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Used as impression materials in a dual phase impression technique. They may also be used for precise duplication of models. Use Regular Set for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs a monophase, heavy, or low viscosity material. Use Fast Set for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.

AQUASIL ULTRA MONOPHASE, AQUASIL ULTRA HEAVY, AND AQUASIL ULTRA LV SMART WETTING IMPRESSION MATERIALS are two-part catalyst/base hydrophilic vinylpolysiloxane impression materials used to record details of hard and soft tissues of the oral cavity. They are formulated for regular set and fast set. AQUASIL ULTRA MONOPHASE and AQUASIL ULTRA HEAVY SMART WETTING IMPRESSION MATERIALS are medium viscosity and available in (1:1 ratio) cartridges or (5:1 ratio) for bulk delivery. AQUASIL ULTRA LV SMART WETTING IMPRESSION MATERIAL is a light viscosity and is available in (1:1 ratio) cartridges.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.

The document is a 510(k) summary for a dental impression material (Aquasil Ultra Smart Wetting Impression Material). It describes the device, its intended use, and states that it is substantially equivalent to a previously cleared predicate device (Aquasil Monophase & Heavy and LV™ S.W. Impression Materials K943574). The letter from the FDA confirms this substantial equivalence.

No studies or performance data related to acceptance criteria are mentioned in the provided text.

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AQUASIL™ RIGID Regular Set SMART WETTING IMPRESSION MATERIAL is designed as a firm tray material. It is designed to be used with Aquasil™ LV (light viscosity) Impression Material (K943574) in a dual phase impression Technique. The combination is ideal for the double arch (Caulk First Bite™ Trays) dual phase technique. The combination may also be used for precise duplications of models.

AQUASIL™ RIGID Fast Set SMART WETTING IMPRESSION MATERIAL is designed as a firm tray material. It is designed to be used with Aquasil™ LV Fast Set Impression Material in a dual phase impression Technique, capturing one or two adjacent preparations. The combination is ideal for the double arch (Caulk® First Bite™ Trays) dual phase technique. The combination may also be used for precise duplications of models.

AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL is a two-part (base/catalyst) hydrophilic vinylpolysiloxane (VPS), crown and bridge impression material used to record the details of hard and soft surfaces of the oral cavity.

AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL is available in Regular Set and Fast Set. These elastomeric impression materials have excellent hydrophilic properties, dimensional accuracy, high tear strength, and resistance to permanent deformation.

AQUASIL™ RIGID Regular Set and Fast Set IMPRESSION MATERIALs improve both wetting on the tooth surface and model detail reproduction.

The provided text describes a 510(k) summary for a dental impression material (AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL). This document focuses on demonstrating substantial equivalence to a predicate device, primarily through biocompatibility testing and a brief mention of "performance data". However, it does not contain the specific information required to answer the questions about acceptance criteria, device performance,study details, and AI-related metrics.

Here's a breakdown of what can be inferred or what is explicitly missing:

Missing Information:

The document is a pre-market notification (510k) for a medical device that is a material, not an AI software or a device that has "performance" in the way an AI algorithm would have sensitivity, specificity, etc. Therefore, most of the requested information (items 1-9) is not applicable or cannot be extracted from this type of regulatory submission. The "performance data" mentioned is likely related to physical properties of the impression material, not a clinical study involving human readers or comparative effectiveness with an AI.

Specific Points Addressing the Request (or explaining why it's not present):

1. Table of acceptance criteria and reported device performance: Not provided. The document focuses on biocompatibility and general characteristics like hydrophilicity, dimensional accuracy, tear strength, and resistance to permanent deformation, but doesn't quantify "acceptance criteria" in a table format with specific performance metrics for these properties.
2. Sample size for the test set and data provenance: No specific test set for performance (as would be measured for an AI device) is mentioned. The biocompatibility tests involved "catalyst and base pastes and the mixed product." Data provenance (country of origin, retrospective/prospective) is not applicable or stated for material testing.
3. Number of experts used to establish ground truth and qualifications: Not applicable. Ground truth for an AI device is not relevant here. Biocompatibility tests are laboratory-based.
4. Adjudication method for the test set: Not applicable. Material testing rather than image interpretation.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is a material, not an AI or image-based diagnostic device.
6. Standalone (algorithm only) performance: Not applicable. This is a physical impression material.
7. Type of ground truth used: Not applicable. Biocompatibility results are laboratory measurements (cytotoxicity levels, mutagenicity, irritation scores), not ground truth in the context of an AI study.
8. Sample size for the training set: Not applicable. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.

What is present in relation to "performance" and "criteria" (albeit not in the requested format):

• Biocompatibility Testing (for the predicate device K943574):
  • Evaluated for: Cytotoxicity (base pastes gave moderate; catalyst pastes non-cytotoxic; mixed product lower value than Reprosil), Dermal Toxicity (mixed product: non-toxic), Irritation (mixed product: non-irritant), Mutagenicity (mixed product: non-mutagenic via Ames test).
• Performance Characteristics (for the new device AQUASIL™ RIGID SMART WETTING IMPRESSION MATERIAL):
  • Hydrophilic properties
  • Dimensional accuracy
  • High tear strength
  • Resistance to permanent deformation
  • Improved wetting on the tooth surface
  • Improved model detail reproduction

Conclusion:

The provided 510(k) summary is for a dental impression material and does not detail the kind of acceptance criteria and studies relevant to an AI/software device or a comparative effectiveness study involving human readers. The "performance data" mentioned refers to physical and biological properties of the material itself, not diagnostic accuracy or expert interpretation.

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