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510(k) Data Aggregation
(148 days)
SmarTemp® X I is a self-curing composite for the fabrication of temporary crowns and bridges, inlays and veneers. SmarTemp® X1 is intended for the fabrication of: temporary crowns, bridges, inlays, long-term temporaries, and temporary veneers.
SmarTemp® X1 is a self-curing, resin-based composite, suitable for the fabrication of temporary crowns, bridges, inlays, onlays, and veneers. It is a bis-acryl resin-based material comprising a 10:1 ratio of base to catalyst components, which when expressed by the user from dual-chamber syringes or cartridges mix through standard snap-in accessory mixing tips. SmarTemp® X1 self-cures in approximately 6 minutes at mouth temperature.
SmarTemp® X1 is packaged in any standard, opaque, dual-chamber syringe or cartridge suitable for containing a 10:1 ratio of base and catalyst components, respectively. The syringe or cartridge is accompanied by standard snap-in automix tips.
The provided text describes the regulatory clearance of a dental material, SmarTemp X1, as substantially equivalent to a predicate device, Luxatemp Ultra/Star. It does not contain information about a clinical study or acceptance criteria related to an AI/ML powered medical device.
However, based on the provided document, I can extract information related to the acceptance criteria and testing for the SmarTemp X1 dental material, which serves as a substitute for the requested AI/ML device information.
Here's the breakdown of the acceptance criteria and the study (bench performance testing) for SmarTemp® X1:
SmarTemp® X1 Acceptance Criteria and Bench Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for SmarTemp® X1 appear to be based on demonstrating equivalence or meeting certain thresholds compared to the predicate device, Luxatemp® Ultra/Star, for critical physical properties.
| Property | Acceptance Criteria (Predicate Device K101710) | Reported Device Performance (SmarTemp® X1) |
|---|---|---|
| Compressive Strength | >300 MPa | >300 MPa |
| Flexural Strength | >100 MPa | >100 MPa |
| Shrinkage |
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(38 days)
For making temporary prostheses, such as crowns or bridges, for use until permanent restorations can be fabricated.
Parkell's temporary C&B resin is a composite material intended for use as in the fabrication of provisional restorations for teeth prepared to receive crowns or bridges until final restorations for these teeth are completed. It is supplied in 50ml AutoMix Cartridges that automatically mix and dispense the proper ratio of base and catalyst (i.e., 1:1). The material is self-curing and sets with minimal heat and shrinkage. SmarTemp features a "rubbery" stage that permits easy trimming with scissors prior to final polymerization. SmarTemp has good physical properties and is suitable for long-term and long-span temporary restorations
The provided text is a 510(k) Summary for a dental product called "SmarTemp Temporary C&B Resin". It describes the product, its intended use, and its substantial equivalence to other legally marketed predicate devices.
However, the summary does not contain any information about specific acceptance criteria, study designs, sample sizes, or performance data for the "SmarTemp" device. The document is typical of a 510(k) summary from 1999, which primarily focuses on demonstrating substantial equivalence through a comparison of technological characteristics and intended use, rather than presenting detailed performance study results against predefined acceptance criteria.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as this information is not present in the provided text. The document only states that the device has "good physical properties" but does not quantify them or provide data from a study.
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