(68 days)
The Polycarb is intended for the fabrication of temporary dental prostheses like partial denture clasps, temporary crowns, and bridges using the Inovativ, LLC Polycarb resin.
The Polycarb material is a thermoplastic resin that is used to fabricate dental prostheses. The resin is used in an injection molding or pressing device to fabricate the prostheses.
This document describes a premarket notification for a dental material called "Polycarb," a thermoplastic resin used for temporary dental prostheses. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting formal acceptance criteria and a detailed study with quantitative performance metrics for the new device.
Therefore, the requested information components related to quantitative performance, such as acceptance criteria tables, sample sizes for test sets, expert consensus, MRMC studies, or standalone algorithm performance, are not applicable to this submission as it primarily addresses the material's properties and equivalence.
Here's an analysis based on the provided text, addressing the applicable points:
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A table of acceptance criteria and the reported device performance:
Not applicable. The submission does not define specific quantitative acceptance criteria or report performance metrics in the way a clinical study for a diagnostic or AI device would. The "performance" assessment is based on demonstrating similar design, function, and physical properties to the predicate device. -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable. The submission focuses on the material's chemical and physical properties and its substantial equivalence. It does not describe a clinical "test set" in the context of evaluating a device's diagnostic or predictive performance. -
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 a "test set" requiring expert ground truth establishment. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No test set or expert adjudication process is described. -
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 submission for a dental material and does not involve AI assistance or human reader studies. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a dental material, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The evaluation is based on the material's characteristics and comparison to a predicate, not on generating a medical "ground truth" for diagnostic purposes. The "truth" in this context is the factual chemical and physical properties of the material. -
The sample size for the training set:
Not applicable. This submission does not involve a training set as it's not a machine learning or AI device. -
How the ground truth for the training set was established:
Not applicable.
Summary based on available information:
The Inovativ Polycarb premarket 510(k) notification (K022030) aims to demonstrate substantial equivalence to an existing predicate device, Flexible Dimensions, LLC "Direct Crown" polycarbonate resin.
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Acceptance Criteria (Implied by Substantial Equivalence): The device (Polycarb) must be similar in design, function, physical properties, and intended use to the predicate device. The submission provides a chemical analysis to support these claims. The intended use is for the fabrication of temporary dental prostheses like partial denture clasps, temporary crowns, and bridges.
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Study that proves the device meets the acceptance criteria: The study is described as a chemical analysis and a comparison of technological characteristics (design, material characteristics, physical properties, handling characteristics, intended use, and functionality) to the predicate device. The submission asserts that "Both the Polycarb and the predicate device are similar in design, material characteristics, physical properties, handling characteristics, intended use and functionality."
Limitations of the provided text for the requested fields: This 510(k) summary is a regulatory filing for a physical material, not for a diagnostic device, software, or AI system, which typically require detailed clinical performance studies with specific statistical measures, ground truth establishment, and expert involvement. Therefore, many of the requested data points (e.g., sample sizes, expert qualifications, adjudication methods, AI assistance) are not found or applicable in this type of submission.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.