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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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VPS Impression Material(Light Body) is to be used as syringeable impression materials for:
-Two-step putty-wash impression technique;
-One-step putty-wash impression technique;

• Two-step impression technique using dual viscosities ;
• Reline impressions ;
  -Fabricating full or partial dentures;

K203824:VPS Impression Material is dental Impression Material. It complies with the requirements of ISO 4823:2015 for dental elastomeric impression materials. It is supplied as atwo-part base/catalyst formulation preloaded in a dual-barrel cartridge. The VPS Impression Material package includes four dual-barrel 50ml cartridges.

The provided text is a 510(k) summary for a dental impression material (VPS Impression Material) and does not contain information about an AI/ML powered medical device. Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document.

The document describes the submission of a conventional medical device (dental impression material) and references standard performance testing (physical properties according to ISO 4823:2015) and biocompatibility testing (ISO 10993-5 and ISO 10993-10) to support its substantial equivalence to a predicate device. These tests are not related to AI/ML device performance metrics like sensitivity, specificity, or AUC, nor do they involve ground truth established by experts or multi-reader studies.

Therefore, I am unable to fulfill the request as it pertains to AI/ML device characteristics.

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

VPS Impression Material is dental Impression Material. It complies with the requirements of ISO 4823:2015 for dental elastomeric impression materials. It is supplied as a two-part base/catalyst formulation preloaded in a dual-barrel cartridge. The VPS Impression Material package includes four dual-barrel 50ml cartridges.

The provided text is a 510(k) summary for a dental impression material. The document demonstrates substantial equivalence to predicate devices, rather than proving a device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding study details and expert adjudication is not present in this document.

However, I can extract the acceptance criteria and performance data for the device based on the non-clinical performance tests presented.

Here's the information derived from the document:

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

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Kerr VPS Impression Material is suitable for impressions in preparation of case study models, orthodontic models, opposing models, simple removable dentures, removable retainers and splints, provisional crown and bridge, and dental impressions.

Kerr VPS impression material is an outstanding A-silicone impression material intended as an alternative to traditional alginate materials. Quick set time, excellent detail reproduction, compatibility with disinfection products, dimensional accuracy and stability make the best alternative. Available in 1:1 cartridges suitable for the Kerr Extruder and in Volume™ 5:1 362 mL foil packs for use in commercially available mixing machines.

This document is a 510(k) premarket notification for a dental impression material named "Kerr VPS Impression Material." The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission does not typically include detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) would for novel, high-risk devices.

Therefore, the specific information requested in the prompt related to acceptance criteria, detailed study designs, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not present in this 510(k) summary.

Here's an analysis based on the provided text, explaining why the requested information is absent and what can be inferred:

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

• Absent. This document does not provide a table of acceptance criteria or specific quantitative performance metrics for the Kerr VPS Impression Material.
• Reason: For a 510(k) substantial equivalence submission, the primary focus is to show that the new device is as safe and effective as a predicate device. This is often done by demonstrating similar technological characteristics, materials, and intended use, rather than extensive de novo performance testing against pre-defined acceptance criteria.

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

• Absent. There is no mention of a "test set" or any specific study that would utilize a test set with a defined sample size.
• Reason: The document focuses on demonstrating similarity to predicate devices rather than presenting novel clinical or performance study data that would typically involve a test set.

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)

• Absent. Since no test set or related performance study is described, there's no mention of experts establishing ground truth.
• Reason: Not applicable to a 510(k) summary of this nature.

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

• Absent. No adjudication method is mentioned as there is no specific performance study outlined.
• Reason: Not applicable.

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

• Absent. No MRMC study is mentioned.
• Reason: This device is a dental impression material, not an AI-powered diagnostic tool. MRMC studies are relevant for evaluating AI systems where human reader performance is a key metric.

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

• Absent. "Standalone" performance is relevant for AI algorithms. This device is a physical material.
• Reason: This question is not applicable to the device type.

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

• Absent. No ground truth is discussed as no formal performance study against a definitive standard is presented.
• Reason: Information not typically included in this type of 510(k) submission for a dental material.

8. The sample size for the training set

• Absent. There is no mention of a "training set."
• Reason: Training sets are relevant for machine learning algorithms. This device is a physical material.

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

• Absent.
• Reason: Not applicable for a physical dental impression material.

Summary of what is present and relevant to "proving" the device meets criteria for regulatory clearance:

• Acceptance Criteria (Implied for 510(k)): The acceptance criterion for a 510(k) is substantial equivalence to predicate devices. This means the device must be shown to be as safe and effective as a legally marketed device and not raise different questions of safety and effectiveness.
• Study Proving Acceptance: The "study" is the 510(k) submission itself, where Sybron Dental Specialties conducted a comparison of the Kerr VPS Impression Material to two predicate devices:
  • 3M ESPE, Position Penta Quick
  • DMG. Status Blue Mixstar
• Mechanism of Proof: The submission aims to prove substantial equivalence by demonstrating that the Kerr VPS Impression Material:
  • Has the same intended use: "impressions in preparation of case study models, orthodontic models, opposing models, simple removable dentures, removable retainers and splints, provisional crown and bridge, and dental impressions."
  • Functions in a similar manner and has similar technological characteristics (A-silicone impression material, quick set time, excellent detail reproduction, compatibility with disinfection products, dimensional accuracy and stability).
  • The FDA's letter states they "have determined the device is substantially equivalent... to legally marketed predicate devices."

In essence, for this 510(k), the "acceptance criteria" is a regulatory determination of substantial equivalence, and the "study" is the comparative analysis presented in the submission to satisfy that requirement, rather than a detailed performance study with explicit outcome measures and statistical analyses.

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Precision VPS Impression Material is intended for use with all crowns, bridges, occlusal and dental impression techniques to reproduce the structure of a patient's teeth and gums.

Precision VPS Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material available in three different viscosities intended for use with all crowns, bridges, occlusal and dental implant impression procedures.

This document is a 510(k) premarket notification for a dental impression material, which typically involves demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with acceptance criteria and a test set and experts in the way machine learning algorithms are evaluated. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not applicable or not provided in the context of this type of regulatory submission.

However, based on the information provided, here's what can be extracted and what cannot:

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

This document does not specify formal "acceptance criteria" or provide "reported device performance" in the quantitative manner typically associated with clinical trials for new medical devices or software. The submission focuses on demonstrating substantial equivalence to legally marketed predicate devices based on the same intended use and basic technological characteristics of a dental impression material.

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

Not applicable. This is a 510(k) submission for a dental impression material, not a study involving a test set of data in the context of a machine learning or diagnostic device study. The "test set" in this context would implicitly be the physical testing of the material's properties (e.g., set time, accuracy, tear strength), which are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no mention of experts establishing a ground truth for a test set in the provided summary.

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

Not applicable. No adjudication method is mentioned as there is no "test set" in the context of human interpretation.

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 dental impression material, not an AI-assisted diagnostic tool or system that would involve human readers or MRMC studies.

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

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

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

Not applicable. The "ground truth" for a dental impression material would likely refer to its physical and chemical properties meeting established standards for accuracy, stability, etc., which are usually validated through bench testing rather than clinical "ground truth" as in diagnostic studies. This summary does not provide details on such testing.

8. The sample size for the training set

Not applicable. The concept of a "training set" is not relevant for a physical dental impression material.

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

Not applicable. The concept of a "training set" and its "ground truth" is not relevant for a physical dental impression material.

Summary of Device and Regulatory Context (Based on provided text):

• Device Name: Precision VPS Impression Material
• Applicant: Discus Dental, Inc.
• Application Type: 510(k) Premarket Notification
• Date of Summary: January 8, 2004
• Intended Use: For use with all crowns, bridges, occlusal, and dental implant impression procedures to reproduce the structure of a patient's teeth and gums.
• Device Description: An addition-reaction base/catalyst polyvinylsiloxane dental impression material available in three viscosities.
• Regulatory Classification: Class II, Product Code ELW, Regulation Number 872.3660 (Impression Material)
• Basis for Substantial Equivalence: Precision VPS Impression Material is claimed to be substantially equivalent to:
  • Aquasil Ultra Smart Wetting Impression Material (Dentsply, Intl., K021416)
  • P2 Polyether (Heraeus Kulzer GmbH, K030318)

The FDA's letter (dated March 25, 2004) confirms that they reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use, allowing it to be marketed. This determination implies that the device has met the necessary regulatory requirements for substantial equivalence, which for this type of device typically involves demonstrating similar technological characteristics and performance (e.g., mechanical properties, biocompatibility) to the predicate devices, rather than a clinical study with primary endpoints and statistical analysis of a test set.

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