VITA Ambria

• K Number: K193436
• Device Name: VITA Ambria
• Manufacturer: VITA Zahnfabrik GmbH H Rauter & Co
• Date Cleared: 2020-05-14 ( 155 days)
• Product Code: EIH
• Regulation Number: 872.6660
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K050362

Intended Use

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

Device Description

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.

AI/ML Overview

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.

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.