FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

PalaXpress ultra was developed as an auto-polymerizing denture and differs from the substantially equivalent device Palapress vario in the increased fracture resistance compared with that material. The product was developed as an autopolymerizing universal denture base material.

The product consists of powder in various shades (pink veined, link live, pink opaque, R50 veined, clear, 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 a outer cardboard box. 12000 g are available upon request.

To make sure denture, powder and liquid are mixed, in a ratio of 30 g : 15 ml (2:1) for the injection procedure, and in a ratio of 10 g powder : 7 ml liquid for the pouring procedure, Polymerization time in the pressure vessel is 30 min, at a water temperature 55°C and a pressure of 2 bar.

The material has a shelf life of 42 months and complies with the requirements of ISO 20795-1:2008 for denture base polymers.

AI/ML Overview

Please note: The provided text describes the PalaXpress ultra, a denture base material. The concept of "acceptance criteria" and related study details you've requested (sample sizes, expert consensus, MRMC studies, standalone performance, training sets) are typically associated with the evaluation of artificial intelligence (AI) or diagnostic devices. This document does not describe such a device or AI-related study.

However, I will extract the closest analogous information available in the document to address your request as best as possible, focusing on the material's compliance with established standards and its claimed performance.

Here's the information based on the provided text, adapted to your request where applicable, and highlighting where the requested information is not available due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard / Property)	Reported Device Performance
Material Properties (ISO 20795-1:2008 for denture base polymers)
Fracture Resistance	Increased fracture resistance compared to substantially equivalent device Palapress vario.
All other properties	Complies with and exceeds the requirements of ISO 20795-1:2008.
Shelf Life	42 months
Biocompatibility (ISO 10993-1)
Cytotoxicity	Met requirements
Sensitization	Met requirements
Irritation / Intracutaneous Reactivity	Met requirements
Subacute / Subchronic Toxicity	Met requirements
Genotoxicity	Met requirements
Clinical Performance (MEDDEV 2.7.1)	Exhibited expected performance and clinical effectiveness without undesirable effects when used as instructed.
Benefit/Risk Ratio	Judged as positive.
Compliance with MDD 93/42/EEC and National European Medical Device Legislation	Meets all relevant requirements.

Explanation:
The "acceptance criteria" here are drawn from the relevant international standards (ISO 20795-1 for material properties, ISO 10993-1 for biocompatibility) and regulatory guidelines (MEDDEV 2.7.1 for clinical evaluation, Medical Device Directive 93/42/EEC). The "reported device performance" reflects whether the device met or exceeded these standards as stated in the submission.

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

Sample size for test set: Not explicitly stated. The document refers to "test results" and "evaluated data" but does not provide specific sample sizes for property testing or biocompatibility assessments.
Data provenance: The standard compliance tests (ISO 20795-1, ISO 10993-1) and clinical evaluation (MEDDEV 2.7.1) were conducted as part of the manufacturer's regulatory assessment for European medical device legislation. The submission is from Heraeus Kulzer, GmbH (Germany) and submitted to the US FDA. The studies were likely performed in Europe. The data is retrospective in the sense that it was generated for internal regulatory purposes before submission.

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

This information is not applicable/available for this type of device. The "ground truth" for a material like PalaXpress ultra is established by adherence to specified physical, chemical, and biological properties as defined by international standards (e.g., ISO) and regulatory requirements, not by expert consensus on interpretations of images or clinical outcomes in the way an AI diagnostic device would be.

4. Adjudication method for the test set

This information is not applicable/available for this type of device. Adjudication methods (like 2+1 or 3+1) are common in clinical trials or studies involving expert assessment of ambiguous cases for diagnostic tools. For a material properties and biocompatibility study, the "adjudication" is typically the successful completion and approval of tests according to established protocols and standards.

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

This information is not applicable/available. An MRMC study is relevant for diagnostic devices (especially those involving image interpretation) to compare the performance of human readers, with and without AI assistance. PalaXpress ultra is a denture base material, not an AI-powered diagnostic tool.

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

This information is not applicable/available. This question is relevant for AI algorithms. PalaXpress ultra is a physical material, not an algorithm.

7. The type of ground truth used

The "ground truth" for PalaXpress ultra is based on:

Standard Specifications: Compliance with material properties defined by ISO 20795-1:2008 for denture base polymers.
Biocompatibility Standards: Adherence to biological safety requirements specified by ISO 10993-1.
Clinical Evaluation: Assessment against the expected clinical performance and safety benchmarks outlined in MEDDEV 2.7.1.

8. The sample size for the training set

This information is not applicable/available. There is no "training set" in the context of developing a physical dental material like PalaXpress ultra, unlike machine learning models. The development process involves iterative formulation and testing, but not a formally defined "training set" for an algorithm.

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

This information is not applicable/available as there is no "training set" for this product as described in machine learning contexts. The "ground truth" for the development and validation of the material's properties was established through adherence to the aforementioned ISO standards and regulatory guidelines during the material formulation and testing phases.

Summary

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.