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Bioplant is a synthetically derived, spherical material which is intended to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region in the below indications.

1. To maintain and restore the bony alveolar ridge after extraction of tooth-roots, i.e., Ridge preservation/Socket grafting;
2. To restore infra-bony defects caused by destructive periodontal disease, i.e., 2-3 wall defects/Class I, II and III furcations;
3. To augment bony defects, i.e., apicocctomies, cystic formation or tumor removal;
4. Ridge augmentation to restore the height and/or width of severely atrophicd alveolar ridges;
5. Augmentations in the maxillary sinus;
6. Trone voids associated with implant placement.

Bioplant is a synthetic polymer bone void filling material which, due to its porosily characteristics, is capable of supporting ingrowth of bony tissue. This non-resorbable and radio-opaque material is used to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region. The material consists of poly methylmethacrylate (PMMA) beads coated with poly hydroxyethyl methacrylate (PHEMA) to increase hydrophlicity of the porous structure, a thin layer of barium sulfate for radio-opacity, and calcium hydroxide for hydrophilicity and to promote bone growth around the PMMA beads. The average particle size of the beads is 750 microns. The product is sterliked using gamma radiation.

The provided document is a 510(k) summary for the device "BIOPLANT," a synthetic bone grafting material. It is a premarket notification to the FDA to demonstrate substantial equivalence to previously marketed devices. This type of document focuses on comparing a new device to existing ones rather than presenting a study outlining specific acceptance criteria and performance metrics in the way a clinical trial or performance study report for an AI/ML medical device would.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as it relates to performance validation with specific metrics, sample sizes, expert involvement, or AI/ML-specific details.

Here's why and what information is available (and what is missing):

Information Provided in the Document:

• Device Name: BIOPLANT (Trade Name), Synthetic Bone Grafting Material (Common Name)
• Intended Use/Indications For Use: To fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region for various conditions listed on pages 1 and 4.
• Substantial Equivalence Claim: The document claims substantial equivalence to Heracus Kulzer, Ostim Bone Grafting Material, and Biomet Inc., HTR-MX. This is the primary "proof" offered for its marketability.
• Device Description: Details on its composition (PMMA beads coated with PHEMA, barium sulfate, calcium hydroxide), average particle size (750 microns), and sterilization method (gamma radiation).
• Regulatory Classification: Class II device, Product Code LYC, Regulation Number 21 CFR 872.3930 (Bone grafting material).

Missing Information (which would be present in a study report for an AI/ML device):

1. Table of Acceptance Criteria and Reported Device Performance: This document does not establish specific acceptance criteria (e.g., minimum sensitivity, specificity, accuracy, or performance against a baseline) for the BIOPLANT device, nor does it report specific performance metrics from a study against such criteria. The entire premise is substantial equivalence to existing devices.
2. Sample Size Used for the Test Set and Data Provenance: Not applicable. There is no performance study described with a test set of data.
3. Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. No ground truth establishment is described for a performance study.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned or applicable. This is not an AI/ML device, nor is it a comparative effectiveness study involving human readers.
6. Standalone (Algorithm Only) Performance Study: Not applicable, as this is a physical medical device, not an algorithm.
7. Type of Ground Truth Used: Not applicable.
8. Sample Size for the Training Set: Not applicable. There is no AI/ML model or training set.
9. How the Ground Truth for the Training Set Was Established: Not applicable.

Conclusion:

The provided document is a 510(k) summary for a synthetic bone grafting material. It demonstrates the device's substantial equivalence to predicate devices already on the market through comparison of intended use, technological characteristics, and safety information. It does not describe a study with performance acceptance criteria, sample sizes, expert ground truth establishment, or other details typically found in a clinical or performance study report for a novel medical device, especially an AI/ML-driven one.

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OptiBond FL is a multi-purpose bonding agent designed to be used in the following situations: composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up materials, and veneers, onlays, and inlays.

The device is a multi-purpose bonding agent designed to be used in the following situations: composite to enamel and/or dentin, composite repair, composite to metal, bonding composite core build-up materials, and veneers, onlays, and inlays.

This document is a 510(k) summary for a dental resin bonding agent, not a study report for a digital health device or AI/ML algorithm. Therefore, it does not contain the information required to answer your specific questions regarding acceptance criteria and a study proving device performance in the context of an AI/ML device.

Here's why and what information is available:

• Device Type: The device described, OptiBond FL, is a Resin Tooth Bonding Agent (a physical dental material), not a digital health device or an AI/ML algorithm.
• Approval Type: This is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical trial or algorithm validation study in the way an AI/ML device would.
• Focus of Document: The document focuses on the device description, intended use, and substantial equivalence to a predicate device (OptiBond Solo Plus 2). It confirms that the FDA reviewed the submission and found the device substantially equivalent.

Therefore, I cannot extract the following information because it is not present in the provided text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document is a regulatory approval notice for a medical device, not a performance study report for an AI/ML system.

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belleGlass Point 4 is a composite restoration material use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges. belleGlass Point 4 may be used by itself or in conjunction with gold, Captek, non precious metal or a fiber re-enforced substructure.

belieGlass Point 4 is a composite restoration material use with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges. belleGlass Point 4 may be used by itself or in conjunction with gold, Captek, non precious metal or a fiber re-enforced substructure. The belleGlass HP crown and bridge fabrication system is comprised of all the components necessary for a dental laboratory to fabricate composite resin-based crowns and bridges and cure them using both light activation combined with a final heat and pressure curing cycle in the belleGlass HP automatic curing device.

This document is a 510(k) summary for a dental restorative material, belleGlass Point 4. It primarily focuses on demonstrating substantial equivalence to previously marketed devices and does not contain information about acceptance criteria or a study proving device performance against such criteria.

Therefore, I cannot provide the requested information. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number or qualifications of experts for ground truth, or adjudication methods.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used, sample size for the training set, or how ground truth for the training set was established.

This document is a regulatory submission for premarket notification, not a clinical or performance study report. Its purpose is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than proving its performance against specific acceptance criteria for a novel functionality.

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XR Primer 2 is a light-cured cavity primer used to wet the interior of a prepared cavity of a tooth prior to application of an adhesive to improve retention of a restoration.

XR Primer 2 is a light-cured cavity primer used to wet the interior of a prepared cavity of a tooth prior to application of an adhesive to improve retention of a restoration.

This document is a 510(k) summary for the XR Primer 2, a light-cured cavity primer. It does not contain information about acceptance criteria or a study proving that a device meets such criteria.

The document primarily focuses on establishing substantial equivalence for the XR Primer 2 to a legally marketed predicate device (the original XR Primer formulation). This type of submission to the FDA (510(k)) generally relies on demonstrating that a new device is as safe and effective as a predicate device, rather than requiring extensive clinical trials to establish new performance metrics against pre-defined acceptance criteria.

Therefore, I cannot extract the requested information from the provided text regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study or related effect size.
6. Standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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belleGlass HP Modeling Gel is a filled resin used as a pre-wetting agent for placing and sculpting layers of composites and it is to be used between layers of cured composite.

belleGlass HP Modeling Gel will make the processing of the belleGlass restorations easier and faster and will improve the quality of the restorations by making the system more user friendly. belleGlass HP Modeling Gel is 50% filled with fine radiopaque reinforcing fillers of 0.4micron average particle size. The gel is similar to "flowable composites" and will assure a strong intimate bond between composite layers as well as reducing the chances of dilution of the enamel and dentin surfaces. By using the belleGlass HP Modeling Gel, surfaces will be less sticky, making it easier to sculpt and after processing easier to polish. The results are closer margins, stronger restorations, and savings of time increasing productivity.

I am sorry, but the provided text from K020178 is a 510(k) summary for a dental modeling gel. It focuses on the chemical composition, intended use, and substantial equivalence to a predicate device.

It does not contain any information about acceptance criteria, study designs, sample sizes, expert ground truth, or performance metrics that would be relevant for describing a typical AI/ML device study.

Therefore, I cannot fulfill your request based on the provided input.

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Optibond Solo Plus 4 is a self-etch primer designed to work in conjunction with a tooth bonding agent. Optibond Solo Plus 4 can be used for indirect situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing, post and core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crowns and bridges (used in conjunction with a resin luting agent).

OptiBond Solo Plus 4 self-etch primer is designed for use with OptiBond Solo Plus adhesive (in Unidose or bottle delivery), both a Class II device which were granted marketing clearance by FDA following the submission of a 510(k) premarket notification. When used with OptiBond Solo Plus or OptiBond Solo Plus with Activator, the self etch primer can be used in the bonding of both direct and indirect restorations. The self-etch primer is used to eliminate the phosphoric acid etch step in the bonding process. Some advantages of using a self etch primer include reduction of post-operative sensitivity and an elimination of steps in the bonding process.

This document is a 510(k) summary for a dental adhesive product, Optibond Solo Plus 4. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study demonstrating acceptance criteria for its performance.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be fully provided from the given text. The document does not describe specific performance acceptance criteria for the bonding agent, nor does it detail a study designed to test against such criteria.

Here's what can be inferred or stated based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. The document's purpose is to demonstrate substantial equivalence, not to define or meet specific performance criteria beyond what is implied by the predicate device's performance.
• Reported Device Performance: Not detailed in terms of specific quantitative outcomes of a performance study. The document broadly states that the device "functions in a manner similar" to predicate devices, implying comparable performance without providing the metrics.

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

• Sample Size for Test Set: Not mentioned. No specific "test set" in the context of a performance study is described.
• Data Provenance: Not mentioned. No performance data from clinical or laboratory studies is presented in this document.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not applicable. Given there's no performance study data presented, there's no mention of experts establishing ground truth for such a study.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No test set or ground truth establishment process is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No. This type of study (common in imaging AI) is not relevant to a dental bonding agent and is not mentioned or implied in the document.
• Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study: No. This concept is not applicable to a physical dental bonding agent product.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not applicable. As no performance study with ground truth is described, this information is not available.

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This document does not describe a machine learning algorithm or a "training set."

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

• Ground Truth Establishment for Training Set: Not applicable.

Summary of what the document does provide:

• Device Name: Optibond Solo Plus 4
• Intended Use: Direct situations (composite to enamel/dentin, repair, amalgam sealing, post and core build-up) and indirect situations (veneers, onlays, inlays, crowns, bridges with resin luting agent).
• Predicate Devices: Kuraray America, Inc., Clearfil Liner Bond 2V.
• Claim of Substantial Equivalence: The document asserts that Optibond Solo Plus 4 is substantially equivalent to other legally marketed devices, including the predicate, and "functions in a manner similar to" these. This is the primary "proof" offered for regulatory clearance, not a detailed performance study against specific criteria.

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Temphase is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges.

Temphase temporary crown and bridge material is a two component, catalyst and base, material dispensed and mixed by a cartridge/static mixing tip combination. Temphase is intended for use in both short and long term crown and bridge temporaries. The material is compatible with light cured composites for repair and characterization. Temphase contains methacrylate components and is radiopaque for easy radiographic identification.

The provided text describes a 510(k) premarket notification for a dental device, "Temphase," a temporary crown and bridge restorative material. The submission focuses on demonstrating substantial equivalence to a predicate device, not on specific performance criteria or a study proving those criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text.

The document is a regulatory approval letter and a summary of safety and effectiveness for a medical device. It attests that the device is substantially equivalent to existing products, thereby allowing it to be marketed. It does not contain the detailed study results or performance data that would typically be required to answer the questions posed.

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BelleGlass HP Opaque 2 is dual cured composite material used to mask metal substrates in crown and bridge work and other materials used for reinforcement or bulk build-up of restorations.

belleGlass HP Opaque 2 is dual cured composite material used to mask metal substrates in crown and bridge work and other materials used for reinforcement or bulk build-up of restorations. belleGlass HP Opaque 2 is also used with the belleGlass HP (heat and pressure) crown and bridge fabrication system where a more durable base for composite crowns and bridges is desired.

This document is a 510(k) Summary for the BelleGlass HP Opaque 2, a dental material. It does not contain information about acceptance criteria or a study proving device performance as it is a premarket notification for a dental material, not an AI/ML powered device. Therefore, I cannot provide the requested information based on the provided text.

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Point 4 Flowable 2 is a low viscosity light cure hybrid resin restorative suitable for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

Point 4 Flowable 2 is a low viscosity light cure hybrid resin restorative suitable for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

This document is a 510(k) premarket notification for a dental restorative material, Point 4 Flowable 2. It does not contain any information about acceptance criteria, device performance, a study, or any of the other specific items requested in your prompt (e.g., sample sizes, expert qualifications, MRMC studies, ground truth details).

The document primarily focuses on:

• Device Name: Point 4 Flowable 2
• Submitter: Sybron Dental Specialties, Inc.
• Device Description: Low viscosity light cure hybrid resin restorative for various dental applications (Class III, IV, V restorations, enamel/porcelain repair, pit and fissure sealant, etc.).
• Intended Use: Same as device description.
• Substantial Equivalence: Claimed to the predicate device "Point 4 Flowable" from Kerr Corporation. The FDA's letter confirms this substantial equivalence.
• Regulatory Information: Classification Name (Tooth Shade Resin Material, 21 CFR § 872.3690), Regulatory Class (Class II).

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details because that information is not present in the provided text.

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OptiBond Solo Plus 3 is a multi-purpose bonding agent designed to be used in direct situations, i.e., composite to enamel and/or dentin, composite repair, composite to metal, amalgam sealing, bonding composite core build-up materials, pit and fissure sealant, and for indirect situations, i.e., veneers, onlays, inlays, crowns, and post cementation.

The device is a multi-purpose bonding agent designed to be used in direct situations including composite to enamel and/or dentin, composite repair, composite to metal, amalgam sealing, bonding composite core build-up materials and fissure sealant, and for indirect situations including veneers, onlays, inlays, crowns, and post cementation.

This is a medical device application for a pit and fissure sealant (OptiBond Solo Plus 3), not an AI/ML device. Therefore, the provided text does not contain information about acceptance criteria, study details, ground truth, or sample sizes related to AI/ML device performance. The document is a 510(k) summary for a traditional medical device demonstrating substantial equivalence to a predicate device.

To answer your request, if this were an AI/ML device, the following information would typically be required but is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not applicable.
• Data Provenance: Not applicable.

3. Number of Experts and Qualifications for Ground Truth of Test Set

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? Not applicable.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable.

6. Standalone Performance Study

• Was a standalone study done? Not applicable.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable.

9. How Ground Truth for Training Set Was Established

• How Ground Truth for Training Set was established: Not applicable.

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