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Permanent cementation of pediatric crowns:

• Stainless Steel crowns
• Zirconia crowns
• 3M™ Pediatric Esthetic Crowns

3MTM RelyX™ Pediatric Resin Modified Glass Ionomer Cement is a radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement. RelyX Pediatric Cement is intended for the cementation of preformed pediatric crowns made of stainless steel, zirconia, and resin composite material.

RelyX Pediatric Cement consists of a base paste and a catalyst paste packaged in the Automix delivery system for direct delivery in consistent mix ratios. The mixing tip attachment offers convenience over traditional hand mixed cement systems and delivers consistent mix ratios. The cement is available in a white shade. The Automix syringe contains 8.5 g of cement material. The product provides both selfcuring and light curing mechanisms which makes it uniquely versatile for the cementation of different restorative materials.

Here's an analysis of the acceptance criteria and the study details for the 3M™ RelyX™ Pediatric Resin Modified Glass Ionomer Cement, based on the provided text:

Important Note: The provided document is a 510(k) summary for a dental cement. It does not describe an AI medical device, but rather a traditional medical device that undergoes physical and chemical performance testing to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested fields related to AI, such as sample sizes for test/training sets, data provenance, ground truth experts, adjudication methods, and MRMC studies, are not applicable and thus not present in this type of document.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implied by the demonstration of "equivalent or superior bonding" and other physical properties compared to predicate devices. The document does not explicitly list numerical acceptance criteria in a table format for each property, but rather states that the "results submitted in the 510(k) demonstrated equivalent or superior bonding."

Here's a table based on the reported performance relative to predicate devices:

Study Details

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

   • Sample Size: Not explicitly stated for each test. The document mentions "data from in vitro testing," which typically involves multiple samples for each test (e.g., several samples per group for adhesion tests, compressive strength, etc.), but the exact number is not provided.
   • Data Provenance: The studies were in vitro testing. The country of origin of the data is not specified, but the submitter is 3M ESPE Dental Products, located in St. Paul, MN, USA. The testing was conducted to support a 510(k) submission to the U.S. FDA. The studies are by nature prospective in the sense that the manufacturer performed them to gain clearance for the device.

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

   • This is not applicable as this is not an AI/diagnostic device. The "ground truth" for material properties is established through standardized physical and chemical testing methods (e.g., ISO standards), not expert consensus.

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

   • Not applicable for this type of in vitro material performance testing. Standardized test methods and measurements are used, not human adjudication.

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:

   • Not applicable. This is not an AI medical device.

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

   • Not applicable. This is not an AI medical device.

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

   • For the physical and chemical properties (adhesion, strength, fluoride release, etc.), the "ground truth" is determined by the results obtained from standardized in vitro test methods (e.g., per FDA Guidance "Dental Cements - Premarket Notification" and ISO 9917-2:2017). For biocompatibility, the ground truth is established by meeting the requirements of ISO 10993-1:2018.

7. The sample size for the training set:

   • Not applicable. This is not an AI medical device, so there is no "training set."

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

   • Not applicable. This is not an AI medical device, so there is no "training set" or corresponding ground truth establishment process in that context.

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Self-curing glass ionomer based radiopaque filling cement, for dental use only. Recommended Indications:
(1) Restoration of primary teeth.
(2) Restorations of Class III, V and limited Class I cavities.
(3) Base linings under composite and amalgam.
(4) Core build-up.

Glass Ionomer Cement (Filling) has two types: Filling II. It is a device composed of various materials including Silica, Alumina, Strontium Fluoride in the powder composition and Poly Carboxylic Acid in the liquid composition which intended to serve as a permanent or temporary tooth filling or as base linings. It's a powder liquid system. The basic operation principle of Glass Ionomer Cement (Filling) is acid-base reaction.

The provided document describes the acceptance criteria and the study (physical and chemical properties tests) for the "Glass Ionomer Cement (Filling)" device (K160345).

Here's the breakdown of the requested information:

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

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

The document does not specify the sample size used for each physical and chemical properties test. It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that it refers to ISO standards and a submission by a Chinese company, it's highly probable the testing was conducted in a laboratory in China following international standards.

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

This section is not applicable as the study described is a series of laboratory-based physical and chemical properties tests against predefined ISO standards, not a clinical study involving human assessment or interpretation requiring expert ground truth establishment.

4. Adjudication method for the test set

This section is not applicable as the study described is a series of laboratory-based physical and chemical properties tests against predefined ISO standards. There is no mention of adjudication for these types of tests.

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 section is not applicable. The document describes a traditional device clearance for a dental material (Glass Ionomer Cement), not an AI-powered diagnostic or assistive device.

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

This section is not applicable as the device is a physical dental material, not an algorithm or AI.

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

The "ground truth" for the performance criteria in this context is established by the ISO 9917-1:2007 standard for Dentistry — Water-based cements - Part 1: Powder/liquid acid-base cements. The reported performance is a direct measurement against these internationally recognized physical and chemical property specifications.

8. The sample size for the training set

This section is not applicable as the device is a physical dental material and not an AI/ML algorithm that requires a training set.

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

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

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Self-curing glass ionomer based radiopaque luting cement, for dental use only. Recommended indications:

(1) Cementation of metal-based inlays, onlays, crowns and bridges;

• (2) Cementation of high strength (zirconia based) all ceramic crowns and bridges;
• (3) Cementation of posts and screws made of metal or high-strength ceramic;
• (4) Cementation of orthodontic bands;
• (5) Restoration of caries in unstressed area (Luting II only).

Glass Ionomer Cement (Luting) has two models: Luting II. It is a device composed of various materials mainly including Silica, Alumina, Strontium Fluoride in the powder composition and Poly Carboxylic Acid in the liquid composition which intended to serve as luting to affix dental devices such as metal-based inlays, onlays, crowns, bridges, and orthodontic bands. It's a powder liquid system, with each part is packaged separately when not in use. The basic operation principle of Glass Ionomer Cement (Luting) is acid-base reaction.

The provided document is a 510(k) summary for a "Glass Ionomer Cement (Luting)" device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on algorithm-driven performance. Therefore, most of the requested information about AI/algorithm-related studies (sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) is not applicable to this document.

However, the document does contain a table of acceptance criteria and reported performance for physical and chemical properties based on the ISO 9917-1:2007 standard.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

• Powder: Free from extraneous material.
• Unset cement: Homogeneous and of a smooth consistency. | Within spec set by standard |
  | 8.1 Net setting time | - For luting: 1.5~8 min
• For restoration: 1.5~6 min | Within spec set by standard |
  | 8.2 Film thickness | - For luting: ≤25 µm
• For restoration: N/A | Within spec set by standard |
  | 8.3 Compressive strength | - For luting: ≥50 MPa
• For restoration: ≥100 MPa | Within spec set by standard |
  | 8.4 Acid erosion | - For luting: ≤0.17 mm
• For restoration: ≤0.17 mm | Within spec set by standard |
  | 8.6.2 Acid-soluble Lead content | - For luting: ≤100 mg/kg
• For restoration: ≤100 mg/kg | Within spec set by standard |
  | 8.7 Radio-opacity | The radio-opacity shall be at least equivalent to that for the same thickness of aluminium. | Within spec set by standard |

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

The document does not specify exact sample sizes for each physical/chemical property test. It mentions that "Biocompatibility tests were performed to satisfied the ISO 10993 standards," but does not detail the specific sample counts for those tests. The data provenance is internal testing conducted by SHANDONG HUGE DENTAL MATERIAL CORPORATION, presumably prospective testing for this specific device.

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

Not applicable. The tests are for physical and chemical properties, measured objectively according to ISO standards, not interpreted by human experts.

4. Adjudication method for the test set

Not applicable. The tests are objective measurements, not subject to adjudication.

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 cement, not an AI-powered diagnostic device.

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

Not applicable. This is a dental cement, not an algorithm.

7. The type of ground truth used

The "ground truth" for the physical and chemical property tests is defined by the specific measurement methodologies and acceptable ranges stipulated in the ISO 9917-1:2007 standard. For biocompatibility, the ground truth would be the thresholds and methodologies defined by ISO 10993 standards.

8. The sample size for the training set

Not applicable. There is no AI algorithm being trained.

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

Not applicable. There is no AI algorithm being trained.

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PULPDENT Triple-Cure™ Paste / Paste Resin-Reinforced Glass lonomer Cement is used to adhere orthodontic brackets and bands to teeth, to cement metallic restorations and as a base and liner under restorations. It combines the advantages of a glass ionomer cement with the added strength of dental resin technology. Triple-Cure™ Paste is a fluoride-releasing, light-cure, self-cure, glass ionomer dental cement in two paste form. It is not recommended for post cementation or veneer cementation.

PULPDENT Triple-Cure™ Paste / Paste Resin-Reinforced Glass Ionomer Cement is used to adhere orthodontic brackets and bands to teeth, to cement metallic restorations and as a base and liner under restorations. It combines the advantages of a glass ionomer cement with the added strength of dental resin technology. Triple-Cure™ Paste / Paste is a fluoride-releasing, light-cure, self-cure, glass ionomer dental cement in two paste form. It is not recommended for post cementation or veneer cementation.

This document (K030036) is a 510(k) premarket notification for a dental device, Pulpdent Triple-Cure™ Paste/Paste Resin Reinforced Glass Ionomer Cement. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of typical AI/medical device performance evaluation.

Here's why and what information is available:

• Type of Device: This is a physical dental cement, not an AI/software as a medical device (SaMD). The evaluation process for physical materials like dental cements focuses on material properties, biocompatibility, and substantial equivalence to existing products.
• Regulatory Pathway: The 510(k) pathway (Premarket Notification) is used for devices that are substantially equivalent to existing legally marketed devices. This means the primary evidence required is a comparison to predicates, not a de novo study with acceptance criteria for novel performance.
• "Safety and Effectiveness" Section: The document references the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials, which states: "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio...both composites and glass ionomers are relatively trouble-free. There is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States." This is a general statement about the class of materials, not specific acceptance criteria or performance metrics for this particular device. It's used to support the overall safety of the material type.

Based on the provided text, I cannot complete the requested tables and information about acceptance criteria and a study to prove they are met because such a study, with specific acceptance criteria and performance metrics (like sensitivity, specificity, etc.), is not part of this 510(k) submission.

However, I can extract the relevant information about the device and its regulatory context:

Device Information:

• Trade Name: PULPDENT Triple-Cure™ Paste / Paste Resin-Reinforced Glass Ionomer Cement
• Classification Name: Adhesive, Bracket and Tooth Conditioner, Resin
• FDA Product Code: DYH, 21 CFR Part 872.3750 (also EMA listed later in the letter)
• Intended Use: Used to adhere orthodontic brackets and bands to teeth, to cement metallic restorations, and as a base and liner under restorations. It's a fluoride-releasing, light-cure, self-cure, glass ionomer dental cement in two paste form.
• Not Recommended for: Post cementation or veneer cementation.
• Predicate Devices:
  • Pulpdent Triple-Cure™ Reinforced Glass Ionomer Orthodontic Cement (This appears to be an earlier version or related product by the same company)
  • GC Fuji Ortho LC (light-cure)
  • GC Fuji Ortho Self-cure
  • Pulpdent Band-Rite

The core of this submission is the "Comparison with Predicate Products," which states: "PULPDENT Triple Cure Paste / Paste is substantially equivalent in composition and intended use to the predicate products listed above. Please see Exhibit 4 for the entire comparison." (Exhibit 4 is not provided in the input text).

Conclusion:

This document is a formal FDA communication regarding a 510(k) clearance for a physical dental cement. It demonstrates substantial equivalence to existing predicate devices, focusing on composition and intended use rather than presenting performance data against specific acceptance criteria in the manner one would for a novel AI/SaMD.

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Glass Ionomer cement is used in a luting application and referred to as a cement for the attachment of indirect restorations and appliances to the teeth. The glass ionomer cements also bond adhesively to tooth structure and they inhibit infiltration of oral fluids at the cement-tooth interface.

Not Found

I apologize, but the provided text from the FDA 510(k) notification for Medental Glass Ionomer Cement Type I and Mirage Glass Ionomer does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

The document is a letter from the FDA stating that the device is substantially equivalent to a predicate device and can therefore be marketed. It outlines regulatory requirements and contact information for further inquiries.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set or data provenance
• Number of experts used to establish ground truth or their qualifications
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

To provide this information, you would need to supply a different document, such as a summary of safety and effectiveness, a clinical study report, or a pre-market approval application summary, which typically contains details about performance testing and acceptance criteria.

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For cementing CR ENDOdontic posts, OR orthodoutics Ensociation ports, and be used as A. Filling or core buildup material, filling or correst, first

Not Found

The provided text is a 510(k) clearance letter from the FDA for a dental cement product. It confirms the device's substantial equivalence to a predicate device but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for the specific information regarding a study proving the device meets acceptance criteria. The letter primarily focuses on regulatory approval and compliance.

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