(23 days)
Alexander alloy intended to be used for inlays, onlays, ¾ crowns, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns, and partial dentures.
Alexander
This is a 510(k) premarket notification for a dental alloy, not a medical device that utilizes AI or requires outcome-based studies. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and AI performance metrics are not applicable in this context.
Here's a breakdown based on the provided document and the nature of the device:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state "acceptance criteria" in the way one would for a performance-based medical device (e.g., sensitivity, specificity, accuracy). Instead, for materials like dental alloys, the regulatory acceptance is primarily based on demonstrating substantial equivalence to a legally marketed predicate device. This involves comparing material properties, intended use, and other characteristics to ensure similar safety and effectiveness.
The "reported device performance" is not quantified in terms of clinical outcomes or diagnostic metrics in this document. The letter indicates that the device, "Alexander," is an alloy intended for various dental restorations (inlays, onlays, crowns, bridges, partial dentures). The performance is implicitly deemed acceptable by the FDA's "substantial equivalence determination."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a material submission, not a study evaluating a device's performance on patient data. The "test set" would refer to the characteristics and properties of the material itself, which would be measured and compared to the predicate, not a dataset of patient cases.
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. There is no concept of "ground truth" established by experts in the context of evaluating a dental alloy for substantial equivalence. The evaluation relies on material specifications and comparison to an existing device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, which is not the case for a dental alloy submission.
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. This device is a dental alloy, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a dental alloy, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for a dental alloy submission relates to its material composition, physical properties, and biocompatibility, which are verified through standard laboratory tests and comparison to a predicate, not through expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set:
Not applicable. This device is a dental alloy. There is no "training set" as understood in machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable. As above, there is no training set for this type of device.
In summary:
The provided document is a 510(k) clearance letter for a dental alloy. The regulatory process for such devices focuses on demonstrating substantial equivalence to a predicate device based on material properties, intended use, and basic safety/performance characteristics. It does not involve the types of clinical studies, AI algorithms, or expert ground truth adjudication described in your request.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
SEP = 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Anderjeet S. Gulati Quality Assurance Manager Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
Re: K032493
Trade/Device Name: Alexander Regulation Number: 872.3060 Regulation Name: Gold-Basted Alloys and precious Metal Alloys for Clinical USE Regulatory Class: II Product Code: EJT Dated: August 8, 2003 Received: August 16, 2003
Dear Mr. Gulati:
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. Gulatl
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. 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 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 Runore
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
Enclosure
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| 510(k) Number (if known): | K032493 |
|---|---|
| --------------------------- | --------- |
Device Name:
Alexander
Indications For Use:
Alexander alloy intended to be used for inlays, onlays, ¾ crowns, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns, and partial dentures.
Kein Muluy for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K032493
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR
(Optional Format 1-2-96)
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.