(64 days)
artBloc® Temp is indicated for use with inLab, CEREC or other CAD-controlled milling equipment for the fabrication of multi-unit long-term temporary crowns or bridges.
A rectangular solid block of PMMA with post attachment for use in a CAD-controlled milling device for production of long-term temporary crowns and bridge abutments.
The provided text describes a medical device, artBloc® Temp, which is a PMMA block for CAD-controlled milling machines. The document is a 510(k) premarket notification summary. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with detailed acceptance criteria and performance metrics typically associated with AI/software devices.
As such, the information requested below, particularly related to acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert involvement, and ground truth establishment, is largely not applicable or not provided in this type of regulatory submission for a physical dental material. There is no mention of an algorithm, AI, or software performance in the context that would require these specific metrics.
Here's a breakdown based on the provided document:
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A table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Compliance to ISO 10477 (Polymer-based crown and veneering materials) Not explicitly stated: The document only states "Tested for compliance to ISO 10477". Specific performance values (e.g., flexural strength, water sorption) are not reported. The implication is that it met the standard's requirements, which serves as the acceptance criteria for material properties. Compliance to ISO 3336 (Dental ceramic applied to metal restorations) Not explicitly stated: The document only states "Tested for compliance to ISO 3336". Specific performance values are not reported. This standard might be referenced for general dental material quality and methods, but PMMA is not ceramic. It's possible this is a general reference or an error in the summary. The core material is PMMA. Compliance to ISO 10993 (Biological evaluation of medical devices) Not explicitly stated: The document only states "Tested for compliance to ISO 10993". Specific biocompatibility results (e.g., cytotoxicity, sensitization) are not reported. The implication is that it met the standard's requirements, which serves as the acceptance criteria for biocompatibility. Substantial Equivalence to Predicate Devices: artegral ImCrown and VITA CAD-Temp Achieved: The FDA letter 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... to legally marketed predicate devices." This is the primary "performance" criterion for a 510(k), meaning its characteristics and intended use are similar enough to existing devices not to raise new questions of safety and effectiveness. Indication for use with inLab, CEREC, or other CAD-controlled milling equipment for the fabrication of multi-unit long-term temporary crowns or bridges. Supported by Predicate Equivalence: The intended use statement confirms this (Page 3 of 48). The predicate devices also serve as evidence that such materials can be used for temporary crowns and bridges with CAD/CAM systems. The "performance" here is functional compatibility and suitability for the intended anatomical and clinical application, implicitly covered by compliance to ISO standards and substantial equivalence. -
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. This document is a regulatory summary for a physical material, not for an AI/software device involving test sets of data. Testing mentioned (ISO standards) would typically involve material samples, but the number of such samples is not specified.
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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/Not provided. Ground truth, in the context of expert review, is not relevant for this type of material submission. Compliance to ISO standards is typically assessed by laboratory testing against pre-defined physical/chemical/biological metrics.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This refers to expert review processes, which are not detailed or implied for this submission.
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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 is a physical dental material, not an AI or imaging device that would involve human readers or AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm discussed in this document.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Material property standards: The "ground truth" for this device would be its physical, chemical, and biological properties meeting the specifications outlined in the referenced ISO standards (ISO 10477, ISO 3336, ISO 10993). This is typically determined through laboratory testing against established benchmarks.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of an AI/software device. For a physical material, development would involve R&D and quality control, but not a "training set" in this sense.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set mentioned or implied, this question is not relevant to the provided document.
§ 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.