Abutment. The document states it is made of "Ti-6A1-4V ELI titanium" and is compatible with certain implant systems. This implies its mechanical and biocompatibility performance is considered equivalent to similar titanium abutments already on the market.

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

   • Not applicable. This device is a mechanical component (dental abutment), not an AI/ML diagnostic tool. There is no "test set" in the context of AI/ML evaluation. Performance is typically assessed through engineering design verification and validation (e.g., mechanical testing, biocompatibility studies), but details of these studies are not provided in this 510(k) summary.

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

   • Not applicable. This is not an AI/ML diagnostic device requiring expert ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) 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 a medical device (dental abutment), not an AI assistance tool for human readers.

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 in the AI/ML sense. For a mechanical device, "ground truth" might refer to fundamental engineering principles, material properties, and established biological responses to materials (biocompatibility). The manufacturer would rely on standards for material composition (Ti-6A1-4V ELI titanium) and mechanical properties for dental applications.

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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TDS Abutment for Nobel Biocare Replace is 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.

TDS Abutment for Nobel Biocare Replace is compatible with the following implant systems: Nobel Replace® Select Straight, Nobel Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage, Nobel Replace Straight, Nobel Replace Tapered, Nobel Replace Straight Groovy, and Nobel Replace Tapered Groovy for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) implants.

Note: Highly angled abutments (i.e. 30°) on implants with diameters less than 4 mm are not intended for the posterior region of the mouth due to limited strength of the implant.

TDS Abutment for Nobel Biocare Replace are titanium and ceramic-titanium abutments designed to be used in conjunction with specific dental implants utilizing the TDS Abutment screw, which is made of Ti-6A1-V ELI titanium and is used to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutment for Nobel Biocare Replace are compatible with Nobel Replace® Select Straight, Nobel Replace Select Straight One Stage, Replace Select Tapered and Replace Select Tapered One Stage, Nobel Replace Straight, Nobel Replace Tapered, Nobel Replace Straight Groovy, and Nobel Replace Tapered Groovy for the 3.5 mm (NP), 4.3 mm (RP), 5.0 mm (WP) and 6.0 mm (WP) implants.

This document is a 510(k) Premarket Notification for a dental implant abutment (TDS Abutment for Nobel Biocare Replace). It is a regulatory submission to demonstrate substantial equivalence to legally marketed predicate devices, not a study reporting on the performance of the device against specific acceptance criteria.

Therefore, the requested information (acceptance criteria, device performance, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, and training set information) is not present in the provided text.

The document primarily focuses on:

• Administrative Information: Manufacturer, contact, device names, classification.
• Intended Use: What the device is designed for.
• Device Description: Materials, compatibility with specific implant systems.
• Equivalence to Marketed Device: Asserting substantial equivalence to existing predicate devices.
• FDA Communication: A letter from the FDA affirming the substantial equivalence determination and outlining regulatory obligations.
• Indications for Use: Formal statement of the device's indications.

The FDA's substantial equivalence determination means they believe the new device is as safe and effective as a legally marketed predicate device, not that specific performance metrics against an acceptance criterion were reported in this submission or that a large-scale clinical study was conducted. For this type of device, substantial equivalence is often established through material testing, mechanical testing, and comparison of design features and intended use to predicate devices, rather than through extensive clinical trials with detailed performance metrics like sensitivity/specificity.

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TDS Abutment is 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.

TDS Abutments are custom titanium or ceramic abutments designed to be used in conjunction with specific dental implants utilizing the screw provided by the implant manufacturer. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch. TDS Abutments made of titanium are available for Nobel Biocare Replace® RP (Ø 4.3 mm) implants. TDS Abutments made of ceramic are available for Nobel Biocare Replace® WP (Ø 5.0 mm) implants and BioHorizons Internal 4.0 (Ø 4.5 mm platform) implants.

This document is a 510(k) premarket notification for a dental device, the TDS Abutment. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device) and does not require premarket approval (PMA). The key aspect of a 510(k) submission is establishing substantial equivalence to an existing predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies.

Therefore, I cannot provide the requested information from this document because it is not present in the provided text. The document focuses on administrative information, device description, and the FDA's clearance decision based on substantial equivalence.

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