(64 days)
artBloc® Temp is indicated for use with inLab, CEREC or other CAD-controlled milling equipment for the fabrication of multi-unit long-term temporary crowns or bridges.
A rectangular solid block of PMMA with post attachment for use in a CAD-controlled milling device for production of long-term temporary crowns and bridge abutments.
The provided text describes a medical device, artBloc® Temp, which is a PMMA block for CAD-controlled milling machines. The document is a 510(k) premarket notification summary. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with detailed acceptance criteria and performance metrics typically associated with AI/software devices.
As such, the information requested below, particularly related to acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert involvement, and ground truth establishment, is largely not applicable or not provided in this type of regulatory submission for a physical dental material. There is no mention of an algorithm, AI, or software performance in the context that would require these specific metrics.
Here's a breakdown based on the provided document:
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A table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Compliance to ISO 10477 (Polymer-based crown and veneering materials) Not explicitly stated: The document only states "Tested for compliance to ISO 10477". Specific performance values (e.g., flexural strength, water sorption) are not reported. The implication is that it met the standard's requirements, which serves as the acceptance criteria for material properties. Compliance to ISO 3336 (Dental ceramic applied to metal restorations) Not explicitly stated: The document only states "Tested for compliance to ISO 3336". Specific performance values are not reported. This standard might be referenced for general dental material quality and methods, but PMMA is not ceramic. It's possible this is a general reference or an error in the summary. The core material is PMMA. Compliance to ISO 10993 (Biological evaluation of medical devices) Not explicitly stated: The document only states "Tested for compliance to ISO 10993". Specific biocompatibility results (e.g., cytotoxicity, sensitization) are not reported. The implication is that it met the standard's requirements, which serves as the acceptance criteria for biocompatibility. Substantial Equivalence to Predicate Devices: artegral ImCrown and VITA CAD-Temp Achieved: The FDA letter states: "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... to legally marketed predicate devices." This is the primary "performance" criterion for a 510(k), meaning its characteristics and intended use are similar enough to existing devices not to raise new questions of safety and effectiveness. Indication for use with inLab, CEREC, or other CAD-controlled milling equipment for the fabrication of multi-unit long-term temporary crowns or bridges. Supported by Predicate Equivalence: The intended use statement confirms this (Page 3 of 48). The predicate devices also serve as evidence that such materials can be used for temporary crowns and bridges with CAD/CAM systems. The "performance" here is functional compatibility and suitability for the intended anatomical and clinical application, implicitly covered by compliance to ISO standards and substantial equivalence. -
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. This document is a regulatory summary for a physical material, not for an AI/software device involving test sets of data. Testing mentioned (ISO standards) would typically involve material samples, but the number of such samples is not specified.
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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/Not provided. Ground truth, in the context of expert review, is not relevant for this type of material submission. Compliance to ISO standards is typically assessed by laboratory testing against pre-defined physical/chemical/biological metrics.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This refers to expert review processes, which are not detailed or implied for this submission.
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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. This is a physical dental material, not an AI or imaging device that would involve human readers or AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm discussed in this document.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Material property standards: The "ground truth" for this device would be its physical, chemical, and biological properties meeting the specifications outlined in the referenced ISO standards (ISO 10477, ISO 3336, ISO 10993). This is typically determined through laboratory testing against established benchmarks.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/software device. For a physical material, development would involve R&D and quality control, but not a "training set" in this sense.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set mentioned or implied, this question is not relevant to the provided document.
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Premarket Notification PMMA Block for CAD-Controlled Milling Machines artBloc® Temp
Merz Dental GmbH
VIII. Premarket Notification 510(k) Summary
:
| Submitted by: | MAY - 2 2008Merz Dental GmbHEetzweg 20D-24321 LutjenburgGermany0 43 81/4 03-4 11 (phone)0 43 81/4 09-1 07 (fax) |
|---|---|
| Contact person: | Dr. Med Claudia Bobrowski |
| Date prepared: | February 15, 2008 |
| Device proprietary name: | artBloc® Temp |
| Common name: | PMMA Block |
| Classification name: | (21 CFR 872.3330) |
| Predicate devices: | artegral ImCrownandVITA CAD-Temp |
| Description of the device: | A rectangular solid block of PMMA with postattachment for use in a CAD-controlled millingdevice for production of long-term temporarycrowns and bridge abutments. |
| Intended use: | artBloc® Temp is indicated for use with inLab andCEREC milling equipment for the fabrication ofmulti-unit long-term temporary crowns or bridges. |
| Characteristics: | A solid rectangular block of durable and astheticpolymer (PMMA) that can be easily milled with aCAD-controlled device into a suitable long-termtemporary restoration (crown or bridge abutment) |
| Testing: | Tested for compliance to ISO 10477, ISO 3336 andISO 10993. |
Page 48 of 48
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like bird with its wings spread, rendered in black. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" in all capital letters. The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2008
Merz Dental GmbH C/O Mr. Richard G. Hunter Principal Washington Regulatory Consultants 5616 Mariola Place, NE Albuquerque, New Mexico 87111
Re: K080556 Trade/Device Name: artBloc® Temp Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: February 25, 2008 Received: February 29, 2008
Dear Mr. Hunter:
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 your 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.
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Page 2- Mr. Hunter
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 (OS) 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Clive Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification PMMA Block for CAD-Controlled Milling Machines
ar1Bloc® Temp Merz Dental GmbH
V. Indications for Use Statement
510(k) Number:
To be assigned
Device Name:
artBloc® Temp
Indications for Use:
artBloc® Temp is indicated for use with inLab, CEREC or other CAD-controlled milling equipment for the fabrication of multi-unit long-term temporary crowns or bridges.
k 6 40 25 €
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart )
(PLEASE DO NOT WRITE BELOW THIS LINE-
Concurrence of CDRH, Office of Device Evaluation (ODE)
Summery
Division Sign-Off) livision of Anesthesiology, General Hospital nfection Control, Dental Devices
Page 10 of 48
10(k) Number:
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.