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The Tru Abutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.

It is compatible with the following systems:

• · Astra Tech OsseoSpeed™ EV 3.0. 3.6, 4.2, 4.8, 5.4 mm
• · Nobel Active™ Internal Connection Implant 3.5, 4.3, 5.0, 5.5 mm
• · Straumann® Bone Level Implants 3.3, 4.1, 4.8 mm

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

The TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or "Screw- and Cement-Retained Prosthesis" (SCRP) restorations. The patient-specific abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-I 36). Each patient-specific abutment is supplied with two identical screws which are used for:

• (1) For fixing into the endosseous implant
• (2) For dental laboratory use during construction of related restoration.

The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.

Mechanical resistance of the implant-abutment connection is essential to ensure correct long-term functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of bases and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established.

The proposed patient-specific abutments are available in internal connections and are compatible with:

• Astra Tech OsseoSpeed™ EV (K120414, K130999)
• Nobel Active™ Internal Connection Implant (K071370) ●
• Straumann® Bone Level Implants (K062129, K140878, K153758, K150938)

The provided text describes the regulatory submission for the TruAbutment DS, a patient-specific CAD/CAM abutment for dental implants. The core of the submission is to demonstrate "substantial equivalence" to existing predicate devices, rather than proving effectiveness through a traditional clinical study with defined acceptance criteria and effect sizes.

Therefore, the information you're asking for regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not directly applicable or available in this document in the way it would be for a machine learning or AI-driven device performance study.

This document focuses on non-clinical testing to demonstrate the physical performance and compatibility of the device.

Here's how to address your request based on the provided document:

Acceptance Criteria and Device Performance

The "acceptance criteria" here are defined by the relevant ISO standards and FDA guidance for dental implant abutments, specifically related to mechanical integrity and biocompatibility, as well as dimensional compatibility with specified implant systems. The "device performance" is reported as having met these criteria.

Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing):

Study Details (as inferable from the document):

Since this is a submission for a physical medical device (dental abutment) and a demonstration of substantial equivalence rather than a novel AI/ML algorithm, most of your specific questions about data sets, experts, and MRMC studies do not apply.

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

   • Sample Size (Test Set): Not explicitly stated as a "test set" in the context of an algorithm. The "test set" here refers to the physical samples of the TruAbutment DS device and compatible implant systems that underwent non-clinical laboratory testing (fatigue, biocompatibility, sterilization, dimensional analysis). The document mentions "worst-case scenario" testing (smallest diameter with maximum angulation), implying a targeted selection of test articles rather than a large, randomized "test set" as understood in a data science context. The exact number of samples for each test (e.g., number of abutments for fatigue testing) is not provided.
   • Data Provenance: The document does not specify the country of origin of the data beyond the standards being international (ISO, ANSI/AAMI). The testing was "non-clinical testing," performed in a laboratory setting. It is retrospective in the sense that the results are being leveraged for a new device submission (K172304), and some tests were performed for a prior predicate device (K152559) and leveraged.

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

   • Not Applicable. "Ground truth" in this context refers to the validated performance of a physical device against established engineering and biological standards. This is determined by laboratory measurements and adherence to specified test protocols, not by expert consensus on data annotations for an AI model.
   • The "experts" would be the engineers and scientists conducting and validating the lab tests according to the standards. Their qualifications are not specified but would be implicit in their ability to conduct such highly technical and regulated testing.

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

   • Not Applicable. This concept is relevant for reconciling discrepancies in human annotations or interpretations for ground truth establishment in AI/ML. For physical device testing, the "ground truth" is defined by the technical specifications and the results of validated laboratory tests.

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:

   • No, not done. This type of study (MRMC) is for evaluating diagnostic performance of AI-assisted human readers. The TruAbutment DS is a physical medical device (dental abutment), not an AI/ML diagnostic tool. The document explicitly states: "Clinical testing was not necessary to establish substantial equivalency of the device."

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

   • Not Applicable. As above, this is not an AI/ML algorithm. Its "standalone" performance means its physical properties and mechanical integrity, which were evaluated through non-clinical laboratory tests.

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

   • The "ground truth" for this device's performance is established by engineering standards (ISO 14801), biocompatibility standards (ISO 10993 series), sterilization standards (ISO 17665, ANSI/AAMI ST79), and dimensional analysis via reverse engineering. These are objective, empirically measured outcomes from laboratory testing, not human-derived consensus or clinical outcomes data.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" in the context of an AI/ML algorithm for this device. The design and manufacturing process for the TruAbutment DS would have been developed iteratively (similar to an engineering "training phase"), but not with a structured data "training set" in the AI sense.

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

   • Not Applicable. See point 7. The "ground truth" during the development of such a device would be based on design specifications, material properties, and iterative engineering testing to ensure the device meets its intended functional requirements and complies with relevant standards.

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Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures.

The Straumann CARES Golden Ti/TiN Abutments are indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.

The previously cleared Straumann CARES Titanium Abutments are placed onto dental implants to support prosthetic reconstructions such as crowns and bridges. The abutment allows for individual customization regarding function and esthetics. The design step is typically performed by the dental laboratory to the specifications from a clinician. The abutments are produced by a Straumann Manufacturing milling center.

The patient-specific abutment is designed by a traditional waxup and subsequent scanning or by scanning of the intraoral setting and designing the element via CAD software. The design information is sent via an Internet portal to Straumann. Straumann verifies the design against the validated design parameters. These design limits include a maximum angulation of 30° and a minimum surface area as follows:

Tooth Position, Minimum surface area mm²
7,10, 24,25, 37
4,5,12,13,20,21,28,29, 47
26,11,2,27,8,9, 43
1-3, 14-16, 17-19,30-32, 56

The abutments are manufactured from solid grade 4 titanium at the Straumann milling center. The abutment is delivered to the dental laboratory for final processing before delivery to the clinician. The abutments are attached to the implant with a titanium alloy basal screw. The occlusal restoration is affixed to the titanium abutment using dental cement.

The proposed devices are a modification of the previously licensed devices. The titanium abutments that serve as the base of the CARES Golden Ti/TiN Abutments (the uncoated abutments) are identical in every respect to the reference devices. The modification consists of the addition of a titanium nitride (TiN) coating on the emergence profile and coronal aspect of the abutment. The apical portion of the abutment consisting of the implant-to-abutment interface is masked during the coating process to assure that the interface remains uncoated.

The provided text describes the Straumann® CARES® Golden Ti/TiN Abutments, a dental device, and its substantial equivalence to predicate devices. It outlines the design, materials, and performance data used to support its clearance.

However, the document is a 510(k) summary for a medical device and therefore, it does not contain information about an AI/ML powered device, a study proving the device meets specific acceptance criteria related to AI/ML performance, or details about ground truth, expert consensus, or multi-reader multi-case studies.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to an AI/ML device, nor can I provide information on sample sizes for test/training sets, data provenance, expert numbers/qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML.

The document focuses on demonstrating substantial equivalence based on material, design, indications for use, and a series of standard performance tests for dental abutments.

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The Straumann CARES® TAN abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/ screw-retained.

Straumann® CARES® TAN Abutments are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths. The abutments are available with interface geometry compatible with the bone level NC (3.3 mm) and RC (4.1 mm) and the tissue level RN (3.3 mm, 4.1 mm) and WN (4.8 mm) implants. The proposed CARES® TAN abutments are provided in a set that contains the individualized abutment and a corresponding basal screw. The Straumann CARES TAN Abutments allow for individual customization regarding function and esthetics. Straumann CARES TAN Abutments are designed by the customer either by means of a traditional wax-up abutment that is subsequently scanned or by scanning of the intraoral situation and designing of the shape by using software such as Straumann CARES Visual. The design data is then transferred to Straumann where the fabrication of the customized abutment is carried out.

The document describes a 510(k) premarket notification for Straumann® CARES® Titanium Alloy (TAN) Abutments. This submission focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than proving the device meets acceptance criteria through a clinical study. Therefore, most of the requested information regarding study design for proving acceptance criteria is not directly applicable.

Here's an analysis of the provided information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data in the typical sense of a clinical trial. Instead, it details design limits for the abutments and then provides a list of bench studies conducted to demonstrate the device's performance characteristics. The "Equivalence Discussion" column in the "Technological Characteristics" table also serves as a comparison to predicate devices, inferring acceptance based on similarity or acceptable differences.

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

The document primarily refers to bench studies. For such studies, the "sample size" typically refers to the number of test specimens. However, the specific sample sizes for the dynamic fatigue, veneer, and corrosion resistance tests are not provided in this summary. The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond being "bench studies."

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)

This information is not applicable as the submission is based on bench studies and a comparison to predicate devices, not on a clinical study requiring expert ground truth for a test set of patient data.

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

This information is not applicable for the same reasons as point 3.

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 as the device is a dental abutment, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable as the device is a physical medical device (dental abutment), not an algorithm.

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

For the bench studies, the "ground truth" would be established by the standardized test methods themselves (e.g., ISO 14801 for dynamic fatigue, ISO 9693-1 for veneer testing, ISO 10271 for corrosion resistance, ISO 10993 for biocompatibility). These international standards define the accepted methods and performance metrics for evaluating such devices. There is no mention of expert consensus, pathology, or outcomes data in the context of establishing ground truth for the performance evaluations.

8. The sample size for the training set

This information is not applicable as there is no training set in the context of this device's evaluation (it's not an AI/machine learning device).

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

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

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The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for sinqle or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.

The CreoDent Solidex® Customized Abutment is compatible with the following:

• . Biomet 3i Osseotite Certain Dental Implants 3.25mm, 4.0mm, 5.0mm, 6.0mm
• o Straumann Bone Level Implants 3.3mm. 4.1mm. 4.8mm

The Solidex® Customized Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard and Screw is CP TI Gr4 meets ASTM F67 and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatibe with:

• Biomet 3i Osseotite Certain 3.25mm, 4.0mm, 6.0mm diameter implants K063341 .
• Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm K083550 K121131 .

The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CreoDent Solidex® Customized Abutment:

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional clinical trial report with specific acceptance criteria as might be found for a novel device. The "acceptance criteria" here are implicitly related to demonstrating performance equivalence to the predicate devices through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) summary, the "acceptance criteria" are the demonstration of equivalent or superior performance to the predicate devices through specific non-clinical tests. The reported device performance is that these tests showed sufficient strength and compatibility.

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

The document describes non-clinical laboratory testing, not human or animal clinical trials. Therefore, the concept of a "test set" in the context of clinical data or AI systems does not directly apply.

• Sample Size for Testing: The document does not specify the exact number of abutments or implants tested in the static/fatigue testing, dimensional analysis, or sterilization validation. It refers to these as "testing" or "analysis" without numerical details on the quantity of items used.
• Data Provenance: The data comes from non-clinical laboratory testing conducted by the manufacturer, CreoDent Prosthetics, Ltd. There is no information regarding country of origin of data beyond the manufacturer's location in New York, USA, or whether it's retrospective or prospective, as it's not a clinical study.

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

This section is not applicable. The "ground truth" for this device's performance is established through internationally recognized engineering standards (ISO 14801:2007E, ISO 17665-1) and direct physical/mechanical testing, not through expert clinical consensus or interpretation of images/data by human experts.

4. Adjudication Method for the Test Set

This section is not applicable. As the testing is non-clinical and based on objective engineering measurements and standards, there is no need for an adjudication method involving human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI algorithms that rely on human interpretation of outputs. The CreoDent Solidex® Customized Abutment is a physical medical device (dental implant abutment), not a diagnostic or AI software.

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

No, a standalone algorithm performance study was not done. This device is a physical product, not an algorithm or AI software.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating the safety and effectiveness of the CreoDent Solidex® Customized Abutment is based on:

• Engineering Standards and Specifications: Adherence to ISO standards (ISO 14801:2007E for fatigue, ISO 17665-1 for sterilization) and ASTM material standards (ASTM F-136, ASTM F67).
• Objective Mechanical and Physical Measurements: Results from static/fatigue testing and reverse engineering dimensional analysis.
• Comparison to Predicate Devices: Demonstrating that the subject device's performance, materials, and indications for use are substantially equivalent to legally marketed predicate devices.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This section is not applicable for the same reason as above; there is no training set for a physical medical device.

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