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The Straumann Custom Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented.

The Straumann Custom Abutments (previously named Straumann CARES Abutments) are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. The Custom Abutments are patient-matched abutments; the customer scans the intraoral situation and designs the shape using a Straumann-approved CAD/CAM software (such as Straumann CARES Visual). The design data is then transferred to Straumann where the fabrication of the custom abutment is carried out at a Straumann validated milling center (FEI: 3024185724 or FEI: 3011221537). The existing Custom Abutments feature a straight screw channel for the basal screw which fixes the abutment to the respective implant. The purpose of this submission is to add Custom Abutments with an angled screw channel to the Straumann Custom Abutment Portfolio. The subject Custom Abutments can be designed and manufactured with an angled screw channel (as opposed to straight), so that the screwexit is located in a favorable position (away from the incisal/occlusal edge and tooth cusps) for esthetic and functional results. The screw channel can be angled, the screwdriver maximum angle is 20°.

The Custom Abutments are designed for connection to implants of the Straumann Dental Implant System. The Custom Abutments have an implant-specific connection interface for the respective compatible implant. The Custom Abutments with the SynOcta geometry (RN or WN) are designed for connection to the Straumann Tissue Level (TL) implants. Those with the CrossFit geometry (NC or RC) are designed for connection to the Bone Level (BL) and Bone Level Tapered (BLT) implants. The Custom Abutments with the TorcFit geometry, are designed for connection to the Straumann Bone Level BLX and BLC (RB/WB or WB) or Tissue Level TLX and TLC (NT, RT, WT) implants. The basal screws feature threads to secure the abutment with the implant inner geometry. The basal screws also contain the connection geometry to mate with the AS screwdrivers for installation into the implant.

The provided text is a 510(k) Summary for "Custom Abutments" and details the substantial equivalence of the device to legally marketed predicate devices. It does not contain information on an AI/ML-driven device or study results proving a device meets acceptance criteria related to AI/ML performance metrics (e.g., sensitivity, specificity, FROC, etc.).

The document describes a dental implant abutment designed for customized patient use, with a key modification being the addition of an angled screw channel. The non-clinical testing sections focus on mechanical fatigue testing, digital workflow validation, sterilization, MRI compatibility, and biocompatibility, as is typical for a medical device of this type.

Therefore, I cannot fulfill your request for information on acceptance criteria and study proving device meets acceptance criteria for an AI/ML device, as the provided text pertains to a traditional medical device (dental abutments) and does not mention any AI/ML component.

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

The Straumann NN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.

The Straumann NN CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cement-retained or directly veneered.

The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Straumann NN CARES Titanium Abutment and NN CARES Ceramic Abutment:

Summary of Device Acceptance Criteria and Study Findings

The provided 510(k) summary for the Straumann NN CARES Titanium Abutment and NN CARES Ceramic Abutment focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. It does not present a study with specific acceptance criteria and reported device performance metrics in the typical sense of a clinical trial or performance study showing quantifiable outcomes like sensitivity, specificity, accuracy, etc.

Instead, the "acceptance criteria" are implicitly met by demonstrating that the new devices share the same fundamental characteristics as their predicates.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. The submission is based on a comparison of characteristics to predicate devices, not a clinical test set with patient data.
• Data Provenance: Not applicable. There is no test set in the traditional sense of a study involving data from patients or a specific geographic region.

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

• Number of Experts: Not applicable. There is no test set requiring expert ground truth establishment for performance metrics.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no test set for which adjudication would be required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. This type of study is not mentioned or implied in the 510(k) summary. The submission focuses on substantial equivalence based on material, design, and intended use, not a comparison of human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Study: No. This device is a physical dental abutment, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of typical software or diagnostic device evaluations. The "ground truth" for this submission is the established legally marketed status and characteristics of the predicate devices. The new devices are deemed "substantially equivalent" if their characteristics match or do not raise new questions of safety or effectiveness compared to the predicates.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physical dental abutment, not a machine learning model that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Conclusion:

This 510(k) submission for the Straumann NN CARES Titanium Abutment and NN CARES Ceramic Abutment falls under the category of substantial equivalence demonstration for a physical device. It does not involve a traditional performance study comparing a device against specific acceptance criteria using a test set with expert-established ground truth, as would be common for diagnostic software or AI-powered devices. The "study" here is the comparison of the new device's characteristics (intended use, material, design, operating principles) to those of legally marketed predicate devices. The FDA's acceptance (clearance) signifies that this comparison demonstrated substantial equivalence.

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