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Visalys® Bulk Fill: Loss of tooth substance due to caries, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in deciduous teeth, core buildups, cavity floor elevation, repair of direct restorations after appropriate pretreatment and splinting / locking of teeth.

Visalys® Bulk Flow: Loss of tooth substance due to caries, fractures, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in decidious teeth, core build-ups, cavity lining, cavity floor elevation, blocking out undercuts, repair of direct restorations after appropriate pretreatment, extended fissure sealing and splinting / locking of teeth.

Visalys® Bulk Fill is a light-cured, nano-hybrid filling composite that can be modeled and is available in a universal shade. For adhesive cementation, a dentin-enamel bond is used. The material is available in screw syringes and can be applied in layers up to 4 mm thick. The filling material contains approx. 82% inorganic fillers by weight. The radiopacity is 2.5 mm aluminium*. The color stability meets the requirements of DIN EN ISO 4049. Visalys® Bulk Fill is thus suitable for both posterior teeth and also for fillings without tunnel preparation in the anterior tooth area, particularly class III and V.

Visalys® Bulk Flow is a light-cured, flowable nano-hybrid filling composite and is available in a universal shade. For adhesive cementation, a dentin-enamel bond is used. The material is available in syringes and can be applied in layers up to 4 mm thick. The filling material contains approx. 72% inorganic fillers by weight. The radiopacity is 2.0 mm aluminium*. The color stability meets the requirements of DIN EN ISO 4049. Visalys® Bulk Flow is thus suitable for both posterior teeth and also for fillings without tunnel preparation in the anterior tooth area, particularly class III and V. Capping is not necessary.

The provided text focuses on the substantial equivalence of dental restorative materials (Visalys® Bulk Fill and Visalys® Bulk Flow) to a predicate device. It does not describe a device that uses AI or machine learning, nor does it detail acceptance criteria related to typical AI/ML performance metrics such as sensitivity, specificity, or AUC.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document. The document describes traditional performance testing for dental materials, primarily focusing on physical and chemical properties and biocompatibility.

Here's an overview of the information present in the document that aligns with the context of a medical device submission, but not specifically for an AI/ML device:

1. Table of acceptance criteria and reported device performance:

The document lists performance tests conducted in accordance with various ISO standards for "Polymer-based restorative materials" (ISO 4049). It states that a "comparison of the parameters in respect to mechanical properties was performed. The results demonstrate the substantial equivalence to the predicate device." However, specific numerical acceptance criteria (e.g., "flexural strength > X MPa") and the reported numerical performance values for the subject devices are not explicitly stated in the provided text. It only mentions that the results demonstrate substantial equivalence.

2. Sample size used for the test set and the data provenance: Not applicable. The tests are bench tests of material properties, not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established by standardized physical/chemical testing, not expert consensus.

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: No, this is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the performance testing is based on established physical and chemical measurements defined by international ISO standards for dental materials.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

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Profisil® Fluoride Varnish is a 5 % sodium fluoride varnish which produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

Profisil® Fluoride Varnish is designed to securely adhere to the tooth surface for several hours while releasing fluoride ions. The varnish contains 5 % sodium fluoride suspended in a mucosa-friendly, pleasantly flavored dimethicone gel. The varnish is available in following versions: mint, berry and unflavored.

The provided document describes a 510(k) premarket notification for a dental device, "Profisil Fluoride Varnish." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials for effectiveness. Therefore, the information typically requested about acceptance criteria and studies proving a device meets them for new effectiveness claims, especially those involving AI or comparative effectiveness with human readers, is not directly applicable to this specific submission.

However, the document does detail how the new device demonstrates equivalence to its predicate, focusing on non-clinical performance and biocompatibility. Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

For "Profisil® Fluoride Varnish," the acceptance criteria for non-clinical performance are based on the international standard EN ISO 17730:2020 "Dentistry - fluoride varnishes."

Biocompatibility Acceptance Criteria:

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

• Test set sample size: Not explicitly stated as this is a non-clinical device evaluation. The "test set" would refer to the samples of the Profisil® Fluoride Varnish subjected to the various physical and chemical tests (e.g., specific batches for pH, viscosity, fluoride release tests) and biocompatibility studies (e.g., cell cultures for cytotoxicity, animal models for sensitization/irritation). The exact number of samples tested for each property is not detailed in the summary.
• Data provenance: The standard EN ISO 17730:2020 is an international standard. Biocompatibility standards like ISO 10993 series are also international. The summary indicates these tests were performed to demonstrate compliance with these standards, suggesting laboratory testing specifically for the Profisil® product. There is no information on country of origin of data beyond the manufacturer being based in Germany. The data is prospective as it was generated to support the current submission.

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

This information is not applicable. The "ground truth" for this type of device comparison is based on established scientific and engineering principles codified in international standards (EN ISO 17730:2020 for dental fluoride varnishes) and biocompatibility standards (ISO 10993 series). The results are objectively measured physical and chemical properties and biological responses, not subjective interpretations by human experts in the sense of medical image analysis.

4. Adjudication Method for the Test Set

Not applicable, as the "test set" involves objective laboratory measurements against predefined standard requirements rather than subjective assessments requiring adjudication.

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 dental fluoride varnish, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant to this submission.

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

Not applicable for the same reason as above; this is a physical dental material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the current device's performance evaluation is based on International Standards:

• EN ISO 17730:2020 "Dentistry - fluoride varnishes" for physical and chemical properties (pH, dynamic viscosity, fluoride release, SEM).
• ISO 10993 series for biocompatibility studies (cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity).

These standards define the acceptable range or nature of results for these properties, which serve as the objective "ground truth" for evaluation.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and therefore does not have a "training set."

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

Not applicable.

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Visalys® CemCore is a dual-curing, adhesive cementation and core build-up composite, which is intended to be used for: a) Permanent cementation of · crowns, bridges, inlays, veneers and adhesive bridges made of metal, ceramic, composite, hybrid and oxide ceramics • root posts and indirect core build-ups b) Composite for · adhesive core build-ups Visalys® CemCore Try In Paste is a water-soluble polyethylene glycol paste for shade matching: · To check the shade selected prior to permanent cementation with Visalys® CemCore. · For covering the cement joint to reduce a layer of inhibition.

Visalys® CemCore is a dual-curing composite containing fluoride for adhesive cementation of indirect restorations and root posts and can be used to fabricate radiopaque core build-ups and abutment fillings. Due to the Active-Connect-Technology (ACT) Visalys® CemCore includes an additional initiator system for the optimization of the adhesive bond. BPA or BPA precursors are not used in the manufacturing process of this device. Visalys® CemCore shall only be used in combination with self-etching Visalys® Tooth Primer. Visalys® Restorative Primer is recommended as the primer for the restoration surfaces. Visalys® CemCore is easy to use and has high adhesive strength and good flowability with stable consistency. Visalys® CemCore is offered in the shades Universal (A2/A3), Dark (A4), Opaque, Bleach and Translucent. The paste should be mixed and dispensed directly from a double syringe with the corresponding mixing tips blue (MLø 3.2 mm). Visalys® CemCore Try in Paste serves to simulate the shade effect of the selected Visalys® CemCore shade on ceramic restorations and for covering the cement joint to reduce a layer of inhibition. The water-soluble paste corresponds in shade and translucence with the completely cured Visalys® CemCore. Visalys® CemCore Try In Paste is offered in the shades Universal (A2/A3), Dark (A4), Opaque, Bleach and Translucent. The paste is dispensed from a syringe and syringe tip.

The provided text describes a 510(k) premarket notification for a dental device, Visalys® CemCore and Visalys® CemCore Try In Paste. It details the device's characteristics, indications for use, and a comparison to predicate devices, along with non-clinical performance testing results.

However, the document does not contain information about a study proving the device meets specific acceptance criteria related to AI/algorithm performance, nor does it refer to human reader studies, ground truth establishment by experts, or training/test set data for an AI system. The assessments are based on bench testing for mechanical properties, biocompatibility, and visual comparisons for shade consistency, all against established ISO or ASTM standards, or internal methods.

Therefore, I cannot fulfill the request as it pertains to AI/algorithm performance and human expert studies because such information is not present in the provided text. The device is a dental material, not an AI-powered diagnostic or assistance tool.

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Restoration primer for treatment of:

metal/silicate ceramics, oxide ceramic and composite surfaces

• · to cement prosthetic restorations
• · to repair fractured restorations with composite materials

Visalys® Restorative Primer with adhesive monomers (10-MDP, silane methacrylate) is for building up adhesive surfaces on restoration materials (metal, composite, as well as silicate and oxide ceramics). Visalys® Restorative Primer is a single component primer. Do not light cure Visalys® Restorative Primer. BPA or BPA precursors are not used in the manufacturing process of this device.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Visalys® Restorative Primer device.

It's important to note that this document is a 510(k) summary for a Class II medical device (Resin Tooth Bonding Agent). For such devices, the FDA often relies on substantial equivalence to a predicate device, which means direct comparative effectiveness studies with human subjects against the predicate might not always be required in the same way as for novel high-risk devices. The information provided is primarily focused on demonstrating this substantial equivalence through bench testing.

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

The acceptance criteria are implicitly derived from the bond strength values of the predicate device, CLEARFIL™ CERAMIC PRIMER PLUS (K150703). The study aims to show that Visalys® Restorative Primer performs similarly. No explicit "acceptance criteria" are stated as numerical thresholds; rather, the "Similar" conclusion in the table below serves as the acceptance.

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

• Sample Size for Test Set: The document does not explicitly state the number of samples or specimens used for the shear bond strength tests. It only lists the resulting bond strength values.
• Data Provenance: The study was conducted by Kettenbach GmbH & Co. KG (located in Eschenburg, Germany). The data is prospective as it involves new bench testing to support the 510(k) submission.

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. This device is a dental primer, and the ground truth for its performance (shear bond strength) is established through in vitro bench testing according to a recognized standard (ISO 16506). This does not involve human expert adjudication of images or clinical outcomes.

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

Not applicable, as the evaluation is based on objective physical measurements (shear bond strength) from bench tests, not on subjective expert consensus or adjudication.

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 dental primer, not an AI-based diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is a dental primer, not an algorithm. The performance evaluation presented is strictly standalone in vitro bench testing of the product's physical properties.

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

The ground truth for the device's performance is established by objective physical measurements (shear bond strength) obtained through standardized in vitro bench testing adhering to relevant ISO standards (specifically, ISO 16506 Chapter A 2.2.5).

8. The sample size for the training set

Not applicable. This is a physical dental product, not a machine learning model. Therefore, there is no "training set."

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

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

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For permanent cementation of tooth structure to: · crowns, bridges, inlays, veneers and adhesive bridges in combination with Visalys® CemCore · root posts in combination with Visalys® CemCore and Visalys® Core · indirect core build-ups in combination with Visalys® CemCore For build-up adhesive bond to structure with Visalys® CemCore and Visalys® Core to fabricate: · adhesive core build-ups

Visalys® Tooth Primer is a self-etching single-component primer with acidic polymers (10-MDP) for adhesive bonding of Visalys® CemCore and Visalys® Core to the dental hard substance. The primer can be applied without additional etching or after selective etching the enamel. Do not light cure Visalys® Tooth Primer. BPA or BPA precursors are not used in the manufacturing process of this device.

This document is a 510(k) Premarket Notification for a dental device, Visalys® Tooth Primer. It is not a document describing an AI/ML medical device, and therefore does not contain the information requested in your prompt regarding acceptance criteria and performance studies for such a device.

The prompt asks for details specifically relevant to AI/ML device testing, such as:

• Acceptance Criteria and Reported Performance Table: Not applicable here, as this device's performance is not measured in terms of AI metrics (e.g., sensitivity, specificity, AUC).
• Sample Size and Data Provenance (Test Set): No test set in the context of AI/ML evaluation.
• Number of Experts and Qualifications (Ground Truth): No expert-based ground truth establishment for a physical dental primer.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Devices like dental primers do not involve human readers assisted by AI.
• Standalone Performance: Not applicable for a physical product.
• Type of Ground Truth: Ground truth for a dental primer would be measured through physical/chemical properties and biocompatibility, not expert consensus or pathology in the AI sense.
• Training Set Sample Size and Ground Truth Establishment: No training set for a physical device.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Panavia™ V5 Tooth Primer) based on:

• Indications for Use (similar)
• Technological Characteristics (similar)
• Non-Clinical Performance Testing:
  • Shear Bond strength on enamel and dentin (according to ISO 29022). The document states the performance "satisfactorily met the requirements," implying it met certain thresholds, but it does not provide specific numerical acceptance criteria or reported values in a table format as requested for an AI device.
  • Biocompatibility tests (ISO 10993 family, ISO 7405) for cytotoxicity, mutagenicity, sensitization, and chemical analysis. The conclusion is "comparable or superior to the predicate device," but no specific numerical criteria or results are provided.
• No Human Clinical Studies: The document explicitly states, "No data from human clinical studies has been included to support the substantial equivalence of Visalys® Tooth Primer."

Therefore, based on the provided text, it is not possible to fill out the requested information about acceptance criteria and study design for an AI/ML medical device. This document describes a traditional dental material, not an AI product.

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Visalys® Core, PL-Core, PL-Core-C, PL-Core-X are dual-curing core build-up materials which are intended to be used for different types of core build-ups and luting of root posts

The Visalvs® Core / PL-Variants are all available in two delivery systems: 1:1 25ml automix catridge, 1:1 5ml double syringe. The pastes should be mixed and dispensed directly from the 5-ml-double syringe with the corresponding mixing tips (MLT Ø 3.2 mm) or using an dispensing gun DS-24 2:1/1:1 for the 25-ml-cartridge with the corresponding mixing tips (MBT Ø 4.2 mm). The Visalys® Core / PL-Core-Variants are available in four different variations: Visalys® Core, PL-Core, PL-Core-C, and PL-Core-X. The Visalys® Core / PL-Core-Variants are available in the following shades: White, Dentin, and Blue. Visalys® Core, developed by Kettenbach, is a dual-curing, fluoride-containing composite used for the fabrication of radiopaque core build-ups and core fillings. The automixing, two-component system is based on a multifunctional acryl composite. BPA or BPA precursors are not used in the manufacturing process of this device. Visalys® Core has a firm consistency with good flow behavior. It is compatible with common light and dual-curing adhesives available on the market (Active Connect Technology) and already achieves strength values as specified with self-curing. Curing can be controlled as required at any time using optional light-curing. PL-Core-C, developed by Kettenbach, is a dual-curing, fluoride-containing composite used for the fabrication of radiopaque core build-ups and core fillings. The automixing, two-component system is based on a multifunctional acryl composite. BPA or BPA precursors are not used in the manufacturing process of this device. PL-Core-C has a firm consistency with good flow behavior. It is compatible with common light and dual-curing adhesives available on the market (Active Connect Technology) and already achieves strength values as specified with self-curing. Curing can be controlled as required at any time using optional light-curing. PL-Core-X, developed by Kettenbach, is a dual-curing, fluoride-containing composite used for the fabrication of radiopaque core build-ups and core fillings. The automixing, two-component system is based on a multifunctional acryl composite. BPA or BPA precursors are not used in the manufacturing process of this device. PL-Core-X has a firm consistency with good flow behavior. It already achieves strength values as specified with self-curing, however curing can be controlled as required at any time using optional light-curing. PL-Core, developed by Kettenbach, is a dual-curing, fluoride-containing composite used for the fabrication of radiopaque core build-ups and core fillings. The automixing, twocomponent system is based on a multifunctional acryl composite. BPA or BPA precursors are not used in the manufacturing process of this device. PL-Core has a firm consistency with good flow behavior. It already achieves strength values as specified with self-curing, however curing can be controlled as required at any time using optional light-curing. Differences between the variants: 1. Visalys® Core and PL-Core C are compatible with all common light and dualcuring adhesives available on the market. 2. PL-Core and PL-Core X can be applied with bondings for which the use with dualcuring composites is recommended. 3. Radiopacity is available in 2.5mm Al (Visalys® Core and PL-Core-X) or 2.0mm Al (PL-Core-C and PL-Core).

The provided document is a 510(k) summary for the dental device Visalys® Core, PL-Core, PL-Core-C, PL-Core-X. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The document does not describe a clinical study in the typical sense (e.g., involving human participants, expert readers, or a specific test set with ground truth established by experts/pathology) to prove performance against acceptance criteria in the way envisioned by your request. Instead, it relies on non-clinical performance testing (bench testing) to demonstrate technical equivalence to existing predicate devices.

Therefore, many of the requested fields related to clinical study design, expert involvement, and reader performance cannot be filled from this document.

Here's the information that can be extracted, adapting to the nature of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document defines acceptance criteria by comparing the device's technological characteristics and mechanical properties to those of predicate devices (LuxaCore Dual, MULTICORE FLOW, Rebilda DC). The "reported device performance" indicates that the new device meets these criteria by demonstrating equivalence.

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

• Test Set Sample Size: Not explicitly stated for each bench test. These are material property tests typically performed on a specified number of samples (e.g., 5-10 per test for ISO standards), but the exact counts are not detailed in this summary.
• Data Provenance: The tests are "non-clinical performance testing" or "bench testing" conducted by Kettenbach GmbH & Co KG in Germany, following international (ISO) and national (ASTM, ADA) standards. This is laboratory data, not patient data.

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

Not applicable. Ground truth for these physical and chemical property tests is established by adhering to standardized test methodologies and measurements, not by expert consensus on clinical findings.

4. Adjudication method for the test set

Not applicable. This refers to consensus building for clinical ground truth, which is not relevant for bench testing.

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 material science study, not an AI-based diagnostic or assistive device.

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

Not applicable. This is a material science study, not an AI-based algorithm.

7. The type of ground truth used

For the non-clinical performance tests: The "ground truth" is the objective measurement of physical and chemical properties of the material according to established international and national standards (e.g., ISO, ASTM, ADA). For biocompatibility, established biological safety parameters are used as ground truth.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this type of material science evaluation. The evaluation involves testing the device itself against established standards and comparing its properties to predicate devices.

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

Not applicable.

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Kingscross temporary crown and bridge material is intended to be used for fabrication of temporary prostheses, such as crowns, partial crowns, bridges, inlays, onlays and veneers, and for customization of prefabricated acrylic and metal crowns and for fabrication of long-term temporary restorations until a permanent restoration is fabricated.

Kingscross, which was developed by Kettenbach, is a highly esthetic composite of fabricating temporary restorations. The two-component system based on a multifunctional acryl composite is produced using no Bisphenol-A or Bisphenol-A precursors in the manufacturing process It has similar properties to a filling material and is available in the following shades: A1. A2, A3, A3.5, B1, B3, Bleach white. Kingscross temporary restorations can also be adjusted and customized using lightcuring composites. The two components (base and catalyst paste) are mixed by using a 50 ml cartridge at the ratio of 10:1 with a dispensing gun. By varying the percentages of two chemical components in the base paste with different percentages of organic peroxide in the catalyst paste four different product variations with different mechanical properties are realized.

The provided 510(k) summary for K122039, Kingscross Temporary Crown and Bridge Material, does not contain a study that proves the device meets specific acceptance criteria in the way typically expected for an AI/ML or diagnostic device.

Instead, this submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of material properties and intended use. The "acceptance criteria" here are implied by the performance of the predicate devices and the relevant industry standards for dental materials.

Here's an analysis based on the provided text, addressing the requested information to the best of its ability given the type of device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a dental material, the "acceptance criteria" are not quantitative thresholds set for a specific study, but rather that the material's properties are comparable to established predicate devices and meet relevant industry standards.

Regarding the other requested information:

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 describes bench testing of material properties (E-Modulus, flexible strength, etc.) and biocompatibility tests.
• Sample sizes for these material tests are not specified. For example, it doesn't state how many samples were tested for compressive strength or E-Modulus for Kingscross or the predicate devices.
• Data provenance is not explicitly stated, but given the manufacturer is Kettenbach GmbH & Co KG in Germany, it's highly likely these tests were performed in Germany or by contract labs following international standards. These would be prospective tests performed specifically for this submission.

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

• Not applicable in the traditional sense for this device. This is a material claim, not a diagnostic or AI device that requires expert ground truth labeling of images or clinical cases. The "ground truth" here is adherence to established material testing standards (e.g., ADA/ANSI Specification No. 53, ISO 9917-1, OECD 487 for biocompatibility). The experts would be the chemists and material scientists performing and interpreting these standardized tests, but their number and specific qualifications are not detailed.

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

• Not applicable. There is no expert adjudication process described for the quantitative material property tests. The results are objective measurements from standardized tests.

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. This is not an AI/ML device or a diagnostic device involving human readers. Therefore, an MRMC study is not relevant and was not performed.

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

• Not applicable. This is a dental material, not an algorithm or AI system.

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

• The "ground truth" for this device's performance is established industry standards and the measured physical and chemical properties of the material itself, as well as the performance characteristics of the legally marketed predicate devices. No pathology, outcomes data, or expert consensus (in the clinical diagnosis sense) was used to establish ground truth for this type of submission.

8. The sample size for the training set

• Not applicable. This device is a material, not an AI/ML model 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 an AI/ML model, there is no ground truth established for one.

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The Identium® Impression Materials are intended to:

• be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums;
• provide models for study and for production of restorative prosthetic devices.

Identium® Heavy (regular 1:1, fast 1:1) is to be used as a heavy-bodied impression material in one-step technique (double mix) for:

• Impressions for crowns/bridges, inlays/onlays and veneer preparations
• Functional impressions
• Impressions for full or partial dentures
• Implant impressions

Identium® Medium (regular 1:1, fast 1:1) is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for:

• Impressions for crowns/bridges, inlays/onlays and veneer preparations
• Functional impressions
• Fixation impressions
• Implant impressions

Identium® Scan Heavy (regular 1:5) is to be used as a heavy-bodied impression material in one-step technique (double mix) for:

• Impressions for crowns/bridges, inlays/onlays and veneer preparations
• Functional impressions
• Impressions for full or partial dentures
• Implant impressions

Identium® Scan Medium (regular 1:5) is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for:

• Impressions for crowns/bridges, inlays/onlays and veneer preparations
• Functional impressions
• Fixation impressions
• Implant impressions

Identium® Scan Light (regular 1:1) is to be used as a syringeable light-bodied impression material in one-step technique (double mix) for:

• Impressions for crowns/bridges, inlays/onlays and veneer preparations
• Reline impressions
• Impressions for full or partial dentures

Identium® Impression Materials are addition-curing, elastomeric materials. Identium® Impression Materials have excellent flow and hydrophilic properties, high shear strength, dimensional accuracy and resistance to permanent deformation. The Identium® Impression Materials include three different viscosities (heavy-bodied, medium-bodied, light-bodied), available in an assortment of delivery systems: Traditional 1:1 50 ml automix cartridge version and 5:1 362 ml foil bags for use in most automatic dispensing and mixing systems (heavy-bodied and medium-bodied versions only). Most of the Identium® Impression Materials are available in a regular-set and a fast-set version.

This looks like a 510(k) premarket notification for dental impression materials, not an AI/ML device. Therefore, the typical "acceptance criteria and study that proves the device meets the acceptance criteria" structure, especially concerning AI/ML performance metrics, ground truth, expert adjudication, MRMC studies, and training sets, does not apply here.

Instead, this document describes a traditional medical device submission where substantial equivalence is demonstrated through:

• Comparison to predicate devices: Showing the new device has similar intended use and technological characteristics to legally marketed devices.
• Performance testing to established standards: Demonstrating compliance with relevant industry and regulatory standards for non-AI devices.

Here's how I can address the request based on the provided document, adapting the categories where necessary:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is typically not included in a 510(k) summary for material performance testing. Standard ISO tests for dental materials use specific sample numbers as defined within the standard itself (e.g., a certain number of specimens for tensile strength, dimensional accuracy, etc.), but these details are not provided in this high-level summary. The data provenance would be laboratory testing conducted by or for the manufacturer (Kettenbach GmbH & Co. KG, Germany).

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

Not applicable for this type of device. "Ground truth" in the context of AI/ML refers to verified labels for image data, clinical diagnoses, etc. For material performance, the "truth" is determined by objective physical and chemical testing methods outlined in standards like ISO 4823, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. Material performance tests are quantitative measurements (e.g., measuring dimensional change, tear strength) and do not involve human adjudication in the sense of reviewing cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images with and without AI assistance. This document is for a dental impression material, which is a physical product, not a diagnostic imaging tool.

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

No, a standalone algorithm performance study was not applicable or performed. This device is a material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective laboratory measurements dictated by the test methods in ISO 4823. This includes quantifiable properties like dimensional stability, tear strength, elastic recovery, etc., measured against the defined acceptance limits within the standard. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

Not applicable. This device is a material, not a machine learning model; therefore, there is no "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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The Identium® Impression Materials are intended to: be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums; provide models for study and for production of restorative prosthetic devices.

Identium Heavy is to be used as a heavy-bodied impression material in one-step technique (double mix) for: Impressions for crowns/bridges, inlays/onlays and veneer preparations. Functional impressions. Impressions for full or partial dentures. Implant impressions.

Identium Medium is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for: Impressions for crowns/bridges, inlays/onlays and veneer preparations. Implant impressions. Fixation impressions. Functional impressions.

Identium Medium soft is to be used as a medium-bodied tray or syringeable impression material in one-step technique (monophase or double mix) for: Impressions for crowns/bridges, inlays/onlays and veneer preparations Functional impressions Reline impressions

Identium Light is to be used as a light-bodied, syringeable impression material in one-step technique (double mix) for: Impressions for crowns/ bridges, inlays/ onlays and veneer preparations. Reline impressions. Impressions for full or partial dentures.

Identium® Impression Materials are addition-curing, elastomeric materials. Identium® Impression Materials have excellent flow and hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Identium® Impression Materials family consists of three different viscosities (heavy-bodied, medium-bodied, light-bodied). They are available in two delivery systems, for use in most automatic dispensing and mixing systems: standard 1:1 (50 ml automix cartridges) and 5:1 (362 ml foil bags). The Identium® Impression Materials are available in regular-set and fastset versions.

Here's an analysis of the provided 510(k) summary for Identium® Impression Materials, outlining the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply states that "Identium® Impression Materials have been evaluated in accordance with the applicable criteria established in Guidance for Industry and FDA Staff: Dental Impression Materials – Premarket Notification (Doc#2203, 8/17/1998) and ISO 4823 (Dentistry – Elastomeric impression materials):2000/Cor 1:2004/Amd 1:2007."

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

The document does not specify the number of experts used or their qualifications for establishing ground truth. The evaluation appears to be based on adherence to ISO standards and FDA guidance for material performance, rather than clinical expert assessment of impressions.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. The evaluation seems to be primarily laboratory-based testing against established material standards.

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 section is not applicable. The device is an impression material, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

This section is not applicable. The device is an impression material, not an algorithm. Performance testing would be material-specific, not algorithm-specific.

7. The Type of Ground Truth Used

The ground truth for the performance evaluation appears to be based on objective measurements and criteria defined in recognized international standards (ISO 4823) and FDA guidance documents for dental impression materials. This typically involves laboratory testing for physical and mechanical properties.

8. The Sample Size for the Training Set

The document does not specify a training set size. This type of submission (510(k) for a physical material) does not typically involve a "training set" in the context of machine learning or AI. Performance is evaluated against established material specifications.

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

This section is not applicable. As mentioned above, there isn't a "training set" in the context of this device. The evaluation is based on meeting the defined physical and chemical properties outlined in the relevant standards and guidance.

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The Panasil® Impression Materials are intended to: be placed on an impression tray (or injected directly into the mouth, depending on the technique and device) and used to reproduce the structure of a patient's teeth and gums; provide models for study and for production of restorative prosthetic devices.

Panasil® initial contact (regular, regular fast, light fast, x-light, x-light fast) is to be used as a syringeable impression material for: Two-step putty-wash impression technique. One-step putty-wash impression technique. One-step impression technique using a foil (plastic putty spacer). One-step impression technique (simultaneous technique) using dual viscosities. Reline impressions. Fabricating full or partial dentures.

Panasil® tray (fast 1:1, soft fast 5:1, soft fast 1:1) is to be used as a heavy-bodied material for: One-step impression technique (simultaneous technique) using single or dual viscosities. Two-step impression technique using dual viscosities. Functional impressions.

Panasil® Impression Materials are addition-curing, elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation. The Panasil Impression Materials include four different viscosities (heavy-bodied, medium-bodied, light-bodied, x-light-bodied), available in an assortment of delivery systems: traditional 1:1 50 ml automix cartridge and 5:1 362 ml foil bags for use in most automatic dispensing and mixing systems.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and 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/prospective). It only mentions that performance testing was conducted.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for this device is based on compliance with established industrial standards (ISO 4823) and FDA guidance, rather than expert consensus on diagnostic images or similar data.

4. Adjudication Method for the Test Set

Not applicable. The testing appears to be quantitative measurements against technical specifications outlined in the referenced standards, not a qualitative assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with AI/diagnostic imaging devices where human readers' performance with and without AI assistance is evaluated. The Panasil® Impression Materials are dental impression materials, which are physical devices.

6. Standalone Performance Study

Yes, a standalone study (algorithm only without human-in-the-loop performance) was effectively done. The performance data section states that the "Panasil® Impression Material subject devices... have been evaluated in accordance with the applicable criteria established in Guidance for Industry and FDA Staff: Dental Impression Materials – Premarket Notification... and ISO 4823." This indicates that the materials themselves were tested against a set of objective technical benchmarks.

7. Type of Ground Truth Used

The ground truth used is based on established industry standards and regulatory guidance. Specifically, the device's performance was evaluated against the technical requirements outlined in:

• ISO 4823 (Dentistry - Elastomeric impression materials):2000/Cor. 1:2004/Amd. 1:2007
• Guidance for Industry and FDA Staff: Dental Impression Materials – Premarket Notification (FOD#2203, 8/17/1998)

8. Sample Size for the Training Set

Not applicable. This device is a dental impression material, not an AI algorithm requiring a training set.

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

Not applicable. As this is not an AI/machine learning device, there is no training set or associated ground truth establishment process in that context.

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