Search Results

It is used to get an exact negative copy of the patient's dental situation and can be used for optical scanning in dental scanners designed for scanning impression material.

Flexitime Monophase Pro Scan is an addition-cross-linking polyvinyl siloxane impression material. Flexitime Monophase Pro Scan is delivered in 380 ml cartridges and is part of the Flexitime Dynamix System. Flexitime Monophase Pro Scan is characterized by the addition of a scannable dye (for scannability). Flexitime Monophase Pro Scan was developed to complement flexitime Monophase regarding scannability and shore hardness, thus improving the impression taking especially for dental implants. Additionally the hydrophilic characteristics for optimal impression taking in the wet surroundings combined with good mechanical properties should be ensured. The mouth retention time for the product is 2.5 minutes.

Flexitime Monophase Pro Scan is for use in the Dynamix automatic dispensing and mixing svstem.

The provided text is a 510(k) summary for a dental impression material, Flexitime Monophase Pro Scan. It focuses on establishing substantial equivalence to existing predicate devices based on physical properties, biocompatibility, and intended use.

Based on the provided document, the requested information for an acceptance criteria and study proving device performance is largely not applicable or not explicitly detailed in the context of a typical AI/medical device performance study.

This document is a regulatory submission for a dental impression material, not an AI or imaging device that would typically have performance metrics like sensitivity, specificity, or reader studies. The "study" mentioned here refers to non-clinical testing to ensure the material meets ISO standards and is biocompatible.

However, I can extract and structure the available information as best as possible to answer your questions where applicable, and note where information is missing or irrelevant to this type of device.

Acceptance Criteria and Device Performance for Flexitime Monophase Pro Scan

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other questions, they are largely not applicable to this type of regulatory submission for a dental impression material. This document is a 510(k) summary focused on demonstrating substantial equivalence to existing predicate devices, rather than a de novo clinical trial for a novel AI or diagnostic device.

Here's an assessment for each point:

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 in the typical sense. The "testing" referred to here are non-clinical lab tests for physical properties (ISO 4823 compliance) and biocompatibility (ISO 10993). The document does not specify sample sizes for these lab tests or their data provenance (e.g., country of origin, retrospective/prospective).

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" in the context of diagnostic accuracy studies (e.g., for AI) is not relevant here. For biocompatibility, an unnamed "toxicologist" performed an evaluation, and "experts" were mentioned in concluding a positive benefit vs. risk ratio, but their number and specific qualifications are not detailed beyond "toxicologist."

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

   • Not Applicable. This is specific to human reader studies or expert consensus for ground truth establishment, which is not described here.

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 dental impression 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. This is a dental impression material, not an algorithm.

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

   • Not Applicable in the typical diagnostic sense. The "ground truth" for this device's performance would be compliance with ISO standards for physical properties and biocompatibility as determined by laboratory testing. For "scannability," the ground truth is simply whether it can be scanned without special preparation.

8. The sample size for the training set:

   • Not Applicable. This is not an AI model, so there is no training set.

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

   • Not Applicable. No training set exists for this type of device.

Ask a specific question about this device