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• Treatment of perforations of root canal and furcation caused iatrogenically or by caries lesions;
• Via canal treatment of root perforation due to internal resorption;
• Surgical treatment of root perforation due to internal resorption;
• Periapical surgery with reverse filling;
• Pulp capping;
• Pulpotomy (removal of affected crown portion of the pulp preserving the vitality and function of the remaining radicular portion)
• Apexogenesis (induction of root development in vital teeth with an inflamed coronal pulp)
• Apexification (induction of formation of a mineralized barrier at the root tip of young permanent teeth with incomplete root development and a necrotic pulp)

MTA REPAIR HP is an endodontic bioceramic reparative cement with high plasticity, composed of mineral oxides in the form of fine hydrophilic particles. It is indicated for cases of root perforation (canal and furcation), iatrogenic or by caries, root perforation by internal resorption, retrofilling, direct pulp capping, pulpotomy, apexigenesis, and apexification.

The plasticizer Polyvinylpyrrolidone is added in the subject device to improve the plasticity of the mixture powder/liquid, with plasticity being understood as the quality of being easily shaped or molded. Thus, the new formulation of the subject device improves handling and insertion into the dental cavity since the pasted after mixing becomes a molding putty type consistency.

The radiopacifier CaWO4 is also added in the subject device to prevent discoloration of the tooth, since CaWO4 does not reduce when exposed to sunlight, unlike Bi2O3 found in the predicate device. Overall properties noted for the subject device include the following:

. Setting time: MTA Repair HP solidifies upon being maintained in a wet environment after spatulation. The start setting time is approximately 15 minutes.
. Radiopacity: Similar to gutta-percha and more radiopaque than dentin and bone.
. Absence of dental discoloring due to the radiopacifier CaWO4 used.

The provided document is a 510(k) premarket notification for a dental device, MTA Repair HP. It focuses on demonstrating substantial equivalence to a predicate device, MTA-Angelus, rather than proving the device meets specific acceptance criteria through a standalone study with a defined test set and ground truth.

Therefore, directly answering many of the requested points regarding acceptance criteria, sample size for test sets, expert adjudication, MRMC studies, and ground truth establishment is not possible from this document. The document's purpose is to show that the new device is as safe and effective as a legally marketed predicate device, primarily through comparison and nonclinical testing against recognized standards.

Here's an analysis of the information available in the document, structured to address your questions as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" in the sense of predefined thresholds for specific performance metrics with corresponding performance results from a dedicated study. Instead, it refers to compliance with recognized standards. The "Device Comparison Table" provides some relevant properties of both the proposed and predicate device.

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

The document refers to "Nonclinical Testing" and "Bench test results" but does not specify sample sizes for any test sets. It mentions that the technological characteristics were cleared in other devices (predicate) and that the nonclinical tests were conducted by the vendor against FDA recognized standards.

• Sample Size: Not specified.
• Data Provenance: The tests were nonclinical (bench tests) conducted by the manufacturer (Angelus Industria De Productos Odontologicos) or its agents, with results submitted to the FDA. The country of origin for the data is Brazil, where the submitter is located. The tests are prospective in the sense that they were performed on the new device, but the results are for substantiation purposes within a regulatory application rather than a clinical trial.

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

This document does not describe "ground truth" established by experts in the context of a diagnostic or predictive device like an AI algorithm. The device is a dental material, and its performance is evaluated against physical and chemical properties and biocompatibility standards. Expert consensus or qualification of experts for ground truth is not applicable here.

4. Adjudication method for the test set

Similarly, an "adjudication method" for interpreting results from diagnostic tests or subjective assessments is not applicable to the nonclinical bench testing described for this dental material. Performance is measured objectively against standard specifications.

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 is not relevant for this type of device (a dental material). This is not an AI-assisted diagnostic or imaging device used by human readers.

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

No. This question pertains to AI algorithms, which is not applicable to a root canal filling resin. The document describes a physical material, not an algorithm.

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

As discussed, the concept of "ground truth" for a diagnostic algorithm is not applicable here. The device's "truth" or performance is assessed by meeting physical, chemical, and biological specifications set forth by recognized national and international standards (e.g., ISO 6876, ANSI/ADA Specification no. 57, ISO 10993 series). These standards define objective measurements for properties like setting time, radiopacity, and cytotoxicity.

8. The sample size for the training set

This question is related to machine learning and AI, which are not relevant to this device. There is no training set for a dental material.

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

Again, this question is not relevant as the device is not an AI or machine learning product.

Summary of what the document indicates regarding "acceptance":

The device MTA Repair HP is deemed acceptable and substantially equivalent to its predicate based on:

• Identical Indications for Use: The applications for both devices are the same.
• Similar Operating Principle: Both are endodontic bioceramic reparative cements.
• Similar Material and Design: While there are minor compositional changes (changing radiopacifier from Bi2O3 to CaWO4 to prevent discoloration, and adding Polyvinylpyrrolidone as a plasticizer to improve handling), these changes were evaluated.
• Nonclinical Testing: The device meets applicable requirements of FDA recognized standards for biocompatibility (ISO 10993 series) and dental materials (ISO 6876:2012, ANSI/ADA Specification no. 57:2000). The "Bench test results allowed us to conclude that MTA Repair HP is well suited for its intended use."
• Critical Properties Maintained: The "critical properties (setting time, solubility and radiopacity)" were not affected by the compositional changes. A minor difference in working time (1 minute) was noted but determined not to affect usability.
• No New Concerns: The FDA concluded that "Any differences in the technological characteristics do not raise new concerns."

In essence, the "acceptance criteria" here are the requirements for demonstrating substantial equivalence to a predicate device and compliance with relevant performance and safety standards for dental materials. The "study" is the nonclinical testing performed by the manufacturer to prove this equivalence and compliance.

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MTA-Fillapex is a root canal sealer intended for the permanent scaling of root canals and may be used in combination with root canal obturation materials.

MTA Fillapex is a mineral trioxide aggregate (MTA) and resin toot canal sealer used during endodontic treatment to permanently fill the canal system following debridement and disinfection. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. Being hydrophilic in nature, MTA-FILLAPEX is desirable as a root filling material because an isolated dry field is not necessary for use. Moisture does not negatively affect the sealing ability and is required for proper setting. It is used in combination with gutta-percha or silver points during root canal obturation.

The provided text describes the 510(k) submission for MTA Fillapex, a root canal sealer. It details performance criteria and tests conducted to demonstrate substantial equivalence to predicate devices, especially a modified version of K113568 with the addition of titanium dioxide to the base paste. However, this document does not describe a study, or acceptance criteria, for a device that uses AI. Instead, it's for a dental material (root canal sealer). Therefore, many of the requested fields related to AI/algorithm performance are not applicable.

Here's an analysis based on the provided text, focusing on the material it does describe:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for each test beyond numerical results (e.g., "33.38 mm" for flow). The data provenance is also not specified in terms of country of origin or whether it was retrospective or prospective. The tests were performed as "Design Verification Tests" in response to a "Failure Modes and Effects Analysis (FMEA)" related to a modification (addition of titanium dioxide).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is for a dental material, not an AI/software device requiring expert ground truth for classification or diagnosis. Performance metrics are based on physical and chemical properties and industry standards.

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

Not applicable. This is for a dental material; there is no adjudication process involving multiple human readers for performance metrics like flow or setting time.

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 for a dental material, not an AI device.

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

Not applicable. This is for a dental material, not an AI algorithm.

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

For the physical and chemical properties (flow, setting time, solubility, radiopacity, etc.), the "ground truth" is established by adherence to industry standards (specifically ISO 6876:2012) and established laboratory testing protocols. For biocompatibility, reliance is placed on previous testing for the predicate device (K113568) and the chemical composition.

8. The sample size for the training set

Not applicable. This is for a dental material, not an AI model requiring a training set.

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

Not applicable. This is for a dental material, not an AI model.

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Bonding all classes of direct composite restorations as well as for indirect procedures involving metal, porcelain, or composite crowns, inlays or onlays. The Angelus products multi-purpose systems also bond amalgam and self-cure composite can be used to bond orthodontic brackets to enamel.

The Fusion Single Link by Angelus is a versatile system for dental bonding. It is a onebottle adhesive system, indicated for restorations, adhesive cementation of indirect restorations (cast metal, porcelain and composite resin veneers) and intraradicular posts (cast metal and prefabricated in metal or fiber). It can also be used for the bonding of orthodontic brackets, and for the repair of porcelain restorations.

Here's a breakdown of the acceptance criteria and the study information for the Fusion Single Link device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "Based on performance data according the ISO/TS 11405: 2003, it was found that the average strength and average resistance of the two devices are substantially equivalent." This implies that despite some numerical differences, the overall performance is considered comparable for the purpose of substantial equivalence.

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

The document does not explicitly state the sample size used for the test set. It mentions "performance data" according to ISO/TS 11405: 2003, but not specific numbers of samples or cases.

The data provenance is not specified beyond being "performance data according the ISO/TS 11405: 2003". It doesn't indicate country of origin or whether it was retrospective or prospective.

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

This information is not provided in the document. The study relies on standardized testing methods (ISO/TS 11405: 2003) to measure bond strength and other properties, rather than expert-established ground truth in a clinical or imaging context.

4. Adjudication Method for the Test Set

Not applicable as the study uses objective measurements based on ISO/TS 11405: 2003, not expert review or consensus for ground truth.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the performance of the new device to a predicate device based on material properties and bond strength, not on clinical interpretation or reading by human experts.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to the device described. The device is a dental adhesive, not an algorithm or AI system. The performance data presented refers to the physical and chemical properties of the adhesive itself.

7. Type of Ground Truth Used

The "ground truth" for this study is based on objective measurements of material properties and bond strength as defined by the ISO/TS 11405: 2003 standard. This standard provides guidelines for testing adhesion to tooth structure, including tensile and shear bond strength measurements.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set" in that sense. The study involves laboratory testing of material properties.

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

Not applicable, as points 8 explains.

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Interlig is indicated for:

• Splinting periodontal involved and mobile teeth to prevent movement
• To reinforce full denture and partial denture repairs
• As a matrix between abutment teeth for receiving a temporary replacement tooth
• As an aid in the reinforcement of temporary crowns and bridge work
• As a space maintainer for orthodontic involved teeth

Interlig is a structure of intertwined glass fibers pre-impregnated with light-cured composite resin.

The provided document K123823 is a 510(k) summary for a dental device called "Interlig," a glass fiber reinforcement material. The document primarily focuses on establishing substantial equivalence to a predicate device ("Splint It" K972985) and does not contain information on detailed acceptance criteria or a specific study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy.

The document states:

• "Interlig has the same intended use and similar technical characteristics as Splint It K972985. The indications for use, materials, form factor, performance and safety characteristics between Interlig and Splint It are the same."
• "Based on the information provided in this premarket notification, we can conclude that Interlig is as safe and effective as the predicated device."

This 510(k) submission relies on demonstrating similarity to a previously cleared device rather than presenting a de novo performance study with specific acceptance criteria and results for the new device. Therefore, I cannot provide the requested information.

However, based on the type of document, I can infer what would typically be presented for such a submission if a new performance study were conducted. Since it is not present in the given text, I will state explicitly that the following is not found in the document.

Information NOT Found in the Provided Document:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set and data provenance.
• Number of experts used to establish ground truth for a test set and their qualifications.
• Adjudication method for a test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Conclusion:

The provided 510(k) summary for K123823 does not contain the detailed performance study information requested. It establishes substantial equivalence to a predicate device (Splint It K972985) based on similar intended use, technical characteristics, indications for use, materials, form factor, performance, and safety characteristics. No specific performance metrics, acceptance criteria, or study results proving such criteria directly for the Interlig device are presented in this document.

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• Treatment of perforations of root canal and furcation caused iatrogenically or by caries lesions
• Via canal treatment of root perforation due to internal resorption
• Surgical treatment of root perforation due to internal resorption
• Periapical surgery with reverse filling
• Pulp capping
• Pulpotomy (removal of affected coronal pulp to preserve vitality of remaining pulp tissue)
• Apexogenesis (induction of root development in vital teeth with an inflamed coronal pulp).
• Apexification (induction of formation of a mineralized barrier at the root tip of young permanent teeth with incomplete root development and a necrotic pulp)

MTA Angelus is a mineral trioxide aggregate cement used for root repair during endodontic treatment, combining the powder and liquid produces a colloidal gel that solidifies to form a barrier.

The provided text describes the 510(k) summary for MTA Angelus, a root canal filling resin, and its establishment of substantial equivalence to predicate devices. However, it does not contain the detailed information required to answer all parts of your request about acceptance criteria and a study proving device performance in the context of an AI/algorithm-based device.

The document is for a traditional medical device (a dental material), not an AI/algorithm-driven one. Therefore, the concept of "acceptance criteria" and "study proving the device meets the criteria" as you've framed it, usually referring to performance metrics like sensitivity, specificity, AUC for an algorithm, is not applicable here.

Instead, the "acceptance criteria" for MTA Angelus are based on demonstrating substantial equivalence to existing legally marketed devices (predicates) by showing similar intended use, technological characteristics, materials, and performing in vitro or bench testing according to existing standards.

Here's a breakdown of what can and cannot be extracted from the provided text based on your request:

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

Study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is performance testing conducted for setting time, solubility, radiopacity, and dimensional changes, which included methods described in ISO 6876 Dental Root Canal Sealing Materials. This testing was performed to "demonstrate substantial equivalence."

The following information CANNOT be extracted from the provided text, as it pertains to AI/algorithm-driven devices, which MTA Angelus is not:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
  • The document describes bench testing (in vitro) not clinical or algorithm testing on data sets.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
  • Not applicable for a materials science bench test.
• 4. Adjudication method (e.g. 2+1, 3+1, none) 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
  • Not applicable as it's not an AI device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  • Not applicable as it's not an AI device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
  • Ground truth for materials testing is typically measured physical or chemical properties, referenced against a standard (like ISO 6876).
• 8. The sample size for the training set
  • Not applicable as it's not an AI device.
• 9. How the ground truth for the training set was established
  • Not applicable as it's not an AI device.

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Perma Fiber / Perma Mesh is indicated for use as reinforcement for:

• · Manufacturing or repair of full or partial dentures, overdentures and orthodontic appliances
• · Temporary and/or permanent plastic/composite crowns and bridges
• · Custom splinting for immobilization of teeth

Perma Fiber / Perma Mesh glass fiber reinforcement material

This document is a 510(k) summary for the Perma Fiber / Perma Mesh dental reinforcement material. It primarily focuses on demonstrating substantial equivalence to a predicate device and obtaining marketing clearance. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study would for a diagnostic or AI-driven device.

The provided text describes the administrative information, device name and classification, and intended use. The FDA letter confirms the substantial equivalence determination for marketing based on the information provided in the 510(k) submission.

Therefore, I cannot extract the requested information in the format provided because the document type does not typically elaborate on clinical study design, performance metrics, ground truth establishment, or multi-reader multi-case studies for this type of dental material.

In summary, the 510(k) process for a device like "Perma Fiber / Perma Mesh" primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing material properties, design, and intended use, rather than extensive clinical studies with specific performance metrics and ground truth as would be seen for a diagnostic or AI device.

Therefore, many of the requested fields are not applicable or the information is not present in the provided 510(k) summary.

Here's how the information would be presented if it were available in this document:

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

• Not Applicable/Information Not Present in the Provided Document: For a dental material like Perma Fiber/Perma Mesh, acceptance criteria would typically relate to physical and mechanical properties (e.g., flexural strength, bond strength, wear resistance, biocompatibility) as measured in benchtop or in vitro studies. No specific acceptance criteria or corresponding device performance results are detailed in this 510(k) summary. The summary focuses on regulatory clearance based on substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable/Information Not Present: This document does not describe a "test set" in the context of clinical performance evaluation or data analysis for a diagnostic or AI device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable/Information Not Present: Ground truth establishment by experts is typically relevant for diagnostic devices or AI applications. This document does not describe such a process.

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

• Not Applicable/Information Not Present: Adjudication methods are relevant for resolving discrepancies in expert opinions for diagnostic ground truth. This is not applicable to this 510(k) summary.

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/Information Not Present: Perma Fiber / Perma Mesh is a physical reinforcement material, not a diagnostic tool or an AI-assisted device. Therefore, MRMC studies are not relevant.

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

• Not Applicable/Information Not Present: This device is not an algorithm.

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

• Not Applicable/Information Not Present: "Ground truth" as a concept for performance evaluation is not relevant for this material's 510(k) submission. For materials, the "truth" would be adherence to specified material properties and biocompatibility.

8. The sample size for the training set

• Not Applicable/Information Not Present: There is no "training set" as this is not an AI or machine learning device.

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

• Not Applicable/Information Not Present: There is no "training set" or associated ground truth for this type of device.

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