(87 days)
Gold Core Plus is indicated for use as crowns, bridges, substrate for accepting high expansion porcelains.
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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.
§ 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.