Search Results

VITA AKZENT LC Indication range:

• Restorations made of hybrid ceramic
• · Restorations made of light-curing veneering material
• · Restorations made of CAD/CAM composites
• · Prefabricated Teeth
• · Denture bases

VITA AKZENT LC is a light-curing methacrylatebased stain/ glaze system for extraoral surface characterization of dental restorations made of hybrid ceramic, resin veneering materials, CAD/CAM composites, prefabricated teeth and denture base resins. It can also be used for internal characterization with the layering technique of veneering composites.

The document describes the VITA Akzent® LC, a light-curing methacrylate-based stain/glaze system for extraoral surface characterization of dental restorations. The acceptance criteria and the study proving the device meets these criteria are outlined in the "Non-Clinical Performance Testing" and "Biocompatibility" sections.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a distinct "test set" in the traditional sense of a clinical study with human subjects. The evaluation was primarily based on non-clinical performance testing and biocompatibility assessment.

• For biocompatibility, the testing was conducted in-vitro/non-clinical based on recognized international standards. Specific sample sizes for these tests (e.g., number of specimens tested for cytotoxicity, irritation, etc.) are not explicitly stated in this summary.
• For adhesion performance, "bench testing" was conducted. The sample size for this testing is not explicitly stated.
• The data provenance is not explicitly stated but is presumed to be from laboratory testing as per the cited ISO standards.

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

This information is not applicable and not provided in the document because the assessment was based on non-clinical (laboratory) testing and established international standards for biocompatibility and material performance, rather than clinical efficacy studies requiring expert evaluation of patient data.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided as the evaluation was based on objective laboratory testing against established standards, not human interpretation of results requiring adjudication.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of VITA Akzent® AC."

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

This concept is not applicable to this device. VITA Akzent® LC is a material (a stain/glaze system), not an algorithm or an AI-powered diagnostic tool. Its performance is determined by its physical and chemical properties as evaluated through non-clinical laboratory tests.

7. The Type of Ground Truth Used:

The ground truth for demonstrating the device's performance relies on:

• Established international standards: ISO 10993-1 (Biological evaluation of medical devices) and ISO 7405 (Dentistry – Evaluation of biocompatibility of medical devices).
• Bench test results: Specifically, "adhesion performance testing" against a reference device.
• Material composition equivalence: Comparison of the chemical composition to predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. As VITA Akzent® LC is a material and not an AI/ML algorithm, there is no "training set" in the conventional sense. Its development would likely involve
iterative formulation and testing, but not machine learning training.

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

This information is not applicable and not provided, as there is no "training set" for this type of device. The formulation and development of the material are based on scientific principles of polymer chemistry and dental material science, combined with performance testing.

Ask a specific question about this device

VITA Lumex® AC is used to veneer the following:

• Full and partial veneering of zirconia
• Full and partial veneering of lithium disilicate
• Partial veneering of feldspar ceramic
• Reconstruction without a substructure
  Materials:
• Zirconia substructures (CTE approx. 10.0 to 10.5 x 10-6 K-1)
• Glass-ceramic substructures (CTE approx. 9.0 to 10.5 x 10-6 K-1)

VITA Lumex® AC is a natural low-fusing veneering ceramic system that is suitable for veneering all ceramic substructures. VITA LUMEX AC standard layering consists of the two Materials DENTINE and ENAMEL. The color-bearing DENTINE materials, which provide good coverage, offer the perfect precondition for the preparation of veneers with intensive shades. With this two-layer alternative, VITA offers an ideal solution for the reproduction of optimal shade results in case of thin walls. Additionally, the intensive shade effect of the DENTINE permits a more generous use of the ENAMEL materials, which create the desired translucency. The user is able to prepare a natural restoration with a lifelike appearance with only two layers. This product is provided non-sterile in glass jars in a powder form to be used in conjunction with the Vita low fusing liquid.

This document is a 510(k) Premarket Notification for the VITA Lumex® AC, a porcelain powder for clinical use, and not a study describing the acceptance criteria and performance of a device that meets those criteria.

Therefore, I cannot provide the requested information, which includes:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone (algorithm-only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document states: "Non-Clinical Performance Testing" on page 5, indicating that "Bench test results allowed us to conclude that VITA Lumex® AC is substantially equivalent to the predicate device for its intended use." It also explicitly states "Clinical Performance Data: Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA Lumex® AC."

This filing relies on bench testing and comparison to predicates, not specific clinical performance studies with acceptance criteria as requested in your prompt.

Ask a specific question about this device

VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrications in the press technique.

Indications

•Occlusal veneers (table tops), veneers

• •Inlays, onlays, partial crowns
• ·Crowns in the anterior and posterior areas
• ·3-unit anterior bridges up to the second premolar
• ·Single tooth restorations as implant suprastructures for anterior and posterior teeth
• ·3-unit bridges as implant suprastructures up to the second premolar
• · Single tooth mesostructures in the anterior and posterior areas
• · Abutment crowns in the anterior and posterior areas

VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrication of restorations in the press technique.

VITA Ambria comes in various shades and is packaged in a plastic case of 5 or 3 pc pellets.

This document is a 510(k) summary for VITA Ambria®, a dental material, and does not contain information about an AI/ML device. Therefore, it does not include the specific details you requested regarding acceptance criteria, study sizes, expert qualifications, or MRMC studies for an AI/ML product.

However, I can extract the information relevant to the device's performance given the available text:

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

   Acceptance Criteria	Reported Device Performance
   Complies to DIN EN ISO 6872: Dentistry - Ceramic Materials	VITA Ambria® meets the applicable requirements of this standard.
   Complies to ISO 10993-1: Biological evaluation of medical devices	VITA Ambria® complies with this standard.
   Complies to ISO 7405: Dentistry – Evaluation of biocompatibility of medical devices	VITA Ambria® complies with this standard.
   Substantially equivalent in performance to VITA PM9 (K050362)	Bench test results allowed the conclusion of substantial equivalence.

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

   • This information is not provided in the document as it refers to non-clinical performance testing of a dental material, not an AI/ML device. The "bench test results" are mentioned, but no specifics on sample sizes for these tests are given. The manufacturer is VITA Zahnfabrik H.Rauter GmbH Co. from Bad Sackingen, Germany.

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 and not provided. The ground truth for biocompatibility and material standards compliance is based on standardized testing procedures, not expert consensus on diagnostic images.

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

   • This information is not applicable and not provided.

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 study was performed or is applicable, as this is a dental material, not an AI/ML diagnostic tool.

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

   • No standalone algorithm performance study was performed or is applicable, as this is a dental material.

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

   • The "ground truth" for the device's performance is compliance with recognized international standards for ceramic dental materials (DIN EN ISO 6872) and biocompatibility (ISO 10993-1, ISO 7405), established through laboratory bench testing.

8. The sample size for the training set:

   • This information is not applicable and not provided, as this is not an AI/ML device requiring a training set.

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

   • This information is not applicable and not provided.

In summary, the provided document is a 510(k) clearance for a dental material (VITA Ambria® zirconia-reinforced lithium silicate press pellets) and not for an AI/ML-driven device. Therefore, the detailed criteria for AI/ML performance are not present. The device's acceptance is based on its compliance with established material and biocompatibility standards and comparison to a predicate device via non-clinical (bench) performance testing.

Ask a specific question about this device