Search Results

Signum metal bond:

• Bonding agent between framework surfaces made of metal alloys (precious metal, non-precious metal or titanium) and (meth-) acrylate-based veneering materials in conjunction with micromechanical retention.
• Bonding agent between partial framework surfaces made of metal alloys (precious metal, nonprecious metal or titanium) and (meth-) acrylate-based veneering materials or denture base materials (hot or auto-polymerizates).
• Bonding agent for extraoral repair of metal supported composite veneers.

Signum universal bond:
Metal

• Bonding agent between framework surfaces made of metal alloys (precious metal, non-precious metal or titanium) and (meth-) acrylate-based veneering materials in conjunction with macromechanical retentions.
• Bonding agent between partial framework surfaces made of metal alloys (precious metal, nonprecious metal or titanium) and (meth-) acrylate-based veneering materials or denture base materials (hot or auto-polymerizates).
• Bonding agent for the extraoral repair of metal-supported composite veneers.
  Zirconium dioxide
• Bonding agent between frameworks, implant abutments and single crowns made of ZrO3 and lightcuring veneering materials.
• Bonding agent for the extraoral repair of composite veneers on ZrO2 frameworks.
  High performance polymers (PEEK)
• Bonding agent between frameworks, implant abutments and individual crowns made of high performance polymers and light-curing veneering materials.
• Bonding agent between partial framework surfaces made of high-performance polymers and lightcuring veneering materials or denture base materials (hot or auto-polymerizate).
• Bonding agent for the extraoral repair of composite veneers on PEEK frameworks.

Signum liquid:
For light-curing veneering materials from Kulzer:

• Restoring the dispersion layer of light curing veneering materials.

Signum composite / Signum composite flow / Signum matrix:
Suitable for veneering the following dental framework materials: Metal alloys (precious metal, non-precious or titanium), zirconia, high-performance polymers (PEEK)
Suitable for partial alteration of the colour and shape of the following dental materials:
• PMMA
• Photopolymers
Suitable for the following prosthetic restorations:
• full and partial veneers for permanent framework-supported crowns and bridges
• veneering removable combination prosthetics (telescopic and tapered crowns and at-tachment prosthetics)
• veneering of superstructures/tertiary structures on implants
• metal-free front tooth and posterior tooth temporary restorations
• alteration of the colour and shape of Kulzer acrylic denture teeth
• alteration of the colour and shape of acrylic-based frameworks (PMMA).
• alteration of the colour and shape of Kulzer photopolymers that are approved for char-acterisation with Signum components (according to the photopolymer instructions for use)

Signum cre-active:
Individual characterization (e.g., of enamel cracks, white spots, imitation fillings, enamel wedges, intermediate colour layers, abrasion surfaces, fissures) of
• light-curing Kulzer veneering materials,
• Kulzer denture acrylic teeth and PMMA,
• (meth-)acrylate-based 3D printing photopolymers in accordance with the photopolymer instructions for use

Signum Bondings (Signum metal bond) are intended for dental works in the laboratory as an adhesion promoter between a given framework made of zirconium dioxide, dental alloys, high performance composites, PMMA, and a second material (e.g. composites or acrylics). These primers are only applied in the laboratory. After restorative work, Signum bondings are encapsulated between framework and the restoration/veneering material and a direct contact to the patient is very unlikely. Signum metal bond is a liquid stored in a 5 mL bottle with dropper and red cap.
Signum universal bond is a liquid stored in a 5 mL bottle with dropper and blue cap.
Signum liquid is indicated for light-curing materials from Kulzer to simplify modeling procedures and restore the dispersion layer of light-curing veneering materials.
Signum liquid is foreseen for dental works in the laboratory, where an adhesion promoter between a given composite layer and a second acrylate based material, including procedures is necessary. After completion of the restorative work, Signum liquid is encapsulated between both layers and a direct contact to the patient is very unlikely. Signum liquid is a liquid stored a 5 mL bottle with a spout and red cap.
Signum composite, Signum composite flow, and Signum matrix are veneering composites for crowns and bridges. The veneering composites are processed by dental technicians for dental restoration by veneering framework supported restorations (for example metal or zirconia frameworks).
After light activated polymerization is inserted into the oral cavity of a specific patient as a custom made device, adapted and connected to the remaining residual teeth or functionally adapted.
The veneering composites are pastes stored in a syringe featuring a plunger and a closing cap.
Signum cre-active are a light-curing color fluids for crown and bridge techniques and prosthetics.
Signum cre-active is used in the dental laboratory to create customized characterizations of dental prosthetic works, that are then inserted into the oral cavity of a specific patient as individualized medical devices, adapted, and connected to the remaining residual teeth or functionally adapted to the edentulous alved Signum cre-activelayers must be covered with veneering material, there is no direct patient contact.
Signum cre-active are liquids stored in a syringe featuring a plunger and a closing cap.

This is a 510(k) summary for a dental device, not a diagnostic AI/ML device. Therefore, the common acceptance criteria and study attributes for AI/ML devices, such as sensitivity, specificity, MRMC studies, ground truth establishment, expert qualifications, and training/test set sizes, are not applicable here.

This document describes the equivalence of several dental materials (Signum composite flow, Signum universal bond, Signum metal bond, Signum composite, Signum matrix, Signum liquid, Signum cre-active) to previously cleared predicate devices based on their intended use, technological characteristics, and performance data from non-clinical testing and literature review.

However, I can extract information related to performance testing that was done and the "acceptance criteria" through a generalized understanding.

Performance Criteria and Device Performance (Generalized to Non-AI/ML Devices)

Study Details (as inferable for non-AI/ML medical devices):

1. Sample Size used for the test set and the data provenance: Not explicitly stated as "sample size for test set" in the context of an AI/ML device. For mechanical and thermal testing, the sample size would refer to the number of material specimens tested, but this is not disclosed. The data provenance includes "internal data and scientific literature."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML diagnostic device requiring expert-established ground truth. The "ground truth" here is the performance of the material against established standards for dental materials.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML diagnostic device with expert adjudication.

4. 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 not an AI/ML diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this type of device, the "ground truth" or reference standard for performance is established through internationally recognized standards for dental materials (e.g., ISO standards) that dictate acceptable ranges for mechanical, physical, and chemical properties. The submission refers to "internal data" and "scientific literature" to support the safety and performance, implying adherence to these established benchmarks.

7. The sample size for the training set: Not applicable. This is not an AI/ML device.

8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Additional Information from the Document:

• Study Type: The submission relies on non-clinical in vitro testing (for mechanical and thermal properties) and a literature-based clinical evaluation for all components.
• "Clinical evaluation is based on internal data and scientific literature currently available." This indicates that no new prospective clinical trials were conducted for this 510(k) submission. Instead, the safety and effectiveness are supported by existing knowledge and data.
• Predicate Device Comparison: The "acceptance criteria" for demonstrating substantial equivalence are primarily met by showing that the new devices have similar intended uses, technological characteristics, and performance to legally marketed predicate devices, which have already demonstrated safety and effectiveness.
• Long-standing Market Presence: Many components ("Signum composite is marketed since 1999, Signum composite flow since 2011 and Signum matrix since 1999," "Signum metal bond is marketed since 2007, Signum universal bond since 2022 and Signum liquid since 1983," "Signum cre-active is marketed since 1991") have a long history of safe use, further supporting their equivalence.

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Photopolymer for 3D printing of individualized, provisional and permanent prosthetic works. Indications

• Long-term temporary restorations (up to 6 months),
• Teeth for removable dentures

dima Print Teeth & Temp is a photopolymer liquid for 3D printing of dental appliances. Its processing by dental healthcare professionals includes 3D printing, cleaning and curing. The final product produced by dental healthcare professionals will be an individual medical device for a special patient, inserted into the oral cavity, adapted and connected to the remaining residual teeth or functionally adapted to a given denture. Dima Print Teeth & Temp is offered in a range of colors.

The provided text is a 510(k) summary for the medical device "dima Print Teeth & Temp". It outlines the general regulatory information, device description, and indications for use. However, it does not contain the detailed information about acceptance criteria, device performance results, sample sizes, expert qualifications, ground truth establishment, or clinical study methodologies that would be expected for a comprehensive study proving the device meets acceptance criteria.

The document states:
"Testing of the physical characteristics as listed in the predicate comparison table was conducted to evaluate the performance of dima Print Teeth & Temp, according to requirements of ISO 10477 and ISO 22112. All requirements were met."

This statement confirms that testing was done and requirements were met, but it does not provide the specific details of the acceptance criteria or the reported performance values. It also explicitly states "Not Applicable" under "Clinical Tests Summary & Conclusions 21 CFR 807.92(b)", indicating that a clinical study of the type described in questions 5, 6, and 7 was not performed or not required for this 510(k) submission.

Therefore, based solely on the provided text, I cannot provide a detailed answer to all parts of your request. I will indicate where the information is not present.

Acceptance Criteria and Device Performance Study for dima Print Teeth & Temp

Based on the provided FDA 510(k) summary (K233868), the device "dima Print Teeth & Temp" was evaluated against performance requirements derived from ISO 10477 and ISO 22112. The summary confirms that "All requirements were met." However, the specific acceptance criteria and the reported numeric performance values are not detailed in this document.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that testing was "according to requirements of ISO 10477 and ISO 22112" and that "All requirements were met." However, the specific quantitative acceptance criteria (e.g., "flexural strength > Y MPa") and the measured device performance (e.g., "flexural strength = Z MPa") are not provided in this 510(k) summary. These details would typically be in the full submission documentation.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the performance testing.
The data provenance (e.g., country of origin, retrospective/prospective) is also not provided in this summary. These physical/material tests are typically conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This type of information is generally relevant for studies involving human interpretation (e.g., imaging devices) where expert consensus is needed for ground truth. For physical material properties testing (as indicated by the reference to ISO 10477 and ISO 22112), ground truth is established by standardized test methodologies and measurements, not by expert consensus on human data. Therefore, this question is not applicable in the context of the reported non-clinical testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in studies where human readers provide subjective assessments that need to be reconciled for ground truth. This was a non-clinical, physical properties test.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document explicitly states "Not Applicable" under "Clinical Tests Summary & Conclusions 21 CFR 807.92(b)". This indicates that a clinical study, including an MRMC study comparing human readers with and without AI assistance, was not performed or not required for this 510(k) submission for this device.

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

No. The device is a "photopolymer liquid for 3D printing of dental appliances," not an AI algorithm. Therefore, a standalone algorithm performance evaluation is not relevant. The device itself is the material.

7. The Type of Ground Truth Used

For the performance testing reported (physical characteristics according to ISO 10477 and ISO 22112), the ground truth is established by standardized laboratory testing procedures and direct physical measurements as defined by the referenced ISO standards. This is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. The device is a material, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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Light curing one-component opaquer to mask framework structures. Signum opaque F is the opaquer component for veneering materials and denture base materials (heat/cold curing denture acrylics) offered by Kulzer.

Signum opaque F is a light-curing, one component opaquer used for extraoral color-masking of framework structures for crowns, bridges, and/or partial dentures. The veneering composites are processed by dental restoration by veneering framework-supported restorations, such as metal or zirconia frameworks.

Signum opaque F is a paste stored in a syringe featuring a plunger and a closing cap. The product is dispensed and is then applied with a disposable brush until the scaffolding frame is completely covered. After polymerization, the crown or bridge is inserted into the oral cavity, adapted and connected to the remaining residual teeth or functionally adapted.

The provided text describes the 510(k) premarket notification for a dental device called "Signum opaque F." However, it does not contain information about the acceptance criteria or the study that proves the device meets those criteria in the context of an AI/ML-driven medical device.

The document is a traditional 510(k) submission for a non-AI dental material (tooth shade resin material). It focuses on:

• Substantial Equivalence: Comparing the new device (Signum opaque F) to a legally marketed predicate device (VITA VM LC FLOW) in terms of indications for use, technological characteristics, and conformance to standards.
• Mechanical and Thermal Testing: Mentioning that these tests were performed (shear bond strength, shelf-life at differing temperatures) but without providing specific acceptance criteria or detailed results.
• No Clinical Study for Performance: Stating that a clinical investigation "is not necessary and the route for this clinical evaluation is literature based" because the product type (veneering composites) is "well-established."

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance, test sets, ground truth establishment, expert adjudication, or MRMC studies, as this information is not present in the provided text.

The request's parameters (AI/ML context, ground truth, experts, MRMC, etc.) are generally relevant to submissions for AI/ML-enabled medical devices, which leverage algorithms that interpret or process medical data. The provided document concerns a dental material's physical and chemical properties and its intended use, not an AI's diagnostic or predictive performance.

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Extended fissure sealing First-layer lining for class I and class II cavities Class I, II, III and V direct restorations Repair of direct and indirect restorations in combination with a suitable adhesive Splinting loosened teeth resulting from trauma or periodontal associated events

Venus Bulk Flow ONE is a light curing, radio-opaque nano-hybrid composite. The uncured dental composite is introduced into the oral cavity to be applied and cured to the tooth structure or restoration pre-treated by the dentist, thus achieving the clinical benefit.

The provided text describes the regulatory submission for the Venus Bulk Flow ONE, a dental restorative material. It focuses on demonstrating substantial equivalence to a predicate device (Venus Diamond Flow, K091635) primarily through non-clinical bench testing. There is no information regarding AI/ML device acceptance criteria or performance.

Here's the breakdown of the information requested, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

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Direct restoration of Class I-V cavities (according to G.V. Black) Direct composite veneers Shape corrections of teeth (i.e. diastemas, congenital defects in teeth, etc.) Splinting of teeth loosened by trauma or periodontal disease Restoration of primary teeth Repairs of porcelain, composite (in combination with an adequate repair-system)

Not Found

I am sorry, but the provided text from the FDA 510(k) approval letter for "Charisma" a "Tooth Shade Resin Material" does not contain any information about acceptance criteria or a study proving the device meets those criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail performance data, clinical study designs, or technical acceptance criteria for the device itself.

The document primarily covers:

• The FDA's review and determination of substantial equivalence.
• Regulatory information and requirements for marketing the device.
• Contact information for FDA divisions.
• The indications for use for the "Charisma" device, listed as:
  • Direct restoration of Class I-V cavities (according to G.V. Black)
  • Direct composite veneers
  • Shape corrections of teeth (i.e., diastemas, congenital defects in teeth, etc.)
  • Splinting of teeth loosened by trauma or periodontal disease
  • Restoration of primary teeth
  • Repairs of porcelain, composite (in combination with an adequate repair-system)

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details based on the given text.

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The iBond Universal System consists of iBond Universal bonding agent and iBond Universal Ceramic Primer. The iBond Universal indications are: Bonding of direct restoration for all cavity classes (Black) using light curing, dual curing or self-curing methacrylate based composites/compomers, Bonding of light curing dual curing or selfcuring core build up materials, sealing of hypersensitive tooth areas, sealing of cavities prior to amalgam restorations, bonding of fissure sealants, sealing of cavities and core preparations prior to temporary cementation of indirect restorations(according to the immediate dentin sealing technique), cementation of indirect restorations with light curing dual-curing or self-curing adhesive resin cements, intraoral repair of composite and compomer restorations, porcelain fused to metal, all ceramic as well as metal restorations.

The iBond Ceramic Primer indications are; surface conditioning of silicate/glass ceramic, specifically for the fixation of indirect restorations with luting composites, for intraoral repair of ceramic veneerings, as well as full ceramic restorations.

Not Found

I am sorry, but the provided text from the FDA 510(k) summary for K150933, regarding the iBond Universal and iBond Ceramic Primer, does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. It does not include the technical study details typically found in a clinical study report or a more comprehensive 510(k) submission summary.

Therefore, I cannot provide the requested information in the table or answer the specific questions about the study design and results based on the provided text.

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Xantasil is a medium flow, addition-curing, elastomer dental impression material that can be used to cover all impression needs where a traditional alginate material would be used, such as impressions for temporaries, crown and bridges, removable dentures, orthodontic models, opposing jaw models, splints, mouth guards and bleaching trays. It is used to get a negative copy of the patients' dental situation.

Xantasil is an addition-curing polyvinyl-siloxane impression material. Xantasil is delivered in 50 ml and 380 ml cartridges. Xantasil is an optimized A-silicone impression material with medium consistency meant as a replacement for alginates. The mouth removal time for the product is 1.5 minutes Xantasil is for use in the Dynamix automatic dispensing and mixing system and the 1:1 Cartridge dispenser.

The provided text describes a 510(k) submission for a dental impression material named Xantasil. The submission focuses on demonstrating substantial equivalence to predicate devices based on physical properties, not on a study with AI in a diagnostic context. Therefore, many of the requested fields are not applicable to this document.

Here's the relevant information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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. This is a dental impression material, and the "test set" here refers to the physical properties measured against ISO 4823 standards for dental materials, not a patient-based test set for an AI device. The document does not specify sample sizes for these physical property tests or data provenance beyond "in compliance with ISO 4823."

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 as typically understood for AI/diagnostic devices doesn't apply here. The "experts" mentioned in the document are involved in judging the benefit/risk ratio, not establishing ground truth for a test set.

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

• Not applicable.

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 not an AI device.

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

• Not applicable. This is not an AI algorithm.

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

• For the physical properties, the "ground truth" is defined by the technical specifications and test methods outlined in ISO 4823 for dental impression materials.
• For the biological compatibility, "bridging data from predicates in accordance with the international standard ISO 10993-1" was used.

8. The sample size for the training set

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable.

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iBond Self Etch is used for bonding of direct light-cured composite restorations (including Polyglas and copomers), bonding of indirect restorations in combination with a light-curing luting cement; porcelain, Polyglas®, and composite restorations (inlays, onlays, veneers, crowns) and sealing hypersensitive areas of teeth.

iBond Self Etch(new formulation is an acetone/water-based formulation of light activated methylacrylate resins.

The provided text refers to a dental bonding agent, iBond Self Etch, and its new formulation. The "study" described is a declaration of substantial equivalence to a predicate device, focusing on material properties and biocompatibility rather than a clinical trial in the traditional sense of comparing AI performance to human performance. As such, many of the requested elements for AI/MRMC studies are not applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• The document describes a modification to an existing device (iBond Self Etch) and a comparison to its predicate (HK Bond K063062).
• The "test set" in this context refers to the samples of the new formulation used for laboratory testing of properties like shear bond strength.
• Sample Size: Not explicitly stated for each test, but it is implied that standard laboratory testing procedures were followed for material characterization.
• Data Provenance: The studies were conducted internally by Heraeus Kulzer, LLC. The document does not specify country of origin for the data (beyond the applicant being in the US) or if it's retrospective or prospective, but it implies prospective lab testing of the new formulation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. This is not a study requiring human expert assessment for ground truth. The "ground truth" for material characteristics like shear bond strength is established by standardized laboratory testing protocols, not expert consensus.

4. Adjudication Method for the Test Set

• Not applicable for the reasons stated above.

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 not an AI device, and therefore no MRMC study was conducted or is relevant.

6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done

• Not applicable. This is not an AI device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the material properties (e.g., pH, refractive index, shear bond strength), the ground truth is established through objective, standardized laboratory measurements following established protocols relevant to dental materials.
• For biocompatibility, the ground truth is based on adherence to international standards (EN ISO 10993) and a toxicological assessment of leachable compounds.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI device, so there is no "training set." The understanding of the device's formulation and properties comes from chemical development and iterative laboratory testing, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

• Not applicable for the reasons stated above.

Summary of the "Study" (Rationale for Substantial Equivalence):

The submission argues for substantial equivalence by demonstrating that the new iBond Self Etch formulation is comparable to its predicate (HK Bond K063062) despite minor modifications (addition of a stabilizer, change in rheological additive). The key elements of the "study" are:

• Comparison of Technical Characteristics: A detailed table highlights that many parameters (content of BHT, indications for use, visual appearance, pH, refractive index, application, dwell time, curing time, compatibility) remain the same.
• Performance Testing: The crucial difference in shear bond strength was tested, and the new formulation exceeded the predicate's performance requirement (>15 MPa for predicate vs. ≥20 MPa for new formulation).
• Biocompatibility Evaluation: The biological compatibility was verified in accordance with EN ISO 10993. A toxicologist reviewed the leachable compounds, concluding that the safety is equivalent to the predicate. No in vivo toxicity studies were performed on the new formulation due to low exposure and animal welfare, relying on the previous testing of the predicate and the toxicological assessment of leachable compounds.
• Risk Analysis: A risk analysis according to ISO 14791 was conducted, concluding that the safety of the new formulation is substantially equivalent.
• Improved Usability: The new formulation offers improved convenience (no refrigeration required, no shaking necessary) while maintaining or improving performance.

In essence, the study is a series of laboratory tests and regulatory assessments to confirm that the minor formulation changes do not negatively impact the device's safety and effectiveness and, in some cases, improve its performance and user convenience.

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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

Study Details (Applicability to this type of device)

1. 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.

2. 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.

3. 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.

4. 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).

5. 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.

6. 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.

7. 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.

8. 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.

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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.

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