Search Results

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.

Ask a specific question about this device

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).

Ask a specific question about this device

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).

Ask a specific question about this device

Dentca Denture Base is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-cured and auto polymerizing resins.

Fabrication of dental prosthetics with Dentca Denture Base requires a computer-aided design and manufacturing (CAD/CAM) system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, stereolithographic additive printer, and curing light equipment.

Dentca Denture Base is a photosensitive resin intended to fabricate removable dentures in a CAD/CAM additive printing process.

The Dentca polymer is a viscous solution of the following compounds: methacrylate-based resins, a photoinitiator that activates at 405 nm visible (blue) light, an inhibitor, and pigments. It comes in two sizes, large and small bottles (see photo at right). It is a Type 4 (lightactivated) acrylic resin as classified by ANSI/ADA Specification No. 12.

The denture fabrication process begins with a traditional casting impression of the oral region in the dentist office. This impression is sent to a dental lab for conversion to digital image in an optical impression system. The denture base is then made layer-by-layer in a stereolithographic laser printer. After attachment of preformed plastic teeth, the denture is cured in a light chamber, and, lastly, sent back to the dentist for try-in and final adjustment.

The provided text describes a submission for a dental device, "Dentca Denture Base," for FDA 510(k) clearance. This device is a photosensitive resin used in a CAD/CAM additive printing process to fabricate removable dentures. The key aspect of the submission, from a performance data perspective, is demonstrating that the new manufacturing method (3D printing) yields a product that is substantially equivalent to existing, manually fabricated denture bases.

Based on the provided text, here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Dentca Denture Base" are primarily based on established industry consensus standards for dental materials, specifically ISO 20795-1 (Dentistry - Base polymers - Part 1: Denture base polymers). While the document doesn't explicitly list "acceptance criteria" in a go/no-go format, it presents key performance specifications derived from this standard that the device was tested against.

Note: The document states "Dentca Denture Base was tested for conformity with the industry consensus standard ISO 20795-1," implying that the reported values meet or exceed the requirements of this standard for these properties.

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

The document does not explicitly state the sample size used for the bench testing (flexural strength, modulus, water sorption, water solubility, residual monomer). It only mentions that these tests were conducted.

Regarding data provenance:

• The data is generated from bench testing of the Dentca Denture Base material.
• The origin of the data (country, specific lab) is not specified, but the applicant (Dentca, Inc.) is based in Los Angeles, CA, USA.
• The testing is inherently prospective as it involves manufacturing and testing samples of the new device.

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

This submission is for a material (denture base resin), not an imaging or diagnostic device requiring expert interpretation of results. Therefore, the concept of "ground truth" established by experts in a concensus fashion (like for medical image analysis) is not applicable here. The ground truth for the material properties is established by the standardized measurement methods outlined in ISO 20795-1.

4. Adjudication Method for the Test Set

As this is bench testing of material properties against a standard, there is no adjudication method in the traditional sense (e.g., 2+1, 3+1). The "results" are quantitative measurements (e.g., 90.2 MPa for flexural strength) obtained through standardized laboratory procedures.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and effect size

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic or classification AI devices where human performance with and without AI assistance is being evaluated. This submission is for a dental material and its manufacturing process, not a diagnostic tool.

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

This question is not directly applicable as the device is a material, not a software algorithm. However, the performance metrics (flexural strength, modulus, etc.) are essentially "standalone" measurements of the material's physical properties. The device itself (the resin) performs its function (forming a denture base) independently of human "performance" in the analytical sense.

7. The Type of Ground Truth Used

The ground truth for the performance of the Dentca Denture Base is based on standardized, objective physical and chemical measurements as defined by ISO 20795-1. For biocompatibility, the ground truth is adherence to established biological safety standards (ISO 10993-1). This is not "expert concensus," "pathology," or "outcomes data" in the typical clinical study context for diagnostic devices.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning or AI models. This submission is for a physical material, not an AI model that learns from data. Therefore, there is no training set in this context. The manufacturing process is based on controlled chemical formulations and physical processes.

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

As there is no "training set" for this material, this question is not applicable. The "ground truth" for the material's properties is derived from the scientific principles and established testing methodologies outlined in the ISO standards, ensuring the material meets the necessary performance and safety criteria for its intended use.

Ask a specific question about this device