Search Results

CHROMA PRINT PREMIUM REGULAR AND FAST SET:
Indications:
Chroma Print Premium is indicated for total or partial impressions of dentate or edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.

HYDRO PRINT PREMIUM REGULAR AND FAST SET
Indications:
Hydro Print Premium is indicated for total or partial impressions of dentate or edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.

PERFIL PRO
Indications:
Perfil Pro is indicated for total or partial impressions of dentate and edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.

PERFIL PRO CHROMA
Indications:
Perfil Pro Chroma is indicated for total or partial impressions of dentate and edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.

PERFIL PRO +
Indications:
Perfil Pro+ is indicated for total or partial impressions of dentate and edentulous mouths in the fabrication of complete and partial removable dentures, orthodontic study models, and impressions for the manufacture of single and multiple restorations, crowns, and fixed bridges.

Device Description – Principle of Operation
The Vigodent Alginate Impression Materials are irreversible hydrocolloid powders intended to be mixed with water to form a paste that sets by gelation. The material is placed in a standard dental impression tray and introduced into the patient's oral cavity to capture the anatomical details of teeth and soft tissues. Once set, the impression is removed from the mouth and poured with dental gypsum to obtain a working model.

Conditions of Use
The products are used in dental clinics and laboratories for total or partial impressions in the fabrication of study models, provisional prostheses, orthodontic appliances, and other preliminary dental applications. The device directly contacts the oral cavity tissues for a short duration (minutes) and does not remain in the body.

Interaction with Patient and Other Devices
The alginate material only interacts with oral tissues during impression taking and does not require any surgical procedure. The material interfaces with standard dental trays and dental gypsum products, with which it is compatible. No electronic components, implants, or additional medical devices are involved.

N/A

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JET BITE & JET BLUE BITE are intended for the registration of occlusion in cases where relationship between the relative positions of maxilla and mandible is required.

Jet Bite and Jet Blue Bite are two component impression materials based on vinylpolysiloxanes used for the registration of occlusion between the maxilla and mandible. Jet Bite and Jet Blue Bite are mixed during application and applied directly to the teeth, after which the mandible is moved into centric occlusion making an impression.

The provided document (FDA 510(k) Clearance Letter - K250969) is for dental impression materials (Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast). Unfortunately, this document does not describe a study involving an AI/software device that requires intricate ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies.

The "Acceptance Criteria and Study" section in the document refers to performance testing for the physical properties of the impression material based on ISO 4823 standards, not an AI model's performance.

Therefore, I cannot fulfill your request for an AI device's acceptance criteria and study details based on the provided text. The document focuses on the substantial equivalence of a physical dental impression material to a predicate device, as opposed to the validation of a software algorithm.

If you have a document describing the validation of an AI/software device, I would be happy to analyze it against your request.

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An addition-cure vinyl polysiloxane dental impression material that is used for all crown and bridge, edentulous, orthodontic and implant impression techniques.

The product is a kind of addition-cure silicon rubber impression material composed of vinyl polysiloxane and various fillers with neutral smell and applicable to impression in dentistry. This product is mainly composed of a matrix and a catalyst. The matrix is mainly composed of polydimethylsiloxane, vinyl silicone oil, methyl hydrogen polysiloxane, silica dioxide, ,calcium carbonate, and colorants. The catalyst is mainly composed of polydimethylsiloxane, silica dioxide, calcium carbonate, platinum catalyst, and colorants.

The provided document is a 510(k) summary for a medical device called "Elastic Impression Material." It details the comparison with a predicate device and includes information on testing performed.

Here's an analysis to extract the requested information:

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

The document references ISO 4823:2021 for device effectiveness. Without the full standard or more specific details from the submission, the exact acceptance criteria for each parameter as defined by ISO 4823 cannot be fully detailed here. However, the document states: "The product submitted for inspection adopts Type 0 type product. which is based on the requirements of the ISO4823 standard, which divides this product into 0, 1, 2 and 3 type products, and the difference between these 4 types is mainly in the difference of 'consistency' index, and its chemical properties and biological evaluation requirements are consistent, and the Type 0 silicone rubber with the largest consistency is fully representative."

This implies that the device was evaluated against the requirements for a "Type 0" elastic impression material as per ISO 4823. The performance is reported as meeting these requirements, which leads to the conclusion of substantial equivalence.

For Biocompatibility, the device was tested according to ISO 10993 standards. The acceptance criteria for these would be specific to each test (e.g., absence of irritation, cytotoxicity, sensitization). The reported performance is that the device "has been verified in accordance with the above FDA recognized standards."

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

The document does not explicitly state the sample sizes used for the non-clinical tests (ISO 4823 or ISO 10993). It only mentions that the device "was tested." The data provenance is not specified beyond the fact that the tests were conducted for Beijing OKVD Biological Technology Ltd. in China. Given these are physical/chemical and biocompatibility tests, they are typically conducted in a laboratory setting, not on patient data. No clinical tests were performed, so concepts like retrospective/prospective clinical data do not apply.

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)

This question is not applicable. The evaluations performed are non-clinical (device effectiveness and biocompatibility) and rely on objective measurements against ISO standards. There is no "ground truth" established by experts in the context of clinical interpretation for this type of device.

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

This question is not applicable as there is no clinical data or expert review process described for the test set.

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 MRMC comparative effectiveness study was done. This device is an impression material, not an AI software or a device that requires human interpretation of outputs.

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

This question is not applicable. The device is a physical impression material, not an algorithm.

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

For device effectiveness (ISO 4823) and biocompatibility (ISO 10993): The "ground truth" is established by the specified requirements and test methodologies within the internationally recognized ISO standards themselves. These standards prescribe objective measurements and criteria, rather than subjective expert consensus or pathology.

8. The sample size for the training set

This question is not applicable. The device is a physical impression material, not an algorithm that requires a training set.

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

This question is not applicable. The device is a physical impression material, not an algorithm that requires a training set.

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Speedex putty/putty soft

• Primary impression in the putty-wash Impression technique
• Pick-up impression in the simultaneous mixing technique
• Impressions for study models, orthodontic models, keys and protective isolation of teeth during fitting of prostheses
  Speedex light body
• Correction material for the correction impression technique
• Syringe material for the two-phase impression technique
• Impression material for relining
  Speedex medium
• Complete and partial prosthetics, correction material for the correction impression technique
• Monophase impression technique, simultaneous mixing technique
• Liner impression material
  Speedex Universal Activator
• Activator for Speedex putty soft; Speedex light body; Speedex medium, for creating dental impressions

Speedex is two-component impression material based on polysiloxanes. Speedex is intended for the recording of the current physical situation in a patient's mouth for the purpose of repairing, reshaping or replacing the patient's teeth. After mixing of a base and activator, the Speedex Materials form pastes which are used individually or in combination as antal impression material, usually together with a standard commerical or individual impression tray, using conventional impression techniques.

The provided text is a 510(k) premarket notification letter and summary for a dental impression material named "Speedex." This document does not describe an AI/ML-based medical device. Therefore, a study proving an AI device meets acceptance criteria, an MRMC study, or information about training and test sets for an algorithm, as requested in the prompt, are not applicable and not present in the provided text.

The document discusses the substantial equivalence of the Speedex dental impression material to a legally marketed predicate device ("PRESIDENT The Original"). Acceptance criteria and performance are outlined in the context of non-clinical performance testing for material properties, rather than AI/ML model performance.

Here's an analysis of the provided information relevant to the material's acceptance criteria and study, as much as possible given the context:

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

The document states: "Performance testing as was conducted to verify that the device complies with the requirements of ISO 4823:2021, and the same testing was carried out on the predicate device to help establish substantial equivalence. These tests include consistency, working time, detail reproduction, linear dimensional change, compatibility with gypsum, elastic recovery, and strain in compression."

While the specific numerical acceptance criteria and reported performance values are not explicitly provided in tables, the document implies that the Speedex device met the requirements of ISO 4823:2021 for these properties. The "Summary & Conclusions" section states: "Based on the non-clinical performance data, the proposed device Speedex is as safe, as effective and performs as well as the predicate Device PRESIDENT the Original." This statement confirms that the device did meet its performance requirements to demonstrate substantial equivalence.

As the exact table is not in the text, it cannot be constructed, but the types of criteria are listed.

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

For non-clinical performance testing of a material, "sample size" typically refers to the number of specimens tested for each property (e.g., number of impression material samples tested for linear dimensional change). This information is not provided in the document.

Data provenance (country of origin, retrospective/prospective) is not applicable in the context of material property testing as described.

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

This concept is not applicable as the testing is for fundamental material properties against an ISO standard, not for medical image interpretation or diagnostic performance involving expert consensus.

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

This is not applicable for 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:

This is not applicable as the device is a dental impression material, not an AI-based diagnostic tool.

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

This is not applicable as the device is a dental impression material, not an AI algorithm.

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

The "ground truth" for this device's performance is compliance with ISO 4823:2021 standards for dental impression materials, and comparison to the predicate device's performance for substantial equivalence. No patient outcomes data or expert consensus on a diagnostic task is used.

8. The sample size for the training set:

This concept is not applicable as this is a physical material, not an AI model requiring a training set.

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

This is not applicable as this is a physical material, not an AI model.

In summary, the provided document pertains to a traditional medical device (dental impression material) and its non-clinical performance testing against an international standard (ISO 4823:2021) to establish substantial equivalence. The detailed questions about AI/ML acceptance criteria, ground truth, and study designs for AI (like MRMC or standalone performance) are not relevant to this type of device and thus not present in the text.

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Chemi-SiL (HB, MB, LB, LBS) - Crown and bridge impression, inlay and onlay impressions

Chemi-SiL Bite-Blu - Impression of the occlusal surface

Chemi-SiL of silicone impression materials are hydrophilic impression materials based on polyvinylsiloxane and it is used for impression of teeth or gingiva. It consists of three different consistencies (heavy body, light body, bite registration material) according to ISO 4823. And it is supplied base and catalyst in contrasting color. Each product is consisted of 1:1 base and catalyst component, packaged in two 50 mL catridges.

This document is a 510(k) Premarket Notification from B&E Korea Co., Ltd. for their dental impression materials, Chemi-SiL (HB, MB, LB, LBS) and Chemi-SiL Bite-Blu. The key focus of this notification is to demonstrate substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Device Performance:

The primary method for demonstrating acceptance criteria and performance is through non-clinical testing based on recognized international standards, specifically ISO 4823 for impression materials and ISO 10993 for biocompatibility. The acceptance criteria are the performance requirements specified by these standards and the reported values of the predicate devices. The device performance is the measured performance of the Chemi-SiL products.

Here's a table summarizing the acceptance criteria (defined by ISO standards and predicate device performance) and the reported device performance for Chemi-SiL. Note that the document compares the subject devices to two different predicate devices based on their specific uses.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical testing based on referenced standards (ISO 4823, ISO 7405, ISO 10993). This implies laboratory-based, controlled experiments rather than a "test set" of patient data in the typical sense of AI/ML models.

• Sample Size: The specific sample sizes for each physical property test are not explicitly stated (e.g., number of specimens tested for consistency). However, compliance with ISO standards usually implicitly requires a minimum number of samples for statistically valid results.
• Data Provenance: The data is generated from prospective laboratory testing of the new device (Chemi-SiL HB, MB, LB, LBS, and Bite-Blu) and compared against reference properties of the predicate devices and the requirements of international standards. The country of origin for the testing itself is not explicitly stated, but the manufacturer is B&E KOREA Co., Ltd. (SOUTH KOREA). The data is not retrospective patient data.

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

This type of testing (ISO standard compliance for physical and biocompatibility properties of impression materials) does not involve experts establishing "ground truth" through interpretation of cases like in medical imaging AI. The "ground truth" or "reference" is derived from:

• The defined physical property metrics and their acceptable ranges as specified in ISO 4823 (e.g., consistency in mm, strain in compression as a percentage).
• The biocompatibility criteria defined by ISO 10993 (e.g., absence of cytotoxicity).
• The performance characteristics of the legally marketed predicate devices, which are assumed to meet regulatory and performance requirements.

Therefore, the concept of qualified experts adjudicating a test set is not applicable here.

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

As explained above, this concerns material properties and biocompatibility, not diagnostic or clinical interpretation. Therefore, no adjudication method (like 2+1 or 3+1) was used for establishing ground truth for a test set. The results are obtained directly from standardized laboratory measurements.

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 MRMC comparative effectiveness study was done or is relevant here. This document is for a dental impression material, not an AI or imaging diagnostic device. The study proves the physical and biological characteristics of the material, not the performance of human readers assisted by AI.

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

Not applicable. This is not an algorithm or AI device. The "standalone" performance here refers to the intrinsic physical and chemical properties of the material itself.

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

The "ground truth" for this device's performance is established by:

• International standards (ISO 4823, ISO 10993, DIN 13903): These standards define the acceptable range or threshold for various physical, chemical, and biological properties.
• Performance data of legally marketed predicate devices: The tested characteristics are compared directly to those of the predicate devices, which are deemed safe and effective.

This is a bench testing/laboratory data type of ground truth, not one derived from clinical outcomes, pathology, or expert consensus on patient cases.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a "training set." The materials are developed and characterized through traditional chemical and material science processes, not machine learning.

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

Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

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DentMix VPS Impression Material is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums.

DentMix VPS Impression Material is an addition-reaction base/catalyst polyviny/siloxane dental impression material intended as an alternative to traditional alginate materials. It is available in regular set and fast set. Both are available in light body, regular body/monophase and heavy body.

The provided document describes the substantial equivalence determination for the "DentMix VPS Impression Material" (K223892) by comparing it to a predicate device, "Elements™" (K151150). The acceptance criteria are based on meeting or exceeding the performance of the predicate device across various physical properties, typically measured against recognized standards like ISO 4823-2015.

Here's the breakdown of the information requested:

Acceptance Criteria and Device Performance

A direct table of "acceptance criteria" is not explicitly stated as distinct from the predicate device's performance. Instead, the study aims to show that the subject device performs at least as well as the predicate device. Therefore, the predicate device's performance serves as the de facto acceptance benchmark.

Note on "Acceptance Criteria": For each of these properties, the acceptance criterion implicitly is that the DentMix VPS Impression Material is functionally equivalent to or performs within an acceptable range compared to the predicate device, often guided by the ISO 4823-2015 standard. "PASS" explicitly indicates meeting a standard. For numerical values, the goal is typically to be similar or better.

Study Details for DentMix VPS Impression Material

The document outlines a comparison study to demonstrate substantial equivalence, primarily focusing on physical properties.

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

   • The document does not explicitly state the numerical "sample size" for each test point (e.g., number of specimens tested for consistency, working time, etc.). However, the values reported for "Linear Dimensional Change," "Elastic Recovery," and "Strain-In-Compression" include standard deviations (e.g., "0.14% (0.01)"), which implies that multiple measurements were taken to calculate an average and variability.
   • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It presents the results as part of a 510(k) submission by IPB Inc.

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

   • This type of detail (number and qualifications of experts) is typically associated with clinical studies or studies where human interpretation or consensus is required (e.g., image analysis). For material property testing as performed here, the "ground truth" is established by direct measurement of physical properties according to standardized test methods (e.g., those described in ISO 4823-2015). Experts in material science or dentistry might design and oversee these tests, but their "consensus" is not the ground truth in the same way it would be for diagnosing a medical image.

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

   • Adjudication methods (e.g., 2+1) are relevant for studies involving human interpretation and potential disagreement (e.g., reading medical images). For physical property testing of dental impression materials, direct measurements are taken, and typically, there is no "adjudication" in this sense. Quality control and adherence to standard protocols ensure reliability.

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, an MRMC comparative effectiveness study was not done. This type of study is completely irrelevant for evaluating a dental impression material, as it's a diagnostic tool comparison for medical imaging interpretation, not a material property evaluation.

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

   • This question is also not applicable. The device is a physical dental impression material, not an algorithm or AI system. The performance evaluated is the inherent physical properties of the material itself.

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

   • The "ground truth" for the performance evaluation in this context is the results of standardized physical property tests as defined by recognized standards (specifically ISO 4823-2015). This is a direct measurement of material characteristics against objective criteria, not based on human consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • This concept is not applicable. The evaluation is a direct comparison of physical material properties against a predicate, not a machine learning model that requires a "training set."

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

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

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No Stress Impress is intended for use as a rebasing and relining impression material as well as for general impressions including but not limited to dentures, root surfaces, and posts.

No Stress Impress is a thermoplastic impression material available for full or partial impressions that comes as a stick or wafer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "No Stress Impress" device, broken down as requested.

The document is a 510(k) Summary for a dental impression material. As such, the "acceptance criteria" are mainly focused on product performance standards and biocompatibility, rather than clinical efficacy metrics typical of AI/software devices. The "study" refers to the testing performed to demonstrate compliance with these standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify sample sizes for the material testing per ISO 4823:2015.
For biocompatibility testing, the following "sample sizes" are implied by the test names, but precise numerical counts of animals/cells are not given:

• Hamsters (for Oral Mucosal Irritation Study)
• Guinea Pigs (for Sensitization Test)
• Cell cultures (for Cytotoxicity Studies)

The data provenance (e.g., country of origin, retrospective/prospective) for these tests is not specified in the provided text.

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

This type of information is not applicable to the "No Stress Impress" device as described in this 510(k) summary. The device is a material, not an AI or diagnostic tool that requires expert interpretation for ground truth establishment. The ground truth for material properties is established by adherence to international standards (e.g., ISO) and laboratory test results.

4. Adjudication Method for the Test Set

This information is not applicable as the device is a material, not a diagnostic or AI device that requires adjudication of expert opinions. The "ground truth" for material properties is determined by the specific outcomes of the standardized tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable to the "No Stress Impress" device. This is a material, not an AI-assisted diagnostic tool.

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

This information is not applicable to the "No Stress Impress" device. It is a material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Material properties and performance standards: Compliance with ISO 4823:2015 for dentistry elastomeric material.
• Biocompatibility test results: Specific empirical outcomes from standardized biological assays (irritation, sensitization, cytotoxicity) conducted according to ISO 10993-1.

8. The Sample Size for the Training Set

This information is not applicable to this device. As a dental impression material, there is no "training set" in the context of machine learning or AI.

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

This information is not applicable to this device for the reasons stated above.

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Impression of inlay, onlay crown, and bridge preparation

• Crown, bridge impression
• Inlay and onlay impression
• Functional impression
• Denture impression
• Study model impression

Bright Impress impression material is a fast-set of addition-reaction silicone elastomer (Vinyl polysiloxane)-based material for dental professionals, consisting of five types (Light, Medium, Heavy, Bite and Putty) with superior hydrophilicity, dimensional accuracy, high tensile strength, and resistant to deformation. It is designed for versatile impression techniques of crowns, bridges, orthodontics and implants.

The document is a 510(k) Summary for the dental impression material "Bright Impress" by Genoss Co., Ltd. It compares the characteristics of Bright Impress to a predicate device, HySil Impression Materials, and presents performance and biocompatibility data.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document provides extensive tables for both biocompatibility and performance for each variant of "Bright Impress" (Light, Medium, Heavy, Putty, Bite). I will consolidate and present a representative sample, focusing on the "Performance Data" which directly addresses how the device meets physical/mechanical acceptance criteria. The "Biocompatibility Data" also uses "Acceptance Criteria" and "P/F" (Pass/Fail) results.

Comprehensive Table of Acceptance Criteria and Reported Device Performance

Important Note: The document often states "Pass" for certain criteria in the performance tables where a specific numerical result might be expected (e.g., Working Time for Bright Impress - Bite, Flexural Strength for Bright Impress - Bite). This indicates that the device met the specified quantitative acceptance criteria, even if the exact number isn't explicitly shown in that particular table. The "Technological Characteristics" section comparing to the predicate does provide specific numbers for some of these.

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

• Sample Size: The document does not explicitly state the sample sizes used for the performance and biocompatibility tests. It lists "Report No." for biocompatibility tests, suggesting external lab reports, but these reports are not provided. For performance, it lists Method (e.g., ISO 4823, DIN 13903) which implies standardized testing procedures that would define sample sizes, but the actual numbers of samples tested are not given.
• Data Provenance: The manufacturer is Genoss Co., Ltd., located in Suwon-si, Gyeonggi-do, Korea, South. The document doesn't specify if the testing was done in Korea or elsewhere. The studies appear to be prospective bench tests and biocompatibility assessments conducted to demonstrate equivalency for regulatory clearance, rather than retrospective or prospective clinical studies on human subjects.

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 to the type of study described. The document outlines bench testing (physical and mechanical properties) and biocompatibility testing of a medical device material. The "ground truth" here is established by adherence to international standards (ISO, DIN) and objective measurements using laboratory equipment, not by human expert consensus on clinical data.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for image interpretation or diagnosis where multiple readers provide opinions, and a consensus process is needed to establish ground truth. The studies described are bench tests and biocompatibility assessments, which rely on objective measurements and established protocols.

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

This is not applicable. This document describes the clearance of a dental impression material, not an AI-powered diagnostic device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or reported.

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

This is not applicable. This device is a material, not software or an algorithm.

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

The "ground truth" for the tests performed is based on:

• International Standards: Adherence to established ISO (International Organization for Standardization) and DIN (Deutsches Institut für Normung) standards for dental materials, which define methods and acceptance criteria for properties like consistency, working time, dimensional change, elastic recovery, and detail reproduction.
• Objective Laboratory Measurements: Data obtained from quantitative measurements in a laboratory setting (e.g., electronic scale for volume, specific instruments for consistency, hardness, flexural strength).
• Biocompatibility Protocol Compliance: Results from standardized biological tests (e.g., Cytotoxicity, Sensitization, Irritation) following ISO 10993 guidelines, indicating the material's interaction with biological systems.

Essentially, the ground truth is objective scientific measurement and compliance with established performance and safety standards.

8. The sample size for the training set

This is not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

This is not applicable as there is no training set for this type of device.

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DENU Light Body(Regular, Fast) / DENU Heavy Body(Regular, Fast)

• Crown and bridge impression
• Inlay and onlay impression
• Denture impression
• Model impression

DENU Putty Set(Regular, Fast)

• Crown and bridge impression
• Inlay and onlay impression

The DENU family of silicone impression materials consists of three different viscosities (light body, heavy body, putty) for various application systems. Products are further classified into Regular type and Fast type, depending on curing time, but there is no difference on viscosity, indications for use, or scope of use. Each device is consisted of 1:1 base and catalyst component, packaged in 560mL jars for DENU Putty set and 50mL syringes for other devices.

This is a 510(k) premarket notification for a dental impression material, DENU Light Body (Regular, Fast), DENU Heavy Body (Regular, Fast), and DENU Putty Set (Regular, Fast). The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the international standard ISO 4823:2021 (Dentistry - Elastomeric impression materials) and the device's performance is compared to these standards and the predicate devices.

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

The document does not explicitly state the sample sizes for each specific physical property test (e.g., how many samples were tested for working time, consistency, etc.). The testing was based on ISO 4823:2021 and other biocompatibility standards (ISO 7405, ISO 10993-10, ISO 10993-11). These standards typically specify the number of samples required for each test. Given the context of a 510(k) submission, it is assumed that the protocol for each standard was followed, including the specified sample sizes (though not explicitly listed in this summary).

The data provenance is retrospective, as the tests have already been performed and the results are being presented. The manufacturer, HDI, Inc., is based in South Korea, implying the tests were likely conducted there or by affiliated labs.

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

This submission describes physical and biological bench testing of an impression material against established international standards. There is no mention of human expert involvement or a "ground truth" established by experts in the context of diagnostic interpretation for this type of device. The "ground truth" for these tests is the objective measurement of physical and chemical properties as defined by the ISO standards.

4. Adjudication method for the test set

Not applicable. As described in point 3, this is bench testing of physical and biological properties. There is no expert adjudication process in this context.

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

Not applicable. This is a medical device submission for a dental impression material, not an AI-powered diagnostic device. No MRMC study was performed.

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

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

7. The type of ground truth used

The ground truth used for this device's evaluation is primarily objective physical and chemical measurements as defined by:

• International Standards: Specifically, ISO 4823:2021 (Dentistry - Elastomeric impression materials) and ISO 10993 series (Biological evaluation of medical devices).
• Predicate Device Performance: The performance characteristics of the proposed device are directly compared to those of the predicate devices (Vonflex STM and Vonflex S Putty).

8. The sample size for the training set

Not applicable. There is no AI or machine learning component to this device, so there is no training set in the conventional sense. The "training" for the device's performance could be considered the iterative formulation and testing by the manufacturer to meet the required specifications, but this is not a data-driven training set like in AI.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question does not apply.

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Accusil Dental Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Accusil Dental Impression Materials are designed for dental applications to define and reproduce the structure of a patient's teeth and gums for producing crowns, bridges, occlusal models and dental implant restorative devices. Base and catalyst components are mixed in an equal ratio 1:1, placed into an impression tray and inserted into the patient's mouth. The material will conform to the patient's dentition and when set will produce a reproduction of the patient's teeth and occlusion.

The document describes the acceptance criteria and performance of Accusil Dental Impression Materials as part of a 510(k) premarket notification for FDA clearance.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that Accusil Dental Impression Materials were tested against specific ISO standards (ISO 4823 and ISO 48-4) and internal protocols. The "Acceptance Criteria" are implicitly derived from the requirements of these standards. The "Reported Device Performance" for Accusil is provided in the comparative table with predicate and reference devices.

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

• Sample Size: Not explicitly stated in the provided text. The document mentions "Accusil light, heavy, monophase and putty were tested" and "Accusil bite registration was tested," implying samples of these product lines were used. However, the exact number of units or measurements for each test is not provided.
• Data Provenance: The testing was performed by Prevest Denpro Limited, based in India ("Export Promotion Industrial Park Bari Brahmana, Jammu 181133 India"). The nature of the testing (physical property measurements against international standards) suggests these were prospective tests conducted on manufactured samples, rather than retrospective data.

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

This information is not applicable to this type of device and study. The "ground truth" for dental impression materials is established by objective physical and chemical measurements against internationally recognized standards (ISO 4823, ISO 48-4), not by expert consensus or interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable. Since the evaluation involves objective physical property measurements against standardized criteria, there is no need for an adjudication method in the context of expert review. The results are quantitative and compared directly to standard specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging AI devices, not for physical property testing of dental impression materials.

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

No, a standalone AI algorithm performance study was not done. This is not an AI-driven device. The testing focused on the physical and chemical properties of the material itself.

7. The Type of Ground Truth Used:

The "ground truth" used for this device is based on objective standards and measurements of physical and chemical properties. Specifically, performance was evaluated against the requirements outlined in:

• ISO 4823 (Dentistry - Elastomeric impression materials)
• ISO 48-4 (Rubber, vulcanized or thermoplastic - Determination of hardness - Part 4: Indentation hardness by means of a durometer)
• Internal protocols for setting time (as ISO 4823 does not specify setting time).

8. The Sample Size for the Training Set:

This information is not applicable. As this is not an AI/machine learning device, there is no "training set."

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

This information is not applicable for the same reason as point 8.

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