GRANDIO by VOCO GMBH | FDA 510(k) Summary

Fillings of class I-V Reconstruction of traumatically affected anteriors Facetting of discolored anteriors l acetting of disociered antine-Locking, splinting of loose anteriors Repair of veneers Filling of deciduous teeth Core build-up under crowns Composite inlays

Device Description

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AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Grandio device:

This document is a 510(k) clearance letter from the FDA for a dental resin material. It does not contain specific acceptance criteria or study results in the format requested, as it's a regulatory clearance document, not a clinical study report.

The letter states that the device, Grandio, is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a legally marketed device that was on the market before May 28, 1976, or to a device that has been reclassified. The substantial equivalence determination is based on the information provided in the 510(k) submission by the manufacturer.

Therefore, the requested information elements cannot be fully extracted from this document. I will fill in what can be inferred or explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device (for indications for use)	Determined to be "substantially equivalent"

Explanation: The FDA clearance process for a 510(k) device like Grandio primarily relies on demonstrating substantial equivalence to a predicate device. This means the new device has the same intended use as the predicate and either has the same technological characteristics or has different technological characteristics but can be shown to be as safe and effective as the predicate and does not raise different questions of safety and effectiveness. The specific performance metrics (e.g., bond strength, wear resistance, color stability) that would have been submitted to demonstrate substantial equivalence are not detailed in this letter.

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

Sample Size: Not specified in this document. Information on test set size would be in the manufacturer's 510(k) submission.
Data Provenance: Not specified in this document. It would typically be from in-vitro studies, some in-vivo animal studies, or limited clinical data if required to demonstrate equivalence.

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

Number of Experts: Not applicable, as this is a regulatory clearance letter, not a clinical study with expert ground truth establishment for a test set. The FDA typically relies on the manufacturer's scientific data and internal review by FDA experts.
Qualifications of Experts: Not applicable in this context. The FDA's internal review team for dental devices (Division of Anesthesiology, General Hospital, Infection Control and Dental Devices), including professionals like Chiu S. Lin, PhD (Director), are the "experts" who reviewed the submission.

4. Adjudication method for the test set

Adjudication method: Not applicable. This document does not describe a clinical study requiring an adjudication process for a test set. The FDA's review process is an internal regulatory determination based on the submitted evidence.

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

MRMC Study: No. This device is a dental resin material, not an AI-powered diagnostic or assistive device. MRMC studies are not relevant to this product.

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

Standalone Study: Not applicable. This device is a dental resin material, not an algorithm or AI system.

7. The type of ground truth used

Type of Ground Truth: For a dental restorative material like Grandio, "ground truth" in the context of substantial equivalence generally refers to established performance benchmarks of the predicate device, recognized international standards (e.g., ISO for dental materials), and scientific principles related to material properties (e.g., mechanical properties, biocompatibility, esthetics). The manufacturer would submit data comparing Grandio's properties to these established benchmarks.

8. The sample size for the training set

Sample Size: Not applicable. This is a material, not a machine learning algorithm that requires a "training set."

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

Ground Truth Establishment: Not applicable. This is a material, not a machine learning algorithm with a "training set" and associated ground truth.

In summary, this document is an FDA clearance letter based on the concept of "substantial equivalence" to a predicate device. It does not provide the detailed study results, acceptance criteria for performance metrics, or specific methodologies of clinical trials or AI model development that would typically be found in a study report. Such information would have been part of VOCO GmbH's 510(k) submission to the FDA.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

JUL 27 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

VOCO GmbH C/O Mr. Gerald W. Shipps Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702

Re: K051867

Trade/Device Name: Grandio Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: July 07, 2005 Received: July 11, 2005

Dear Mr. Shipps:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Gerald W. Shipps

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jengitte Y. Michaelons.

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): |<05|86 7

Device Name: GRANDIO

Indications for Use:

x AND/OR Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Chao

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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KASIK

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.