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• Impression material in a dual phase impression technique
• Precise duplication of models
• Capturing multiple unit impressions
• Impression of inlay, crown, bridge and partial denture etc.

Vonflex S™, as the additional polymerization silicone type, is composed of a two component (base and catalyst, mixing ratio 1:1) hydrophilic vinyl polysiloxane impression material for all dental impression techniques. Vonflex S™ consists of light-bodied, medium-bodied or heavy-bodied consistencies in delivery systems of cartridges and/or tubes. It has normal set and fast set that would be desired by the operator.

The provided text is a 510(k) Summary for a dental impression material named "Vonflex S™". This document aims to demonstrate substantial equivalence to a predicate device, not necessarily to set and prove acceptance criteria in the same way one might for an AI/ML medical device.

The study presented here is a comparison of the performance characteristics of the new device (Vonflex S™) against a legally marketed predicate device (Aquasil Ultra Smart Wetting Impression Material). The goal is to show that Vonflex S™ is substantially equivalent and therefore safe and effective for its intended use, not to prove that it meets specific, pre-defined acceptance criteria in isolation.

However, we can infer "acceptance criteria" as the performance characteristics of the predicate device, against which the new device is compared. The study involves bench testing of physical and chemical properties.

Here's an attempt to structure the information based on your request, with the understanding of the nature of this 510(k) submission:

1. Table of Acceptance Criteria (Inferred from Predicate Device Performance) and Reported Device Performance

The acceptance criteria are inferred from the performance of the predicate device, as the goal is to demonstrate substantial equivalence. The tables in the document compare varying consistencies (Heavy, Medium, Light, Light XLV) of Vonflex S™ against their respective predicate device counterparts. Below are representative tables for "Vonflex S™ Heavy" and "Vonflex S™ Light XLV". Similar tables are present for Medium and Light consistencies in the original document.

Vonflex S™ Heavy - Acceptance Criteria (Predicate) vs. Device Performance

Vonflex S™ Light XLV - Acceptance Criteria (Predicate) vs. Device Performance

2. Sample Size and Data Provenance

• Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of impressions or tests performed for each physical property). It only presents the measured values.
• Data Provenance: The tests were conducted by Vericom Co., Ltd. in the Republic of Korea. The data is reported for the new device (Vonflex S™) and the predicate device (Aquasil Ultra Smart Wetting Impression Material). The study is retrospective in the sense that it evaluates the manufactured product against existing standards and a predicate device.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. This study does not involve human readers or interpretations of images/data that would require expert consensus. The "ground truth" for each characteristic (e.g., flow properties, tear strength) is determined by laboratory measurements according to established international standards (ISO 4823).
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is a scientific and technical bench testing comparison, not a clinical study involving human judgment that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic interpretation devices, not for a dental impression material's physical and chemical properties.
• Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: Not applicable. This device is not an algorithm or software. The performance evaluation focuses on the physical and chemical properties of the material itself.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the performance characteristics is derived from measurements of defined physical and chemical properties conducted according to the ISO 4823 standard. For biocompatibility, the ground truth is established through standard biological evaluation tests (Cytotoxicity, Genotoxicity, Oral mucous Irritation, Sensitization) as per ISO 10993. The performance of the predicate device also serves as a comparative ground truth to establish substantial equivalence.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a material, not a machine learning algorithm that requires a training set.

9. How Ground Truth for Training Set was Established

• How Ground Truth was Established: Not applicable.

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It is used for all crown, bridge and orthodontic impression techniques.

Vonflex S™ Putty, as the additional polymerization silicone type, is composed of vinyl polysiloxane impression materials that make oral tissue shape precisely. polychoxane improofien materials that natio of a looks probobility, helps to make precise impression taking.

This is a 510(k) premarket notification for a dental impression material, Vonflex S™ Putty, and not an AI or software device. Therefore, many of the requested categories related to AI/software performance, such as sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, and AI-specific acceptance criteria, are not applicable to this document.

The acceptance criteria and performance data presented here are for the physical and biological properties of a dental material.

1. Table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance:
This document describes performance testing for a dental impression material. The specific sample sizes for each physical property test are not detailed in this summary. The data provenance is Vericom Co., Ltd., Republic of Korea, as they conducted the tests (prospective in the context of this submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is for performance testing of a physical material, not for a diagnostic device requiring expert interpretation or ground truth establishment in the typical AI/software sense. The "ground truth" for these tests are the defined standards within ISO 4823 and ISO 10993.

4. Adjudication method for the test set:
Not applicable. This is for performance testing of a physical material, not for a diagnostic device with 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 is not an AI-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-powered device.

7. The type of ground truth used:
For physical properties, the "ground truth" is defined by the requirements and test methods specified in the international standard ISO 4823 (Dentistry - Elastomeric impression materials). For biocompatibility, the "ground truth" is based on the safety endpoints and test methods specified in ISO 10993 (Biological evaluation of medical devices).

8. The sample size for the training set:
Not applicable. This is not an AI-powered device that requires a training set.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI-powered device that requires a training set or its associated ground truth establishment.

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• Standard bite registrations in the end bite position -
• Portrayal of antagonists -
• Coating of bite forks -
• Key material for needle point registration -
• -Production of small model segments

Not Found

1. Acceptance Criteria and Reported Device Performance:

The provided document (K140966) is a 510(k) clearance letter for a dental impression material, "Vonflex™ S Bite." It appears to be a traditional 510(k) submission seeking substantial equivalence to a predicate device. This type of regulatory submission typically focuses on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety or effectiveness.

Therefore, the "acceptance criteria" for this device are not framed as specific performance metrics against a pre-defined threshold for an AI algorithm. Instead, the acceptance criteria revolve around demonstating substantial equivalence to an existing predicate device. The "reported device performance" would be the summary of the tests and data provided by the manufacturer in their 510(k) submission to support this substantial equivalence.

Without additional documents (like the full 510(k) submission), it's impossible to provide a table of specific quantitative acceptance criteria directly from the FDA letter. However, based on the nature of a 510(k) for an impression material, the acceptance criteria and likely performance evaluation would revolve around characteristics relevant to dental impressions.

Likely Acceptance Criteria and Reported Performance (General based on impression materials):

• Portrayal of antagonists
• Coating of bite forks
• Key material for needle point registration
• Production of small model segments (as stated in the "Indication for use" section) |
  | Technological Characteristics Equivalence:
• Material composition and properties
• Physical/mechanical properties relevant to impressions
• Biocompatibility | - Composition: Likely similar elastomer (e.g., vinyl polysiloxane, polyether) to predicate.
• Setting Time: Within clinically acceptable range, comparable to predicate.
• Dimensional Stability/Accuracy: Demonstrated to be stable and accurate post-setting, comparable to predicate via in-vitro testing.
• Tear Strength: Sufficient to prevent tearing during removal, comparable to predicate.
• Hydrophilicity/Wettability: Adequate for good adaptation to oral tissues, comparable to predicate.
• Flowability/Viscosity: Appropriate for specific impression techniques, comparable to predicate.
• Biocompatibility: Demonstrated via ISO 10993 testing or reference to predicate's biocompatibility. |
  | Performance Data Equivalence:
• Functional performance
• Safety | - Clinical Performance (if studies were performed): E.g., successful impression taking and model fabrication. If clinical studies were performed, they would compare Vonflex™ S Bite to the predicate device.
• Safety: Evaluation for adverse reactions, allergic responses, or cytotoxic effects (often covered under biocompatibility). |

Note: The FDA letter explicitly states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This confirms the focus on substantial equivalence.

The document provided does not contain information on points 2 through 9, as it is a 510(k) clearance letter and not a detailed study report. The information requested in points 2-9 is typical for the evaluation of a novel AI/ML-driven medical device, especially regarding diagnostic accuracy or performance improvement studies. Since this device is a dental impression material, these specific types of studies (MRMC, expert adjudication for AI ground truth, training and test sets for AI) are not applicable.

However, to address the prompt for completeness based on typical medical device evaluations for non-AI devices, I can infer the general approaches for similar materials:

Hypothetical General Information for a Non-AI Device (like an Impression Material), if Study Details were Available:

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

• Test Set: For an impression material, "test set" typically refers to the number of impressions taken, or the number of samples subjected to physical/mechanical testing.
  • In-vitro testing: Might involve dozens to hundreds of samples for various physical and mechanical properties (tensile strength, tear strength, dimensional accuracy, etc.).
  • Clinical testing (if performed): Could range from 20-50 patients for a pilot study, to several hundred for a larger comparative study, depending on the endpoints.
• Data Provenance:
  • In-vitro: Lab-controlled environment, likely conducted by the manufacturer or a contract research organization.
  • Clinical: Could be retrospective (review of existing patient records where the material was used) or prospective (new clinical study specifically designed for the 510(k)). Country of origin would be where the manufacturing and/or clinical sites are located (e.g., Republic of Korea, based on the applicant's address).

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

• For an impression material, "ground truth" isn't typically established by expert consensus in the same way it is for diagnostic AI. Instead, "ground truth" often refers to:
  • Reference standards in physical/mechanical tests: E.g., measurements against a known calibration standard, or a predicate device's established performance.
  • Clinical outcomes: E.g., success of prosthetic fit, patient satisfaction, absence of complications.
• "Experts" involved:
  • Lab technicians/Engineers: With expertise in material science and dental materials testing.
  • Dentists/Prosthodontists: With clinical experience in taking impressions and evaluating restoration fit. Qualifications would be standard dental degrees and potentially specialty certifications.

4. Adjudication Method for the Test Set:

• Not applicable in the AI sense. For clinical outcomes, if multiple clinicians evaluate the impressions or restorations, agreement might be assessed via inter-rater reliability statistics (e.g., Kappa statistic). For lab tests, standard quality control and reproducibility measures are used.

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

• No. MRMC studies are specific to evaluating human reader performance with and without AI assistance, particularly in diagnostic contexts. This is not relevant for an impression material.

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

• No. This concept is specific to AI algorithms.

7. The Type of Ground Truth Used:

• Defined Standards/Reference Materials: For physical and mechanical properties, ground truth comes from established metrics (e.g., ISO standards for dental materials), standardized measurement techniques, and comparison to the predicate device.
• Clinical Success/Outcomes: In clinical studies, the "ground truth" would be the successful clinical application as judged by objective criteria (e.g., excellent marginal fit of restoration, stable bite registration, no patient discomfort) and potentially subjective patient feedback.

8. The Sample Size for the Training Set:

• Not applicable in the AI sense. For an impression material, "training set" doesn't exist for an algorithm. Instead, it would refer to the data used in the material's development and optimization phase. This might involve numerous iterations of formulation changes and subsequent small-batch testing.

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

• Not applicable in the AI sense. For material development, "ground truth" during "training" would be established by desired performance targets (e.g., "we need a setting time of 3-5 minutes," "tear strength must exceed X MPa") derived from clinical needs, market analysis, and predicate device performance. These targets guide the iterative development process.

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