(96 days)
The Sinfony® system is indicated for use as a light-curing composite veneer material for:
- full and partial coverage of:
- fixed crown and bridgework .
- telescopic and conical crowns .
- precision attachments
- implant superstructures .
- adhesive bridgework .
- laminate veneers .
- o individualizing denture teeth
- individualizing long-term temporary restorations .
light-curing composite veneer material
The provided text describes a 510(k) premarket notification for a dental material (Sinfony®), focusing on its substantial equivalence to previously cleared devices. It outlines the intended use and states that physical and technical characteristics were compared using specific ISO and DIN standards. However, it does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study proving device performance as typically understood for AI/ML device evaluations.
Specifically, the document discusses a dental material and its mechanical properties, not an AI/ML device, and thus the concepts of "device performance," "sample size for test set," "experts to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set," and "ground truth for training set" are not applicable in the context of this traditional medical device submission.
Therefore, I will only be able to provide information relevant to the material described in the input text.
Here's what can be extracted and inferred from the text provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Measured Characteristics) | Reported Device Performance (Reference Standard) |
|---|---|
| Surface finish | Compared to Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604) |
| Flexural strength | Compared to Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604) |
| Water absorption | Compared to Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604) |
| Solubility | Compared to Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604) |
| Color and translucency | Compared to Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604) |
| Color stability | Compared to Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604) |
| Surface hardness | Compared to Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604) |
| Improved mechanical properties | Allows for full (not just partial) coverage of crown and bridgework veneers, including occlusal areas (compared to Visio-Gem®) |
Note: The document states "To support substantial equivalence... characteristics of Sinfony® have been compared to those of Visio-Gem® using tests undertaken pursuant to ISO 10477 and DIN 53456." It does not provide the specific numerical acceptance thresholds or the detailed quantitative results for each characteristic, only that they were compared to establish substantial equivalence.
Regarding the other points, the provided text does not contain the information requested, as it pertains to a different type of medical device (a dental material) than what your questions imply (an AI/ML device). Therefore, the following points cannot be answered from the provided input:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a material test.
- 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): Not applicable for a material test.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a material test.
- 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 as this is not an AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI device.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For material testing, "ground truth" is typically established by standardized physical/chemical measurements rather than expert consensus on diagnostic images or pathology. The "ground truth" here is the performance of the predicate device and the standards ISO 10477 and DIN 53456.
- 8. The sample size for the training set: Not applicable as this is not an AI device.
- 9. How the ground truth for the training set was established: Not applicable as this is not an AI device.
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II. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
ESPE is submitting a 510(k) premarket notification for modifications to its Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604), to create modified veneer materials that provide improved mechanical properties and aesthetics. The Sinfony® system is indicated for use as a light-curing composite veneer material for:
- full and partial coverage of:
- fixed crown and bridgework .
- telescopic and conical crowns .
- precision attachments
- implant superstructures .
- adhesive bridgework .
- laminate veneers .
- o individualizing denture teeth
- individualizing long-term temporary restorations .
ESPE is claiming substantial equivalence to its previously cleared Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604). The products have similar intended uses, except that, due to its improved mechanical properties, Sinfony® provides full (not just partial) coverage of crown and bridgework veneers, including occlusal areas. Sinfony® and the Visio-Gem® products also
WA01A/133508.1
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have similar ingredient composition. Further, both products are intended for use by a dental technician outside the mouth in a commercial dental laboratory or laboratory in a dental office. To support substantial equivalence to the predicate product, the physical and technical characteristics of Sinfony® have been compared to those of Visio-Gem® using tests undertaken pursuant to ISO 10477 and DIN 53456. These characteristics include surface finish, flexural strength, water absorption, solubility, color and translucency, color stability, and surface hardness.
ESPE's 510(k) has been submitted on September 17, 1997, by Dr. Barbara Wagner-Schuh at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 22 1997
Dr. Barbara Wagner-Schuh Requlatory Affairs ESPE GmbH & Company KG. ESPE Platz D-82229 Seefeld, OBB.
K973513 Re : Trade Name: Sinfony Dentin, Opaque-Dentin, Enamel, Enamel Modifier Requlatory Class: II Product Code: EBF Dated: December 1, 1997 Received: December 4, 1997
Dear Dr. Waqner-Schuh:
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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory 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
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Page 2 - Dr. Wagner-Schuh
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
Device Name:
(-10(K) 4
Sinfony® Light-Curing Crown and Bridge Full Coverage Composite Material
Indications for Use:
.
ﻠﺴﻠﺔ
Full and partial coverage of:
- fixed crown and bridgework .
- telescopic and conical crowns .
- precision attachments .
- implant superstructures .
- adhesive bridgework ◆
- laminate veneers .
- individualizing denture teeth
individualizing long-term temporary restorations
Swarup Kumar
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .
Prescription Use __ X
Or
Over-the-Counter Use $\underline{No}$
WA01A/133508.1
§ 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.