Grandio SO is a condensable, methacrylate based dental filling composite for all cavity Classes with excellent physical properties e.g. Wear resistance, compressive strength, color stability and durability in the mouth. Grandio SO has optimal opacity and can be easily polished. It is therefore highly qualified for long lasting, esthetic restorations.

AI/ML Overview

The provided document is a 510(k) summary for a dental filling composite named "Grandio SO." It establishes substantial equivalence to a predicate device based on shared intended uses and improved physical features. However, this document does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding sample sizes, expert involvement, or ground truth establishment.

The 510(k) summary focuses on the device description, its intended uses, and technological characteristics in comparison to a predicate device. It states that the device has "improved physical features" and that "performance data and results... support the safety and effectiveness of Grandio SO for the intended use" but does not elaborate on what that performance data entails, what specific acceptance criteria were used, or how those criteria were met through a study.

Therefore, I cannot provide the requested table and study details based on the given text.

Here's what I can extract and what is missing based on your request:

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

Acceptance Criteria: Not specified in the document.
Reported Device Performance: The document vaguely mentions "improved physical features" and that "performance data and results... support the safety and effectiveness." No specific performance metrics or values are provided.

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

Sample Size: Not mentioned.
Data Provenance: Not mentioned. The manufacturer is VOCO GmbH, located in Cuxhaven, Germany, but this doesn't specify the origin of any test data.
Retrospective/Prospective: Not mentioned.

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):

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

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

Not mentioned.

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 device is a dental filling material, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This is not an algorithmic device.

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

Not mentioned. Given it's a dental material, "ground truth" would likely refer to engineering and biocompatibility testing standards rather than medical image interpretation.

8. The sample size for the training set:

Not applicable. This is a material, not a machine learning algorithm.

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

Not applicable. This is a material, not a machine learning algorithm.

In summary, the provided 510(k) document is a regulatory submission for a dental composite material. It does not include the detailed study information typically found for diagnostic or AI-driven medical devices that require extensive clinical performance evaluation against specific acceptance criteria. The claim of "improved physical features" and supporting "performance data" is made without presenting the specific data or the methodology of how it was generated or evaluated against acceptance criteria.

Summary

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FDA CDRH DMC
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K102351

OCT 1 5 2010

Received

510(k) SUMMARY

Contact:	M. Th. Plaumann
Date prepared:	August 16, 2010
	NOV - 2 2010
Trade or proprietary name:	Grandio SO
Classification name:	Material, Tooth Shade, Resin (872.3690)
Predicate device:	Grandio, K051867, VOCO GmbH

Device description:

Grandio SO is a condensable, methacrylate based dental filling composite for all cavity Grandro So is a contential features excellent physical properties Classes with the morganie strength, color stability and durability in the mouth. e.g. Wear resistance, oomprocerve birgin, edes of optimal opacity and can be easily polished. It is therefore highly qualified for long lasting, esthetic restorations.

Grandio SO is processed according to current state of the art procedures for light curing condensable dental composites, thus, Grandio SO can be applied by any dental condensable domported, "that" of materials. Like the predicate device Grandio it profosoional who

Intended use:

Grandio SO is intended for use as:

class I to V fillings a
reconstruction of traumatically affected anteriors ﺖ
facetting of discolored anteriors .
faceting of dioblored antonomic for improved aesthetic appearance -
locking, splinting of loose anteriors ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
repairing veneers -
restoration of deciduous teeth -
core-build-up under crowns -
composite inlays -

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Technological characteristics:

Grandio SO and the legally marketed device Grandio, K051867 (VOCO GmbH) share the same indications but have improved physical features. Grandio SO has been optimized with regard-to-several-physical-parameters.

Grandio SO based on nanohybrid technology just like the predicate device Grandio. This technology relies on the optimal mixture of inorganic filler diameters.

The components of Grandio SO serve the same purpose as the ingredients of the predicate device Grandio.

The prior use of all of the components of Grandio SO in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary.

We believe that the prior use of the components of Grandio SO in legally marketed devices and the performance data and results.also provided support the safety and effectiveness of Grandio SO for the intended use.

VOCO GmbH, Qctober 13th, 2010

Dr. Thorsten Gorkensmeier

Dr. Thorsten Gerkensmeier (Regulatory Affairs)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Manfred T. Plaumann Managing Board Voco GMBH Anton-Flettner-Strasse 1-3 Cuxhaven Germany D-27472

Re: K102351

Trade/Device Name: Grandio SO Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: October 13, 2010 Received: October 15, 2010

Dear Mr. Plaumann:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

NOV - 2 2010

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Page 2- Mr. Plaumann

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Nh fo

Anthony D. Watson, B.S., M.S., M.B.A. 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 Statement

510(k) Number:	K102351
Device Name:	Grandio SO

NOV - 2 2010
Indications for Use:

Grandio SO is intended for use as:

class I to V fillings
reconstruction of traumatically affected anteriors
facetting of discolored anteriors
correction of shape and shade for improved aesthetic appearance
locking, splinting of loose anteriors
repairing veneers
restoration of deciduous teeth
core-build-up under crowns
composite inlays

Prescription Use	X	OR	Over-The-Counter Use
------------------	---	----	----------------------	--

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruaner

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

510(k) Number: K160235

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.