LC FLOWFILL by S & C POLYMER GMBH

This is a 510(k) premarket notification for a dental material (LC FLOWFILL). The provided text describes the regulatory clearance process rather than a study evaluating the performance of an AI-powered device. Therefore, most of the requested information regarding acceptance criteria and a study proving a device meets these criteria is not applicable.

Here's an assessment based on the provided text:

A table of acceptance criteria and the reported device performance
- Not Applicable. The submission is for a dental filling material, not an AI-powered device with performance metrics like sensitivity or specificity. The "acceptance criteria" here refer to regulatory requirements for demonstrating substantial equivalence to a predicate device, rather than performance metrics of an AI algorithm.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This information pertains to studies validating AI device performance, which is not present in the provided document. The submission focuses on chemical composition and intended use comparison.
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)
- Not Applicable. Ground truth establishment by experts for a test set is relevant for AI performance evaluation. This document describes a traditional medical device (dental filling material).
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used in studies involving expert reviews, typically for AI validation, which is not the subject of this document.
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. MRMC studies are designed for evaluating the impact of AI on human reader performance, which doesn't apply to a dental filling material.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This applies to AI devices, not a dental filling material.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For a dental filling material, "ground truth" would relate to material properties and clinical performance (e.g., strength, biocompatibility, longevity). The submission asserts substantial equivalence based on chemical composition and intended use rather than providing specific performance data validated against a clinical ground truth.
The sample size for the training set
- Not Applicable. This is relevant for AI model training, not for a traditional medical device like a dental filling material.
How the ground truth for the training set was established
- Not Applicable. As above, this applies to AI model development.

Summary based on the provided text:

The provided document is a 510(k) summary for a dental filling material called LC FLOWFILL. The primary objective is to demonstrate substantial equivalence to a predicate device, "FLOW IT" by Pentron USA.

Acceptance Criteria (Regulatory perspective): The main "acceptance criterion" for this submission is demonstrating that LC FLOWFILL is substantially equivalent to a legally marketed predicate device in terms of intended use, performance, indications, labels, and instructions for use.
Study Proving Acceptance Criteria: The "study" isn't a clinical trial or AI validation study in the typical sense. Instead, the manufacturer (S & C Polymer GmbH) asserts substantial equivalence based on:
- Chemical composition comparison: Stating that "The chemical composition and use of LC FLOWFILL material is substantially equivalent to 'FLOW IT'." (Page 1)
- Intended use, performance, indications, labels, and instructions for use comparison: Stating that these aspects are "substantially similar to the predicted device." (Page 1)

The FDA's letter confirms that they have "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This FDA determination serves as the "proof" that the device meets the regulatory acceptance criteria for market clearance.

In essence, the document is a regulatory filing for a conventional medical device, and therefore the modern AI-centric questions are not applicable to its contents.

Summary

{0}------------------------------------------------

10. 510(k) Summary or Statement

SUMMARY
Kaa0 108

Gentleman:

This submission is pursuent to paragraph 510(k) of the Federal Drug and Cosmetic Act of May, 1976 (as amended) (Title 21 USC). All informations contained herein are to be considered and treated as CONFIDENTIAL COMMERCIAL INFORMATION.

It is the intention of S & C Polymer GmbH to manufacture the LC FLOWFILL cited above which can be used as LC FLOWFILL material.

S & C Polymer spezializes in manufacturing, distributing and marketing numerous dental materials and related items worldwide.

It is S & C Polymer GmbHs intention to manufacture the cited product herein at its facility located at Robert-Bosch-Straße 5, D-25335 Elmshorn (formerly Offenauer Weg 19, D-25335 Bokholt-Hanredder), Germany, employing Good Manufacturing Practices (GMPs) pursuant and according to Title 21 CFR. S & C Polymer GmbH is certified to DIN EN ISO 9001 / DIN EN 46001 and Medical Device Directive 93/42/EEC, annex II.

The above cited product may be offered and marketed in the United States by Henry Schein Inc. and/or Pharmex, in which case S & C Polymer will maintain control and govern the production and primary packaging. Henry Schein Inc. and/or Pharmex will maintain the claims, labels, instructions and indications by themselves which are consistent with this submission and final FDA 510(k) clearance to market by Henry Schein Inc. and/or Pharmex.

The cited LC FLOWFILL material S & C Polymer GmbH manufactures for Henry Schein Inc. and/or Pharmex is commonly found in current dental materials.

The purpose of this material for use by the dentist is to clinically fill human teeth (restauration in the case of mostly destroyed tooth structure). The material is in general placed against an applied adhesive system.

The chemical composition and use of LC FLOWFILL material is substantially equivalent to "FLOW IT", a product manufactured and marketed by Pentron USA. S & C Polymer GmbH s and Henry Schein Inc. and/or Pharmex`s intented use, performance, indications, proposed labels and instructions for use (see attached) are substantially similar to the predicted device (see attached).

Respectfully submitted

Jürgen Engelbrecht, Ph. D.
Regulatory Compliance Officer

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 1999

Jürgen Ebgelbrecht, Ph.D. President S & C Polymer Silicon- und Composite-Spezialitäten GmbH Robert-Bosch-StraBe 5 D-25335 Elmshorn GERMANY

Re : K990108 LC FLOWFILL Trade Name: Requlatory Class: II Product Code: EBF February 23, 1999 Dated: Received: March 1, 1999

Dear Dr. Engelbrecht:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

{2}------------------------------------------------

Page 2 – Dr. Engelbrecht

through 542 of the Act for devices under the Electronic Chrough 342 or the not al provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA debering of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed production wour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

v A. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

K990108

510 (k) NUMBER (IF KNOWN):

IC FLOWFILL DEVICE NAME:

. :

INDICATIONS FOR USE: LC FLOWFILL is a flowable light current micro hybride composite for tooth r fillings, sealings and cementing.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON AND THER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

. .

Prescription Use
(Per 21 CFR 801.109) OR Over-The-Counter-Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K990108

้ ( (

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.