(29 days)
Precious alloy for use in Ceramic dental restorations.
Precious Alloy for use in dental restorations where porcelain application is indicated.
Criterion is a White Porcelain Dental Alloy.
The provided text describes a Special 510(k) Premarket Notification for a dental alloy named "Criterion." This is a regulatory submission for a medical device, and the content focuses on demonstrating substantial equivalence to existing predicate devices rather than a detailed performance study with acceptance criteria in the way one might see for an AI algorithm or a novel diagnostic device.
Therefore, many of the specific questions about acceptance criteria, test sets, ground truth establishment, and MRMC studies are not applicable to this type of regulatory submission and device.
Here's a breakdown of the information that is applicable and how it relates to the provided text:
1. A table of acceptance criteria and the reported device performance
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Acceptance Criteria: The core "acceptance criteria" for a Special 510(k) are demonstrating substantial equivalence to existing predicate devices. This means showing that the new device has "the same intended use and the same technological characteristics as the predicate device" or "the same intended use as the predicate device and different technological characteristics and the information submitted demonstrates that the device is as safe and effective as the legally marketed device without raising different questions of safety and effectiveness."
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Reported Device Performance: The document states:
"In support of this 510(k), Sterngold has provided information to demonstrate conformity with FDA's guidance document entitled Guidance Document for the Preparation of Premarket Notifications 510 s] for Dental Alloys)."
And concludes:
"Based on the indications for use, technological characteristics, and comparison to predicate devices, Criterion has been shown to be safe and effective for its intended use."Since this is an Abbreviated 510(k), the performance is implicitly proven by adherence to the specified guidance document for dental alloys, which would outline material properties, biocompatibility, and other relevant characteristics. Specific numerical performance metrics are not listed in this summary, as the "performance" is primarily defined by meeting established standards for dental alloys.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not explicitly stated. This type of information is generally found in performance studies for novel devices or AI algorithms, not typically for a Special 510(k) for a material like a dental alloy, where conformity to standards and comparison to predicate devices are the primary focus. The "test set" here would refer to the samples of the Criterion alloy tested against the established guidance document and potentially compared to predicate devices' known properties. The document does not specify the number of alloy samples or their origin.
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. "Ground truth" established by experts in this manner is relevant for diagnostic devices or AI, not for a material science submission for a dental alloy. The "ground truth" for a dental alloy performance would be the scientific and engineering standards for such materials.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used to resolve disagreements in expert interpretations, typically in diagnostic or qualitative assessments. This is not relevant for demonstrating substantial equivalence for a dental alloy primarily based on physical and chemical properties and adherence to guidance documents.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, iI so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. MRMC studies are conducted for diagnostic devices, especially those involving human interpretation, to assess the impact of a device (or AI) on reader performance. This is entirely outside the scope of a submission for a dental alloy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This submission is for a physical dental alloy, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For a dental alloy, the "ground truth" for its safety and effectiveness is established by material science standards, biocompatibility testing, mechanical property testing, and clinical experience/history of use for similar predicate devices, all typically outlined or referenced within relevant FDA guidance documents for specific device types. The submission indicates conformity with the "Guidance Document for the Preparation of Premarket Notifications 510s] for Dental Alloys)." The specific details of these tests are not provided in the summary but would be part of the full 510(k) submission.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of a dental alloy submission. This term applies to machine learning or AI models.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is irrelevant.
In summary, the provided document is a regulatory summary for a dental alloy seeking market clearance through substantial equivalence to existing devices, not a clinical or performance study of an AI or diagnostic device. Therefore, many of the detailed questions about test sets, ground truth establishment, and expert involvement for qualitative assessments are not addressed or applicable to this type of submission.
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Criterion
Special 510(k) Premarket Notification: Abbreviated 510(k)
Ka21741
510(k) Summary
Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Sterngold is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Sterngold chooses to submit a summary of the safety and effectiveness information. The summary is as follows:
| Trade Name: | Criterion |
|---|---|
| Sponsor: | Sterngold23 Frank Mossberg DriveP.O. Box 2967Attleboro, MA 02703-0967Registration #2921595 |
| Device Generic Name: | Dental Alloy |
| Classification: | According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II. |
Predicate Devices:
| Alloy Name | 510(k) | Manufactured By |
|---|---|---|
| Jel 96 | (k) 944679 | Jelenko |
| Argedent 74 | (k) 892335 | Argen |
| Degudent GS | (k) 905387 | Degussa |
| V-Supra Plus | (k) 993508 | Metalor |
Product Description:
Criterion is a White Porcelain Dental Alloy.
Indications for Use:
Precious alloy for use in Ceramic dental restorations.
Safety and Performance:
This submission is a Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Sterngold has provided information to demonstrate conformity with FDA's guidance document entitled Guidance Document for the Preparation of Premarket Notifications 510 s] for Dental Alloys).
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, Criterion has been shown to be safe and effective for its intended use.
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2002
Ms. Maria Rao Quality Manager Sterngold 23 Frank Mossberg Drive Attleboro, Massachusetts 02703-0967
Re: K021741
Trade/Device Name: Criterion Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: May 20, 2002 Received: May 28, 2002
Dear Ms. Rao:
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.
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
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Page 2 - Ms. Maria Rao
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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.
Timothy A. Ulatowski Director 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 1 of
510(k) Number (if known): K021741
Device Name: __ Criterion
Indications for Use:
Precious Alloy for use in dental restorations where porcelain application is indicated.
(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)
OR
Over-the -Counter Use_
Susan Runne
(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, and General Hospital Dey 510(k) Number -
§ 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.