Search Results

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.

Ask a specific question about this device

Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. The Titanium Base abutments consists of two major parts. Specifically, the titanium base and mesostructured components make up a two-piece abutment.

All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Blank are to be sent to a Preat validated milling center for manufacture.

Preat Abutments is a dental implant abutment system that includes ten (10) abutment designs compatible with twelve (12) OEM implant systems. The subject device abutment platform diameters range from 3.0 mm to 6.5 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 6.5 mm. The subject device includes the following abutment designs: temporary, esthetic angled 15°, multi unit straight, multi-unit angled 17°, ball (Clix Ball and O-Ring), titanium base, and titanium blank. The system also includes corresponding abutment screws.

All abutments and screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and are provided non-sterile to the end user. All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Base or Titanium Blank are to be sent to a Preat validated milling center for manufacture. All superstructures are to be manufactured from zirconia conforming to ISO 13356.

The Titanium Base abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction.

For the Titanium Base abutment, the design parameters for the CAD/CAM zirconia superstructure are: Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations - 4.0 mm; Maximum gingival height - 5.0 mm; and All zirconia superstructures are for straight abutments only.

The design parameters for the CAD/CAM Titanium Blank custom abutment are: Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restoration - 4.0 mm; Maximum Angle - 30°; and Maximum gingival height - 1.5 mm to 2.65 mm (varies by implant line).

The provided document is a 510(k) Premarket Notification for dental implant abutments. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance data from a clinical or standalone study. Therefore, most of the requested information regarding acceptance criteria for an AI/device performance study, sample sizes for test/training sets, expert qualifications, and ground truth establishment is not available in this document.

The document details the technical and material characteristics of the Preat Abutments and compares them to predicate devices to argue for their equivalence. It includes non-clinical performance data related to mechanical testing, sterilization, and biocompatibility, but not data related to an AI's diagnostic performance or human reader improvement with AI assistance.

Here's an attempt to answer the questions based on the provided text, indicating when the information is not present:

Analysis of Device Performance and Acceptance Criteria (Based on Substantial Equivalence)

This 510(k) submission for Preat Abutments relies on demonstrating substantial equivalence to existing legally marketed predicate devices. The "acceptance criteria" here are implicitly related to meeting the performance characteristics and safety profiles of these predicates, rather than specific statistical thresholds for a new diagnostic algorithm's accuracy or efficacy. The "study" proving acceptance is primarily the non-clinical testing performed and the comparison to predicate devices.

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 in the context of an AI/diagnostic performance study. For the mechanical testing, the document states "worst-case constructs were subjected to static compression fatigue testing," but does not specify the number of samples or "test set" size.
• Data Provenance: Not applicable for location (country of origin), as this is a physical device testing submission. The data is from laboratory testing (mechanical, biocompatibility, sterilization validation). The testing is prospective in nature, as it was conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. There is no "ground truth" established by experts in the context of a diagnostic performance study. The ground truth for mechanical and material properties is based on established engineering standards and test methods (e.g., ISO 14801, ISO 10993, ISO 17665).

4. Adjudication Method for the Test Set

• Not applicable. No human-based adjudication was performed for a diagnostic test set.

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

• No. This is not a submission for a diagnostic AI device, so an MRMC comparative effectiveness study was not performed.
• Effect Size: Not applicable.

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

• No. This is not an AI algorithm submission. The "standalone" performance here relates to the physical device's mechanical and material properties, which were tested in a laboratory setting as described under "Performance Data."

7. The Type of Ground Truth Used

• For physical device performance: The "ground truth" is defined by international standards (e.g., ISO 14801 for mechanical testing, ISO 10993 for biocompatibility, ISO 17665 for sterilization) and engineering specifications derived from predicate device performance and design. It's not clinical outcomes data or expert consensus in the diagnostic sense.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set." The understanding of predicate device performance and design parameters, which inform the design and testing of the subject device, is derived from existing regulatory clearances and documented technical specifications of those predicate devices.

Ask a specific question about this device

Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations.

All digitally designed abutments for use with Inclusive Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Compatible Implant System: MegaGen AnyRidge® Implant System Implant Diameter (mm) 3.5, 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4 Platform Diameter (mm) 3.5 and 5.0

Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge Implant System are made of titanium alloy and have a prefabricated, precision interface (implant/ abutment connection) and are to be used for fabrication of patient-specific custom abutments using CAD/CAM technology. Each patient-specific abutment is individually prescribed by the clinician and manufactured by a Prismatik Dentalcraft authorized milling center. The proposed device is compatible with the MegaGen AnyRidge Implant System (K140091); 3.5, 4.0. 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4mm implant diameter. Abutments are made from alloyed titanium Ti-6Al-4V ELI which meets ASTM standard F-136.

The Titanium Abutment Blanks are used for fabrication of all-titanium patient-specific abutments. These abutments include Multi-unit, Esthetic, and Straight Abutments. The Straight Abutments come in both Engaging and Non-Engaging connections. The Straight abutments 4.5 mm and 6.0 mm are used for support of CAD/CAM fabricated crowns / bridges or CAD/CAM fabricated zirconia copings. A patient-specific finished device for the 4.5 mm and 6.0 mm straight abutments will consist of both the titanium base and zirconia coping and will contain no angle correction.

The provided text describes the submission of Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge® Implant System for FDA 510(k) clearance, asserting substantial equivalence to predicate devices. The study conducted is primarily non-clinical performance testing.

Here's the breakdown of the requested information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format alongside specific reported device performance values. Instead, it states that "The technological characteristics of the subject device have been verified to be essentially the same as the predicate device based on assessments of material composition, dimensional features, and mechanical properties." and that "Comparative testing was performed to show equivalence to the predicate device. This testing was performed according to ISO 14801:2007." This implies that the acceptance criteria are met if the device's performance is comparable to, or within the established range of, the predicate devices under the specified ISO standard for dental implants.

The reported device performance is that it met the requirements of ISO 14801:2007 through Reliability Calculation, Fatigue Testing, and Static Load Failure Testing.

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

The document does not specify the exact sample sizes used for the non-clinical tests (Reliability Calculation, Fatigue Testing, Static Load Failure Testing).

The data provenance is retrospective, as it relies on established standards and comparative testing against predicate devices. The document does not mention the country of origin of the data, but the testing was conducted to meet FDA guidance and ISO standards.

3. Number of Experts and their Qualifications for Ground Truth

This question is not applicable to this submission. The ground truth for this type of device (dental abutments) is established through objective, standardized mechanical and material testing as per ISO and FDA guidance, rather than expert consensus on interpretive data (e.g., medical images).

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data, typically in diagnostic studies. For mechanical performance testing, the results are objectively measured against established standards.

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

No. An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient cases, often with and without AI assistance, to measure improvements in diagnostic accuracy or efficiency. The device in question is a dental abutment, and its effectiveness is determined by mechanical and material properties, not human interpretation of cases.

6. Standalone Performance Study (Algorithm Only)

No. A standalone algorithm performance study was not done. This device is a physical medical device (dental abutment), not an AI algorithm. Its performance is assessed through laboratory testing, not algorithmic output without human involvement.

7. Type of Ground Truth Used

The ground truth used for this device is based on established engineering standards and regulatory guidance. Specifically:

• ISO 14801:2007: Standard for fatigue testing of endosseous dental implants.
• FDA Guidance: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
• Material Standards: ASTM standard F-136 for Ti-6Al-4V ELI.
• Biocompatibility Testing: Applicable prior biocompatibility testing for reference devices K121406 and K143353 (Sensitization, Cytotoxicity, and Systemic Toxicity).

These standards define the acceptable mechanical properties, material composition, and biological safety for such devices.

8. Sample Size for the Training Set

This question is not applicable. The device is a physical medical device, not an AI model that requires a training set.

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

This question is not applicable, as there is no training set for a physical dental abutment.

Ask a specific question about this device

The Inclusive Titanium Abutments for Camlog Screw-Line Implants are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the CAMLOG Screw-Line Implants in 3.3mm, 3.8mm, 4.3mm, 5.0mm, and 6.0mm diameters.

The Inclusive® Titanium Abutments for Camlog Screw-Line Implants are endosseous implant abutments which are placed in to the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. These abutments are made of titanium grade Ti-6AL-4V ELI (meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. These abutments are compatible with the CAMLOG Screw-Line Implants as follows: 3.3mm, 3.8mm, 4.3mm, 5.0mm, and 6.0mm diameters.

This document describes the non-clinical testing for the Inclusive Titanium Abutments for Camlog Screw-Line Implants. It focuses on demonstrating substantial equivalence to a predicate device through mechanical performance testing rather than clinical study. Consequently, information typically associated with clinical studies, such as multi-reader multi-case studies, ground truth establishment for clinical endpoints, or human reader performance, is not applicable or provided.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify a numerical sample size for the mechanical performance testing. It states that "All testing conducted met the acceptance criteria and evaluated the worst-case scenario," implying sufficient testing was performed to cover relevant configurations and conditions.
• Data Provenance: The data provenance is from laboratory mechanical testing. This is a non-clinical study, not directly tied to a specific country of origin for patient data. It is inherently retrospective as the testing has already been completed.

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

• This question is not applicable as the study is a non-clinical mechanical performance study rather than a study with human subject data requiring expert ground truth for clinical outcomes. The "ground truth" here is the adherence to established engineering standards (ISO 14801, ISO 14971, ANSI-AAMI ST79-2006).

4. Adjudication Method for the Test Set

• This question is not applicable as the study is a non-clinical mechanical performance study. Adjudication methods are typically employed in clinical trials to resolve discrepancies in expert assessments of clinical endpoints.

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 question is not applicable. The device is a physical dental implant component, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study involving human readers with or without AI assistance is irrelevant to this submission.

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

• This question is not applicable. The device is a physical dental implant component, not an algorithm or software.

7. The Type of Ground Truth Used

• The "ground truth" for this non-clinical study is defined by established engineering and medical device standards:
  • Mechanical Performance: ISO 14801: 2007 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants.
  • Mechanical Compatibility: ISO 14971 - Dynamic fatigue test for endosseous dental implants.
  • Sterilization Validation: ANSI-AAMI ST79-2006: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
  • Design Conformance: Conformance to design input and parameters determined by reverse engineering of existing, approved devices.

8. The Sample Size for the Training Set

• This question is not applicable as the study is a non-clinical mechanical performance study and does not involve AI or machine learning that requires a "training set" of data.

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

• This question is not applicable for the reasons stated in point 8.

Ask a specific question about this device