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Stela Primer: - Dentin and enamel bonding
Stela Capsule - Direct Class I, II, III and V cavities. Ideally Class I and II - Base or liner - Core build-ups.

The Stela Capsule System is an easy to use bulk-fill radiopaque self-cure dental restorative system for dental professional use. The system comprises:

• Stela Capsule - a capsule consisting of powder and liquid components which are mixed and activated when the capsule is pushed down. After mixing with a triturator (amalgamator) an applicator is used to dispense the paste.
• Stela Primer an adhesive liquid packaged in a bottle. A bendable disposable brush applicator is used to apply Stela Primer.
  The combination of Stela Primer and Stela Capsule will bond to both enamel and dentin without scrubbing or light curing.

This is a 510(k) premarket notification for a dental device, specifically the Stela Capsule System. The provided text describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices. However, this document does not contain the detailed acceptance criteria for a study and the specific performance reported against those criteria in the format you requested for AI/algorithm performance.

The document discusses bench testing for physical and chemical properties of the dental material, and biocompatibility testing. These are not studies that define acceptance criteria or performance for an "AI/algorithm" device in the manner you've described.

Therefore, I cannot populate the table or answer questions 2 through 9 as they pertain to AI/algorithm performance in medical image analysis or similar AI-driven diagnostic/therapeutic applications.

The document indicates:

• The device is not an AI/algorithm-based device. It's a dental restorative material (capsule system and primer).
• No standalone or human-in-the-loop performance studies directly related to AI/algorithm performance were conducted or reported.
• No ground truth derived from experts or pathology for AI training/testing is mentioned.
• No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned.

However, I can extract information regarding the bench testing performance for the Stela Capsule System and how it met ISO standards, which serves as a form of "acceptance criteria" for this type of medical device.

Based on the provided text, here's what can be extracted regarding the material performance and acceptance criteria for the Stela Capsule System:

The Stela Capsule System underwent biocompatibility testing and non-clinical performance data (bench testing) to demonstrate its safety and effectiveness relative to predicate devices and relevant ISO standards.

1. Table of Acceptance Criteria and Reported Device Performance (for Bench Testing):

Regarding the other questions (AI/Algorithm specific):

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/algorithm study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/algorithm study. Ground truth in this context refers to chemical/physical measurements and biological reactions, not expert interpretations of data.
4. Adjudication method for the test set: Not applicable.
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 study was not done as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI device.
7. The type of ground truth used: For biocompatibility, the "ground truth" is the universally accepted biological response measures defined by ISO 10993 series. For bench testing, the "ground truth" is the physical and chemical properties measured against ISO 4049 and ISO 29022 standards.
8. The sample size for the training set: Not applicable. This device does not involve a training set for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

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The TOKUYAMA UNIVERSAL BOND II is indicated for:

• Direct anterior and posterior restorations with light-curing, dual-curing, and self-curing composite materials
• Intraoral repair of composite restorations, porcelain fused to metal, metal, and all-ceramic restorations without an additional primer
• Cementation of indirect restorations and veneers when combined with light-cure, dual-cure, and self-curing resin cements
• Bonding of core build-ups made of core build-up materials
• Bonding of denture resin to metal base, clasp or attachment
• Repair of denture with metal base, clasp or attachment
• Bonding of opaque resin to a metal base in the fabrication of resin-faced crowns

The TOKUYAMA UNIVERSAL BOND II device is a two-component self-cured dental adhesive system for both direct and indirect restorations that can be used with self-etch, selective-enamel-etch and total-etch techniques. As a universal adhesive, TOKUYAMA UNIVERSAL BOND II has been designed to be fully compatible with light-cured, self-cured and dual-cured composite materials.
TOKUYAMA UNIVERSAL BOND II contains phosphoric acid monomer, bisphenol A di(2-hydroxy propoxy) dimethacrylate (Bis-GMA), triethylene glycol dimethacrylate (TEGDMA), 2-Hydroxyethyl methacrylate (HEMA), MTU-6 (thiouracil monomer), silane coupling agent, peroxide, borate catalyst, acetone, ethanol and purified water.
Bond A and Bond B are packaged in separate plastic bottles. A group of polymerization agents is contained in the Bond A and Bond B to avoid reaction during storage, and the polymerization reaction begins upon mixing. When the mixture is applied thinly to adherends and concentrated by air-drying, a cured layer is formed by polymerization of methacrylic monomers. The cured layer functions as an adhesive layer for enhancing adhesiveness of polymerization resin to the adherends.
The device improves the bond strength of polymerizable resin material (adhesive resin cement, acrylic resin, and composite resin) to indirect restorative materials such as glass-ceramics (porcelain), oxide-ceramics (zirconia and alumina), metals (precious and non-precious), and resin materials including inorganic filler.
The TOKUYAMA UNIVERSAL BOND device does not come sterilized and is not intended to be sterilized prior to use.

The provided document describes the TOKUYAMA UNIVERSAL BOND II, a dental adhesive. The acceptance criteria and the study to prove the device meets these criteria are outlined through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes (number of replicates or specimens) used for each tensile bond strength test. However, it indicates that testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015. This ISO standard typically specifies details on sample preparation and testing procedures.

The data provenance is not explicitly stated in terms of country of origin, but the submitting company is Tokuyama Dental Corporation, located in Tokyo, Japan. The testing is non-clinical bench testing, so it is retrospective in the sense that it evaluates the manufactured device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This is a non-clinical bench testing study for a dental adhesive, not a study involving diagnostic interpretation or human expert judgment to establish ground truth for a test set. The ground truth for performance is objective physical measurements based on established ISO standards.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is non-clinical bench testing with objective physical measurements. There is no subjective adjudication required.

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 non-clinical study for a dental adhesive, not an AI-assisted diagnostic device.

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

Not applicable. This is a non-clinical study for a dental adhesive, not an algorithm. The device's performance is measured standalone from human intervention other than its application as per the instructions for use.

7. The Type of Ground Truth Used:

The ground truth used for performance evaluation is objective physical measurements of tensile bond strength and working time, compared against pre-defined in-house specifications (derived from the predicate device) and ISO standards. Biocompatibility was also assessed in accordance with ISO 10993-1:2009.

8. The Sample Size for the Training Set:

Not applicable. This device is a dental adhesive, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As this is not an AI/ML algorithm, there is no training set or associated ground truth establishment process.

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• All classes of direct restoration with composites (class I, II, III, IV and V);
• Adhesive luting (in addition to resin cement) of prosthetic pieces (post/cores, crowns, onlays/inlays, veneers etc.) made of fiberglass, ceromer, ceramic, resin and metal;
• Adhesive repairs in ceramic and composites.
  *Only for Ambar Universal APS: Use as metallic or ceramic primer.

Ambar APS is a light-curing 5th generation adhesive (two-step adhesive, total etch technique) for bonding restorative materials to dental tissue (enamel and/ or dentin). As the primer and the bonding agent are combined in a single bottle, acid etching is the only previous step needed before applying the adhesive to dentin and enamel.
Ambar Universal APS is a single flask self-etch light-curing adhesive system (Seventh Generation) responsible for the union between tooth structure (enamel and dentin) and restorative materials. The primer and bonding agent are combined in a single flask. Prior use of acid etchant is optional on both tooth 's enamel and dentin, it can be used, therefore, in three ways: self-etch, selective-etch and total-etch.

This document, a 510(k) premarket notification from the FDA, describes DentsCare LTDA's dental bonding agents (Ambar APS and Ambar Universal APS) and their substantial equivalence to predicate devices. The listed information pertains to the non-clinical testing conducted to demonstrate the device's performance characteristics, not a human-in-the-loop AI study. Therefore, sections related to multi-reader multi-case (MRMC) comparative effectiveness, number of experts for ground truth, adjudication methods, or training set details are not applicable here.

The study proves the device meets acceptance criteria through a series of physical and chemical tests comparing the subject devices to internationally recognized commercial adhesives (predicates).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are explicitly stated as "if the adhesive under study has a mean $\ge$ than the competing adhesives analyzed," or similar comparative statements.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes (e.g., number of specimens tested) for each physical/chemical test. It presents mean values with standard deviations, which implies multiple measurements were taken for each test. The data provenance is not specified beyond being "non-clinical testing" and conducted for a Brazilian manufacturer (DentsCare LTDA). It is implicitly a prospective evaluation of newly manufactured devices under controlled laboratory conditions, not retrospective or prospective patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable. The "ground truth" for this type of non-clinical testing is established by physical and chemical measurements (e.g., MPa for strength, pH values) performed in a laboratory setting, not by human expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

This section is not applicable, as the data collection involves objective physical/chemical measurements, not subjective evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This document describes non-clinical laboratory testing of dental bonding agents, not an AI-assisted diagnostic device evaluated with human readers.

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

Yes, in a sense, the performance described here is "standalone" to the device itself (the bonding agent) and its inherent physical/chemical properties, rather than its interaction with a human user or an AI algorithm. The performance metrics are intrinsic to the material.

7. The Type of Ground Truth Used

The ground truth used for these tests is objective, quantitative physical and chemical measurements obtained through laboratory testing, such as:

• Adhesive Strength: Measured in Megapascals (MPa).
• Conversion Rate: Percentage of monomer converted to polymer.
• Shear Bond Strength: Measured in Megapascals (MPa).
• pH: pH value.
• Viscosity: Measured in milliPascal-seconds (mPa.s).
• Water Sorption/Solubility: Measured in micrograms per cubic millimeter ($\mu g/mm^3$).
• Stability: Duration under specific temperature conditions.

8. The Sample Size for the Training Set

This section is not applicable. This is not an AI/machine learning study, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This section is not applicable, as there is no training set for this type of non-clinical device testing.

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1. Direct dental restorations (e.g., resin-based composites, resin-modified glass ionomers, resin core build-ups, compomers).
2. Indirect dental restorations (e.g., metal, resin-based composite, dental ceramics such as porcelain, pressed ceramic, lithium disilicate, lithium silicate or zirconia).
3. Desensitization of dentin.
4. Sealing of dentin, cementum or enamel.

The Parkell® Universal Adhesive is a single-component, one-bottle, light-cured universal bonding agent which utilizes proven 4-META and 10-MDP chemistry to enhance penetration into prepared enamel and dentin surfaces and to establish strong bonds to dental surfaces such as restorative composites, metals, dentin, enamel, cementum, and dental ceramics (e.g., porcelain, lithium disilicate, zirconia, or hybrid ceramics). The Device is useful for all direct and indirect dental restorations, desensitizing teeth, and sealing tooth structures against microleakage. Moreover, the Device can be used without prior acid-etching of dentin or cutting of enamel surfaces.

The Parkell® Universal Adhesive will be provided in a single bottle, with standard applicator brushes for applying the adhesive to treatment surfaces.

The provided document is a 510(k) premarket notification for the "Parkell® Universal Adhesive" and primarily focuses on demonstrating substantial equivalence to a predicate device, the "Scotchbond® Universal Adhesive."

Here's an analysis of the acceptance criteria and study information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the acceptance criterion for Shear Bond Strength is "at least about 6MPa" (denoted as "= 6 MPa | >= 6 MPa | >= 6 MPa |
| Dentin | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Silver alloy | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Cobalt-chrome alloy | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Porcelain, following acid etching | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Porcelain, following sandblasting | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Lithium disilicate, following sandblasting | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Lithium disilicate, following HF acid etching | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Zirconia, following sandblasting | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Composite Resin (self-cure) | >= 6 MPa | >= 6 MPa | >= 6 MPa |
| Composite Resin (light-cure) | >= 6 MPa | >= 6 MPa | >= 6 MPa |

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample size used for each shear bond strength test. It mentions that tests were performed "on a variety of dental substrates." The data provenance is not specified (e.g., country of origin, retrospective or prospective), but it's implied to be laboratory testing as part of a premarket notification for a dental adhesive.

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

This information is not applicable as the study described is a laboratory performance test (shear bond strength) for a dental adhesive, not a study involving expert-derived ground truth. The "ground truth" here is the physical measurement of bond strength.

4. Adjudication method for the test set:

This information is not applicable for the same reason as point 3.

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:

This is not applicable. The device is a dental adhesive, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is a physical product (dental adhesive), not an algorithm. The shear bond strength tests are a form of standalone performance evaluation for the physical properties of the adhesive.

7. The type of ground truth used:

The "ground truth" for the performance evaluation of the dental adhesive is based on physical measurement of shear bond strength in a laboratory setting, in accordance with ISO standards.

8. The sample size for the training set:

This is not applicable. The device is a physical product (dental adhesive), not a machine learning model that requires a training set.

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

This is not applicable for the same reason as point 8.

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