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The product is a self-curing composite for the fabrication of temporary crowns, bridges, inlays, onlays and veneers.

TempFIT Temporary Crown and Bridge Resin is a self-curing composite for the fabrication of temporary crowns, bridges, inlays, onlays and veneers. The mixing ratio, based on volume, base paste: catalyst paste =1:1 or 10:1. TempFIT Temporary Crown and Bridge Resin is delivered in a bio-cartridge. The curing mechanism between methacrylates is self-curing, which fundamentally belongs to free radical polymerization in reaction principle. Free radical polymerization typically occurs in unsaturated molecules containing double bonds. Both methacrylate resins in TempFIT Temporary Crown and Bridge Resin and silane coupling agents on filler surfaces contain numerous carbon-carbon unsaturated double bonds. When the two-component system is mixed, a redox reaction generates abundant free radicals that initiate the polymerization of these double bonds.

This FDA 510(k) clearance letter is for TempFIT Temporary Crown and Bridge Resin. It addresses the substantial equivalence of this device to a legally marketed predicate device (Luxatemp Ultra/Star, K101710).

However, this document does not describe the kind of AI/ML device study that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, and the use of expert readers for ground truth establishment. Instead, it focuses on the equivalence of a dental biomaterial product based on its physical, chemical, and biological properties.

Therefore, I cannot directly extract the detailed information requested regarding acceptance criteria and a study proving device performance in the context of an AI/ML medical device. The document describes a non-clinical testing approach for a dental material.

Here's how I can address your request based on the provided text, while highlighting the limitations:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for a Dental Material):

Study Details (Non-Clinical for a Dental Material):

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

   • The document mentions "test results demonstrated the qualification and substantial equivalence." However, it does not specify the sample sizes of the materials tested for each physical property.
   • Data Provenance: The tests were performed according to ISO 10477 and Internal standard SOP of the company (HUGE SOP). Given the submitter's location (Rizhao City, China), the testing was likely conducted in China. The study is a non-clinical, laboratory-based performance test, not involving patient data.

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

   • Not applicable in this context. The "ground truth" for chemical and physical properties are established through standardized laboratory measurement techniques as per ISO standards and the company's internal SOPs, not through expert human interpretation in the way AI/ML ground truth is established.

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

   • Not applicable. This is a non-clinical material test, not a subjective human-reading assessment.

4. 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 type of study is relevant for AI-assisted diagnostic devices. This submission concerns a dental biomaterial.

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

   • Not applicable. This is not an algorithm-based device.

6. The type of ground truth used:

   • The "ground truth" for the physical and chemical properties of the temporary crown and bridge resin are the established measurement protocols and thresholds defined by ISO 10477 and the company's internal SOPs. These are objective, quantitative measurements (e.g., MPa for flexural strength, µm/mm³ for water sorption).

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set. The "development" of the material would involve chemical formulation and iterative testing, but not a "training set" in the computational sense.

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

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

In summary, the provided FDA clearance letter demonstrates a material's safety and effectiveness through adherence to established material standards and comparison to a predicate device, rather than through an AI/ML performance study.

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Resin for Temporary Crown & Bridge is indication of temporary dental restorations in conjunction with extra-oral curing light equipment. Duration is less than 30 days in oral environment.

The Resin for Temporary Crown & Bridge is made by Methacrylate Oligomer based on the Urethane Acrylate Oligomer with 0.01~0.1wt% inorganic filler. It has stored in a brown 1000ml of HDPE bottle. It contains materials with colors of A2 based on the shade guide. This Product is a liquid photo-curable material that is polymerized by UV laser at 405nm. It can be used to make a tooth model with a photo-curable polymer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (405nm) by the photo-initiator contained in the resin. Curing in a 3D printer is related to the conditions of the printer equipment, and is typically 0.1 to 0.010mm in thickness, and is output at a resolution of 0.1 to 0.03 mm on the x, y axis. This device should use ZENITH 3D Printer equipment using UV light source of Dentis Co., Ltd., and it is possible to produce three dimensional printed matter by curing lamination step by step a thicknesses of 100, 50 and 16um.

The provided text is a 510(k) Summary for a medical device called "Resin for Temporary Crown & Bridge." It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for the device itself.

Based on the provided text, here's what can be extracted and what cannot:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance data. Instead, it mentions that "Performance testing confirmed the Resin for Temporary Crown & Bridge demonstrated equivalent or better performance to the predicate device or acceptance criteria referred to ISO 10477." This implies that ISO 10477 serves as the acceptance criteria for certain performance aspects, and the device met or exceeded them without providing specific values.

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

• Sample Size: Not specified.
• Data Provenance: Not specified, but the testing was "non-clinical testing" conducted to validate the product against the company's specified design requirement.

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

This information is not applicable and not provided. The study conducted was non-clinical testing focused on material properties and biocompatibility, not human interpretation or diagnostic accuracy.

4. Adjudication method for the test set:

Not applicable. There was no human interpretation involved in establishing ground truth for this type of non-clinical 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 device is a material for dental restorations, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used:

For the non-clinical testing, the "ground truth" was established by standards and internal company specifications. Specifically:

• Biocompatibility was evaluated based on ISO 10993-3, EN ISO 10993-5, EN ISO 10993-10 and EN ISO 10993-11.
• Performance specifications (e.g., compressive & tensile loads, hardness, water sorption, solubility) were compared to the predicate device or acceptance criteria referred to ISO 10477.

8. The sample size for the training set:

Not applicable. This device is a material, not a machine learning model requiring a training set.

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

Not applicable. No training set was used.

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Evadyne® is a light cured single-component material for the temporary restoration of crowns, bridges, or similar dental prostheses. Evadyne is intended for the general dental patient population.

NeoDental Chemical Products, Inc, (NeoDental) wishes to submit their Evadyne® Temporary Crown and Bridge Resin for 510(k) clearance. Evadyne®, (shown in Figure 1) is a yellowish translucent, light-cured temporary restoration material for direct filling. After curing, Evadyne can be removed in one piece when the permanent restoration is to be placed. Evadyne® is packaged as a multiple use syringe, with new tips being attached for each patient. The syringe can be used until empty. The syringe is kept capped between uses and is fitted with a new tip just prior to use. The syringe is cleaned with an alcohol wipe before and after use.

The provided document is a 510(k) Summary for a dental device called "Evadyne Temporary Crown and Bridge Resin". It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the format requested (e.g., diagnostic accuracy metrics like sensitivity, specificity, or AUC).

Instead, the document focuses on:

• Device Description and Intended Use: Explaining what the Evadyne resin is and how it's used.
• Substantial Equivalence to a Predicate Device: Comparing Evadyne to Fermit-N (K934978) based on intended use, indications, and technological characteristics. The argument for substantial equivalence relies on them having similar applications, mechanisms of polymerization, and general properties, while acknowledging some differences in composition, flow, and flexural strength.
• Non-Clinical Test Data (Biocompatibility): This section details the biocompatibility evaluation, primarily through referencing recognized consensus standards (ISO 10993-1) and listing specific biological tests conducted (Cytotoxicity, Sensitization, Genotoxicity, Irritation) in 2001-2002 by Covance Lab. It also mentions that the main ingredient (UDMA) and filler (fluoroaluminosilicate glass) are widely used and have a history of safe use, and that 76,000 units have been sold since 2005 without reported incidents.
• Claims of Equivalence, not Performance Targets: The document concludes that Evadyne is "substantially equivalent" to the predicate device, not that it meets specific quantitative performance targets or acceptance criteria in a comparative study against a pre-defined threshold.

Therefore, I cannot populate the requested table or answer most of the questions because the necessary information (acceptance criteria, device performance metrics, study design for accuracy, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance data) is not present in the provided text.

The closest information related to "acceptance criteria" is the device's conformance to biocompatibility requirements according to ISO 10993-1 and the fact that "Results were found to conform to requirements (see section 15)," but the specific numerical acceptance criteria for these biological tests are not detailed here. The "reported device performance" is simply the claim of being "substantially equivalent" and having an uneventful safety record over several years.

Summary of what cannot be provided from the text:

1. Table of acceptance criteria and reported device performance: Not available. The document discusses "substantially equivalent" to a predicate, and conformance to biocompatibility standards, but no quantitative performance metrics or specific acceptance criteria are listed.
2. Sample size for the test set and data provenance: Not applicable as it's not a performance study measuring accuracy. Biocompatibility tests would have their own sample sizes (e.g., guinea pigs for sensitization), but these are not for device performance against a diagnostic target.
3. Number of experts used to establish ground truth & qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not conducted or reported.
6. Standalone performance study: No such study described or reported.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable (no AI/ML involved).
9. How ground truth for the training set was established: Not applicable.

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"Self Cure Temporary Crown and Bridge Material" is indicated for the fabrication of temporary crown, partial crown, inlay, onlay and/or bridges.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Self Cure Temporary Crown and Bridge Material." This type of document does not typically contain the detailed information required to describe acceptance criteria and the specifics of a study proving a device meets those criteria, especially for software-based or AI/ML devices.

The 510(k) letter primarily states that the device is substantially equivalent to a predicate device and is intended for the fabrication of temporary crowns, partial crowns, inlays, onlays, and/or bridges.

Therefore,Based on the provided document, I cannot extract the information required to populate the table and answer the questions regarding acceptance criteria and the study details. This document is a regulatory approval letter, not a study report.

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Pulpdent Temporary Crown and Bridge Material is used by the dental professional to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Pulpdent Temporary Crown and Bridge Material is a dual-cure, glass-filled, resin composite used by the dental professional to make a temporary prosthesis, such as a crown or bridge, to be used until a permanent restoration can be fabricated.

The provided document is a 510(k) Premarket Notification for the Pulpdent Temporary Crown and Bridge Material. It does not contain a study with acceptance criteria and device performance metrics in the format requested.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices already on the market, which is a different regulatory pathway than providing specific performance metrics against pre-defined acceptance criteria from a clinical or technical study.

Here's why the requested information cannot be fully extracted from this document:

• No specific acceptance criteria: The document doesn't list quantitative or qualitative acceptance criteria that the device had to meet through a dedicated study. Its primary claim is substantial equivalence to existing devices.
• No reported device performance data from a specific study: The document states that the device is "substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products." It also references general usage over 20 years for similar materials. However, it does not present new performance data from a study conducted specifically for the Pulpdent Temporary Crown and Bridge Material against pre-defined criteria.
• No information on sample size, ground truth establishment, expert qualifications, or adjudication methods: Since no specific performance study is detailed, these related parameters are not present.
• No mention of AI assistance or MRMC studies: The device is a dental material, and the document predates the widespread regulatory consideration of AI in medical devices, so these are not applicable.

Summary of what can be inferred or directly stated from the document regarding "acceptance" for regulatory purposes:

The "acceptance" in this context refers to the FDA's determination of substantial equivalence to legally marketed predicate devices, which allows the device to be marketed.

Acceptance Criteria for Regulatory Approval (Substantial Equivalence):

Information Not Found / Not Applicable (based on the provided document):

1. Sample size used for the test set and the data provenance: Not applicable as a specific performance study with a test set is not detailed. The substantiation relies on equivalence to existing devices and broad general usage data for similar materials.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. 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 device is a dental material, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: For the purposes of substantial equivalence, the "ground truth" is largely assumed by the historical safety and effectiveness of the predicate devices and the general class of materials. No specific new ground truth for this device is established in this document.
7. The sample size for the training set: Not applicable. The device is a material, not a machine learning algorithm.
8. How the ground truth for the training set was established: Not applicable.

In conclusion, the document serves as a regulatory submission (510(k)) demonstrating substantial equivalence, not as a detailed technical report of a performance study against specific acceptance criteria.

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Temporary CROWN AND BRIDGE Resin is indicated for use as a temporary restorative material for crown and bridge, inlay, and/or onlay restorations.

Cosmedent TEMPORARY CROWN AND BRIDGE RESIN is a self-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers. These materials have sufficient physical properties to function in the oral cavity for up to 90 days and have esthetic qualities that mimic natural tooth appearance.

The provided text describes a 510(k) submission for a medical device, a Temporary Crown and Bridge Resin. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for proving new performance against acceptance criteria through a clinical study of the type usually associated with AI/software devices. Therefore, many of the requested points related to AI/software performance studies are not applicable to this document.

However, based on the information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" in this context are the physical and mechanical properties of the predicate device (Luxatemp) that the applicant device (Cosmedent TEMPORARY C&B Filling Material) aims to be substantially equivalent to. The reported performance is the measured properties of the Cosmedent device.

2. Sample size used for the test set and the data provenance: Not applicable. This document pertains to material properties testing, not a clinical study with a "test set" in the context of AI/software or diagnostic performance. The testing would have been conducted in a laboratory setting. No information on the number of samples tested for the material properties is provided.

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 like compressive strength is established through standardized laboratory testing methods, not expert consensus.

4. Adjudication method for the test set: Not applicable. Material properties are measured objectively.

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/software device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/software device.

7. The type of ground truth used: For the material properties (compressive strength, flexural strength, percent filler by weight, radiopacity), the ground truth is established through objective laboratory measurements following established standards for dental materials.

8. The sample size for the training set: Not applicable. This is not an AI/software device with a training set.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/software device.

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TEMPORARY CROWN AND BRIDGE MATERIAL is indicated for direct fabrication of TEMFORANT CROWN THD BRIDGE nlays, crowns or bridges used in indirect restorative procedures.

The TEMPORARY CROWN AND BRIDGE MATERIAL is a two-component, methacrylate-based material. The volume mix of this automixed material is a 1:1 ratio. The unit dose delivery system matchui. "The votential risks associated with asepsis and the need for disinfection.

I am sorry, but the provided text from the K060293 document primarily discusses the regulatory approval (510(k) summary) rather than a study detailing acceptance criteria and device performance. The document describes the device, its intended use, and technological characteristics, and then proceeds with the FDA's clearance letter.

There is no information within the provided text that describes:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or training set.
• Data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for a training set was established.

The document focuses on demonstrating substantial equivalence to a predicate device (Luxatemp Automix, K924830) based on material composition and intended use, rather than presenting a performance study with detailed statistical results against specific acceptance criteria.

Therefore, I cannot fulfill your request for details on acceptance criteria and a study proving the device meets them based on the provided input.

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Flex Span Temporary Crown & Bridge Material is intended to be used to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Flex Span Temporary Crown & Bridge Material is to be used on dental patients in a dental office environment. Flexspan has the capability of being dual-cured, ic, visible light cure and/or self-cured. The optional light curing ability will give the dentist a choice of not waiting too long for the material to fully cure, if there is a need to fasten the hardening of the material.

The provided text does not contain information regarding an acceptance criteria table or the results of a study to prove device performance. The document is a 510(k) summary and FDA clearance letter for a dental material, not a clinical study report. Therefore, I cannot generate the requested table and study details.

The 510(k) summary states that "Cytotoxicity test has been performed" and that "all the ingredients used in the formulation are widely used in dental industry and in our own composite compositions, which are known to be safe and effective." However, it does not provide specific acceptance criteria, test results, sample sizes, or details about the ground truth or expert involvement as requested.

The FDA letter confirms that the device is substantially equivalent to a predicate device (Temphase, K020092), meaning it has the same intended use and similar technological characteristics, and that it is as safe and effective as the predicate. This substantial equivalence determination is the basis for its market clearance, but it does not involve the detailed criteria or study types requested in your prompt for an AI-based medical device.

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Temporary crown and bridge material

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a "Temporary Crown and Bridge Material." This type of document is a regulatory approval for a medical device and does not contain information about acceptance criteria, study designs, sample sizes, or ground truth establishment for an AI/ML powered device.

Therefore, I cannot provide the requested information based on the given input. The document is for a traditional medical device, not an AI/ML one, and thus does not include the details of an AI/ML performance study.

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