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PEEK Biosolution is intended to be used for the fabrication of permanent dental restorations using CAD/CAM techniques. These are:

• Fully anatomical crowns and bridges (max. 2 pontics and min. 13 mm² connector cross-section)
• Crown copings and bridge substructures for composite veneering (max. 2 pontics and min.13 mm² connector cross-section))
• Telescopic primary and secondary crowns and frameworks
• Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide.

PEEK Biosolution is a solid disc composed of polyether ether ketone (PEEK) and is indicated for the fabrication of permanent dental restorations using CAD/CAM techniques and equipment.

The provided text describes the regulatory filing for the PEEK Biosolution dental material, which is a Class II medical device. The information details the device's characteristics, intended use, and a comparison to a predicate device (breCAM.BioHPP) to establish substantial equivalence.

Here's an analysis of the provided text in relation to your request for acceptance criteria and study details:

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

The provided document includes a table titled "Physical Properties of PEEK Biosolution and breCAM.BioHPP" which clearly lists various physical and mechanical properties. The "passing value" serves as the acceptance criteria for most of these tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for each of the physical and mechanical tests. It also does not directly state the data provenance in terms of country of origin or whether the studies were retrospective or prospective. It only mentions that "All tests were performed according to GLP requirements," which implies a certain standard of research practice but not the specific design or origin.

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)

This information is not applicable to this type of device and study. The testing for the PEEK Biosolution material is based on standardized physical and mechanical property measurements, not on expert interpretation of medical images or clinical outcomes that would require a "ground truth" established by human experts.

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

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints, where disagreements between evaluators need to be resolved. The tests performed for this device are objective measurements of material properties.

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

An MRMC comparative effectiveness study is not applicable to this device. This type of study assesses the performance of diagnostic devices, especially those involving human interpretation, and often in the context of AI assistance. PEEK Biosolution is a dental material, not a diagnostic tool or an AI-powered system designed to assist human readers.

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

This is not applicable to the PEEK Biosolution device as it is a physical dental material, not an algorithm or AI system.

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

For the physical and mechanical testing: The "ground truth" in this context refers to the established scientific and engineering principles and the measurement methods defined by international standards (e.g., ISO 11357, ISO 62, ISO 10477, ISO 1183, ISO 20795-1). The device's performance is compared against these predetermined criteria as defined by the standards and often to the predicate device's measured performance.
For biocompatibility: The ground truth was established by recognized standards like ISO 10993-1 and USP Class VI, which define the acceptable biological response of materials in contact with the body.

8. The sample size for the training set

This is not applicable as PEEK Biosolution is a physical dental material and does not involve AI or machine learning models that require training sets.

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

This is not applicable for the same reason as #8.

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Device for fabrication of dental bases for removable dentures.

The Merz Dental GmbH M-PM-Disc (Pink) is a disc composed of solid polymethylmethacrylate (PMMA) in sizes ranging from 90 x15 mm to 114.8 x 25 mm.

The PMMA is a highly cross-linked material manufactured by Merz Dental GmbH under a proprietary process and branded as OMP-N. MP-M-Disc (Pink) is composed of > 95 % PMMA with less than 2% MMA residual. Additional components are coloring agents that include: titanium dioxide, iron oxide yellow, iron oxide black, iron oxide red, azocondensation pigment red, and rayon fibers for veined shades.

This document describes the M-PM-Disc (Pink), a dental device used for the fabrication of dental bases for removable dentures. The submission is a 510(k) premarket notification to the FDA. The following information addresses the requested points based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the M-PM-Disc (Pink) are based on international standards for dentistry (ISO 10477 and ISO 20795-1). The device's performance is reported directly against these standards.

The device also underwent biocompatibility testing according to ISO 10993-5 (in vitro cytotoxicity) and ISO 10993-10.2 (guinea pig sensitization model), and "met the applicable standards", showing it was nontoxic and non-sensitizing.

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

The document does not explicitly state the sample sizes for the test sets used for each specific physical parameter measurement. However, typical laboratory testing for material properties involves multiple samples to ensure statistical significance. The data provenance is implied to be from Merz Dental GmbH's internal testing, as they "tested OMP-N for physical/chemical properties and biocompatibility." The country of origin of the data would be Germany, given Merz Dental GmbH's address. The data is prospective, generated specifically for this regulatory submission.

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

This document does not involve a test set requiring expert ground truth in the way a medical imaging AI would. The "ground truth" for the material properties is established by the standardized testing methodologies of ISO 10477 and ISO 20795-1. The experts involved would be the laboratory technicians and scientists performing the tests and interpreting the results according to these international standards. Their qualifications would involve expertise in materials science, mechanical testing, and adherence to ISO guidelines.

4. Adjudication Method for the Test Set

Not applicable. The evaluation of material properties by objective, standardized laboratory tests does not typically involve human adjudication in the same way clinical diagnostic assessments do. Results are typically measured directly and compared against pre-defined thresholds within the ISO standards.

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

No, an MRMC comparative effectiveness study was not done. This device is a material for dental fabrication, not a diagnostic AI tool that would involve human readers interpreting cases.

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

Yes, in a sense, a "standalone" evaluation of the material properties was performed. The OMP-N PMMA material was tested in isolation, and its physical and biocompatibility characteristics were measured and compared directly against performance standards. There is no "human-in-the-loop" performance associated with the material's inherent properties.

7. The Type of Ground Truth Used

The ground truth used for evaluating the M-PM-Disc (Pink) is based on established international standards for dentistry (ISO 10477, ISO 20795-1, ISO 10993-5, ISO 10993-10.2). These standards define the acceptable range or minimum/maximum values for various physical, chemical, and biological properties of dental polymer materials.

8. The Sample Size for the Training Set

Not applicable. This submission is for a material (M-PM-Disc), not an AI algorithm. Therefore, there is no concept of a "training set" in the context of machine learning. The robust properties of the PMMA material are inherent to its composition and manufacturing process.

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

Not applicable, as there is no training set for an AI algorithm. The material's properties (strength, water sorption, etc.) are intrinsic and established through standardized scientific testing processes.

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The Merz Dental GmbH M-PM-Disc (Clear) is indicated for the fabrication of removable bite splints such as mouthguard and nightguards.

The Merz Dental MP-M-Disc (Clear) is a solid disc composed of a highly cross-linked homogenous combination of polymethylmethacrylate (PMMA) copolymers known as an Interpenetrated Polymer Network (IPN). This is the same material used in Merz Dental artegral Denture Teeth (K030588) and the Merz Dental M-PM-Disc (Tooth Colored) (K071548). The difference is that the MPM-Disc (Clear) PMMA does not have added pigments. The M-PM-Disc (Clear) PMMA contains polymethylmethacrylate cross-linked polymer based on methacrylic acid esters, residual peroxide and residual monomer up to a maximum of 1%. It is offered in sizes from 90 x15 mm to 114.8 x 25 mm. Bite splints are prepared from the disc using a milling technique.

The provided document describes a 510(k) premarket notification for a dental device, the Merz Dental GmbH M-PM-Disc (Clear). This submission focuses on establishing substantial equivalence to previously marketed devices based on non-clinical testing and shared material properties, rather than an AI/ML-based device. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are not applicable in this context.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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The Merz Dental GmbH Denture Base Resins with Prosthetic Color System (Promolux, Promolux Hi, Weropress and PremEco PCS) are indicated for:

• Relining a denture surface that contacts tissue ●
• Repairing a fractured denture, or
• Forming a new denture base

Merz Dental Denture Base Resins with Prosthetic Color System are composed of the following products:
• Promolux: A heat processed PMMA denture base resin
• Promolux Hi: A heat-processed PMMA denture base resin formulated for greater strength
· Weropress: A two part cold curing PMMA denture base resin
: PremEco PCS: A two part cold curing PMMA denture base resin with individual tints for aesthetic coloration of gingival portion of a denture base
These products are intended for the preparation of denture bases. They are composed of PMMA and cured by standard heat or cold setting methods. The Prosthetic Color System is a three part system composed of the following: (1) PMMA polymer with various tints in a powder form, (2) MMA liquid for mixing with the powder, and (3) a cold-casting resin (PMMA and MMA) for final preparation of the denture base. The hot and cold curing denture materials contain standard dental colorants and catalyst systems. One of the hot cured dental base materials, Promolux Hi, is formulated to increase impact resistance.

This document is a 510(k) Summary for Merz Dental GmbH Denture Base Resins with Prosthetic Color System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with performance metrics in the way a medical imaging AI would. Therefore, many of the requested categories (e.g., sample size for test/training, number of experts, adjudication method, MRMC studies, standalone performance) are not applicable to this type of submission.

Here's a breakdown of the available information:

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

The acceptance criteria are that the device materials meet the requirements of two international ISO standards for denture base polymers. The reported device performance is that the materials met these standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. Performance testing for material properties typically involves laboratory-controlled testing of material samples, not patient data. The provenance for such tests would usually be the testing laboratory, which is not specified beyond being performed by the manufacturer.

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)

This information is not applicable/provided. Ground truth, in the context of this 510(k), refers to material property measurements against established international standards (ISO). This typically involves laboratory technicians and machinery, not clinical experts establishing a ground truth from patient data.

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

This information is not applicable/provided. Adjudication methods are relevant for clinical assessments, especially in cases where human readers are establishing ground truth from medical images. For material property testing, the measurements are objective.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted image interpretation, which is not the subject of this 510(k) submission.

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

This information is not applicable. This submission details physical material properties of denture resins, not the performance of an algorithm.

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

The "ground truth" for the material performance testing was based on references to international standards (ISO 1567:2000, ISO 20795-1, ISO 10993-5, ISO 10993-10.2). The materials were tested to ensure they met the specified requirements in these standards for physical and biological properties.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" in the context of material property testing for denture resins. The submission focuses on demonstrating that the final product meets specified standards.

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

This information is not applicable/provided. As there is no training set, there is no ground truth established for one.

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Artegral HD are posterior preformed plastic denture teeth for use in:

• supra construction for combined, fixed removable dental prostheses .
• hybrid construction for implant-supported dental prostheses .
• cover denture .
• total prostheses .
• model cast prostheses ●
• . partial dentures

artegral HD are preformed posterior plastic teeth made from an Interpenetrated Network (IPN) of polymethylmethacrylate (PMMA) with two finer Networks. The tooth neck is made from Organic Modified Polymer Network (OMP-N) and the incisal and dentine portions of the tooth are made from Highly Modified Polymer-Network (HMP-N). OMP-N has added insoluble PMMA spheres, and HMP-N has added amorphous silicon dioxide nanoparticles and fluorapatite. The artegral HD teeth comply with all the requirement of ISO 22112:2005 Dentistry - Artificial teeth for dental prostheses. The additives in artegral HD teeth are known biocompatible materials.

The provided document, K120404, pertains to the 510(k) premarket notification for the Merz Dental GmbH artegral HD preformed plastic denture teeth. This submission focuses on chemical and physical characteristic comparisons to a predicate device, rather than a diagnostic AI device requiring performance metrics like sensitivity or specificity. Therefore, many of the requested categories related to AI device performance evaluation are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and 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 diagnostic data. The testing involved samples of the artegral HD teeth and their material components.
• Data Provenance: The tests were conducted internally by Merz Dental GmbH (Germany). The specific labs or testing facilities are not detailed, but the document refers to compliance with international standards (ISO, USP, EC, OECD, EN/DIN), implying standard testing methodologies. All testing was prospective, as it was performed on the device components for the purpose of this submission.

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

• Not applicable. This device is not a diagnostic tool requiring expert interpretation of images or clinical data to establish ground truth. The "ground truth" here is compliance with established physical, chemical, and biological standards.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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 device is not an AI-assisted diagnostic tool.

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

• Not applicable. This device is not an algorithm. Performance testing was done on the physical product and its constituent materials.

7. The type of ground truth used:

• Standard-based compliance: The ground truth for this device is based on the requirements and limits defined in established international and national standards for artificial denture teeth and biocompatibility, such as:
  • ISO 22112:2005 Dentistry - Artificial teeth for dental prostheses
  • ISO/CD 20795-1 "Dentistry - Base polymers - Part 1: Denture base polymers"
  • USP 29 (United States Pharmacopeia)
  • ISO 10993 Part 5 (Biological evaluation of medical devices - Tests for in vitro cytotoxicity)
  • EC method B.6. (European Commission method)
  • OECD guideline 406 (OECD Guidelines for the Testing of Chemicals - Skin Sensitisation)
  • EN/ISO/DIN 10993-10.2 (Biological evaluation of medical devices - Tests for irritation and skin sensitization)

8. The sample size for the training set:

• Not applicable. This device does not use machine learning, so there is no training set.

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

• Not applicable. See point 8.

In summary: The K120404 submission for Merz Dental GmbH artegral HD preformed plastic denture teeth is primarily a substantial equivalence claim based on demonstrating that the device meets the physical, chemical, and biological safety requirements of relevant international standards. It does not involve AI or diagnostic performance studies that would utilize concepts like ground truth established by experts, test sets, or training sets. The "proof" that the device meets acceptance criteria comes from the successful completion of the specified laboratory tests according to the cited standards.

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artBloc® Temp is indicated for use with inLab, CEREC or other CAD-controlled milling equipment for the fabrication of multi-unit long-term temporary crowns or bridges.

A rectangular solid block of PMMA with post attachment for use in a CAD-controlled milling device for production of long-term temporary crowns and bridge abutments.

The provided text describes a medical device, artBloc® Temp, which is a PMMA block for CAD-controlled milling machines. The document is a 510(k) premarket notification summary. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with detailed acceptance criteria and performance metrics typically associated with AI/software devices.

As such, the information requested below, particularly related to acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert involvement, and ground truth establishment, is largely not applicable or not provided in this type of regulatory submission for a physical dental material. There is no mention of an algorithm, AI, or software performance in the context that would require these specific metrics.

Here's a breakdown based on the provided document:

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

   Acceptance Criteria	Reported Device Performance
   Compliance to ISO 10477 (Polymer-based crown and veneering materials)	Not explicitly stated: The document only states "Tested for compliance to ISO 10477". Specific performance values (e.g., flexural strength, water sorption) are not reported. The implication is that it met the standard's requirements, which serves as the acceptance criteria for material properties.
   Compliance to ISO 3336 (Dental ceramic applied to metal restorations)	Not explicitly stated: The document only states "Tested for compliance to ISO 3336". Specific performance values are not reported. This standard might be referenced for general dental material quality and methods, but PMMA is not ceramic. It's possible this is a general reference or an error in the summary. The core material is PMMA.
   Compliance to ISO 10993 (Biological evaluation of medical devices)	Not explicitly stated: The document only states "Tested for compliance to ISO 10993". Specific biocompatibility results (e.g., cytotoxicity, sensitization) are not reported. The implication is that it met the standard's requirements, which serves as the acceptance criteria for biocompatibility.
   Substantial Equivalence to Predicate Devices: artegral ImCrown and VITA CAD-Temp	Achieved: The FDA letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This is the primary "performance" criterion for a 510(k), meaning its characteristics and intended use are similar enough to existing devices not to raise new questions of safety and effectiveness.
   Indication for use with inLab, CEREC, or other CAD-controlled milling equipment for the fabrication of multi-unit long-term temporary crowns or bridges.	Supported by Predicate Equivalence: The intended use statement confirms this (Page 3 of 48). The predicate devices also serve as evidence that such materials can be used for temporary crowns and bridges with CAD/CAM systems. The "performance" here is functional compatibility and suitability for the intended anatomical and clinical application, implicitly covered by compliance to ISO standards and substantial equivalence.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not provided. This document is a regulatory summary for a physical material, not for an AI/software device involving test sets of data. Testing mentioned (ISO standards) would typically involve material samples, but the number of such samples is not specified.

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/Not provided. Ground truth, in the context of expert review, is not relevant for this type of material submission. Compliance to ISO standards is typically assessed by laboratory testing against pre-defined physical/chemical/biological metrics.

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

   • Not applicable/Not provided. This refers to expert review processes, which are not detailed or implied for this submission.

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 physical dental material, not an AI or imaging device that would involve human readers or AI assistance.

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

   • Not applicable. There is no algorithm discussed in this document.

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

   • Material property standards: The "ground truth" for this device would be its physical, chemical, and biological properties meeting the specifications outlined in the referenced ISO standards (ISO 10477, ISO 3336, ISO 10993). This is typically determined through laboratory testing against established benchmarks.

8. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI/software device. For a physical material, development would involve R&D and quality control, but not a "training set" in this sense.

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

   • Not applicable. As there is no training set mentioned or implied, this question is not relevant to the provided document.

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For use as a milling blank in the fabrication of provisional crowns and bridges.

Discs of PMMA in two sizes and three shades for milling into provisional crowns and bridges

The provided text describes a 510(k) premarket notification for a dental device, specifically a "Wieland Zeno CAO temporary PMMA disc, tooth-colored." This device is a material for fabricating provisional crowns and bridges, not an AI/ML powered device. As such, the concept of "acceptance criteria for an AI device" and the associated study characteristics (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to the information provided in this document.

The document states that the device was tested for compliance to ISO 3336 and ISO 10993. These are standards for dental materials and biocompatibility, respectively. The acceptance criteria would be defined by these ISO standards, and the "study" would be the testing performed to demonstrate compliance with these material properties and safety standards.

Therefore, I cannot fulfill the request as formatted for an AI/ML powered device using the given text. The information required (e.g., number of experts, adjudication methods, AI performance metrics) is simply not present because the device is a physical dental material and not a software-based diagnostic or analytical tool.

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artegral ImCrown is indicated for use as a provisional anterior crown when fitted with the CEREC 3D and inLab.

Various shapes and sizes of preformed anterior crowns composed of IPN-PMMA with an attachment device for use in the CEREC 3D and inLab Systems.

The provided document is a 510(k) premarket notification for a dental device, "artegra® ImCrown," which is a preformed temporary crown. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria with quantifiable metrics.

Therefore, many of the requested elements for describing an acceptance criteria study (such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, specific training set details) are not applicable or not explicitly stated in this type of regulatory submission.

Here's an analysis based on the information provided, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with specific performance metrics for the device. Instead, the "device performance" is primarily demonstrated by compliance with established international standards and a statement of intended use, implying that if it meets these standards, it is suitable for its intended purpose.

Explanation:

• ISO 3336: Specifies requirements for dental polymeric materials for crowns and bridges. Compliance implies the material properties (e.g., strength, durability, biocompatibility) meet a recognized standard. Without the full test report, specific acceptance values (e.g., flexural strength > X MPa) are not provided in this summary.
• ISO 10993: Covers biological evaluation of medical devices. Compliance implies the device materials are biocompatible and do not pose unacceptable biological risks. Again, specific acceptance criteria (e.g., no cytotoxicity detected in X assay) are not detailed here.
• Intended Use Statement: Demonstrating that the device can fulfill its intended purpose, which is to function as a provisional anterior crown when used with specified systems. The FDA clearance confirms its suitability for this indication.
• Substantial Equivalence: This is the primary "performance metric" for a 510(k). The device performs "as well as" or "similarly to" a legally marketed predicate device.

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

• Sample Size for Test Set: Not specified in the provided summary. Testing for ISO standards often involves a specific number of samples for each test (e.g., mechanical testing, biocompatibility). However, the exact numbers used for this device are not disclosed here.
• Data Provenance: Not explicitly stated (e.g., retrospective/prospective). The testing would have been conducted by the manufacturer (Merz Dental GmbH) in Germany, or by a certified testing laboratory. It would be considered prospective testing for the purpose of demonstrating compliance.

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

• Not Applicable. For a device like a temporary crown, "ground truth" isn't established by expert consensus in the same way it would be for an AI diagnostic algorithm. Performance is typically assessed against physical and chemical specifications defined by the ISO standards and the material's intended function. The "experts" would be the engineers and scientists conducting the laboratory tests according to standard protocols.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers/experts when establishing ground truth for diagnostic accuracy studies. This is not relevant for the type of laboratory and biocompatibility testing described for this dental device.

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 device is a physical dental product (a preformed crown), not an AI diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant.

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

• Not Applicable. As this is a physical device and not an algorithm, standalone performance (in the context of AI) is not relevant. The "standalone" performance here would refer to the device's material properties and fit, which are covered by the ISO testing.

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

• The "ground truth" for this device's performance would be compliance with the specifications outlined in ISO 3336 and ISO 10993 (e.g., specific thresholds for mechanical properties, absence of cytotoxic effects). These standards define acceptable performance based on scientific and clinical understanding of dental materials.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set." The device is manufactured based on established material science and engineering principles.

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

• Not Applicable. See point 8.

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Artegral, and Polystar® Selection are intended for use as teeth in dentures.

Artegral, and Polystar® Selection preformed plastic teeth are prefabricated devices composed of polymethylmethacrylate and cross-linking co-polymers of methacrylic acid (IPN) intended for use as teeth in dentures.

Artegral, and Polystar® Selection preformed plastic teeth are prefabricated devices composed of polymethylmethacrylate and cross-linking co-polymers of methacrylic acid (IPN).

The provided text describes a 510(k) premarket notification for "Artegral and Polystar Selection Performed Plastic Denture Teeth." This is a regulatory submission for a medical device, and the information contained does not directly correspond to the requested details about acceptance criteria and a study proving a device meets those criteria in the context of an AI/algorithm-based medical device.

The document discusses the intended use of the denture teeth, their chemical composition, and states that "Performance and safety testing activities were conducted against recognized standards to establish the reliability characteristics of the new devices. Testing involved bench studies, and biocompatibility tests." However, it does not provide specific acceptance criteria, reported performance, or details of a study in the format requested for an AI/algorithm.

Therefore, I cannot provide the requested table and study details. This document pertains to a physical dental device and its regulatory clearance, not an AI-driven one with specific performance metrics like sensitivity, specificity, or reader studies.

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