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Flexitime Xtreme 2 is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridge, edentulous and partial impressions.

The products are developed under the project name D 948. The Flexitime Xtreme 2 Light Flow , Medium Flow and Heavy Tray each are addition-crosslinking polyvinyl siloxane impression materials , all delivered in 50 ml cartridges, and are part of the Flexitime Xtreme -system. The Flexitime Xtreme 2 assortment is characterised by the addition of Blackbeery-aroma and is technically characterized by a short working time of appr. 1.5 min and a short time in mouth period of min. 1.5 min.. These products, which show a shorter working time and setting time, are highly desired for single step impressions especially in combination with the double arch impression technique. The materials were developed to ensure hydrophilic characteristics for optimal impression taking in the wet surroundings of the mouth combined with good mechanical properties. The materials are based on the existing materials D 919 (Flexitime Light Flow and Flexitime Medium Flow) and Flexitime Xtreme Heavy Tray to meet the requirements of the US market.

The provided text describes the safety and effectiveness of the dental impression material Flexitime Xtreme 2. However, it does not detail a study with the specific acceptance criteria, device performance metrics, and methodologies like sample size, ground truth establishment, expert qualifications, or adjudication methods in the way typically expected for a medical device AI/CAD software submission.

Instead, the document highlights compliance with existing standards and regulations for a conventional medical device (dental impression material). Therefore, I will extract information related to the device's characteristics and the evaluations conducted to demonstrate its safety and effectiveness, interpreting them as meeting acceptance criteria for compliance rather than specific performance metrics against a defined ground truth.

Here's a breakdown of the available information:

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

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

The document does not specify a "test set" in the context of an AI/CAD device. The evaluations described are primarily focused on compliance with material standards and general clinical safety/effectiveness. There is no mention of specific sample sizes for clinical trials or material testing beyond the general statement that "laboratory prototypes have been compiled" and that clinical evaluation was performed according to MEDDEV 2.7.1.

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

Similar to point 2, the concept of establishing "ground truth" for a test set with expert consensus is not directly applicable here. The "experts" referred to are those who conducted the biocompatibility evaluation and the clinical evaluation.

• Clinical Evaluation: "A positive benefit versus risk ratio can be stated by the experts for Flexitime Xtreme 2..." The qualifications of these experts are not explicitly detailed beyond being involved in a "clinical evaluation report ... in accordance with MEDDEV 2.7.1."
• Biocompatibility Evaluation: Conducted according to EN ISO 10993-1. The individuals performing this are not specifically named or qualified in the summary, but it's implied they are qualified to interpret such standards.

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

No adjudication method is described, as this is not a study involving human readers or AI in a diagnostic or prescriptive capacity.

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 is not applicable as the device is a dental impression material, not an AI/CAD system. There are no "human readers" or "AI assistance" in the context of this submission.

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

This is not applicable.

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

For the safety and effectiveness of the dental impression material, the "ground truth" is established through:

• Compliance with International Standards: EN ISO 4823 (physical properties), EN ISO 10993-1 (biocompatibility), EN ISO 14971 (risk analysis), and MEDDEV 2.7.1 (clinical evaluation).
• Laboratory Testing: "Target-performance comparisons" to functional specifications.
• Clinical Evaluation: Assessment of clinical performance and safety, leading to a conclusion of a positive benefit/risk ratio by experts. This is likely based on clinical observations and professional judgment rather than a single, objective "ground truth" like pathology.

8. The sample size for the training set:

Not applicable, as this is not an AI/CAD system.

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

Not applicable, as this is not an AI/CAD system.

Summary of the "Study" (Compliance and Evaluation instead of a traditional clinical study):

The device (Flexitime Xtreme 2) meets its "acceptance criteria" by demonstrating compliance with relevant international and European medical device standards and legislation. The "study" comprises various evaluations:

• Nonclinical Tests: Biocompatibility testing (EN ISO 10993-1) and physical property testing (EN ISO 4823). The biological compatibility was verified, and a toxicological evaluation confirmed it meets requirements, with a positive benefit/risk ratio. Physical properties were shown to be "good" according to the standard.
• Clinical Evaluation: Performed in accordance with MEDDEV 2.7.1. This involved critically evaluating the clinical benefits against potential risks. It concluded that the products exhibit the claimed technical performance, with acceptable risks when weighed against benefits, leading to a positive benefit-risk ratio.
• Risk Analysis: Conducted according to DIN EN ISO 14971, concluding that the application of Flexitime Xtreme 2 is safe.

These evaluations, rather than a single "study," collectively prove the device meets its acceptance criteria for safety and effectiveness within the regulatory framework for dental impression materials. No specific quantitative performance metrics against a defined ground truth (as would be seen for an AI diagnostic device) are provided, as the nature of the device does not necessitate such a study design.

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Flexitime Xtreme is a polyvinylsiloxane silicone impression material used for all inlay, crown and bridge, edentulous and partial impressions.

Flexitime Xtreme is a polyvinylsiloxane silicone impression material.

This document is a 510(k) clearance letter for a dental impression material, Flexitime Xtreme. It does not contain information about acceptance criteria or a study proving device performance in the context of AI/machine learning. Therefore, I cannot extract the requested information.

Ask a specific question about this device