(120 days)
Flexitime Fast & Scan is an addition-cross-linking polyvinyl siloxane impression material for all inlay, crown and bridges, endentulous and partial impression.
The Flexitime Fast & Scan range of 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.
Flexitime Fast & Scan Impression Materials are addition-cross-linking polyvinyl siloxane materials. The Flexitime Fast & Scan Impression Materials family consists of Light Flow, Medium Flow, Dynamix Putty, Easy Putty and Dynamix Heavy Tray. Flexitime Light Flow, Medium Flow, Heavy Tray are delivered in 50 ml cartridges while Flexitime Fast & Scan Dynamix Putty and Dynamix Heavy Tray are delivered in 380 ml Cartridges and Flexitime Fast & Scan Easy Putty is delivered in a 300 ml container.
The Flexitime Fast & Scan assortment is characterized by the addition of Titanium Dioxide (in order to ensure scannability) and is technically characterized by an extra-oral working time of up to 1.5 minutes and a short time in mouth of 2.0 minutes. The materials were developed to ensure hydrophilic characteristics for optimal impression taking in the wet surroundings of the mouth combined with good mechanical properties. Also, they ensure scannability with state of the art red laser light impression scanners.
Flexitime Fast & Scan products are part of the Flexitime System.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Heraeus Flexitime Fast & Scan Impression Materials:
Upon review of the provided 510(k) summary, it's immediately apparent that this document describes a dental impression material, not a medical device in the typical sense of a software-driven diagnostic or imaging tool. As such, many of the requested categories for AI-based device studies (like sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) are not applicable to this type of product.
This 510(k) is focused on demonstrating substantial equivalence to predicate devices based on physical properties, biocompatibility, and intended use as an impression material. The "study" referenced is primarily a non-clinical evaluation against established ISO standards and a clinical evaluation based on the existing scientific literature and technical results for similar products.
Here's a breakdown of the requested information, noting where it is not applicable (N/A):
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance (Flexitime Fast & Scan) |
|---|---|
| Material Properties: | A. Physical Properties (Implied Equivalence to Standards) |
| Scannability | Can be prepared without requiring additional surface treatment for optical scanning in dental scanners designed for scanning impression materials (e.g., 3shape D700 laser scanners). Achieved by the addition of Titanium Dioxide. This enables scannability without prior powdering, which is required for the predicate device, Flexitime Fast and Scan (K102770). |
| Extra-oral Working Time | Up to 1.5 minutes. |
| Time in Mouth | 2.0 minutes. |
| Hydrophilic Characteristics | Ensures optimal impression taking in the wet surroundings of the mouth. |
| Mechanical Properties | Good mechanical properties. |
| ISO Compliance | The physical properties of the additional Flexitime Fast& Scan assortments (Dynamix Heavy Tray and Easy Putty) are like Flexitime Fast and Scan (K102770) and Flexitime (K000629) products, and are in compliance with ISO 4823. The new assortment is also claimed to be like the original Flexitime Fast & Scan (K102770) in this regard. |
| B. Biocompatibility: | Verified in accordance with international standards, specifically FDA recognized standard EN ISO 10993-1. A biocompatibility evaluation report documented this, concluding a positive benefit/risk relation and equivalence to the predicate device's safety. |
| C. Clinical Performance: | Based on a critical evaluation of scientific data and technical results, the products are expected to exhibit the claimed technical performance. Potential undesirable clinical effects and risks are well controlled and accepted, leading to a positive benefit versus risk ratio for dentistry when applied according to instructions. This also contributes to the conclusion of substantial equivalence to the predicate device in terms of safety and clinical benefits. The device has the same indications for use, warnings, and contraindications as the predicate device. |
| D. Risk Analysis: | A risk analysis was carried out, concluding that the safety of Flexitime Fast & Scan for its intended use is substantially equivalent to the predicate device. |
Study Details (Applicability to this type of device)
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Sample size used for the test set and the data provenance:
- Not Applicable (N/A) in the context of an AI device. This 510(k) does not describe a study involving a "test set" of patient data for diagnostic accuracy like an AI algorithm would. Instead, performance is assessed through material property testing and reference to standards.
- For Biocompatibility: "The biological compatibility of Flexitime Fast & Scan was verified in accordance with the international standards." This implies testing on biological models or in-vitro tests, but specific sample sizes or provenance of test samples are not detailed in this summary.
- For Material Properties: Testing of physical properties (working time, setting time, hydrophilicity, mechanical properties, scannability) would involve batches of the material itself, tested in laboratory settings. Details on the number of samples tested for each property are not provided in this summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. There isn't a "ground truth" establishment in the sense of expert annotation of medical images for an AI algorithm.
- For the Clinical Evaluation: The document mentions "experts" stating a positive benefit-risk ratio for Flexitime Fast & Scan, and a "toxicologist" performed the biocompatibility evaluation. Specific numbers and detailed qualifications beyond "toxicologist" and "experts" are not provided. These are likely experts in dental materials science and toxicology, respectively.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. This concept applies to expert consensus in AI model validation, not to the testing of physical properties or biological compatibility of a dental impression material.
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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:
- N/A. This is completely irrelevant for a dental impression material. There are no "human readers" or "AI assistance" in the context described in this 510(k).
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This device is a material, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A (in the AI context).
- For material properties: The "ground truth" would be established by validated test methods specified in standards like ISO 4823.
- For biocompatibility: The "ground truth" is defined by the criteria within ISO 10993-1.
- For clinical evaluation: The "ground truth" is based on existing scientific data and accepted dental practices for impression materials, leading to an expert-judged benefit-risk assessment rather than a direct patient outcome study of the device itself.
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The sample size for the training set:
- N/A. This concept is for machine learning models and does not apply to a physical impression material.
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How the ground truth for the training set was established:
- N/A. This concept is for machine learning models and does not apply to a physical impression material.
Summary of the Device's "Study" Approach:
The "study" for this device, as detailed in the 510(k) summary, is primarily a non-clinical evaluation against recognized international standards for dental impression materials (ISO 4823 for physical properties, ISO 10993-1 for biocompatibility) and a clinical evaluation that critically assesses scientific data and technical results to confirm expected performance and a favorable benefit-risk profile. The crucial aspect for its FDA clearance is demonstrating substantial equivalence to existing legally marketed predicate devices, particularly regarding its physical properties (adherence to ISO standards), biocompatibility, and intended use, with an added feature of scannability without powdering.
§ 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).