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Linings for single-surface and multiple-surface composite fillings
Core build-up prior to crown placement
Primary tooth fillings
Stress bearing Class I restorations with at least one additional support outside of the filling area
Stress bearing Class II restorations when the isthmus is less than half of the intercuspal distance and with at least one additional support outside of the filling area
Cervical fillings, if aesthetics is not the prime consideration
Single-surface and multiple-surface temporary fillings
Fissure sealing

Device Description

Ketac Universal Aplicap is a radiopaque glass ionomer restorative delivered in capsules used for bulk fillings. It can be applied without lining; releases fluoride ions and is available in various shades corresponding to the Vita™ Classical color system.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "Ketac Universal Aplicap" dental cement and its substantial equivalence to a predicate device, "Equia." The text details various performance criteria, comparisons, and biocompatibility studies. However, it does not explicitly outline "acceptance criteria" as pass/fail thresholds against which the device performance is measured in a structured table or clinical study with patient outcomes. Instead, it compares the performance of Ketac Universal Aplicap to the predicate device and relevant ISO standards.

Based on the provided text, here's an attempt to extract and synthesize the requested information, acknowledging that some specific details (like direct acceptance criteria with pass/fail values, sample sizes for all tests, detailed expert qualifications, and specific multi-reader multi-case study results) are not fully present for an AI-based device, as this document pertains to a dental cement:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of "acceptance criteria" with defined pass/fail thresholds. Instead, it compares the performance of Ketac Universal Aplicap against the predicate device (Equia) and relevant ISO standards. The "Comparison" column implicitly acts as an assessment of whether the performance is considered acceptable or substantially equivalent.

Performance Characteristic	Acceptance Criteria (Implicitly based on Predicate/ISO)	Reported Device Performance (Ketac Universal Aplicap)	Comparison to Predicate (Equia) & Notes
Consistency	Comparable to predicate (16 mm)	14 mm	Comparable to Equia (16 mm). "No guidance or standard available to refer to."
Maximum solubility	Low level, meeting ISO 9917-1:2007 requirements	0.11%	Equia (0.06%) is lower, but "both materials have a solubility on a low level that does not effect biocompatibility or mechanical properties. Moreover, Ketac Universal Aplicap meets the ISO 9917-1:2007 requirement with no acid soluble arsenic or lead content (0.00 mg/kg)."
Dimensional change, 24 hrs	Comparable to predicate (0.16%)	0.24%	"Comparable to Equia at 24 hours". "The dimensional change as single property is not addressed by a standard or guidance."
Dimensional change, 72 hrs	Comparable to predicate (0.12%)	0.18%	"Comparable to Equia at 72 hours." "Based on the accuracy of the test method it is concluded that the changes of lengths of Ketac Universal Aplicap are comparable to those of Equia."
Working time (in-house)	Suitable for dentist preference	1:48 min:sec	Higher than Equia (1:12 min:sec). "Depends on the preference of the dentist. A longer working time provides the dentist with more time to handle the material." "Not addressed by a standard or guidance."
Setting time (in-house)	Suitable for dentist preference	2:42 min:sec	Longer than Equia (2:12 min:sec). "The ideal working and setting times depend on the preferences of dentists."
Setting time (ISO 9917:2007)	Within 1.5 - 6.0 minutes	2:30 min:sec	Equia (1:43 min:sec). Both "within the limit of 1.5 - 6.0 minutes."
Bonding strength, enamel	Comparable to predicate (5.0 MPa)	5.7 MPa	"Comparable adhesion values on human enamel."
Bonding strength, dentin	Clinically sufficient	5.1 MPa	Lower than Equia (10.0 MPa). "The review of clinical literature was presented in the 510(k), The literature showed that bonding strength of Ketac Universal Aplicap is sufficient for use. Therefore, this difference has no significant impact."
Fluoride release, 1 day	Not explicitly defined standard	4.0 ppm	Lower than Equia (5.9 ppm). "Not addressed by a standard or guidance."
Fluoride release, 1 week	Not explicitly defined standard	8.7 ppm	Lower than Equia (13.5 ppm). "Ketac Universal Aplicap and Equia release fluoride ions over a time period of at least 12 months."
Fluoride release, 2 weeks	Not explicitly defined standard	11.4 ppm	Equia data not provided.
Fluoride release, 1 month	Not explicitly defined standard	14.8 ppm	Lower than Equia (21.5 ppm). "The release of Equia is higher than Ketac Universal Aplicap during the first month. Afterwards the release rates are comparable."
Fluoride release (3,6,9,12 months)	Not explicitly defined standard	22.4, 29.2, 35.1, 39.8 ppm	Generally lower than Equia (30.4, 38.6, 44.6, 49.4 ppm) during the first month, then "comparable" release rates.
Compressive Strength (ISO 9917-1)	Limit of 100 MPa for glass polyalkenoate cements	188 MPa	Equia (200 MPa). Both "show comparable values according to the ISO method and both are above the limit of 100 MPa for glass polyalkenoate cements."
Compressive Strength (In-house)	Higher than predicate considered beneficial	251.4 MPa	Higher than Equia (206.7 MPa). "Should be beneficial for the longevity." "According to the modified method of ISO 9917-1."
3-Point Flexural Strength	Comparable to predicate (46.4 MPa)	50.2 MPa	"Similar 3-point flexural strengths." "Not addressed by a standard or guidance for water based glass ionomer cements." "Nearly identical."
Surface Hardness 24 hours	Higher than predicate considered beneficial	667.0 MPa	Higher than Equia (498.7 MPa). "Should be beneficial for the longevity." "Not addressed by a standard or guidance."
Biocompatibility	Safe for intended use per ISO and FDA guidance	Assessed as safe	Assessed by a board-certified toxicologist according to recommendations in FDA guidance and internationally recognized standards (ISO 10993 series, ISO 7405). The conclusion is that Ketac Universal Aplicap is safe for its intended use.

2. Sample sizes used for the test set and the data provenance

The document does not explicitly state the sample sizes for the "test set" (i.e., for the in vitro physical and mechanical properties comparison). For biocompatibility, it states "assessed by a board-certified toxicologist" but doesn't mention sample sizes of biological tests.

Regarding data provenance, the studies are described as "in-house testing" for some parameters (working time, setting time, compressive strength), and comparisons are made against ISO standards. The submitter is "3M Deutschland GmbH" in Germany, implying the data generation origin. The studies are in vitro evaluations of material properties, not clinical trials with patient data, so "retrospective or prospective" does not directly apply in the usual clinical sense.

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

This question is more pertinent to clinical studies or AI/diagnostic device evaluations where "expert ground truth" is established for patient cases. For this dental cement, the "ground truth" for material properties is established through standardized (e.g., ISO, P/L acid-base cements, Adhesives Notched Edge Sheer Bond Strength) or in-house mechanical and chemical testing methods.

For biocompatibility, the assessment was performed by "a board-certified toxicologist." The exact number (e.g., one or a team) is not specified.

4. Adjudication method for the test set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or expert reviews of ambiguous cases, particularly for AI diagnostic devices. This document describes material science testing and comparisons to predicate devices and standards, not a process that would involve human adjudication of results in that manner. The "comparison" is based on objective measurements and established chemical/physical principles.

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

No, an MRMC comparative effectiveness study was not done. These studies are specific to diagnostic devices, particularly those involving human interpretation (readers) and AI assistance, to assess changes in diagnostic performance. This document is for a dental cement.

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

This question is not applicable. The device is a dental cement, not an algorithm.

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

The "ground truth" for the performance comparisons comes from:

Standardized Test Methods: Adherence to, or comparison against, ISO standards (e.g., ISO 9917-1 for dental cements).
Predicate Device Performance: Direct measurement and comparison of properties against a legally marketed predicate device (Equia).
Clinical Literature Review: For bonding strength to dentin, "a clinical literature review showed that a performance in the range of Ketac Universal Aplicap are clinically sufficient." This implies that existing clinical evidence for similar materials and their performance is considered a form of "ground truth" for clinical sufficiency.
Toxicological Assessment: For biocompatibility, a board-certified toxicologist's assessment based on international standards forms the ground truth for safety.

8. The sample size for the training set

This is not applicable as the device is a dental cement, not an AI model requiring a training set.

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

Not applicable, as there is no training set for a dental cement.

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