(88 days)
Flexitime Fast & Scan is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridges, edentulous and partial impression.
The Flexitime Fast & Scan range products are prepared without requiring additional surface treatment for optical scanning in dental scanners designed for scanning impression materials, such as the 3 Shape D700 laser scanners.
The products are developed under the project name D 942. The Flexitime Fast & Scan Light Flow. Flexitime Fast & Scan Medium Flow and Flexitime Fast & Scan Dynamix Putty each are addition-cross-linking polyvinyl siloxane impression materials. Flexitime Fast & Scan Light Flow and Medium Flow are delivered in 50 ml cartridges while Flexitime Fast & Scan Dynamix Putty is delivered in 380 ml cartridges.
They are part of the Flexitime-system. The Flexitime Fast & Scan assortment is characterized by the addition of Titanium- Dioxide (in order to ensure scannabilty) and is technically characterized by a extraoral working time of up to 1.5 min and a short time in mouth of 2.0 min. These products are highly desired for double-mix impressions (single step) and correction impressions (two step 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. Furthermore the materials were developed to ensure scannability with state of the art red laser light impressions scanners. The materials are based on the existing materials D 919 (Flexitime Light Flow and Flexitime Medium Flow) and Flexitime Dynamix Putty to meet the requirements of the European and US market. Flexitime Light Flow and Flexitime Medium Flow are marketed since August 2009 and Flexitime Dynamix Putty is marketed since Mav 2007.
The provided document does not contain explicit acceptance criteria in the form of a table with specific thresholds for device performance. It describes the physical, biocompatibility, and clinical evaluations conducted for the Flexitime Fast & Scan dental impression material, stating that it meets relevant standards and has a positive benefit/risk ratio.
However, based on the information provided, here's a structured response addressing the requested points where data is available or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets requirements of EN ISO 10993-1 and DIN EN ISO 10993 for toxicological risk. | "The biological compatibility of Flexitime Fast & Scan was verified in accordance with the international standards." |
| "A toxicological evaluation report has confirmed that the product Flexitime Fast & Scan meets the requirements of the DIN EN ISO 10993 standard." | ||
| "The results were discussed in a Biocompatibility Evaluation Report and the benefit/risk-relation has been judged as positive." | ||
| Physical Properties | Meets requirements of EN ISO 4823: 2007 for dental impression materials. | "The products fulfill all requirements of the EN ISO 4823: 2007." |
| "The physical properties of Flexitime Fast & Scan were determined in accordance with EN ISO 4823. The results have shown good properties of Flexitime Fast & Scan in accordance to this standard." | ||
| Clinical Performance & Safety | Positive benefit/risk ratio in comparison to potential risks as per MEDDEV 2.7.1. | "A positive benefit versus risk ratio can be stated by the experts for Flexitime Fast & Scan..." |
| "...potential undesirable clinical effects and risks seem well controlled and acceptable, when weighed against their benefits in dentistry." | ||
| Functional Specification (Prototypes) | Requirements of the functional specification are fulfilled. | "The target-performance comparisons prove that the requirements of the functional specification are fulfilled by these laboratory products." |
| Functional Specification (Scale-up Material) | Functional specifications are fulfilled for the scale-up material. | "...the upscaling by the process development department shows the functional specifications are fulfilled also for the scale up material." |
| Scannability | Ensures scannability with state-of-the-art red laser light impression scanners (e.g., 3 Shape D700). | "This pigment [Titanium-Dioxide] ensures together with the bright shading of the material the scanability in red light laser scanners." |
| "Furthermore the materials were developed to ensure scannability with state of the art red laser light impressions scanners." | ||
| "The Flexitime Fast & Scan range products are prepared without requiring additional surface treatment for optical scanning in dental scanners designed for scanning impression materials, such as the 3 Shape D700 laser scanners." | ||
| Shelf Life | 24 months. | "Acc. the current shelf life report a shelf life of 24 month can be assumed." |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for any of the non-clinical or clinical evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions "experts" involved in the clinical evaluation ("A positive benefit versus risk ratio can be stated by the experts for Flexitime Fast & Scan"). However, it does not specify the number of experts or their qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for establishing ground truth or evaluating the test results.
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 device is a dental impression material, not an AI or imaging device that would typically involve human readers or AI assistance. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable or expected. The document does not mention any such study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
As mentioned above, this is a dental impression material, not an algorithm, so a standalone algorithm performance study is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical evaluation, the "ground truth" seems to be derived from a "critical evaluation [that] followed the procedures outlined in the corresponding clinical evaluation plan" and resulted in a "positive benefit versus risk ratio" as stated by experts. For physical properties, the "ground truth" is adherence to international standards like EN ISO 4823. For biocompatibility, it's adherence to EN ISO 10993. These rely on established scientific and regulatory benchmarks.
8. The sample size for the training set
The document refers to the product as a "revised version" of existing products (Flexitime Dynamix Putty, Flexitime Light Flow, and Flexitime Medium Flow) and that the materials were "based on the existing materials D 919 (Flexitime Light Flow and Flexitime Medium Flow) and Flexitime Dynamix Putty." It also mentions "accepted laboratory prototypes" (JAG 165-02/ULL 1150-2, FRM 14240-1/FRM 14242-1, and ULL 1152-1/ULL 1152-2) used for target-performance comparisons and further development. However, it does not provide specific sample sizes that would constitute a "training set" in the context of machine learning or AI models, as this is a material science product.
9. How the ground truth for the training set was established
Given that this is a material, not an AI system, the concept of a "training set" and its "ground truth" in the AI sense is not directly applicable. However, the development process involved utilizing "existing materials" and "laboratory prototypes" for which target performance requirements were established. These requirements likely served as the "ground truth" or benchmarks during the experimental and development phases to ensure the new formulation met the desired characteristics (e.g., scannability, mechanical properties, hydrophilicity). These benchmarks would have been established through established material science testing methodologies and regulatory standards (e.g., EN ISO 4823).
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).