Search Results

Denture Base Resin is a light-curable polymerizable resin intended to be used for the fabrication of full and partial removable dentures. Fabrication of denture base Resin requires a digital denture file, 3D printer and post-curing unit.

Denture Base Resin is a liquid light-curable material. The product should be used in combination with the 3D printer. Printer and resin must be optimized to each other in order to get complete and precise printed parts. The 3D printer and the post-curing unit of SHINING3D make use of a light source to polymerize the Denture Base Resin.

I am sorry, but the provided text does not contain information about the acceptance criteria and study that proves the device meets the acceptance criteria in the format you requested, as it pertains to a medical device's AI/algorithm performance.

The document is a 510(k) premarket notification for a Denture Base Resin (a material used for making dentures). It focuses on:

• Substantial Equivalence: Comparing the new resin to an existing predicate resin based on material composition, intended use, manufacturing process, and various performance and biocompatibility tests for dental materials.
• Non-Clinical Performance Tests: These tests are for the physical and biological properties of the resin material itself, such as mechanical properties according to ISO 20795-1, color stability according to ISO 7491, biocompatibility according to ISO 10993-1 and ISO 7405, and shelf-life.
• No Clinical Study: The document explicitly states, "No clinical study is included in this submission."

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI/algorithm, nor can I answer questions about sample sizes for test sets, data provenance, ground truth establishment by experts, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in the provided text which describes a physical dental material, not an AI medical device.

Ask a specific question about this device

Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.

Fabrication of dental prosthetics with Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.

The Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need.

Denture Base resin is intended exclusively for professional dental work.

Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.

I am sorry, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter and summary for a denture base resin, focusing on the substantial equivalence to a predicate device through biocompatibility and bench testing.

Specifically, the document does not describe acceptance criteria for a study, nor does it detail a study that proves a device meets such criteria in the way you've outlined for AI/software-based medical devices.

The document describes material testing for a physical product (denture resin), not the performance of an algorithm or AI model. Therefore, information such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and how training ground truth was established, are not present.

The "performance data" mentioned in the document refers to:

• Biocompatibility Testing: According to ISO 10993-1, covering tests like Cytotoxicity, Genotoxicity, Acute Systemic Toxicity, Subchronic toxicity, Irritation, and Sensitization.
• Bench Testing: According to ISO 20795-1, covering tests like Ultimate Flexural Strength and Modulus, Water Sorption and Solubility, Residual Methyl Methacrylate Monomers, Homogeneity, Surface Characteristics, Shape Capability, Translucency, Polishability, Colour, Freedom from Porosity, Color Stability, Maximum stress intensity factor, Total fracture work, and Bonding to synthetic polymer teeth.

These are tests of the physical properties and biological safety of the material, not algorithmic performance.

Ask a specific question about this device

Denture Base Resin 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
•denture bases
Denture Base Resin is intended exclusively for professional dental work.

The Denture Base Resin is an alternative to traditional heat cured and auto polymerization resins. The resins are available in two (2) different colors ( white, red). Denture Base Resin can be used with PioNext D Series. PioNext D Series printers include a 3D printing system that utilizes Digital Light Process (DLP) technology, with automatic feeding process, and a UV LED (405nm) curing process. The dental appliance is then cured in the PioNext UV-02 curing chamber and sent back to the dentist for try-in and final adjustment.

I'm sorry, but this document does not contain the information required to answer your request. The provided text is a 510(k) premarket notification letter from the FDA regarding a "Denture Base Resin" device.

It does not provide details about acceptance criteria or a study proving that an AI/software-based device meets these acceptance criteria. Instead, it focuses on dental resin material properties and non-clinical performance tests, not AI or software performance.

Therefore, I cannot provide:

• A table of acceptance criteria and reported device performance for an AI/software.
• Sample sizes used for test sets or data provenance for AI/software.
• Number of experts or their qualifications for establishing ground truth for AI/software.
• Adjudication methods for AI/software test sets.
• Information about MRMC comparative effectiveness studies or effect sizes for AI assistance.
• Standalone performance of an AI algorithm.
• Type of ground truth for an AI/software.
• Sample size for training sets for an AI/software.
• How ground truth was established for training sets for an AI/software.

The document discusses "Denture Base Resin" and its properties, and confirms its substantial equivalence to predicate devices based on non-clinical performance tests related to dimensional stability, color stability, translucency, flexural strength, freedom from porosity, and water solubility. There is no mention of AI, machine learning, or software performance evaluation in this context.

Ask a specific question about this device

Glidewell™ 3DP Denture Base Resin is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

Glidewell™ 3DP Denture Base Resin, is a light-curable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates. Glidewell™ 3DP Denture Base Resin, is a light-cured methacrylic material with photo initiators that form a polymer during 3D printing. Glidewell™ 3DP Denture Base Resin is printed using digital light processing (DLP). The DLP printer and resin are optimized to each other in order to achieve complete and precise printed parts. The light source provided by the DLP printer (405nm wavelength), and the post-curing light box polymerize the resin which forms a hardened denture base. Once cured, Glidewell™ 3DP Denture Base Resin has the mechanical property that meets the performance criteria for Type 4: Light-activated materials as defined in the FDA-recognized consensus standard ISO 20795-1:2013 Dentistry - Base polymers - Part 1: Denture base polymers, including flexural strength, flexural modulus, water sorption and water solubility.

The subject device, Glidewell™ 3DP Denture Base Resin, has the same formulation and manufacturing process as the predicate device, Glidewell™ 3DP Denture Base Resin (K213765), which contains silver sodium hydrogen zirconium phosphate. In vitro studies on the subject device, Glidewell™ 3DP Denture Base Resin, demonstrated a reduction in the following microorganisms: Streptococcus mutans, Streptococcus mitis, Staphylococcus aureus, Escherichia coli, Klebsiella pneumonia, Candida albicans, Candida glabrata, Candida tropicalis, MRSA (Methicillin Resistant Staphylococcus aureus), VRE (Vancomycin Resistant Enterococcus).

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them, presented in the requested format.

It's important to note that this document is a 510(k) Summary, which is a regulatory submission for medical devices. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trial results. Therefore, some information typically found in a full clinical study report (like detailed sample sizes for training sets or expert qualifications for ground truth) may not be explicitly stated for components not directly studied in this submission. The "study" described herein refers primarily to the in vitro antimicrobial testing.

Acceptance Criteria and Device Performance

Glidewell™ 3DP Denture Base Resin is a Class II device (Product Code EBI, Regulation Number 21 CFR 872.3760). The primary focus of the additional testing in this 510(k) submission (K241493) seems to be the antimicrobial properties of the resin, as its physical properties are stated to be identical to the predicate device (K213765).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Antimicrobial Tests (Test Set): The specific number of samples (replicates) used for each microorganism in the in vitro tests (ASTM E2180-07 and ASTM E2647-13) is not explicitly stated in this summary. These are typically material tests on prepared resin samples, not patient-derived data.
• Physical Properties: Not explicitly stated as the data for the subject device is leveraged from the predicate device (K213765), implying prior testing was performed for the predicate.
• Data Provenance: The studies are in vitro laboratory tests conducted by the manufacturer or their contracted labs. The provenance is internal to the manufacturer (Prismatik Dentalcraft, Inc.) and is retrospective as it supports a 510(k) submission. No country of origin for data generation is specified beyond the company's location in Irvine, California, USA.

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

• Not Applicable. For these in vitro material and microbiology tests, "ground truth" is established by the standardized methods themselves (e.g., cell counts, optical density measurements, mechanical property testing according to ISO standards). This is not equivalent to establishing ground truth for AI algorithms based on expert interpretation of medical images. The tests measure objective physical and biological properties.

4. Adjudication Method for the Test Set

• Not Applicable. As these are in vitro laboratory tests measuring objective properties, an adjudication method among experts (like 2+1 or 3+1 for image reviews) is not relevant.

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 denture base resin, not an AI software intended to assist human readers (e.g., radiologists). Therefore, an MRMC comparative effectiveness study is not relevant to this submission. The summary explicitly states: "Clinical studies have not been conducted to demonstrate that the presence of silver sodium hydrogen zirconium phosphate in Glidewell™ 3DP Denture Base Resin results in improved clinical outcomes."

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

• Not Applicable. This is a material (resin) device, not an algorithm.

7. The Type of Ground Truth Used

• For Antimicrobial Tests: Ground truth is established by quantitative microbial culture methods (viable plate counts) as per ASTM E2180-07 and ASTM E2647-13. The "control samples of regular denture without antimicrobial agent" serve as the baseline for comparison.
• For Physical Properties: Ground truth is established by standardized mechanical testing procedures as per ISO 20795-1:2013.
• For Biocompatibility: Ground truth is established by standardized biological evaluation tests per ISO 10993-1:2018 and ISO 7405:2018.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of this device because it is a physical material, not an AI/ML algorithm that requires training data.

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

• Not Applicable. As there is no training set for an AI/ML algorithm.

Ask a specific question about this device

NextDent Jet Denture Base is a light curing resin intended for 3D printing of a full or partial denture base to form a denture. The product, when used in combination with NextDent Jet Denture Teeth can be used for 3D printing a removable full or partial denture. For dental professional use only.

NextDent Jet Denture Teeth is a light curing resin intended for the 3D printing of artificial teeth to form a denture, temporary crowns or bridges. The product, when used in combination with NextDent Jet Denture Base can be used for 3D printing a removeable full or partial denture. For dental professional use only.

NextDent Jet Denture resins are pre-mixed combinations of acrylate-based light-cure resins with pigments, polymerized via photo initiators in a 3D printer setting for the fabrication of full or partial denture bases and artificial teeth to form a denture and for the fabrication of temporary crowns or bridges. The resins must be used in combination with 3D Systems printers that support MultiJet Printing technology. Devices are produced in an automated additive manufacturing method where ultra-thin layers of photopolymer material are jetted onto a build tray. Immediately after being jetted, each photopolymer layer is cured by UV light. The process repeats layer by layer until the 3D part is complete. Upon completion the support material is removed, and the product is cleaned. When printing a denture base, bonding of artificial teeth to the denture base is possible to form a denture. The bonding agent instructions should be followed. Printed parts are finished using conventional dental methods and instruments.

The provided text is a 510(k) Premarket Notification from the FDA for "NextDent Jet Denture Base" and "NextDent Jet Denture Teeth". It describes the device, its intended use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices.

However, the provided text does not contain information related to an AI/ML device. Specifically, there is no mention of acceptance criteria for an AI algorithm, test set details, expert involvement in ground truth establishment, MRMC studies, or training set information. The testing described focuses on the mechanical and biocompatibility properties of the dental resins, adhering to ISO standards for dental materials.

Therefore, I cannot provide an answer that describes the acceptance criteria and the study proving an AI/ML device meets them based on the provided text. The questions posed in your prompt (e.g., sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types for AI, training set details) are relevant to AI/ML device evaluations but are not addressed in this document, as it pertains to a materials-based medical device.

Ask a specific question about this device

Denture Base Resin is used for the fabrication of removable dentures.

The Denture Base Resin mainly consist of denture base resin (powder), polymethyl methacrylate (PMMA), methyl methacrylate, ethylene glycol dimethacrylate, titanium dioxide, ferric oxide, iron oxide yellow and ferric tetroxide. The resin block is milled using the CAD/CAM technique to form the removable dentures. The product combines the prosthetic denture teeth with the denture base.

The provided document is a 510(k) premarket notification for a medical device called "Denture Base Resin." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness or safety through new clinical trials. Therefore, the information typically requested in your prompt regarding AI/ML device performance (e.g., acceptance criteria for a specific AI metric, human-in-the-loop performance, large test sets, expert ground truth adjudication) is not applicable to this submission.

This document describes a traditional dental material. The performance data presented are for material properties, not an AI/ML algorithm.

Here's why many of your detailed questions cannot be answered by this document:

• AI/ML Device: This is not an AI/ML device. It's a physical material used for fabricating dentures.
• Acceptance Criteria for AI Performance: The acceptance criteria are for physical material properties as defined by ISO standards, not for AI metrics like sensitivity, specificity, AUC, or F1-score.
• Sample Size for Test Set (AI): There's no AI test set. Instead, there are samples of the material tested for its physical and chemical properties.
• Data Provenance (AI): Not applicable. The "data" are laboratory measurements of material properties.
• Experts for Ground Truth (AI): Not applicable. Ground truth for material properties is established through standardized laboratory testing methods.
• Adjudication Method (AI): Not applicable.
• MRMC Study (AI): Not applicable. This refers to human reader performance with/without AI assistance for diagnostic tasks, which is irrelevant here.
• Standalone Performance (AI): Not applicable.
• Type of Ground Truth (AI): For this device, "ground truth" refers to the measured physical and chemical properties of the material against established standards (e.g., ISO, FDA guidance).
• Training Set (AI): Not applicable. This device is not developed using machine learning.
• Ground Truth for Training Set (AI): Not applicable.

Based on the provided document, here's what can be extracted regarding the "acceptance criteria" (which are performance specifications for the material) and its "study" (which are non-clinical bench tests):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the relevant ISO standards (ISO20795-1: 2013, ISO 4049: 2019, ISO 7491: 2000) and the comparison to the predicate device. The performance data demonstrate compliance with these standards and 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 for each bench test conducted (e.g., how many specimens for flexural strength). It generally states that "Performance testing were conducted to verify that the subject device met all design specifications." Specific sample sizes would be detailed in the full test reports, which are not part of this summary.
• Data Provenance: The tests are non-clinical bench tests performed in a laboratory setting, presumably by the manufacturer (Aidite (Qinhuangdao) Technology Co., Ltd) or a contracted lab. The country of origin for the data is implicitly China, as the manufacturer is based there. The data are retrospective in the sense that they were collected prior to the submission.

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

• Not applicable as this is not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" for material properties is established through standardized and validated laboratory testing procedures as per ISO standards.

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

• Not applicable. This concept applies to human reader studies often seen with diagnostic AI/ML devices, not material property 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:

• No, an MRMC comparative effectiveness study was not done. This is not an AI/ML device.

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

• No, a standalone algorithm performance study was not done. This is not an AI/ML device.

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

• The "ground truth" for this device's performance is derived from standardized laboratory measurement methods as described in the cited ISO standards (e.g., ISO20795-1 for denture base polymers, ISO 4049 for polymer-based restorative materials, ISO 7491 for color stability) and biocompatibility testing according to ISO 10993-1. Comparison is also made to the performance characteristics of the predicate device.

8. The sample size for the training set:

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

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

• Not applicable.

Ask a specific question about this device

The SprintRay High Impact Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair, of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.

Fabrication of dental prosthetics with High Impact Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.

The High Impact Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need.

High Impact Denture Base Resin is intended exclusively for professional dental work. SprintRay High Impact Denture Base Resin is offered in following shades/colors:

• Light Pink .
• Original Pink ●
• . Light Meharry
• Original Meharry .
• . Dark Meharry

High Impact Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.

The provided text describes the regulatory clearance for a dental resin, not an AI/ML powered device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and a study that proves the device meets those criteria for an AI/ML device.

However, based on the information provided for the SprintRay High Impact Denture Base, I can extract information related to its performance and equivalence to a predicate device. This information pertains to the physical and biocompatibility characteristics of the resin, not AI/ML performance.

Here's a summary of the performance data and equivalence to predicate devices, as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the industry consensus standard ISO 20795-1 and the biocompatibility testing standards. The reported device performance indicates that the SprintRay High Impact Denture Base functioned as intended and the outcomes were as expected against these standards.

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

• The document does not explicitly state sample sizes for each specific test (e.g., number of samples for flexural strength). It broadly states that "High Impact Denture Base was tested for conformity with the industry consensus standard ISO 20795-1." These standards typically specify sample sizes for their respective tests.
• Data provenance is not provided (e.g., country of origin, retrospective or prospective). The tests are laboratory-based bench and biocompatibility tests, not clinical studies involving patient data.

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

• Not applicable. The "ground truth" for this device is based on established scientific and engineering standards (ISO standards) and laboratory test results, not expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set:

• Not applicable. This concept is relevant for studies involving human interpretation or clinical data, which is not the case here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is not an AI/ML powered 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 powered device.

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

• The "ground truth" is defined by the performance specifications and methodologies outlined in recognized international standards for dental materials (e.g., ISO 20795-1 for physical properties, ISO 10993 for biocompatibility).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML powered device, so there is no "training set."

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

• Not applicable. As above, there is no "training set" for this type of device.

Ask a specific question about this device

SprintRay Denture Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair, of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material.

Fabrication of dental prosthetics with SprintRay Denture Base resin requires computer-aided design and manufacturing system that includes the following components not part of the device: oral casting impression, digital denture base file created in an optical impression system, 3D printer, and curing light equipment.

SprintRay Denture Base consists of a curable dental acrylate resin that is designed to be used in conjunction with a scanned 3D image of a patient's teeth, and 3D printer assembly, to locally manufacture out a dental appliance in dental offices based on the clinician's judgment of patient need.

SprintRay Denture Base resin is intended exclusively for professional dental work. SprintRay Denture Base resin is offered in following shades/colors:

• Light Pink
• Original Pink
• Light Meharry
• Original Meharry
• Extra Light Pink
• Medium Pink
• Dark Pink
• Dark Meharry
• Deep Dark Meharry

SprintRay Denture Base is designed to meet appropriate ISO standards for flexibility, sorption, and solubility to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions are provided on cleaning the material prior to providing it to a patient. Curing is performed with a UV lamp. The appliance is then cleaned, trimmed, and verified to fit in the dental office before the patient leaves.

The SprintRay Denture Base is a light-curable polymerizable resin used for the fabrication and repair of full and partial removable dentures and baseplates. The 510(k) summary provides details on the performance data, primarily bench testing, to demonstrate substantial equivalence to the predicate device, Dentca Denture Base (K143033).

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for SprintRay Denture Base are based on conformity with the industry consensus standard ISO 20795-1 for dental base polymers, as well as biocompatibility standards. The reported performance indicates that the device met these criteria.

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

The document does not explicitly state the sample sizes used for the biocompatibility or bench testing. It refers to "battery of testing" for both categories. The provenance of the data is implicit as part of a regulatory submission to the FDA, suggesting the tests were conducted by or for SprintRay Inc. The document does not specify the country of origin of the data or whether it was retrospective or prospective, but for bench and biocompatibility testing of a material, these distinctions are generally less relevant than for clinical studies involving patient data.

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

This information is not provided in the document. For bench chemistry and physical property testing, "ground truth" is typically established by certified laboratory equipment and validated test methods, not human expert consensus, so this question is not directly applicable in the usual sense for this type of device.

4. Adjudication method for the test set

Not applicable, as the performance testing described is primarily objective laboratory testing against established standards, not interpretation by human experts.

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. The SprintRay Denture Base is a dental material, not an AI-powered diagnostic or assistive device for human readers. No MRMC study or AI assistance is mentioned or relevant to this device's performance testing.

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

Not applicable. This device is a material, not an algorithm.

7. The type of ground truth used

For biocompatibility testing, the ground truth is established by the accepted biological responses and safety profiles defined in international standards (ISO 10993-1 and ISO 7405) for medical devices.

For bench testing, the ground truth is established by the specified material properties and performance requirements outlined in the industry consensus standard ISO 20795-1 for dental base polymers. The results of physical and chemical tests are compared against the limits and ranges defined by this standard.

8. The sample size for the training set

Not applicable. This device is a material, not a machine learning model, and therefore does not have a "training set" in the context of AI or similar algorithms.

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

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

Ask a specific question about this device

Denture Base Polymers is used for fabrication and repair of partial and full denture base for patients with missing teeth.

Denture Base Polymers contains powder and liquid, wherein the power is mainly composed of polymethyl methacrylate, and the main composition of the liquid is methyl methacrylate.

This document is a 510(k) premarket notification for a medical device called "Denture Base Polymers." It's a submission to the FDA (U.S. Food & Drug Administration) to demonstrate that the device is "substantially equivalent" to legally marketed predicate devices, meaning it's as safe and effective as a device already on the market.

However, the provided text does not describe a study involving "acceptance criteria" and "device performance" in the context of an AI/algorithm-based diagnostic or prognostic device. It's for a dental material (denture base polymers), which is a physical product, not a software or AI device.

Therefore, I cannot extract the information required for your request, such as a table of acceptance criteria for AI performance, sample sizes for test sets in an AI study, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document primarily focuses on:

• Chemical composition of the denture material.
• Technological characteristics (e.g., heat curing, self-curing).
• Physical and chemical properties that meet ISO standards (ISO 20795-1 for Dental base material).
• Biocompatibility testing (following ISO 10993 standards) to ensure it's safe for use in the human body.
• Comparison to predicate devices to demonstrate substantial equivalence for its intended use (fabrication and repair of partial and full denture base).

It explicitly states: "10. Clinical Performance Data: Not applicable. Clinical performance testing has not been performed on the subject device." This further confirms that no clinical studies in the sense of a performance study for an AI device were conducted or are being reported here.

Ask a specific question about this device

Glidewell™ 3DP Denture Base Resin is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 3DP Denture Base Resin is indication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

Glidewell™ 3DP Denture Base Resin is a light-cured resin for the fabrication of removable 3DP denture bases, including full and partial dentures, fabricated in a professional dental setting. The resin is compatible with DLP printers utilizing wavelengths of 405nm and is offered in G1 (standard pink), G3 (medium pink) and G4 (dark pink) shades formulated to match gingival tissue.

Here's a breakdown of the acceptance criteria and the study information for the Glidewell™ 3DP Denture Base Resin, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device