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Used in the fabrication, repair or rebasing of complete or partial removable dentures and other removable dental appliances.

LIQCRYLIC™ PRO DENTAL RESIN is a pourable, cold-curing powder and liquid polymethyl methacrylate denture base material. It is color stable due to the fact that it utilizes a barbituric acid based catalyst system in lieu of the conventional benzoyl peroxide/amine catalyst system. It will be marketed in the popular Lucitone® 199 denture base shades. LIQCRYLIC™ PRO DENTAL RESIN mixes more quickly, has a shorter cure cycle and can be finished easier than the conventional pour resins currently available in the U.S. market.

Here's an analysis of the provided 510(k) summary, specifically addressing your points about acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a dental resin (LIQCRYLIC™ PRO DENTAL RESIN), which is a material used for dentures. This type of device typically undergoes testing for material properties (e.g., strength, color stability, biocompatibility) rather than diagnostic accuracy or performance against a "ground truth" as you might find with an AI-powered medical imaging device. Therefore, many of your specific questions related to AI device performance metrics (MRMC studies, standalone performance, expert consensus on images, training sets) are not applicable in this context.

Based on the provided document, here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a quantitative table format that lists specific thresholds for performance metrics. Instead, it relies on substantial equivalence to a predicate device and a history of safe use.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in terms of a formal test "set" for human or AI performance. The equivalence is based on the long history of the material.
• Data Provenance: The "data" primarily stems from the long-term clinical use and market history of the predicate device (Palapress Vario) and similar formulations marketed by DENTSPLY in Europe and South America for over 25 years (technology is over 30 years old). This would be considered retrospective observational data (clinical history). The countries of origin mentioned are the U.S. (for predicate), Europe, and South America (for similar devices).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable. The device is a material, not a diagnostic tool requiring expert interpretation of images or clinical data for ground truth establishment. Equivalence is primarily based on material properties and clinical history.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable for this type of device and submission.

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

• Not applicable. This is a material, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" here is primarily established through:
  • Clinical Outcomes Data (Historical): The long clinical history of the predicate and similar devices demonstrating safe and effective use in patients.
  • Material Science Testing: Implied mechanical and physical property testing to ensure the new resin performs comparably or better than the predicate, though specific results are not detailed in this summary.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the 510(k) summary):

The submission for LIQCRYLIC™ PRO DENTAL RESIN relies on demonstrating substantial equivalence to an already legally marketed predicate device, Palapress Vario (K902115), and leveraging the long clinical history of this technology.

• Basis of Proof:
  • Substantial Equivalence: The manufacturer asserts that LIQCRYLIC™ PRO DENTAL RESIN is "substantially equivalent" to Palapress Vario in its technological characteristics. This implies that the new device has similar fundamental scientific technology, design, and performance characteristics compared to the predicate.
  • Long Clinical History: DENTSPLY highlights that the predicate device has been marketed in the U.S. since 1992, and DENTSPLY itself has marketed similar devices (Selecta-plus® Material and Trevapress® Material) in Europe and South America for over 25 years. The underlying technology is stated to be "over 30 years old." This extensive market history serves as the primary evidence for safety and effectiveness, obviating the need for de novo biocompatibility studies.
  • Performance Data: While not detailed, the summary states that "the performance data support the safety and effectiveness." This would typically involve laboratory testing of material properties (e.g., strength, working time, cure time, color stability) to ensure it meets appropriate standards and is comparable or superior to the predicate. The summary specifically calls out that it "mixes more quickly, has a shorter cure cycle and can be finished easier," and is "color stable due to the fact that it utilizes a barbituric acid based catalyst system."

In essence, the "study" for this device is not a single, formalized clinical trial as one might see for a drug or an interventional device, nor is it a performance study for an AI algorithm. Instead, it's a compilation of evidence derived from:

1. Comparison of technological characteristics to a legally marketed predicate.
2. The established safety and efficacy profile of the predicate and similar long-marketed devices based on their historical clinical use.
3. Internal performance testing to support claims of equivalence and, in some cases, improvement.

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