(79 days)
Flash VPS Impression Materials are indicated to be used for all precision impressions (of e.g .: crown, bridge, inlay and onlay preparations).
Flash materials are classified as impression materials (21 C.F.R. § 872.3660) because they are devices intended to reproduce the structure of a patient's teeth.
Flash will be available as wash and tray materials. The wash materials will be available in one viscosity (light-bodied), each of them in a regular set and a super-quick set version. The tray materials will be available in two different viscosities (putty and heavy-bodied) in a regular set and a super-quick set version.
As the predicate devices, Flash materials are two component (base paste/catalyst) vinyl polysiloxane impression materials designed either to be used in 3M Deutschland GmbH's mixing, dosing and dispensing device, Garant™, or to automatically be mixed and dispensed in the Pentamix™ device of 3M Deutschland GmbH.
This 510(k) summary does not contain the level of detail necessary to complete all sections of your request. It's a summary of substantial equivalence to predicate devices, rather than a detailed report of a study proving specific performance metrics against acceptance criteria.
However, I can extract the information that is present and indicate where details are missing.
Description of Acceptance Criteria and Device Performance
This 510(k) summary asserts the device's "substantial equivalence" to three predicate devices (Future Wash/YPS, Dimension Penta H, and 3M ProPlus System) rather than presenting specific acceptance criteria and performance data for the Flash materials themselves. The basis for equivalence relies on:
- Indications for Use: Flash materials are indicated for "all precision impressions" similar to the predicate devices.
- Physical and Mechanical Properties: The document states that Flash was compared to the predicate devices regarding these properties, showing "substantial equivalence." However, no specific performance metrics or acceptance criteria for these properties (e.g., tear strength, dimensional stability, setting time) are provided.
- Chemical Composition: Flash's chemical composition is described as similar to the predicate devices (two-component vinyl polysiloxane impression materials).
- Biocompatibility: Biocompatibility testing was carried out, and the conclusion was that Flash materials are biocompatible for their intended use. No specific acceptance criteria or results are detailed.
Therefore, a table of acceptance criteria and reported device performance cannot be generated with specific numerical values from this document. The "acceptance criteria" are implicitly "being substantially equivalent to the predicate devices."
Study Details
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, not typically a detailed study report with specific performance data against explicit acceptance criteria.
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Table of Acceptance Criteria and Reported Device Performance:
Feature/Property Acceptance Criteria (Implicit) Reported Device Performance (Implicit) Indications for Use Same as predicate devices Indicated for "all precision impressions (of e.g.: crown, bridge, inlay and onlay preparations)," which is stated as equivalent to predicate devices. Physical & Mechanical Properties Similar to predicate devices (specific values not stated) Comparison showed "substantial equivalence" to predicate devices. No specific quantitative data provided. Chemical Composition Similar to predicate devices Two-component (base paste/catalyst) vinyl polysiloxane impression materials, designed for 3M Deutschland GmbH's mixing devices (Garant™, Pentamix™), similar to predicate devices. Biocompatibility Meets internationally recognized guidelines and risk assessment for intended use Biocompatibility assessments concluded that Flash materials are biocompatible for their intended use. No specific test results or criteria provided. Safety & Effectiveness Substantially equivalent to predicate devices Concluded to be "substantially equivalent in safety and effectiveness" to predicate devices (Future Wash/YPS K051797, Dimension Penta H K000591, 3M ProPlus System K963766). -
Sample size used for the test set and the data provenance: Not specified in this 510(k) summary. The document mentions "performance data" was used for comparison but does not detail the sample sizes for any tests. The data provenance would likely be internal testing by 3M Deutschland GmbH (Germany).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not specified. For a dental impression material, ground truth is typically based on objective physical/chemical measurements rather than expert consensus on, for example, image interpretation.
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Adjudication method for the test set: Not applicable/Not specified.
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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-powered diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental impression material, not an algorithm.
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The type of ground truth used: For physical and mechanical properties, "ground truth" would be established by standardized testing methods and measurement instruments, yielding objective data (e.g., tensile strength in MPa, dimensional change in percentage). For biocompatibility, it would be based on recognized testing standards (e.g., ISO 10993 series) and expert toxicological assessment. The document does not detail these test results.
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The sample size for the training set: Not applicable. This device is a dental impression material; there is no "training set" in the context of machine learning.
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How the ground truth for the training set was established: Not applicable.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).