(113 days)
Used only with FINESSE™ Low-Fusing Porcelain for the fabrication of dental restorations: for inlays, onlays, veneers, complete crowns on anterior teeth, and for single crowns on selected posterior teeth.
The FINESSE™ALL-CERAMIC SYSTEM is a glass-ceramic material designed to be used with Finesse™ Low-Fusing Porcelain. By combining the core material with the Finesse™ Low-Fusing Porcelain, the laboratory can offer the recognized aesthetics wear characteristic and chair-side polishability of Finesse™ Low-Fusing Porcelains combined with the aesthetic benefits of an all-ceramic system.
A dental restoration is prepared by placing a glass material in a heat and pressure deformable crucible. Heat is applied to the crucible to bring the glass to a "working" temperature. The glass is brought into contact with a mold having a preformed dental restorative cavity. The crucible is crushed and the molten glass is then injected into the mold. After cooling, the glass coping is removed from the mold. The glass restoration is heat treated to crystallize into a glass-ceramic. Finesse™ Low-Fusing Porcelain is then applied on the glass-ceramic coping to complete the restoration.
The provided document is a 510(k) summary for the DENTSPLY FINESSE™ ALL-CERAMIC SYSTEM, a dental material. It describes the device, its intended use, and technological characteristics, along with evidence of its safety and substantial equivalence to a predicate device.
However, the document does not contain information about specific "acceptance criteria" in the format of performance metrics (like sensitivity, specificity, accuracy) typically associated with AI/ML-based medical devices or diagnostic tools. It also does not describe a "study that proves the device meets the acceptance criteria" in terms of clinical performance evaluation using ground truth, expert readers, or statistical comparisons of device performance.
Instead, the "acceptance criteria" and "study" described in this document relate to the material's biocompatibility and its comparability to existing devices.
Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-cytotoxicity | Non-cytotoxic (MEM Elution Test) |
| Non-mutagenicity | Non-mutagenic (Ames Mutagenicity Assay) |
| Non-irritancy | Non-irritant (Hamster Cheek Pouch Irritation Study) |
| Substantial Equivalence to DICOR® Castable Ceramic (K830955A) for intended uses (inlays, onlays, veneers, complete crowns on anterior teeth, and single crowns on selected posterior teeth) | Found substantially equivalent by FDA for stated indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not applicable in the context of clinical performance evaluation as commonly understood for AI/ML devices. The "test set" here refers to samples used in material safety testing (e.g., biological samples for cytotoxicity, mutagenicity, and irritation). The specific number of samples for these tests is not provided in the document.
- Data Provenance: The studies were conducted on laboratory samples and animal models (hamster). No information on country of origin for these specific tests is provided, nor whether they were retrospective or prospective studies on human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. The "ground truth" for the material safety tests (cytotoxicity, mutagenicity, irritation) is determined by established laboratory protocols and biological endpoints, not by human experts interpreting clinical data. For the substantial equivalence, the "ground truth" is regulatory comparison to a predicate device, which is an FDA determination, not an expert consensus on a test set of clinical cases.
4. Adjudication Method for the Test Set
- Not applicable. There was no adjudication method involving multiple experts for interpreting test results in the clinical sense mentioned in the prompt. The material tests follow defined methods with clear endpoints.
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. This document describes a dental material, not an AI/ML-based diagnostic system that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This document describes a dental material, not an algorithm.
7. The type of ground truth used
- For Material Safety: Laboratory test results (e.g., cell viability, mutation rates, irritation scores) using established biological assays.
- For Substantial Equivalence: Comparison to the technological characteristics, intended use, and safety profile of the predicate device (DICOR® Castable Ceramic).
8. The Sample Size for the Training Set
- Not applicable. This document describes a dental material, not an AI/ML system that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This document describes a dental material, not an AI/ML system.
Summary of Device Performance/Studies from the Text:
The document states:
"The FINESSE™ ALL-CERAMIC SYSTEM has been evaluated by the MEM Elution Test and found to be non-cytotoxic, by the Ames Mutagenicity Assay and found to be non-mutagenic, and by the Hamster Cheek Pouch Irritation Study (mucous membrane) and found to be a non-irritant."
These are standard biocompatibility tests for medical devices and materials. The results indicate that the material meets safety standards related to cellular toxicity, genetic mutation, and tissue irritation.
The substantial equivalence claim is based on:
- Prior use of components in predicate medical devices.
- Results of the toxicity and irritation testing.
- Performance data (though specific performance testing beyond biocompatibility is not detailed in the summary, it implies mechanical/physical property data would have been submitted to FDA for comparison).
In conclusion, the provided text pertains to a traditional medical device (dental material) clearance rather than an AI/ML diagnostic or assistive device. Therefore, many of the requested bullet points, which are highly relevant to clinical performance evaluation of AI/ML systems, are not applicable to this document.
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510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
DENTSPLY International
570 West College Avenue P.O. Box 872 York, PA 17405-0872 171 845-7511 P. J. Lehn Tele
CONTACT: P. Jeffery Lehn
May 19, 1997 DATE PREPARED:
TRADE OR PROPRIETARY NAME: FINESSE™ ALL-CERAMIC SYSTEM
872.6660 CLASSIFICATION NAME: Porcelain Powder for Clinical Use
K830955A DICOR® Castable Ceramic PREDICATE DEVICE:
DEVICE DESCRIPTION: The FINESSE™ALL-CERAMIC SYSTEM is a glass-ceramic material designed to be used with Finesse™ Low-Fusing Porcelain. By combining the core material with the Finesse™ Low-Fusing Porcelain, the laboratory can offer the recognized aesthetics wear characteristic and chair-side polishability of Finesse™ Low-Fusing Porcelains combined with the aesthetic benefits of an all-ceramic system.
A dental restoration is prepared by placing a glass material in a heat and pressure deformable crucible. Heat is applied to the crucible to bring the glass to a "working" temperature. The glass is brought into contact with a mold having a preformed dental restorative cavity. The crucible is crushed and the molten glass is then injected into the mold. After cooling, the glass coping is removed from the mold. The glass restoration is heat treated to crystallize into a glass-ceramic. Finesse™ Low-Fusing Porcelain is then applied on the glass-ceramic coping to complete the restoration.
INTENDED USE: The FINESSE™ ALL-CERAMIC SYSTEM is used only with Finesse™ Low-Fusing Porcelain for the fabrication of dental restorations: for inlays, onlays, veneers, complete crowns on anterior teeth, and for single crowns on selected posterior teeth.
TECHNOLOGICAL CHARACTERISTICS: All components in the FINESSE™ ALL-CERAMIC SYSTEM have been used in predicale medical devices or have been found safe for dental use.
The FINESSE™ ALL-CERAMIC SYSTEM has been evaluated by the MEM Elution Test and found to be non-cytotoxic, by the Ames Mutagenicity Assay and found to be non-mutagenic, and by the Hamster Cheek Pouch Irritation Study (mucous membrane) and found to be a non-irritant.
We believe that the prior use of the components in predicate devices, the results of the toxicity and irritation testing, and the performance data support the safety and effectiveness of the FINESSE™ ALL-CERAMIC SYSTEM for the intended uses.
000001
JUL 2 1997
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP | | 1997
Mr. P. Jeffrey Lehn Director, Corporate Compliance & Regulatory Affairs DENTSPLY International 570 West College Avenue York, Pennsylvania 17405
K971869 Re : Finesse™ All-Ceramic System Trade Name: Regulatory Class: II Product Code: ETH Dated: July 24, 1997 Received: July 25, 1997
Dear Mr. Lehn:
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 reqistration, 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 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 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531
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Page 2 - Mr. Lehn
through 542 of the Act for devices under the Electronic enrough Siz of on 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 requlation (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 requlation entitled, "Misbranding by reference to one arket 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
Tim 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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PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 801.109)
510(K) Number:
Device Name:
FINESSE™ALL-CERAMIC SYSTEM
Indications for Use:
Used only with FINESSE™ Low-Fusing Porcelain for the fabrication of dental restorations: for inlays, onlays, veneers, complete crowns on anterior teeth, and for single crowns on selected posterior teeth.
Susan Runver
(Division Sign Off) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Dental Infection Control,
and Gereral Hospital De aces
K971869
- Prescription Use Yes
OR
Over-The-Counter Use No
§ 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.