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Fluorcanasite is a CAD/CAM machinable glass ceramic block, batched from standard glass-making ingredients which are intended to be used by trained professionals in a dentist's office for the manufacture of all-ceramic inlays, onlays, crowns, and veneers.

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental ceramic device named "Fluorcanasite Dental Ceramic" (K100794). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit acceptance criteria and performance studies in the way one might see for AI/ML devices or novel therapies.

Therefore, the study design elements typically requested for AI/ML or clinical trials (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable to this submission. The "study" here is a series of non-clinical, benchtop tests designed to characterize the material properties of the new device and compare them to a predicate device.

Here's an analysis based on the information provided, specifically addressing the criteria where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission are generally that the new device performs "as well as, or better than" the predicate device for relevant characteristics, demonstrating substantial equivalence. The predicate device's performance often serves as the de facto benchmark.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Fluorcanasite)
Biaxial Flexural Strength	Comparable to or greater than 360 MPa (Predicate: IPS e. max CAD)	271.3 MPa
CTE	Comparable to 10.45 ppm/°C (Predicate: IPS e. max CAD)	8.8 ppm/°C
Chemical Solubility	Comparable to or less than 30-50 µg/cm² (Predicate: IPS e. max CAD)	722 µg/cm²
Fracture Toughness	Comparable to or greater than 2.0-2.5 MPa m1/2 (Predicate: IPS e. max CAD)	4.2 MPa m1/2
Hardness	Comparable to 5.94 GPa (Predicate: IPS e. max CAD)	5.18 GPa
MTBS (ceramic composite)	N/A (Predicate not applicable or reported)	27.59 MPa
Biocompatibility	Meets ISO 10993-5 standards	Meets ISO 10993-5 standards
Uranium Content	Low/negligible activity concentration (Specific limits not stated, but results show very low/undetectable levels)	X MPa") are often derived from recognized standards (like ISO 6872:2008) or from the predicate device's published properties. The conclusion states "Fluorcanasite performed as well as, or better than, the predicate device," which is the overall acceptance criterion for substantial equivalence. It's important to note that while some values are numerically "worse" than the predicate (e.g., lower flexural strength, higher solubility), the FDA determined substantial equivalence based on the totality of the data and the overall intended use, suggesting these differences were not deemed to raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated as a number of "samples" in a clinical human-subject sense. The non-clinical tests (Biaxial Flexural Strength, CTE, Chemical Solubility, Fracture Toughness, Hardness, MTBS, Biocompatibility, Uranium content) would have involved multiple specimens of the material as per the test methodologies (e.g., ISO standards), but the exact number of specimens is not provided.
Data Provenance: The non-clinical testing was conducted, and the summary was prepared in the UK (Applicant address: Derbyshire, UK). The Uranium content analysis was managed under "NPL LRQA registration to ISO 9001:2000," indicating a UK National Physical Laboratory (NPL) involvement.
Retrospective or Prospective: N/A for benchtop material testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Experts: Not applicable. Ground truth, in this context, is established by adherence to recognized international standards (e.g., ISO 6872:2008, ISO 10993-5) for material property measurements and radiochemical analysis methodologies.
Qualifications: Not applicable for this type of submission. The qualifications would be implied by the accreditation and expertise of the laboratories conducting the standardized tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving subjective human interpretation that would require an adjudication method. The measurements are objective material properties.

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 a dental ceramic material, not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a dental ceramic material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is derived from standardized material testing methodologies (e.g., ISO 6872:2008, ISO 10993-5) and analytical chemistry techniques (for uranium content), which provide objective, measurable physical and chemical properties of the material.
The "truth" of comparability is then assessed against the predicate device's reported properties.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. There is no "training set."

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