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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 Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Straumann Bone Level implants with a Narrow CrossFit Connection (NC) Ø3.3mm or Regular Crossfit Connection (RC) Ø4.1mm or Ø4.8mm.

The Zimmer Zfx Titanium Abutment for the Straumann Bone Level implant system is designed for use with Straumann Bone Level implants to support single or multi tooth restorations. The abutment/implant interface is a conical connection with 4 grooves for insertion guidance.

The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System is a patient specific dental implant abutment with a competitor compatible interface. The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.

The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.

The abutment is composed of Titanium alloy (Ti6Al4V), and secured to the implant with a separate Titanium alloy screw for retention.

The new abutment will be offered in Narrow CrossFit (NC) Ø 3.3mm and Regular CrossFit (RC) Ø 4.1mm or Ø 4.8mm implant connection sizes.

The provided document is a 510(k) Pre-Market Notification for a dental abutment, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study with a test set of data. Therefore, many of the requested elements for AI/machine learning device studies are not applicable to this document.

However, I can extract information related to the non-clinical testing performed to support the substantial equivalence claim.

Here's the breakdown based on the provided document:

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

The document does not explicitly define acceptance criteria in a quantitative table format for performance metrics like accuracy, sensitivity, or specificity, as would be expected for an AI/ML device. Instead, "acceptance criteria" are implied by demonstrating compatibility and equivalent mechanical performance to a predicate device through non-clinical testing.

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

• Sample Size for Test Set: The document does not specify a "test set" in the context of an AI/ML study, but for non-clinical testing:
  • Reverse Engineering: Based on "actual measurements taken from Straumann Bone Level implants, abutments and retaining screws." The exact number of units measured is not specified.
  • Fatigue Testing: The number of Zimmer fabricated abutments and OEM implants used for fatigue testing is not specified.
• Data Provenance: The data is internally generated from non-clinical laboratory testing performed by Zimmer Dental Inc. (USA) and references FDA guidance documents. This is prospective data collection for the purpose of regulatory submission.

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

Not applicable. This is not an AI/ML study involving human expert ground truth for classification or diagnosis. The "ground truth" for compatibility and mechanical performance was established through engineering analysis and physical testing against established standards and predicate device performance.

4. Adjudication method for the test set

Not applicable. No expert adjudication method was employed as it was not an AI/ML study requiring human interpretation or consensus for a "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. This is a medical device submission for a physical dental abutment, not an AI/ML software. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not applicable. This is a physical dental abutment, not an algorithm.

7. The type of ground truth used

For the non-clinical testing:

• Compatibility: "Ground truth" was established by reverse engineering measurements of existing, legally marketed Straumann Bone Level implant components and developing dimensional specifications, and by conducting tolerance and rotational analyses to ensure proper fit.
• Mechanical Fatigue: "Ground truth" was established by comparing the fatigue test results of the new device to the fatigue testing data of the predicate device (#3, Straumann Bone Level Anatomic Abutment), as well as adherence to FDA guidance standards for dental implant abutments.
• Sterilization: Validation against a minimum sterility assurance level (SAL) of 10⁻⁶, a recognized standard.
• MRI Safety: Adherence to FDA guidance for assessing passive implants in an MR environment.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. There is no training set for an AI/ML model.

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