Search Results

Paladon ultra is a heat curing high impact denture base resin designed for injection procedure and press and pack technique for:

• . maxillary and mandibular prostheses
• implant over-denture .

Paladon ultra was developed as a heat curing high impact denture base resin similar to the substantially equivalent device Palaimpact. The product consists of powder in various shades (pink, pink veined, pink live, R50 ыланың жұмысыздың құрылы veined, light pink, light reddish pink, shade 200, dark pink) and liquid. 80 ml or 500 ml of liquid is supplied in brown glass bottles in an outer cardboard box, the 100 g or 1000 g powder is supplied in square HD-PE bottles in an outer cardboard box. 12000 g are available upon request. To make a denture, powder and liquid are mixed, in a ratio of 21 g : 10 m!. The material should be polymerised by heating. The material has a shelf life of five years and fully complies with the requirements of ISO 20795-1:2008 for denture base polymers with improved impact resistance.

The provided text is a 510(k) Summary for the dental device "Paladon ultra." It details the device's substantial equivalence to a predicate device and notes its compliance with ISO 20795-1:2008 for denture base polymers. However, the document does not describe a study involving readers (human or AI), sample sizes for test sets, ground truth establishment by experts, or any MRMC comparative effectiveness study. The testing mentioned is focused on the physical and biological properties of the material itself.

Therefore, many of the requested items cannot be extracted from this document, as they pertain to clinical or reader-based evaluations that are not present.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable. The tests are on the material properties, not a dataset from patients or images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/reader studies (e.g., disease presence) is not established in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 document describes a dental material, not an AI or imaging device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This document describes a dental material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For physical properties: The ground truth is defined by the technical specifications and test methods outlined in ISO 20795-1:2008.
For biocompatibility: The ground truth is established through laboratory tests as required by ISO 10993-1.
For clinical performance: The ground truth is established by clinical evaluation in accordance with MEDDEV 2.7.1, assessing expected performance and safety based on existing knowledge and the properties of the material.

8. The sample size for the training set: Not applicable. This document describes a dental material, not an AI system with a training set.

9. How the ground truth for the training set was established: Not applicable.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a combination of non-clinical (laboratory) tests and a clinical evaluation, rather than a single study with a "test set" in the context of reader studies or AI performance.

• Nonclinical Tests: These involved evaluating the material's physical properties according to ISO 20795-1:2008 for denture base polymers with improved impact resistance. Additionally, biocompatibility was assessed in accordance with ISO 10993-1, covering tests for cytotoxicity, sensitization, irritation/intracutaneous reactivity, subacute/subchronic toxicity, and genotoxicity. The document states that toxicological risk was evaluated, and a biological evaluation report confirmed the product meets ISO 10993 requirements.
• Clinical Evaluation: This evaluation was performed in accordance with MEDDEV 2.7.1 and the Medical Device Directive 93/42/EEC. It involved a critical assessment of the clinical benefits versus potential risks of Paladon ultra. The evaluation concluded that the product exhibits the claimed clinical and technical performance and that potential undesirable clinical effects and risks are well controlled and acceptable when weighed against their benefits in dentistry.

In essence, the "study" is a comprehensive regulatory assessment involving adherence to established international standards for material properties and biological safety, coupled with a clinical risk/benefit analysis based on the device's intended use and comparison to existing well-known materials.

Ask a specific question about this device