(9 days)
The Enamelite Porcelain Powders are aerosol devices intended to be used as spray applications of ceramic porcelains and glazes for dental restorations (crowns and bridges), which are produced in dental laboratories.
Ceramic Finishing Glaze (Nova Ceramic Spray Glaze). The Enamelite Nova Ceramic Spray Glaze is essentially identical to that used in the Leach and Dillon Shake n Spray powders. It is made of glass frit and is applied to dental restorations in an aerosolized uncontaminated form. Like all other porcelain powders, the Nova Ceramic Spray Glaze is only applied on dental restorations in dental laboratories. As with the parent Leach and Dillon device, the Nova Ceramic Spray Glaze in an aerosol form decreases the in-process time of hand applied glazing methods while providing a substantially more even coating of glaze. Both the parent and modified devices allow the dental technician to apply glaze on either single or multiple units at one time. The Nova Ceramic Spray Glaze is used to construct restorations that fire at temperatures from 650° C to 930° C. Various types of porcelains that are compatible with Nova Glaze include porcelain-fused-to metal, pressed ceramic restorations and milled zircon restorations. The Nova Glaze enables the dental technician the ability to spray a glaze over unfired dental ceramic stains and over unfired add-on porcelains which some restorations may require to esthetically match the dental patient's natural teeth. This flexibility will make these adjustments more efficient for the technician saving multiple firings staining, shading and repairing restorations.
Opaque Porcelain (Tru-Paque) The Tru-Paque opaque porcelain powder is a ceramic opaque spray porcelain intended to mask metal sub-structures. This provides a base layer for bonding additional translucent body porcelain layers of "Porcelain-Fused-to-Metal" (PFM) dental restorations. The purpose of opaque porcelains is to mask the dark color of metal sub-structures called "copings" used in porcelain-fused-to-metal constructed dental restorations, and to provide a layer to which translucent body porcelains are bonded. The Enamelite Tru-Paque is offered in an uncontaminated aerosolized form. As with the parent Leach and Dillon devices, the Tru-Paque opaque porcelain is applied on dental restorations in dental laboratories.
The provided text is a 510(k) summary for a medical device called "Nova Ceramic Spray Glaze and Tru-Paque Opaque Porcelain." This document is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. It is not a study report that details acceptance criteria and device performance in the way a clinical trial or a validation study for a diagnostic algorithm would.
Therefore, many of the requested elements of your prompt, such as acceptance criteria, reported device performance metrics (like sensitivity, specificity, AUC), sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment methods for training or test sets, are not applicable or not present in this type of regulatory submission.
This document focuses on demonstrating that the new device is "substantially equivalent" to an already legally marketed predicate device (Leach and Dillon Shake and Spray Porcelain Powders - K895889). The primary method used here is comparing technological characteristics rather than extensive performance studies with statistically derived acceptance criteria.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics in the way a diagnostic device would. Instead, it states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Function as intended and provide benefits over predicate. | "Verification and Validation testing of the Enamelite devices was successfully performed and demonstrates that the modified devices function as intended." Specific claimed benefits: "reduced particle size delivers a thinner more uniform coating resulting in more life-like dental restorations" and "decreases the in-process time of hand applied glazing methods while providing a substantially more even coating of glaze." |
| Substantial Equivalence to Predicate Device (K895889) | Demonstrated through comparison of technological characteristics: both are aerosol spray delivery systems for porcelain powders; both allow consistent/controllable applications. The key differences (reduced particle size) are presented as improvements that lead to better results. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "Verification and Validation testing" but does not detail the size or nature of the test sets used.
- Data Provenance: Not specified. No information on country of origin or whether testing was retrospective/prospective.
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/not specified. This type of submission does not involve expert-established ground truth for performance metrics in the context of diagnostic accuracy.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/not specified.
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 is not an AI-based diagnostic device. It is a dental material/delivery system.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used
- Type of Ground Truth: Not applicable in the traditional sense of diagnostic accuracy. The "ground truth" for this device would be its physical and chemical properties, its ability to adhere, its aesthetic outcome, and its compatibility with dental restorations, verified through laboratory/bench testing rather than clinical expert consensus or pathology reports.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that uses a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document states that "Verification and Validation testing of the Enamelite devices was successfully performed and demonstrates that the modified devices function as intended." This is a general statement typical of 510(k) submissions for devices like this. The core of the "proof" for substantial equivalence lies in the comparison of technological characteristics between the proposed device and the predicate device, as outlined in section 6 of the submission. The key arguments are:
- Similar Mechanism: Both use aerosol spray delivery systems for porcelain powders.
- Consistent Application: Both systems provide consistent and controllable applications.
- Improved Feature: The only significant difference (reduced particle size) is presented as an improvement leading to "thinner more uniform coating resulting in more life-like dental restorations" and decreased in-process time.
The FDA's finding of substantial equivalence (as indicated in the letter from Susan Runner, DDS, MA) confirms that based on the provided information, the device is considered as safe and effective as a legally marketed predicate device. This is primarily a regulatory determination based on technological comparison and general validation rather than a detailed performance study with explicit statistical acceptance criteria for diagnostic accuracy.
{0}------------------------------------------------
510(k) Summary for [Product Name]
1. SPONSOR
Enamelite LLC 1800 Business Park Drive Suite 406 Clarksville, TN 37040 Contact; Phillip Pitts, V.P. Products and Technology Tel#-931-647-7171 Fax#-931-647-7171 Email- ppitts(@enamelitellc.com
Date Prepared : March 14, 2003
2. Device Name
Proprietary Name: Nova Ceramic Spray Glaze and Tru-Paque, Opaque Porcelain Common/Usual Name: Porcelain Powders Classification Name: Porcelain Powders
3. PREDICATE DEVICES
Leach and Dillon Shake and Spray Porcelain Powders - K895889
4. DEVICE DESCRIPTION
Ceramic Finishing Glaze (Nova Ceramic Spray Glaze). The Enamelite Nova Ceramic Spray Glaze is essentially identical to that used in the Leach and Dillon Shake n Spray powders. It is made of glass frit and is applied to dental restorations in an aerosolized uncontaminated form. Like all other porcelain powders, the Nova Ceramic Spray Glaze is only applied on dental restorations in dental laboratories. As with the parent Leach and
1 Q
{1}------------------------------------------------
Dillon device, the Nova Ceramic Spray Glaze in an aerosol form decreases the in-process time of hand applied glazing methods while providing a substantially more even coating of glaze. Both the parent and modified devices allow the dental technician to apply glaze on either single or multiple units at one time. The Nova Ceramic Spray Glaze is used to construct restorations that fire at temperatures from 650° C to 930° C. Various types of porcelains that are compatible with Nova Glaze include porcelain-fused-to metal, pressed ceramic restorations and milled zircon restorations. The Nova Glaze enables the dental technician the ability to spray a glaze over unfired dental ceramic stains and over unfired add-on porcelains which some restorations may require to esthetically match the dental patient's natural teeth. This flexibility will make these adjustments more efficient for the technician saving multiple firings staining, shading and repairing restorations.
Opaque Porcelain (Tru-Paque) The Tru-Paque opaque porcelain powder is a ceramic opaque spray porcelain intended to mask metal sub-structures. This provides a base layer for bonding additional translucent body porcelain layers of "Porcelain-Fused-to-Metal" (PFM) dental restorations. The purpose of opaque porcelains is to mask the dark color of metal sub-structures called "copings" used in porcelain-fused-to-metal constructed dental restorations, and to provide a layer to which translucent body porcelains are bonded. The Enamelite Tru-Paque is offered in an uncontaminated aerosolized form. As with the parent Leach and Dillon devices, the Tru-Paque opaque porcelain is applied on dental restorations in dental laboratories.
ર્ડ. INTENDED USE
The Enamelite Porcelains Powders are aerosol devices intended to be used as spray applications of ceramic porcelains and glazes for dental restorations (crowns and bridges), which are produced in dental laboratories.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The modified Enamelite Porcelain Powders and the predicate Leach and Dillon Porcelain Powders both include aerosol spray delivery systems to deliver the porcelain powders. Both the Nova Ceramic Spray Glaze and Tru-Paque opaque porcelain powders allow for consistent and controllable applications of porcelain powders. Both systems consist of highly refined aerosol delivery systems. The only significant difference between the predicate and the proposed devices is that Nova Ceramic Spray Glaze and Tru-Paque opaque porcelains are of a reduced particle size as compared to the larger sized porcelain
{2}------------------------------------------------
particles in the original Leach and Dillon product. As a result, the reduced particle size delivers a thinner more uniform coating resulting in more life-like dental restorations. Verification and Validation testing of the Enamelite devices was successfully performed and demonstrates that the modified devices function as intended.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle.
MAR 2 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Philip Pitts Vice President, Products and Technology Enamelite, LLC 1800 Business Park Drive, Suite 406 Clarksville, Tennessee 37040
Re: K030859
Trade/Device Name: Nova Ceramic Spray Glaze and Tru-Paque Opaque Porcelain Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH Dated: March 14, 2003 Received: March 18, 2003
Dear Mr. Pitts:
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 vour 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.
{4}------------------------------------------------
Page 2 - Mr. Philip Pitts
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 (301) 594-4613. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Susan Runoee
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
{5}------------------------------------------------
K030859 510(k) Number (if known):
Device Name: Nova Ceramic Spray Glaze, Tru-Paque Opaque Porcelain
Indications For Use:
The Enamelite Porcelain Powders are aerosol devices intended to be used as spray applications of ceramic porcelains and glazes for dental restorations (crowns and bridges), which are produced in dental laboratories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | X |
|---|---|
| OR | |
| Over-The-Counter Use |
Kein Muly for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number | K030859 |
|---|---|
| --------------- | --------- |
§ 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.