(145 days)
Masky is indicated for use when patients require a partial denture prosthetic that has a substantial amount of exposed metal in the frame. Masky covers exposed metal areas to reduce visual impact of framework in the mouth. Can also cover wires used in orthodontic appliances to make appliances less visible.
Resin material that is biologically inert once cured on the metallic framework, similar to ArtGlass, with exception of curing methodology. ArtGlass cures by light; Masky by heat.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Masky) |
|---|---|
| Biocompatibility: Absence of chromosomal aberrations induced in vitro. | Masky demonstrated no negative results in this test, indicating no chromosomal aberrations. |
| Biocompatibility: No adverse effect on cell viability using propidium iodide uptake. | Masky demonstrated no negative results in this test, meaning no adverse effect on cell viability. |
| Biocompatibility: Non-mutagenic in the Ames Salmonella/microsome test. | Masky demonstrated no negative results in this test, indicating it is non-mutagenic. |
| Biocompatibility: Absence of sister chromatid exchange in vitro. | Masky demonstrated no negative results in this test, indicating no sister chromatid exchange. |
| Similar in design, composition, and function to predicate device (ArtGlass). | Masky is a resin material that is biologically inert once cured, similar to ArtGlass, with the exception of curing methodology (ArtGlass cures by light, Masky by heat). |
| Intended Use: Cover exposed portions of metallic frameworks in partial denture prostheses for natural appearance. | Masky is indicated for this use and the biocompatibility tests support its safe application. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "tests as performed by the Istituti Ortopedici Rizzoli for Pressing Italy" but does not specify the number of samples or specimens used for each test.
- Data Provenance: The tests were performed in December 1996 by the Istituti Ortopedici Rizzoli for Pressing Italy. This indicates the data is retrospective (performed prior to the 510(k) submission) and originated from Italy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The tests performed are laboratory-based biocompatibility assays, not studies requiring expert interpretation of clinical data in the same way, for example, a diagnostic imaging study would. The ground truth for these tests would be established by the scientific methodologies and controls inherent in each assay.
4. Adjudication Method for the Test Set
This information is not applicable/not provided in the document. The biocompatibility tests are objective laboratory assays with predetermined endpoints, rather than subjective assessments that would require an adjudication method.
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, an MRMC comparative effectiveness study was not conducted. This device is a material (tooth shade resin), not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. "Masky" is a material, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant here.
7. The type of ground truth used
The ground truth used for "Masky" is based on the results of standardized laboratory biocompatibility tests. These included:
- Evaluation of chromosomal aberrations (in vitro)
- Evaluation of cell viability (using propidium iodide uptake)
- Mutagenicity in Ames Salmonella/microsome test
- Evaluation of sister chromatid exchange (in vitro)
8. The Sample Size for the Training Set
This information is not applicable/not provided. "Masky" is a material, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, "Masky" is a material, not an AI/ML algorithm requiring a training set. The "ground truth" related to its performance is established through the objective laboratory tests mentioned in point 7.
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Pressing North America, Inc. 4311 SW Research Way Corvallis, Oregon 97333 541 754 1238 PHONE 541 754 7478 FAX
September 15, 1997
510(k) Summary
This is to notify you of the intention of Pressing North America, Inc. to import and distribute the following device for:
ressing Di Monticelli Italy Emilia Romagna 233 033 Cattolica, Italy 011 378909948 Phone 011 378909958 Fax Stefano Monticelli, Administrator Establishment #9026751
Contact person for Pressing North America, Inc. (submitter): Thomas D. Maddux, 4311 SW Research Way, Corvallis, Oregon, 97333. Phone 541 754 1238, Fax 541 754 7478
Proprietary Name: MASK Y
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Common or Usual Name:. Tooth shade resin material
Establishment Registration Number: 3031160
Classification name: 872.690
Performance Standard: Unknown
Substantial Equivalence: This product is similar in design, composition, and function to ArtGlass, manufactured by Hereaus Kulzer which was the subject of Premarket Notification #K954115.
510(k) summary
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Intended Use: To cover exposed portions of metallic frameworks in partial denture prostheses, for more natural appearance.
Technological Characteristics: Resin material that is biologically inert once cured on the metallic framework, similar to ArtGlass, with exception of curing methodology. ArtGlass cures by light; Masky by heat.
Clinical Performance Summary: Both ArtGlass and Masky are biologically inert once cured; tests as performed by the Istituti Ortopedici Rizzoli for Pressing Italy on the material address standard tests for biocompatibility. The tests, performed in December 1996, are enclosed in this 510(k) application; as follows:
-
- EVALUATION OF CHROMOSOMAL ABERRATIONS INDUCED IN VITRO BY HEAT CURING RESIN FOR THE COVERING OF CrCo PROSTHESES;
-
- EVALUATION OF THE EFFECT OF HEAT CURING RESIN FOR THE COVERING OF CrCo PROSTHESES ON CELL VIABILITY USING PROPIDIUM IODIDE UPTAKE;
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- MUTAGENICITY OF HEAT CURING RESIN FOR THE COVERING OF CrCo PROSTHESES IN THE AMES SALMONELLA / MICROSOME TEST;
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- EVALUATION OF SISTER CHROMATID EXCHANGE IN VITRO INDUCED BY HEAT CURING RESIN FOR THE COVERING OF CACo PROSTHESES.
Clinical Performance Conclusions: Masky had no negative results in testing that contraindicates use with dental prostheses.
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Image /page/2/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 eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1998
Mr. Thomas D. Maddux Corporate Secretary Pressing DI Monticelli Rag. Stefano C/O Pressing North America Incorporated 4311 SW Research Way Corvallis, Oregon 97333
Re : K973542 Trade Name: Masky Requlatory Class: II EBI Product Code: Dated: January 28, 1998 Received: January 30, 1998
Dear Mr. Maddux:
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 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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Maddux
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 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 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
Timot Directdr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Page | |
|---|---|
| 01 | 1 |
| 510(k) Number (if known): | K973542 |
|---|---|
| Device Name: | Masky |
Indications For Use:
Statement of Indications for Use:
Masky is indicated for use when patients require a partial denture prosthetic that has a substantial amount of exposed metal in the frame. Masky covers exposed metal areas to reduce visual impact of framework in the mouth. Can also cover wires used in orthodontic appliances to make appliances less visible.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suank Rurrer
(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, and General Hospital Devices 10 510(k) Number
Prescription Use ી (Per 21 CFR 801.109)
OR
Over-The-Counter Use No
(Optional Format 1-2-96)
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.