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SmileGuard™ light curable resin is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards and splints.

The SmileGuard™ system combines the light-curable resin, for use with a scanner with design software, validated 3D printer and a curing unit. These components are used together during the additive manufacture of dental appliance splints/mouth guards. The light-curing resin is a proprietary composition of acrylate/methacrylate, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories and dental practices to make customized bite splints, using the 3D-printer. The resin is filled in lightproof 1 kg PE bottles labeled and offered together with a programmed RFID chip (referred to as TAG), which is required for use with the validated EnvisionTEC 3D printers. The TAG contains information identifying the resin: material, name and amount. The SmileGuard™ resin is an alternative material to heat-curing and auto-polymerizing resins.

The provided text describes the 510(k) premarket notification for a device named "SmileGuard™", a light-curable resin for fabricating orthodontic and dental appliances. The document is primarily focused on demonstrating substantial equivalence to a predicate device (KeyPrint® KeySplint Soft™) through comparative testing of material properties, rather than an AI-driven medical device requiring clinical performance studies directly involving AI.

Therefore, many of the requested fields regarding acceptance criteria, study design for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for AI models are not applicable to this specific device and the information provided. The document focuses on the physical and chemical properties of the resin, its biocompatibility, and manufacturing process.

Here's a breakdown of the provided information relevant to your request, with an explanation of why other aspects are not present:

Device Description:
SmileGuard™ is a light-curable resin used with a scanner, design software, validated 3D printer, and curing unit for the additive manufacture of dental appliance splints/mouth guards.

Intended Use:
Fabrication of orthodontic and dental appliances such as mouthguards, nightguards, and splints.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are not performance metrics in the sense of diagnostic accuracy (like sensitivity/specificity for AI), but rather material property specifications and biocompatibility requirements for the resin. The acceptance criteria are based on established ISO and ASTM standards for dental polymers and biocompatibility.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a laboratory testing program as outlined in Section VII of the 510(k) Summary.

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

• Sample Size: The document does not explicitly state the number of samples (e.g., number of test specimens) used for each physical property test (Tensile, Flexural, Impact, Hardness). It provides mean values and standard deviations, implying multiple samples were tested for each property.
• Data Provenance: The testing was conducted in a laboratory setting. No information about country of origin of data is provided beyond the manufacturer and regulatory consultant being based in Germany and the US respectively. The tests performed are prospective bench tests (physical property measurements and biocompatibility testing on newly manufactured resin samples).

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 is not a study involving human interpretation of data for "ground truth" (e.g., medical image reading). The "ground truth" for material properties is established by the results of standardized physical and chemical tests performed in a laboratory, and for biocompatibility by the results of in vitro and in vivo biological tests according to ISO standards. No human expert "adjudication" of these test results in the sense of diagnostic interpretation is mentioned or required.

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

• Not applicable. This type of adjudication is relevant for human expert consensus in diagnostic studies (e.g., radiology reads), not for laboratory material testing or biocompatibility assessments.

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 material for fabricating dental appliances, not an AI-driven diagnostic or assistive tool for human interpretation. Therefore, MRMC studies and assessment of human reader improvement with AI assistance are irrelevant.

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

• Not applicable. There is no standalone AI algorithm in the context of this device. The device is a material.

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

• The "ground truth" for this device's performance is derived from objective, quantitative measurements obtained through standardized laboratory tests (e.g., ISO, ASTM standards for material properties) and biological test results for biocompatibility (ISO 10993 series). It is not based on expert consensus, pathology, or outcomes data in the usual clinical sense.

8. The sample size for the training set:

• Not applicable. This is not an AI model requiring a training set.

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

• Not applicable. No training set for an AI model.

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E-Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns and temporary bridges in dental laboratories. The material is an alternative to traditional restorative dental material. E-Temp is intended exclusively for professional dental work. Fabrication of dental applications with E-Temp requires a computer aided and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression or in case of artificial teeth for dental prostheses the digital dental files based on manufacturer's data, a digital light processing (DLP) printer, and curing light equipment.

The E-Temp system combines a scanner with design software, the light-curable resin, a 3D printer and a curing unit. These components are used together during the manufacture of the customized temporary crowns or bridges. The light-curable resin is a proprietary composition of acrylates, methacrylates, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories to make the customized temporary crowns and bridges for patients who need restoration of their natural teeth. E-Temp is available in six different colors. The resin is packaged in lightproof 1 kg PE bottles along with a programmed RFID chip (referred to as TAG), which is required for use with the validated 3D printers. The TAG contains information identifying the resin material, name and amount. E-Temp resin is an alternative material to heat-curable and auto-polymerizable resins. EnvisionTECs Perfactory® 3D-Printer DLP models designed and validated for use with the E-Temp light cured resin are: EnvisionOne cDLM, with LED, Micro series, with LED, Vida Series, with LED, P4K Series, with LED, D4K Series, with LED.

This document is a 510(k) premarket notification for the dental device E-Temp, a light-curable resin for temporary crowns and bridges. It does not contain information about an AI/ML powered device. Therefore, I cannot extract the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or comparative effectiveness studies for an AI device.

The document primarily focuses on the substantial equivalence of the E-Temp resin to a predicate device, based on material properties, biocompatibility, and manufacturing processes, which are standard for dental materials.

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E-Dent 1000 is a light-curable resin indicated for the fabrication of:

• individual and fixed permanent full single crowns, permanent partial crowns in front and posterior area,
• individual and fixed single veneers,
• artificial teeth for dental prostheses, which are used for removable permanent full dentures,
• individual and removable monolithic full and partial dentures

in dental laboratories. The material is an alternative dental material. E-Dent 1000 is intended exclusively for professional dental work. Fabrications with E-Dent 1000 requires a computer aided and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression, or in case of artificial teeth for dental prostheses the digital dental files based on manufacturer's data, a digital light processing (DLP) printer, and curing light equipment.

The E-Dent 1000 system combines a scanner with design software, the light-curable resin, a 3D printer and a curing unit. These components are used together during the manufacture of the customized E-Dent 1000 restorative dental products.

The light-curable resin is a proprietary composition of acrylates, methacrylates, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories to make the customized temporary crowns and bridges for patients who need restoration of their natural teeth.

E-Dent 1000 is available in six different colors.

The resin is packaged in lightproof 1 kg PE bottles along with a programmed RFID chip (referred to as TAG), which is required for use with the validated 3D printers. The TAG contains information identifying the resin material, name and amount.

E-Dent 1000 resin is an alternative material to heat-curable and auto-polymerizable resins.

EnvisionTECs Perfactory® 3D-Printer DLP models designed and validated for use with the E-Dent 1000 light cured resin are:
• EnvisionOne cDLM, with LED
• Micro series, with LED
• Vida Series, with LED
• P4K Series, with LED
• D4K Series, with LED

The provided text describes a 510(k) premarket notification for a dental material (E-Dent 1000), not an AI/ML medical device. Therefore, a direct answer to the request regarding acceptance criteria and a study proving an AI/ML device meets them, including details like sample size for test sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, and training set details, cannot be extracted from the given document.

The document focuses on the substantial equivalence of the E-Dent 1000 resin to predicate dental materials based on physical and chemical properties, biocompatibility, and manufacturing processes, not on the performance of a software algorithm.

However, I can extract the relevant information about the non-AI device's performance testing and acceptance criteria as described in the document:

Here's the information about the E-Dent 1000 device's performance and acceptance criteria, adapted to the closest relevant sections of your request, noting where the information is not applicable to an AI/ML device:

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

The document states that testing was conducted to evaluate the performance of manufactured crowns, artificial teeth, veneers, and dentures according to specific ISO standards. The "acceptance criteria" are implied by compliance with these standards, and "reported device performance" is the statement that the device meets these requirements.

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

• Sample Size: Not explicitly stated for each test, but implied by the successful completion of testing according to ISO standards. Sample sizes for material testing are standard for these types of evaluations.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is a material test, not a patient data study.

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

• Not Applicable: This is a material science and biocompatibility study, not a study involving expert-established ground truth from images or clinical data. The "ground truth" is defined by compliance with established international standards for dental materials.

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

• Not Applicable: No human adjudication is involved in these laboratory material 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

• Not Applicable: This is not an AI/ML device.

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

• Not Applicable: This is not an AI/ML device.

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

• Type of Ground Truth: Established international standards for dental materials (e.g., ISO 10477, ISO 4049, ISO 7491, ISO 20795-1) for physical/mechanical properties, and ISO 10993 for biocompatibility.

8. The sample size for the training set

• Not Applicable: There is no "training set" as this is not an AI/ML device. For material development, formulation and process optimization would occur, but these are not referred to as "training sets" in this context.

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

• Not Applicable: See point 8.

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E-Denture Pro is a light-curable resin indicated for the fabrication of denture bases fabricated in dental laboratories for full removable dentures. The material is an alternative to traditional heat-curable and auto polymerizing resins. E-Denture Pro is intended exclusively for professional dental work. Fabrication of denture bases with E-Denture Pro requires a computer-aided and manufacturing (CAD/CAM) system that includes the following components: digital denture base files based on a digital impression, a digital light processing (DLP) printer, and curing light equipment.

The E-Denture Pro system combines a scanner with design software, the light-curable resin, a 3D printer and a curing unit. These components are used together during the manufacture of the customized denture base for the removable full denture. The light-curable resin is a proprietary composition of acrylates, methacrylates, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories and dental practices to make the denture bases for removable full dentures. The resin is offered in lightproof 1 kg PE bottles along with a programmed chip (referred to as TAG), which is required for use with the 3D printer. The TAG contains information identifying the resin material, name and amount. E-Denture Pro resin is an alternative material to heat-curable and auto-polymerizable resins. EnvisionTECs Perfactory® 3D-Printer models designed and validated for use with the E-Denture Pro light cured resin are: EnvisionOne cDLM, with LED Vida Series, with LED P4K Series, with LED D4K Series, with LED

The document is a 510(k) Summary for the EnvisionTEC E-Denture Pro, a light-curable resin for fabricating denture bases. The study outlined is a bench testing study comparing the E-Denture Pro to a predicate device and relevant standards, not a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable to this type of device and study.

Here's the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the requirements of DIN EN ISO 20795-1:2013, Dentistry – Base Polymers and ISO 10993 for biocompatibility. The reported device performance is compared with the predicate device (K191497, NextDent Denture 3D+).

Note: The document states that the testing "produced results that are similar to the predicate" and that "the noted differences... raise no new questions of safety and effectiveness." This implies the performance values for Flexural Strength, Secant Modulus, and Flexural Strain, while not identical, are considered acceptable by the FDA for substantial equivalence.

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

• Sample Size: The document does not specify the exact sample sizes (number of specimens or denture bases) used for each physical and chemical test.
• Data Provenance: The data is from laboratory testing conducted by EnvisionTEC, likely in Germany (based on the submitter's address). This is considered prospective data generation for the purpose of regulatory submission.

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

Not applicable. This is a materials science and engineering characterization study, not an expert-based diagnostic or classification study. The "ground truth" is established by the specified international standards (DIN EN ISO 20795-1:2013 and ISO 10993).

4. Adjudication method for the test set

Not applicable. The tests are quantifiable material property measurements against established standards, not subject to expert 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 is not an AI-assisted diagnostic device, nor a study involving human readers.

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

Not applicable. This device is a material (resin) used in a CAD/CAM system, not a standalone algorithm.

7. The type of ground truth used

The ground truth used for performance evaluation is based on:

• International Standards: DIN EN ISO 20795-1:2013 (Dentistry – Base Polymers) for mechanical and physical properties of denture bases.
• International Biocompatibility Standards: ISO 10993 for biological evaluation of medical devices.
• Comparison to a Legally Marketed Predicate Device: The performance is also benchmarked against the NextDent Denture 3D+ (K191497) to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set."

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

Not applicable (as there is no training set).

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EnvisionTEC's E-Guard is a light-cured resin. It is a polymer used to create removable structures for therapeutic restorations, i.e. bite guards/splints and occlusal night guard/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.

The E-Guard system combines a scanner with design software, the light-cured resin, a 3D printer and a curing unit. These components are used together during the manufacture of the dental appliance splint/bite guard. The light-curing resin is composed of acrylate/methacrylate, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories and dental practices to make customized bite splints, using the 3D-printer. The resin is offered in lightproof 1 kg PE bottles along with a programmed chip (referred to as TAG), which is required for use with the 3D printer. The TAG contains information identifying the resin material, name and amount. The E-Guard resin is an alternative material to heat-cured and auto-polymerizing resins.

The provided text describes the acceptance criteria and a study proving the substantial equivalence of the E-Guard device to a predicate device, VeriSplint.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "The requirements for flexural strength, flexural modulus, water solubility and water sorption content were met" by the E-Guard device, even though some reported values are quantitatively different from the predicate or general acceptance criteria. This suggests the criteria itself may have a range or different specific thresholds that were met. For instance, the predicate's bending strength is stated as "> 100 MPa", and the E-Guard's values (85.1 MPa, 79.4 MPa) are lower. However, the conclusion still states the requirements were met, implying that the specific ISO standard allows for this difference or the context of the comparison focuses on overall substantial equivalence rather than identical performance values in every aspect.

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

• Sample Size: For explicit physical properties like Bending Strength and Bending Modulus, the document mentions "Testing of 2 samples, same lot". The overall number of manufactured bite splints used for the performance evaluation according to DIN EN ISO 20795-2:2013 is not explicitly stated, beyond stating "Testing was conducted to evaluate the performance of a manufactured bite splint."
• Data Provenance: Not explicitly stated, but likely from internal laboratory testing conducted by EnvisionTEC GmbH, a German company ("D-45968 Gladbeck Germany"). The tests were performed according to ISO standards, which are international. It is a retrospective study in the context of this 510(k) submission, as the data was collected prior to the submission.

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

This information is not provided in the document. The ground truth for the physical and biocompatibility testing is based on established international standards (DIN EN ISO 20795-2:2013 and ISO 10993) rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

This information is not applicable as the 'ground truth' is determined by quantitative measurements against ISO standards for material properties and biocompatibility, not by expert review of individual cases requiring adjudication.

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 dental material, and the evaluation focuses on its physical and biological properties, not a diagnostic or interventional imaging tool that would typically involve human readers.

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

Not Applicable. The device is a light-cured resin used in an Additive Manufacturing process for dental appliances. It is a material, not a software algorithm, so "standalone" performance in the context of AI algorithms is not relevant. The performance evaluation is of the material itself and the manufacturing process.

7. The Type of Ground Truth Used

The ground truth used for performance validation is based on established international standards for dental materials:

• DIN EN ISO 20795-2:2013, Dentistry - Base Polymers - Part 2: Orthodontic base polymers: For flexural strength, flexural modulus, water solubility, and water sorption content.
• ISO 10993: For biocompatibility.

8. The Sample Size for the Training Set

Not Applicable. As a physical material evaluated against defined standards, there is no "training set" in the context of machine learning or AI models. The material's properties are inherent to its composition and manufacturing process, not learned from data in a training set.

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

Not Applicable. (Refer to point 8).

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