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Stela Primer:

• Dentin and enamel bonding

Stela Automix:

• Direct Class I, II, III and V cavities. Ideally Class I and II.
• Base or liner
• Core build-ups.

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

• Stela Automix a double-barrel syringe containing two pastes which are mixed and dispensed with a single-use mixing tip and
• 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 Automix will bond to both enamel and dentin without scrubbing or light curing.

The provided text describes a 510(k) premarket notification for a dental device (Stela Automix System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving the device meets specific performance acceptance criteria for an AI/ML medical device or a new type of device.

Therefore, the document does not contain the information needed to answer your request about acceptance criteria, study design for AI/ML performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies.

The document primarily discusses:

• Biocompatibility testing: To ensure the device materials are safe for biological contact.
• Non-clinical performance data (bench testing): To compare the physical and chemical properties of the Stela Automix System to predicate devices and ensure it meets relevant ISO standards (e.g., working time, setting time, flexural strength, shade, color stability, radio-opacity, shear bond strength).

No information regarding AI/ML device performance, human-in-the-loop studies, or the statistical details usually associated with such studies (like sample size for test sets, number of experts for ground truth, adjudication methods, or training set details) is present because this is not an AI/ML device.

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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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Permanent cementation of:

• 1. Porcelain fused to metal (PFM) to crowns and bridges
• 2. Prefabricated/cast posts
• 3. Metals to crowns, bridges, inlays & onlays, orthodontic appliances & posts
• 4. Ceramics (high strength)* to crowns & bridges, inlays & onlays
• *E.g. Zirconia, Lithium Disilicate,
• 5. Ceramics (low strength)* to inlays
• *E.g. Feldspathic porcelains, Glass ceramics

Riva Cem Automix™ is a radiopaque, fluoride releasing, resin modified glass ionomer luting cement.

Riva Cem Automix™ is intended for the cementation of crowns, bridges, inlays, posts (fibre-reinforced), and orthodontic appliances.

Riva Cem Automix™ consists of a base paste and a catalyst paste packaged in the automix delivery system for direct delivery in consistent mix ratios. Riva Cem Automix™ is available in a universal light-yellow shade in a double barrel syringe. The automix tip offers convenience over traditional hand mixed systems.

The product provides both self-cure and tack cure mechanisms which makes it versatile for the cementation of different restorative systems.

The provided text is a 510(k) premarket notification for a dental cement called "Riva Cem Automix." It focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility testing, rather than an AI-powered diagnostic device. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving an AI device meets those criteria.

Specifically, the document lacks information on:

1. Acceptance criteria for an AI device and reported device performance: The document details acceptance criteria and performance for a dental cement, focusing on physical and chemical properties like working time, setting time, film thickness, flexural strength, radio-opacity, shear bond strength, and fluoride release. These are not acceptance criteria for an AI device.
2. Sample size for a test set and data provenance: No AI test set is mentioned. The "performance data" section refers to in-vitro bench tests for a physical product.
3. Number of experts and their qualifications for ground truth: Not applicable as it's not an AI device study requiring human expert labeling of data.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted as it's not an AI device study.
6. Standalone (algorithm-only) performance: Not applicable.
7. Type of ground truth used: For the dental cement, the ground truth is established by standardized laboratory testing methods (e.g., ISO standards) measuring physical and chemical properties, not expert consensus or pathology on images.
8. Sample size for the training set: Not applicable as no AI training set is mentioned.
9. How ground truth for the training set was established: Not applicable.

In summary, the provided document describes the regulatory approval of a dental cement, not an AI medical device.

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Direct Applications:

• Light cured composite restorations
• Light cured compomers
• Cavity sealing prior to placement of indirect restorations
• Composite repair of porcelain and hybrid ceramic restorations
• Sealing exposed root surfaces which are causing hypersensitivity
• Core build ups using light cure/dual cure composites
• Protective varnish for glass ionomer (GI) filling

Indirect Applications:

• Cementation indirect restorations

Zipbond is a single-component, (meth)acrylate-based material which functions as a combined etch-and-rinse (total-etch), self-etch and selective-etch dental adhesive. It offers an adhesive application technique for both direct indications and bonds to enamel, dentin, composites, cements. When used with a LED light curing device, Zipbond can be used with self-cure, dual-cure and light cure resin cements, composites and core-build up materials. Zipbond provides the operator with three choices of enamel and dentin pre-treatment: Self-etch mode: no phosphoric acid etching required prior to application, Selective-etch mode: selective phosphoric acid etching to enamel, Total-etch mode: phosphoric acid etching of both enamel and dentin.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Zipbond™ device:

It's important to note that the provided documents are a 510(k) premarket notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically focuses on comparing the new device against the predicate, rather than establishing strict acceptance criteria for a novel technology or conducting extensive standalone performance studies with human readers, as might be done for an AI/software as a medical device (SaMD).

Therefore, some of the requested information (like MRMC studies, specific effect sizes of AI with human readers, or detailed ground truth establishment for large training sets) is not applicable or not explicitly detailed in this type of submission for a dental bonding agent.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device and meeting relevant ISO standards.

Table of Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: Not explicitly stated for each test (pH, shear bond strength, biocompatibility). These are typically laboratory bench tests, where sample sizes are determined by statistical requirements for each specific test, but not usually presented in the 510(k) summary as "test set sample size" in the context of imaging or AI.
   • Data Provenance: The studies are in-vitro bench tests and biocompatibility tests conducted for the purpose of this 510(k) submission. They are prospective tests conducted by SDI Limited. The country of origin of the data would be Australia, where SDI Limited is based.

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

   • This information is not applicable in the context of this device and study. For a dental bonding agent, "ground truth" typically refers to physical measurements and standardized test results rather than expert interpretation of medical images or diagnostic outcomes. The "ground truth" for bond strength, pH, or biocompatibility is established by the methods themselves, not by expert consensus.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in expert-dependent tasks, such as reviewing medical images. For physical and biocompatibility testing of a dental material, the results are typically objectively measured outcomes of the standardized tests.

4. 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 is not applicable for a dental bonding agent. This type of study is relevant for evaluating diagnostic imaging software where human readers (e.g., radiologists) use AI assistance to improve their performance. Zipbond™ is a physical dental material, not an AI-powered diagnostic tool.

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

   • Not applicable. Zipbond™ is a chemical product (dental bonding agent), not an algorithm or a software device. The "standalone" performance here refers to its efficacy and safety as a product itself, which is what the non-clinical performance data (pH, shear bond strength, biocompatibility) aims to demonstrate.

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

   • The "ground truth" for the non-clinical performance data is based on objective, standardized laboratory measurements according to established ISO protocols (e.g., ISO 29022:2013 for shear bond strength, ISO 10993-1 and ISO 7405 for biocompatibility) and internal methods (e.g., pH measurement). It is not based on expert consensus, pathology, or outcomes data in the typical sense used for diagnostic devices.

7. The sample size for the training set:

   • Not applicable. As Zipbond™ is a dental material and not an AI/machine learning model, there is no "training set" in the context of algorithm development.

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

   • Not applicable. There is no "training set" for this device.

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Treatment of dentinal hypersensitivity. For use in adults over the age of 21.

Riva Star is a two-component device made up of Riva Star Step 1, containing silver diamine fluoride liquid, and Riva Star Step 2, containing aqueous potassium iodide liquid. Riva Star Step 1 silver diamine fluoride solution is applied to the tooth, immediately followed by Riva Star Step 2 aqueous potassium iodide, which forms an immediate reaction precipitate of silver iodide, thereby reducing tooth sensitivity by physically occluding the open dentinal tubules. Riva Star as well as predicates are liquids or gels that are applied to the teeth using an applicator brush or similar application.

The provided text describes the performance and equivalency of the device "Riva Star" to predicate devices, primarily "Advantage Arrest" and "Super Seal," for the treatment of dentinal hypersensitivity. However, the text does not contain a formal table of "acceptance criteria" and subsequent "reported device performance" against those criteria in a structured format. Instead, it discusses comparability to predicate devices and results from various tests, which indirectly serve as evidence of the device's acceptable performance.

Based on the information provided, here's a structured response outlining the key aspects:

1. Table of Acceptance Criteria and Reported Device Performance

As there is no explicit table of quantitative acceptance criteria provided in the text, I will infer what appears to be the implicit acceptance criteria from the non-clinical and clinical performance testing sections and present the reported performance of Riva Star against those objectives. The primary objective is substantial equivalence to predicate devices.

• Ion Release: Riva Star released less fluoride and silver ions compared to primary predicate Advantage Arrest in a 7-day in vitro study, "demonstrating that Riva Star is as safe as Advantage Arrest."
• Biocompatibility: Passed Cytotoxicity (ISO Agarose, ISO Direct contact), Sensitisation (ISO Guinea Pig Maximization Sensitization), Oral Mucosal Irritation (Hamsters, collar method, 7 day), and Oral Acute Toxicity (Mice - 7 day) tests, providing "evidence of biocompatibility." Cytotoxicity results were "equivalent" to Advantage Arrest. |
  | 6. Shelf Life | Met: Stability testing established a shelf life of "25 months when stored between 2ºC (35ºF) to 8ºC (45ºF)." |
  | 7. Clinical Effectiveness in Reducing Dentinal Hypersensitivity | Met: A double-blind randomized clinical trial showed that "Riva Star was more effective than Super Seal in reducing dentine hypersensitivity after 7 days." This demonstrates clinical effectiveness, furthering the case for substantial equivalence. |

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

• Non-Clinical Hydraulic Conductance Study: Not explicitly stated how many dentin samples were used.
• Non-Clinical In Vitro Ion Release Study: Not explicitly stated how many samples of Riva Star and Advantage Arrest were tested.
• Biocompatibility Studies (Animals):
  • Sensitization: Guinea Pigs (sample size not specified)
  • Oral Mucosal Irritation: Hamsters (sample size not specified)
  • Oral Acute Toxicity: Mice (sample size not specified)
• Clinical Performance Testing:
  • Sample Size: Patients with "recognisable tooth sensitivity on both sides of their upper arch" (Exact number of patients/teeth not specified, but implied to be sufficient for a randomized clinical trial).
  • Data Provenance: The study was a "double blind randomised clinical trial on patients." The country of origin is not explicitly stated in the provided text.
  • Retrospective or Prospective: Prospective (clinical trial).

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

• Clinical Performance Testing: Ground truth (reduction in dentinal hypersensitivity) was established by patient responses recorded on a Visual Analogue Scale (VAS). This indicates self-reported patient pain levels, not expert consensus as the primary ground truth.
• Non-Clinical Studies: Ground truth for hydraulic conductance, SEM imaging, ion release, and biocompatibility was established through objective laboratory measurements and biological assays, not expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

• Clinical Performance Testing: The primary "ground truth" was patient-reported pain levels via Visual Analogue Scale (VAS). This is a self-adjudication method. The trial was "double blind randomized," suggesting measures were taken to prevent bias in data collection and interpretation. No external expert adjudication method (e.g., 2+1, 3+1) is mentioned for the clinical trial.
• Non-Clinical Studies: No adjudication method as these involved objective laboratory measurements.

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 involving human readers or AI assistance was not mentioned. The device, Riva Star, is a dental product (tooth desensitizer), not an imaging or diagnostic AI-powered device that would typically undergo such a study design.

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

• Not applicable. Riva Star is a physical product (liquid solution) applied by a clinician, not an algorithm.

7. The Type of Ground Truth Used

• Non-Clinical Studies (Hydraulic Conductance, SEM, Ion Release, Stability): Objective laboratory measurements and observations (e.g., fluid flow rate, microscopic images showing precipitate formation, ion concentrations, physical property measurements).
• Biocompatibility Studies: Biological assay results (e.g., cell viability, observed irritation/sensitization responses in animal models).
• Clinical Performance Testing: Patient-reported outcomes (self-reported pain levels) using a Visual Analogue Scale (VAS).

8. The Sample Size for the Training Set

• Not applicable. Riva Star is a physical medical device, not an AI/machine learning algorithm requiring a training set.

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

• Not applicable, as there is no training set for this device.

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Direct anterior/posterior restorations and veneers. Core build ups. Indirect inlays, onlays and veneers. Splinting. Composite and porcelain repair. Sandwich technique with glass ionomers. For professional use only.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a dental device called "Aura." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria for the device's performance, the results of any studies demonstrating the device meets such criteria, or details regarding study design, sample sizes, expert involvement, or adjudication methods.

Therefore, I cannot provide the requested table and study details. The document primarily focuses on regulatory approval based on substantial equivalence, rather than detailed performance study results.

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