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VITA ENAMIC Implant Solutions is indicated for use as a component of a two-piece abutment system, consisting of a tibase component, and a mesostructure or abutment crown. VITA ENAMIC Implant Solutions is intended for use in partially or fully edentulous mandible or maxillae for fabrication of permanent, anterior or posterior, single unit CAD/CAM abutments. VITA ENAMIC Implant Solutions is indicated for use in conjunction with the CAD/CAM component of the Sirona Dental CAD/CAM system and the following Tibase abutments and implant bodies: (See Table 1 in document for list of compatible Ti Base/Implant Systems).

VITA ENAMIC Implant Solutions (IS) is a hybrid ceramic CAD/CAM block, consisting of ~86% (by weight) feldspar ceramic and ~14% polymer. The VITA ENAMIC Implant Solutions is milled then bonded to a titanium (Ti) base for a two-element solution with mesostructure or a single-element solution with abutment crown. The compatible Ti bases to VITA ENAMIC IS block interface size and CAD/CAM system are as follows: Ti Base: Sirona TiBase (K111421), CAD/CAM System: Sirona software – inlab 15.0 and above, Sirona software – CEREC 4.4 and above, Titanium Bases: Compatible titanium bases are shown in Table 1. VITA ENAMIC IS is offered in a block form, with a mandrel attachment, to permit securing it into a CAD/CAM machine for milling into its final form. The VITA ENAMIC IS blocks have a pre-drilled hole compatible with Sirona TiBase (K111421) to allow the mesostructure or abutment crown bonded to a titanium base to be connected to the implant. VITA ENAMIC IS blocks are identical to VITA ENAMIC blocks (K122269) in geometry, with the exception of a pre-drilled hole.

The document is a 510(k) premarket notification for a dental device, VITA ENAMIC® Implant Solutions (IS). It aims to demonstrate substantial equivalence to legally marketed predicate devices, not to establish new performance criteria. Therefore, the traditional concept of "acceptance criteria" and a "study to prove the device meets acceptance criteria" as might be seen for a novel AI device with specific performance metrics (e.g., sensitivity, specificity) does not directly apply in this context.

Instead, the submission demonstrates that the VITA ENAMIC IS device is substantially equivalent to existing predicate devices by showing it meets applicable recognized standards for dental materials and has comparable technical characteristics. The criteria for acceptance in this regulatory context are based on a comparison to the predicate devices.

Here's a breakdown of the information requested, adapted to the context of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, for a 510(k) submission, "acceptance criteria" are typically the demonstrated equivalence to predicate devices and compliance with recognized standards. The "reported device performance" is how the VITA ENAMIC IS compares to these predicates and standards.

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

The document refers to "Bench test results" and states that "No human clinical testing was performed." The testing appears to be primarily material and mechanical property testing following ISO standards. The specific sample sizes for these bench tests are not provided in this document. The data provenance is implied to be internal testing by the manufacturer (Vita Zahnfabrik H.Rauter GmbH Co.), likely conducted in Germany, and is retrospective for the purpose of this submission.

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

This is not applicable to a 510(k) submission for a dental implant abutment material, which relies on objective material property testing against recognized standards rather than expert-derived ground truth.

4. Adjudication method for the test set

Not applicable. The "test set" here refers to physical material and mechanical property tests, which yield objective measurements, not subjective evaluations requiring adjudication.

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 not an AI-powered diagnostic device, but a dental implant material. No MRMC studies were performed.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" in this context is established by recognized ISO standards for dental materials and implant systems (e.g., ISO 6872, ISO 10477, ISO 14801) and by the existing performance characteristics of legally marketed predicate devices. The testing verifies that the device meets these established engineering and material benchmarks.

8. The sample size for the training set

Not applicable. There is no AI model or training set involved.

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

Not applicable. There is no AI model or training set involved.

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• Full and partial veneering of metal frameworks: crowns, bridges, telescopic crowns, implant superstructure
• Individualization of and layering on VITA ENAMIC®
• Layering-over long-term temporaries made from VITA CAD-Temp®
• Individualization of acrylic teeth
• Reproduction of gingival components
• Metal-free crowns and three-unit anterior bridges as long-term temporary restorations
• Veneering of removable and partially removable dentures (according to the manufacturer's information)
• Inlays
• Veneers

VITA VM LC Flow is a light-cured microparticle indirect composite material for fixed and removable restorations for extraoral fabrication.

This document describes the VITA VM® LC Flow, a dental veneering material. It does not describe an AI/ML powered device, therefore, the requested information elements related to AI/ML device testing (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, and ground truth establishment for training set) are not applicable.

Here's the relevant information that can be extracted:

Acceptance Criteria and Device Performance:

The primary acceptance criteria mentioned are adherence to the FDA recognized standard, ISO 10477:2004(E) – Dentistry – Polymer-based crown and bridge materials. The device's performance is compared against this standard and predicate devices.

Study Information:

1. Sample size used for the test set and the data provenance: Not explicitly stated for each specific test, but the testing was "bench testing" performed in accordance with ISO 10477:2004(E) – Dentistry – Polymer-based crown and bridge materials standard. The country of origin for the data is not specified, but the submitter is based in Germany. The data is retrospective as it refers to performance data from tests conducted prior to the submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device relying on expert interpretation of results. The "ground truth" for the physical property tests is based on the methods described in the ISO standard.

3. Adjudication method for the test set: Not applicable.

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.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the device's performance validation is based on the physical and chemical property testing methodologies outlined in the ISO 10477:2004(E) and related biocompatibility standards (ISO 10933-1:2009, ISO 7405:2008). These are objective measurements rather than expert consensus or patient outcomes.

7. The sample size for the training set: Not applicable as this is not an AI/ML device.

8. How the ground truth for the training set was established: Not applicable.

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Enamic® is indicated for use as a dental restoration including inlays, onlays, veneers, and crowns.

The Vita Enamic® block consists of interpenetrating networks of ceramic and polymer material to form a solid block of material. The unique marriage of the two materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This results in a material with significantly lower brittleness of a pure ceramic and better abrasion behavior than a pure resin, (similar to natural enamel). The material is milled in a dental CAD/CAM machine into its restorative form.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets said criteria in the way a clinical or diagnostic performance study would.

The document is a 510(k) summary for a dental CAD/CAM block called Enamic®. It focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against specific acceptance criteria through a clinical or diagnostic study.

Here's why the requested information cannot be extracted from the provided text:

• Acceptance Criteria and Device Performance (Table): There are no specified performance metrics (e.g., sensitivity, specificity, accuracy) or corresponding target values mentioned. The document focuses on physical properties and material characteristics rather than diagnostic or clinical performance.
• Sample Size for Test Set and Data Provenance: This is not applicable as there's no clinical "test set" in the context of diagnostic performance.
• Number of Experts and Qualifications: Not applicable. Ground truth for diagnostic performance is not established.
• Adjudication Method: Not applicable.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned as this is not a diagnostic device.
• Standalone Performance Study: Not mentioned.
• Type of Ground Truth Used: Not applicable in the context of diagnostic performance. The "ground truth" for this device revolves around its material properties and safety.
• Sample Size for Training Set: Not applicable as this is not an AI/ML device requiring a training set in the conventional sense.
• How Ground Truth for Training Set was Established: Not applicable.

What the document does provide in terms of "proving acceptance criteria":

The document states that a "Summary of Non-Clinical Performance Data" was generated through bench testing:

• Bench Testing: Performed in accordance with FDA recognized standards ISO 10477 and ISO 6872.
• Conclusion: "The results of this testing allowed us to conclude that Enamic is safe and effective for its intended use."

The "acceptance criteria" in this context would be compliance with these ISO standards, and the "study" would be the described bench testing. However, the specific numerical acceptance criteria and the reported device performance values are not detailed in this 510(k) summary. It only states that the device "remains compliant to the ISO standards applied to these material types" and that "Comparisons of the physical properties of the Enamic to the predicate devices are included in this application."

In summary, the provided document does not contain the type of information requested for a diagnostic or clinical performance study. It is a 510(k) summary focused on demonstrating substantial equivalence of a dental material to existing predicate devices, primarily through material characterization and compliance with international standards.

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Vitablocs® are indicated for use as a dental restoration including inlays, onlays, veneers, crowns and bridges.

Not Found

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for the Vitablocs® device, which is a dental restoration material.

This document primarily states that the device has been found substantially equivalent to predicate devices and outlines regulatory requirements. It does not contain any information about specific acceptance criteria, study designs, sample sizes, ground truth establishment, or any performance data of the device itself.

Therefore, I cannot provide the requested information, including the table of acceptance criteria and reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

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Vita VMK Master® is indicated for use as part of a dental restoration in the form of a ceramic veneering material (full or partial) of a metal substructure.

Not Found

I apologize, but the provided text from the FDA 510(k) K093446 for "Vita VMK Master®" does not contain information about acceptance criteria, device performance metrics, or details of a study that would prove the device meets such criteria.

The document is a clearance letter stating that the device is substantially equivalent to legally marketed predicate devices. It covers regulatory aspects, such as compliance with FDA regulations, registration, labeling, and adverse event reporting.

The "Indications for Use" section simply describes the intended purpose of the device as a ceramic veneering material for a metal substructure in dental restorations, to be used by a dental professional.

Therefore, I cannot provide the requested information based on the given input.

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Vitablocs® are indicated for use as a dental restoration including inlays, onlays, veneers and crowns.

Not Found

I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for Vitablocs®, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as registration, labeling, and good manufacturing practices, and specifies the indications for use.

However, it does not include:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, or ground truth for any studies.
3. Information about experts, adjudication methods, or MRMC comparative effectiveness studies.
4. Information about standalone algorithm performance or training sets.

Therefore, I cannot fulfill your request based on the given input.

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