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The Zfx Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.

All digitally designed custom abutments or superstructures and/or hybrid abutment crowns for use with Zfx TiBase or Pre-Milled Blank Abutments are intended to be sent to a Zfx validated milling center for manufacture.

The Zfx TiBase abutments for the 03.25 mm Certain implant bodies, and 03.1 mm Eztetic implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

The subject device, Zfx Abutments, consists of two abutment types, a TiBase and a Pre-milled Abutment Blank, with corresponding retaining screws. Zfx Abutments are offered in a variety of connections compatible with ZimVie dental implants. All abutments and screws are provided non-sterile.

TiBase Abutments: Subject device TiBases are two-piece abutments. The pre-manufactured titanium base component is the apical part. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. The subject device TiBase abutments are available in hexed/engaging and non-hexed/nonengaging configurations. The engaging TiBase abutments are intended for single and multi-unit restorations and the non-engaging TiBases are intended for multi-unit restorations. The superstructure is intended to be manufactured at a Zfx validated milling center.

Pre-milled Abutment Blanks: The Pre-milled Abutment Blank is a cylindrical titanium alloy abutment designed for patient-specific abutment fabrication with CAD/CAM technology. The patient-specific abutment milled from a Pre-milled Abutment Blank is secured directly to the implant using a retaining screw. Pre-milled Abutment Blanks are available in an engaging/hexed design only for single-unit and multi-unit restorations.

Retaining Screws: Corresponding retaining screws are packaged with the abutment and replacement screws are available individually. All screws are compatible with the corresponding ZimVie dental implants.

Material Composition: All subject device abutments are made of titanium alloy Ti-6Al-4V ELI conforming to ASTM F136. Screws are made of either titanium alloy Ti-6A1-4V ELI conforming to ASTM F136, or Gold-Tite® screws with stainless steel conforming to ASTM F138. Gold-Tite screws have a gold-plating conforming to ASTM B488 and ASTM B571. Zirconia superstructures for use with the TiBase Abutments are made of zirconia conforming to ISO 13356.

The provided text is an FDA 510(k) clearance letter for Zfx Abutments, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and supporting data in the way a clinical study report or a formal performance evaluation report would.

Therefore, the information required to answer many of the questions regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not present in this document. The document primarily outlines the device's technical specifications, indications for use, and a comparison to predicate devices, supported by non-clinical testing data (mechanical testing, biocompatibility, sterilization, etc.).

However, I can extract the information that is available and explain why other requested details are missing.

Acceptance Criteria and Device Performance (Based on "Equivalence to Marketed Devices" and "Performance Data" sections):

This document describes a substantial equivalence submission, meaning the acceptance criteria are primarily demonstrated by showing the device is as safe and effective as a legally marketed predicate device. The performance is assessed through non-clinical testing to ensure it meets established standards comparable to the predicate.

Missing Information and Explanations:

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

   • Not provided. This document details a 510(k) submission based on non-clinical testing for substantial equivalence, not a clinical trial or performance study with human data. The "Performance Data" section explicitly states: "No clinical data were included in this submission." Therefore, there is no "test set" in the context of clinical images or patient data to analyze. The "samples" used were physical samples for mechanical, sterilization, and biocompatibility testing. The data provenance would be from laboratory tests.

2. 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/Not provided. As no clinical data or clinical "test set" was used, there was no need for expert adjudication to establish ground truth from patient data. The ground truth for mechanical and material properties is established by engineering specifications and industry standards.

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

   • Not applicable/None. No clinical test set to adjudicate.

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 device (Zfx Abutments) is a physical dental implant component, not an AI software/device. Therefore, an MRMC study or AI assistance is not relevant to its performance evaluation for this submission.

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

   • Not applicable. As above, this is a physical medical device, not an algorithm or AI.

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

   • The "ground truth" for demonstrating substantial equivalence for this device relies on engineering specifications, material standards (e.g., ASTM, ISO), mechanical test results (e.g., forces to fracture), and comparative analysis with the predicate device's established safe and effective performance. There is no clinical outcomes ground truth cited here.

7. The sample size for the training set:

   • Not applicable. This refers to a dataset for training an AI model. This device is not an AI/software.

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

   • Not applicable. As above, no training set for an AI model.

In summary, this document is a regulatory clearance letter focused on substantial equivalence for a physical dental device. The "study" proving it meets acceptance criteria consists of various non-clinical bench tests and a comparison to a predicate device's specifications and performance, rather than a clinical study with patients or an AI model's performance evaluation.

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Encode® Patient Specific Dental Abutments made from oral scans provided from Sirona CEREC AC Scanner System and inLab Software v3.65 are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. Encode® Patient Specific Dental Abutments are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Encode® Patient Specific Dental Abutments are designed specifically for a patient using a CAD/CAM system. The abutments are designed from a threedimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which are derived from the scan. The abutments are manufactured from titanium alloy (Ti 6Al-4V ELI) or biocompatible Zirconia TZP. The abutment design is limited according to BIOMET 3i Specifications, as follows:

The provided text is a 510(k) summary for a medical device (Encode® Patient Specific Dental Abutments). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not contain the detailed study information about acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, or MRMC studies that you've requested.

The "Performance Data" section merely states: "Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648." This is a high-level statement and does not provide specific acceptance criteria or quantitative performance results.

The "Equivalence Data" section emphasizes that the new option of oral scans has the "same intended use and indications, principles of operation, and technological characteristics" as previously cleared devices and that "Validation data demonstrates that the modified process results in a finished device that is just as safe and effective as Encode® Patient Specific Dental Abutments that are currently cleared under K032263 & K052648." Again, this is a qualitative statement of equivalence, not a detailed report of a study proving specific acceptance criteria are met.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document focuses on demonstrating substantial equivalence rather than presenting a performance study with detailed acceptance criteria and results.

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Encode® Patient Specific Dental Abutments made from oral scans provided from 3M ESPE Lava Chair Scanner and the 3M Lava COS (2.0) software are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. Encode® Patient Specific Dental Abutments are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Patient Specific Dental Abutments are Encode® designed specifically for a patient using a CAD/CAM system. The abutments are designed from a threedimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which are derived from the scan. The abutments are manufactured from titanium alloy (Ti 6Al-4V ELI) or biocompatible Zirconia TZP. The abutment design is limited according to BIOMET 3i Specifications, as follows:

The provided text focuses on the 510(k) summary for the Encode® Patient Specific Dental Abutments, particularly the addition of oral scan data input. It describes the device, its intended use, and its equivalence to previously cleared devices.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

Reported Device Performance: The document states, "The abutments are manufactured from titanium alloy (Ti 6Al-4V ELI) or biocompatible Zirconia TZP. The abutment design is limited according to BIOMET 3i Specifications, as follows:" and then lists the specifications provided in the table above. This indicates that the device's performance aligns with these specified design parameters.

The "Performance Data" section further states: "Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648." This implies that the device successfully produced abutments within the specified design parameters when using the new oral scan input.

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 does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It generally refers to "validation performed on scanning equipment and software."

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)

The document does not specify the number of experts used or their qualifications for establishing ground truth.

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

The document does not describe any adjudication method used 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. This device is a dental abutment, not an AI-assisted diagnostic tool for human readers. The validation focuses on the accuracy of the CAD/CAM system and oral scanner to produce the intended physical device.

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

This is not a software algorithm that performs a diagnostic task. The "algorithm" here is the CAD/CAM software that designs the dental abutment based on scan data. The performance validation was for the overall system (scanner + software + manufacturing) to produce a physical device that meets pre-defined design specifications. It is a "standalone" performance verification in the sense that the system itself, from input scan to manufactured abutment, was validated to ensure it produces the desired physical outcome.

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

The ground truth for this device appears to be the established design specifications and physical characteristics of the dental abutments as cleared in the predicate devices K032263 & K052648. The "Performance Data" section indicates that "Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648." This suggests the ground truth is the "intended design"—meaning the established, accepted dimensions and shapes of the predicate abutments.

8. The sample size for the training set

The document does not mention a specific "training set" or its sample size. The focus is on the integration and validation of a new input method (oral scans) for an existing CAD/CAM system, rather than training a novel AI algorithm.

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

Since no training set is explicitly mentioned for an AI algorithm (as this is not an AI diagnostic device), the concept of ground truth establishment for a training set does not directly apply in the usual sense. The closest equivalent is that the CAD/CAM system's design parameters and the physical characteristics of the manufactured abutments are based on established dental engineering principles and the specifications of the predicate devices.

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BIOMET 3i Patient Specific Dental Abutments (Encode®) Designed Using Cadent iTero Scanner and inLab Software v3.5are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient. These are intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

Encode® Abutments are designed specifically for a patient in a CAD/CAM system. The abutments are designed from a three-dimensional intra-oral optical scan or resin model scan and then machined/milled according to the parameters created in a digital file which is derived from the scan. The abutments are manufactured from titanium alloy or ceramic.

The provided text is a 510(k) summary for a medical device and does not contain the detailed information required to answer all parts of the request. The document specifically states that "Validation performed on scanning equipment and software to ensure accuracy of scanning models to produce the intended design as cleared in K032263 & K052648." However, it does not provide specific acceptance criteria, study methodologies, sample sizes, ground truth details, or effectiveness study results in the format requested.

Therefore, the following information can be extracted based on the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. The document only mentions "Validation performed on scanning equipment and software."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Not specified. The document does not describe the establishment of a ground truth by experts for the validation.

4. Adjudication method for the test set:

• Not specified.

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:

• No MRMC comparative effectiveness study is mentioned. This device is an accessory to dental implants (abutments) designed using CAD/CAM, not an AI-based diagnostic tool for human readers.

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

• The performance validated relates to the accuracy of the CAD/CAM system (scanner and software) in producing the intended design. While the process is largely automated (algorithm only in terms of design generation post-scan), specific standalone algorithm performance metrics are not provided. The phrase "algorithm only" in the context of an "AI" evaluation is not applicable here as it is a CAD/CAM design and manufacturing process, not an AI diagnostic algorithm.

7. The type of ground truth used:

• The ground truth explicitly mentioned is "the intended design as cleared in K032263 & K052648." This implies a comparison to a predefined standard or previously cleared designs/specifications, likely through dimensional accuracy measurements or similar engineering validation methods, rather than clinical outcomes or pathology.

8. The sample size for the training set:

• Not applicable. This is not a machine learning model that undergoes a "training" phase in the conventional sense. The "training" here would refer to the historical data or engineering principles used to develop the CAD/CAM software, which is not detailed.

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

• Not applicable for the reasons mentioned in point 8. The "ground truth" for the CAD/CAM software development would be based on engineering specifications, dental anatomy, and functional requirements for abutments, but the document does not elaborate on this.

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