(87 days)
Gold Core Plus is indicated for use as crowns, bridges, substrate for accepting high expansion porcelains.
Not Found
Here's an analysis of the provided text regarding the acceptance criteria and study for the Gold Core Plus device:
Based on the provided K023499 510(k) summary for Gold Core Plus, the device is a dental alloy. The regulatory review process for this type of device, particularly in 2003, primarily focused on establishing substantial equivalence to a legally marketed predicate device rather than on performance against specific quantitative acceptance criteria demonstrated through clinical studies in the way you might see for software or more complex medical devices.
Therefore, many of the requested categories related to clinical study design, sample sizes, ground truth, and expert adjudication are not applicable to this submission. The "acceptance criteria" here are fundamentally about demonstrating that the new device is as safe and effective as the predicate device.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantially Equivalent to Predicate Device: | Gold Core Plus is substantially equivalent to Pentron Laboratory Technologies, LLC., Jewel Cast II (K003039). |
| Same elements as predicate (or non-safety/effectiveness impacting difference): | Gold Core Plus contains the same elements as Jewel Cast II with the exception of one element (Molybdenum). |
| No adverse effect on safety: | The addition of Molybdenum does not affect safety. |
| No adverse effect on effectiveness: | The addition of Molybdenum does not affect effectiveness. |
| Improved corrosion resistance (demonstrated by new element): | The addition of Molybdenum has improved the corrosion resistance of the alloy. |
| Established safe use of new element (Molybdenum): | Molybdenum has been used successfully in Ni-Cr alloys for over 30 years. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. The submission focuses on elemental composition comparison and general knowledge of material properties, not a test set of patient data or device performance data from a specific study.
- Data Provenance: Not applicable. The "data" here refers to the chemical composition of the alloys and historical use of Molybdenum, not clinical or performance data from a specific country or study type.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth, in the context of clinical or diagnostic performance, is not established for this type of device submission. The FDA reviewers are experts in dental materials.
- Qualifications of Experts: The experts involved are the FDA reviewers from the Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, who review premarket notifications against existing regulations and scientific understanding of materials.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There is no "test set" in the context of a clinical performance study with adjudication. The evaluation is based on chemical composition and historical material use.
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
- MRMC Study: Not applicable. This is a material (dental alloy), not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Study: Not applicable. This is a dental alloy, not an algorithm.
7. The type of ground truth used
- Ground Truth Type: For this device, the "ground truth" for substantial equivalence is primarily based on:
- Chemical Composition Analysis: Comparing the elemental makeup of the new device to the predicate.
- Material Science Principles: Understanding how the addition of Molybdenum affects properties like corrosion resistance, and relying on established knowledge of Molybdenum's safe and effective use in similar alloys.
- Regulatory Precedent: The predicate device (Jewel Cast II, K003039) having already been cleared by the FDA.
8. The sample size for the training set
- Sample Size: Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable. No training set for a machine learning model is involved.
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21.0 510(K) SUMMARY
JAN 1 3 2003
Gold Core Plus is indicated for use as crowns, bridges, substrate for accepting high expansion porcelains. Gold Core Plus is substantially equivalent to Pentron Laboratory Technologies, LLC., Jewel Cast II, K003039. Gold Core Plus contains the same elements as Jewel Cast II with the exception of one element. However, the addition of this element does not affect safety or effectiveness because it has improved the corrosion resistance of the alloy. Also, Molybdenum has been used successfully in Ni-Cr alloys for over 30 years.
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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2003
Ms. Annmarie Tenero Paralegal Pentron Laboratory Technologies, LLC 53 North Plains Industrial Road P.O. Box 724 Wallingford, Connecticut 06492-0724
Re: K023499 Trade/Device Name: Gold Core Plus Regulation Number: 21 CFR 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Code: EJH Dated: October 16, 2002 Received: October 18, 2002
Dear Ms. Tenero:
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 - Ms. Annmarie Tenero
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 (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) you may obtain. 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 Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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5.0 INDICATION FOR USE STATEMENT
11023499 510(k) NUMBER (IF KNOWN):
Gold Core Plus DEVICE NAME:
INDICATION FOR USE:
Gold Core Plus is indicated for use as crowns, bridges, substrate for accepting high expansion porcelains.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 2 (Per 21 CFR 801.109) OR
Over -The-Counter-Use (Optional Format 1-2-96)
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Susan Rummer
Division Sign-Off
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number ._
Pentron Laboratory Technologies, LLC. 510K Submission – Gold Core Plus
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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.