The provided FDA 510(k) summary for the "Sterngold 1" dental alloy does not contain the detailed information typically found in a study demonstrating device performance against specific acceptance criteria for AI/imaging devices.

This document describes a "Special 510(k): Abbreviated 510(k)" for a dental alloy, not an AI or imaging device. The regulatory pathway for this type of device relies on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than conducting performance studies with detailed acceptance criteria as would be expected for a diagnostic AI tool.

Therefore, many of the requested categories are not applicable to this submission.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The submission is for a dental alloy, which relies on demonstrating conformity with FDA guidance for dental alloys and comparison to predicate devices, rather than performance metrics like sensitivity, specificity, or image quality against acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. There is no "test set" in the context of an AI/imaging device described. The submission focuses on the material properties and intended use of a dental alloy.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. Ground truth establishment by experts for a test set is not relevant for a dental alloy submission.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

Not applicable. This is not an AI-assisted device.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used:

Not applicable. The "ground truth" for a dental alloy would relate to its material properties, biocompatibility, and mechanical performance, which are assessed against recognized standards and predicate device data, not through expert consensus on diagnostic images or pathology.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not a machine learning device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of the K022252 Submission for Sterngold 1 Dental Alloy:

The K022252 submission for Sterngold 1 is an Abbreviated 510(k) for a "Yellow Crown and Bridge Alloy." This pathway is used to demonstrate substantial equivalence to legally marketed predicate devices by conforming to recognized standards and guidance documents.

Acceptance Criteria (Implicit): Conformance to FDA's "Guidance Document for the Preparation of Premarket Notifications [510(k)'s] for Dental Alloys" and equivalence in material properties and safety/effectiveness to predicate devices (Harmony Medium, Monogram II).
Study That Proves the Device Meets Acceptance Criteria: The submission itself, by providing information to demonstrate conformity with the FDA's guidance document for dental alloys, serves as the "study." This typically involves presenting data on material composition, mechanical properties, and biocompatibility, as well as a comparison to the predicate devices. The conclusion states: "Based on the indications for use, technological characteristics, and comparison to predicate devices, Sterngold 1 has been shown to be safe and effective for its intended use."

The FDA's review resulted in a determination of substantial equivalence, allowing the device to be marketed. This regulatory pathway does not necessitate the types of performance studies or ground truth establishment described in the prompt, which are more relevant for diagnostic devices, particularly those incorporating AI.

Summary

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Stern old 5100k · Premarket Notification - Abbreviated SEP 1 9 2002

Kozzz52

510(k) Summary

Purs any to 12(i)(3)(A) of the Food, Drug and Cosmetic Act, Sterngold is required to submit with this Premarket Noti ication either an "...adequate summary of any information respecting safety and effectiveness or state that info mation will be made available upon request of any person." Sterngold chooses to submit a summary of the safe y and e fectiveness information. The summary is as follows:

Trade Name:	Sterngold 1
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

Pre licate Devices:

Alloy Name	510(k)	Manufactured By
Harmony Medium	(k) 905330	Ivoclar
Monogram II	(k) 895064	Leach & Dillon

Product Description:

Ste ngold 1 is a Yellow Crown and Bridge Alloy.

Indication: for Use:

Pre ious al oy for use in Crown and Bridge dental restorations.

Sat ty and Performance:

This submission is a Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled "The Ne v 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket No ificatio is." In support of this 510(k), Sterngold has provided information to demonstrate conformity with FD 1's guilance document entitled Guidance Document for the Preparation of Premarket Notifications [510(k) 's] for Dental Alloys).

Conclusion:

Ba ed on the indications for use, technological characteristics, and comparison to predicate devices, Sterngold 1 has been show to be safe and effective for its intended use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines that suggest the head, body, and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 9 2002

Ms. Maria Rao Quality and Regulatory Affairs Manager STERNGOLD 23 Frank Mossberg Drive Attleboro, Massachusetts 02703-0967

Re: K022252

Trade/Device Name: Sterngold 1 Regulation Number: 872.3060 Regulation Name: Gold-based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJS Dated: June 28, 2002 Received: July 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 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.

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.

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Page 2 - Ms. Rao

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,

Patricia Cunliffe

Timothy A. Ulatowski 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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Sterngold 510(k) Premarket Notification - Abbreviated June 28, 2002 Sterngold 1

Kozz252

Page of

510(k) Number (if known):

Device Name: Sterngold 1

Indications for Use:

Precious Alloy for use in Crown and Bridge Dental Restorations.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use צ (Per 21 CFR 801.109)

Over-the -Counter Use

Susan Ruma

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K003252

Regulation Number and Section

§ 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.