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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

• 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."

• 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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