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1. Furcation or root perforation treatment via canal
2. Furcation or root perforation treatment via surgical
3. Internal reabsorption treatment via canal or surgical
4. External reabsorption treatment
5. Retrofilling in parendodontic surgery
6. Direct and Indirect pulp capping
7. Apexification
8. Apexogenesis and Pulpotomy

One-Fil Putty Injectable is a premixed material intended for permanent root canal filling. It is based on a tricalcium silicate composition, which undergoes setting and hardening in the presence of moisture.
The product is packaged in a paper box with four syringes in a vinyl packaging, and the contents in the glass syringe are white paste type.

This FDA 510(k) clearance letter and summary are for a dental material, not an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, ground truth establishment, training set details, and expert qualifications) are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the study proving it meets them.

Acceptance Criteria and Device Performance for One-Fil Putty Injectable (K251884)

The "One-Fil Putty Injectable" is a dental root canal filling material. Its acceptance criteria are based on conformance to international standards for dental materials, specifically ISO 6876, and comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by conformance to ISO 6876 and the performance of the predicate device (One-Fil Putty, K243353). The reported performance of the subject device is directly compared to the predicate device in the 510(k) summary.

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• Temporary inlay and onlay treatments of the cavity.
• Sealing of openings for implant screws.
• Relining material for temporary crowns and bridges.
• Covering of the gingival margin
• Fixing of resin matrix during filling placement.
• Block-out material for retentive ares in the dental arch, e.g. before taking impressions.

Once-Fil Flow is a light-curing filling material designed for temporary restorations. It serves as an interim solution before the placement of a final prosthesis, providing functions such as pulp protection and maintaining tooth position. The material is suitable for temporary fillings in prepared cavities and inlay/onlay cases.

To accommodate different clinical needs, Once-Fil Flow is available in two shades. The Yellow shade is ideal for anterior teeth, where esthetics are a priority, while the Blue shade provides clear visual contrast, making it easier to identify and remove before permanent restoration.

The application process involves preparing the tooth surface, applying an appropriate amount of material, and light-curing it. Once cured, the material can be finished and polished using conventional instruments.

The provided FDA 510(k) clearance letter and summary for "Once-Fil Flow" does not describe an AI medical device or an AI/ML software. Instead, it pertains to a dental resin material. Therefore, the request to describe the acceptance criteria and study proving the device meets those criteria for an AI device cannot be fulfilled from the provided text.

The information in the provided text focuses on the material characteristics and biocompatibility of a dental flowable resin. The regulatory context described is for a Class II medical device, product code EBF (Tooth Shade Resin Material), regulated under 21 CFR 872.3690.

The document highlights the basis for substantial equivalence to a predicate device (Clip Flow by VOCO GmbH, K153493) through:

• Identical Indications for Use: Temporary inlay/onlay, sealing implant screw openings, relining temporary crowns/bridges, covering gingival margin, fixing resin matrix, and block-out material.
• Similar Technological Characteristics: Light curing type, similar materials (with minor differences confirmed by performance and biocompatibility), same intended user, similar delivery method, same period of use and shelf-life.
• Performance Testing (Non-Clinical): Appearance, Weight, Packaging, Sensitivity to Ambient Light, Curing Depth, Water Sorption/Solubility, Color and Color Stability, and Shore D Hardness, all tested in accordance with ISO 4049 and ISO 868.
• Biocompatibility Testing: ISO 10993 series tests including cytotoxicity, irritation, systemic toxicity, and skin sensitization.

No information regarding AI, machine learning, clinical image analysis, or human reader studies is present in the provided text. The request for details on sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone AI performance, ground truth types, and training set information is not applicable to this specific device (a dental resin material) based on the supplied documentation.

Therefore, since the input document describes a physical dental material and not an AI/ML medical device, I cannot extract the requested information regarding AI acceptance criteria and study details.

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• Anterior and posterior restorations.
• Indirect restorations for Inlays, onlays and veneers.

Any-Com Flow is a composite resin material designed for use in anterior and posterior restorations. It is composed of an enhanced zirconia filler, and all shades of the material are radiopaque. It is conveniently packaged in a syringe with a wide caliber. Dentists can dispense the material using their own instruments and apply it to the tooth.
The product offers a wide range of options with a total of 9 shades available. Dentists can select shades such as A1, A2, B1, B2, etc., based on the desired brightness, yellowness, and darkness that match the patient's natural teeth.
After the appropriate tooth pretreatment process for the selected shade, Any-Com Flow is applied to the teeth using enclosed tip and in the appropriate amount. Once applied, it is permanently bonded to the tooth structure by using a photopolymerizer owned by the dentist for photocuring.

This document is a 510(k) clearance letter for a dental composite resin called "Any-Com Flow". It establishes substantial equivalence to a predicate device, "Any-Com". The information provided primarily focuses on the device's technical specifications and a comparison to its predicate, rather than a clinical study evaluating its real-world performance against specific acceptance criteria in a human population.

Therefore, it is impossible to fully answer all aspects of your request as this document does not contain information about:

• A study that proves the device meets specific acceptance criteria in a clinical setting with human subjects.
• Clinical test set sample sizes, data provenance, expert panels, adjudication methods, MRMC studies, or specific efficacy criteria that would be relevant for devices that provide diagnostic or prognostic outputs.
• Training set sample sizes or how their ground truth was established, as this is not an AI/ML device relying on such training.

However, I can extract the acceptance criteria and reported performance based on the non-clinical testing conducted to demonstrate substantial equivalence, which is the focus of this 510(k) application. This non-clinical testing adheres to international standards (ISO 4049 and ISO 10993).

Here's the information extracted and formatted to answer your request as much as possible given the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria: The document states that the performance tests were conducted "in accordance with ISO 4049" and biocompatibility tests "in accordance with ISO 10993." For a 510(k) submission, the "acceptance criteria" are implied to be that the device successfully meets all relevant requirements and limits defined by these international standards for dental restorative materials and biocompatibility, respectively, and that its performance is substantially equivalent to the predicate device. The exact numerical limits from the ISO standards are not provided in this 510(k) summary.

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

• Sample Size: The document does not specify the exact sample sizes used for each non-clinical performance test (e.g., how many specimens were tested for flexural strength). These details would typically be found in the full test reports referenced in the submission, not the summary.
• Data Provenance: The tests were conducted by MEDICLUS Co., Ltd., which is based in the Republic of Korea. The testing is non-clinical (laboratory-based) rather than patient-derived data, so there is no "country of origin of the data" in the sense of patient demographics. The tests are "retrospective" in the sense that they were conducted for this specific submission.

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

• This information is not applicable. The "test set" here refers to physical samples of the dental material, and the "ground truth" is established by direct measurement against known ISO standards and methods, not by expert consensus (e.g., no radiologists or other medical professionals are involved in interpreting results for material properties like flexural strength).

4. Adjudication method for the test set

• This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for interpreting complex clinical data or images by multiple experts. For material property testing, results are quantitative measurements against an established standard, not subjective interpretations requiring 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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or screening devices that assist human readers (e.g., radiologists interpreting images). Any-Com Flow is a dental restorative material, not an AI device.

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

• No, a standalone algorithm performance study was not done. Any-Com Flow is not an algorithm or an AI device. The "performance" refers to the physical and chemical properties of the material itself.

7. The type of ground truth used

• The "ground truth" for the non-clinical performance tests is based on direct physical and chemical measurements against the specified methodologies and requirements of ISO 4049 (for dental polymer-based restorative materials) and ISO 10993 (for biological evaluation of medical devices). This is akin to established scientific and engineering standards for material properties.

8. The sample size for the training set

• This information is not applicable. Any-Com Flow is a dental material, not a machine learning model. Therefore, there is no "training set."

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

• This information is not applicable, as there is no training set for this device.

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• 1. Furcation or root perforation treatment via canal
• 2. Furcation or root perforation treatment via surgical
• 3. Internal reabsorption treatment via canal or surgical
• 4. External reabsorption treatment
• 5. Retrofilling in parendodontic surgery
• 6. Direct and indirect pulp capping
• 7. Apexification
• 8. Apexogenesis and Pulpotomy

One-Fil putty is a permanent root canal filling repair material with tricalcium aluminate compound that are premixed and designed to be convenient for use. It is hardened by moisture, has characteristics of adhesion and workability. The product is packaged in a paper box with one or two syringes in a tray, and the contents in the glass syringe are white paste type.

The provided document is a 510(k) summary for the medical device "One-Fil Putty." This device is a dental root canal sealer. The document describes the device's characteristics and compares it to a predicate device to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document doesn't explicitly present "acceptance criteria" in a separate table format with pass/fail thresholds. Instead, it lists "Performance Tests in accordance with ISO 6876" as the standards against which the device was evaluated. The results for the "One-Fil Putty" are presented within the "Comparison Chart" (Section 8.1) alongside the predicate device's information for some parameters.

Here's a consolidated table of the performance data extracted from the document, with the understanding that the accepted performance is inferred from compliance with the mentioned ISO standards:

Note: The document only provides the performance results for the subject device and in some cases for the predicate. It does not explicitly state the numerical acceptance criteria for many of these tests. Compliance with the cited ISO standards (e.g., ISO 6876) implies that accepted criteria were met. For "Foreign substance" and "Packaging," the description given serves as the implied acceptance criterion. For "Setting time" and "Solubility," specific numerical limits for ISO 6876 are not provided in this document, only the measured values for the subject device.

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

The document does not provide details on the sample sizes used for the non-clinical performance tests (e.g., how many units were tested for setting time, solubility, etc.).
The data provenance (country of origin of the data, retrospective or prospective) is also not specified in the provided text.

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

This information is not applicable as the document describes performance testing of a physical material (dental root canal sealer) against international standards (ISO 6876, ISO 13116, ISO 10993, etc.), not a diagnostic or AI-based device requiring expert ground truth for interpretation.

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

This information is not applicable as the document describes performance testing of a physical material, not a diagnostic study requiring adjudication of interpretations.

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 information is not applicable as the device is a physical dental material, not an AI-assisted diagnostic tool.

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

This information is not applicable as the device is a physical dental material, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the performance tests (foreign substance, setting time, solubility, radiopacity, pH, biocompatibility, shelf-life) is established by objective measurements and laboratory tests conducted according to recognized international standards (ISO 6876, ISO 13116, ISO 10993).

8. The sample size for the training set:

This information is not applicable as the device is a physical material and does not involve an algorithm or a training set in the context of AI/machine learning.

9. How the ground truth for the training set was established:
This information is not applicable as the device is a physical material and does not involve an algorithm or a training set.

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• Base under Class I and Class II direct restorations
• Liner under direct restorative materials
• Restoration of small cavities
• Class III and V restorations
• Core build-ups

Any-Com Bulk is a light cured. radiopaque, flowable restorative material for both posterior and anterior restorations. It is designed to be used as a base-liner for Class I and II restorations. The product allows a technique in which a cavity up to 4mm in depth can be filled and cured in a single increment. The product offers 5 shades options available. Users can select shades such as A 1, A2, A3, TL and Blue, based on the desired brightness, yellowness, and darkness that match the patient's natural teeth. After the appropriate tooth pretreatment process, fill the appropriate amount of product to applying area. Once light cured, the composite can be finished and polished using conventional finishing and polishing instruments.

The provided text is a 510(k) summary for a dental restorative material called "Any-Com Bulk." It is a submission to the FDA seeking substantial equivalence to a legally marketed predicate device. The document focuses on demonstrating that the new device is as safe and effective as the predicate.

However, the question asks for acceptance criteria and study details related to a device that uses AI (given the questions about multi-reader multi-case studies, ground truth establishment for training, etc.). The provided text describes a tooth shade resin material (a bulk fill flowable restorative), which is a physical material and not an AI-powered device.

Therefore, I cannot extract the requested information because the document does not pertain to an AI device. There are no tables of acceptance criteria for AI performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details for an AI model.

The document discusses non-clinical tests for a material, such as:

• Performance Tests: Appearance, Weight, Packaging, Sensitivity to Ambient Light, Curing Depth, Flexural Strength, Water Sorption/Solubility, Color and Color stability, Radiopacity in accordance with ISO 4049.
• Biocompatibility Tests: Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subacute/Subchronic Toxicity, Genotoxicity, Implantation, Chronic Toxicity, Carcinogenicity (all conforming to ISO 10993 series).

These are typical tests for a dental material, not an AI software device.

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• Anterior and posterior restorations
• Core build-up
• Indirect restorations for inlays, onlays and veneers.

Any-Com is a composite resin material designed for use in anterior and posterior restorations. It is composed of an enhanced zirconia filler, and all shades of the material are radiopaque. It is conveniently packaged in a syringe with a wide caliber. Dentists can dispense the material using their own instruments and apply it to the tooth. The product offers a wide range of options with a total of 20 shades available. Dentists can select shades such as A1, A2, B1, B2, etc., based on the desired brightness, yellowness, and darkness that match the patient's natural teeth. After the appropriate tooth pretreatment process for the selected shade, Any-Com is applied to the teeth using suitable instruments and in the appropriate amount. Once applied, it is permanently bonded to the tooth structure by using a photopolymerizer owned by the dentist for photocuring.

The provided document describes the FDA's 510(k) clearance for the "Any-Com" dental filling material. It does not contain information about a study proving the device meets specific acceptance criteria in the manner of a clinical trial or performance study with defined metrics like sensitivity, specificity, and sample sizes for AI/ML devices.

Instead, the document details a non-clinical performance evaluation to establish substantial equivalence to a predicate device (3M Filtek Universal Restorative), which is a different type of assessment.

Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

The document lists several non-clinical tests performed, implying these are the metrics considered for substantial equivalence. It states that the test results "support that the subject device is substantially equivalent to the predicate devices." No specific quantitative acceptance criteria or numerical reported performance values are provided in this document.

2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The tests performed are non-clinical, likely laboratory-based material property tests, not a "test set" in the context of an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for material properties is typically established by standardized test methods.

4. Adjudication method for the test set:
This information is not applicable and not provided. Again, this relates to expert review for diagnostic devices, not material property testing.

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 information is not applicable and not provided. The device, Any-Com, is a dental filling material, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. This device is a material, not an algorithm.

7. The type of ground truth used:
For the non-clinical performance data, the "ground truth" would be established by the standardized test methods (e.g., ISO 4049 for dental polymer-based restorative materials, ISO 10993 for biocompatibility). These standards define how to measure specific properties.

8. The sample size for the training set:
This information is not applicable and not provided. This device is a material, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:
This information is not applicable and not provided. There is no training set for this type of device.

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Permanent sealing of root canal

One-Fil is a convenient premixed ready-to use, injectable calcium silicate composition which requires the presence of water to set and harden. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, and a holder.

The provided text focuses on the 510(k) summary for a dental root canal sealer named "One-Fil." It describes the device, its intended use, and a comparison to a predicate device ("Well-Root™ST"). However, the document does not describe a clinical study that proves the device meets specific acceptance criteria in the way a diagnostic AI/ML device would.

Instead, the performance data presented is based on non-clinical tests (bench testing and biocompatibility) against established standards. Therefore, most of the requested information for acceptance criteria and a study demonstrating performance against those criteria is not applicable in this context.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't define explicit "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that the device was tested in accordance with existing standards.

Regarding the study proving the device meets acceptance criteria:

The document does not describe a clinical or comparative effectiveness study of "One-Fil." The demonstration of meeting "acceptance criteria" is based on the device conforming to established international standards (ISO 6876, ISO 10993, USP) and demonstrating substantial equivalence to a predicate device through non-clinical testing.

The remaining points of your request are not applicable to this document as it pertains to a dental filling material, not an AI/ML-driven diagnostic device.

2. Sample size used for the test set and the data provenance: Not applicable. This document describes bench testing and biocompatibility assessments, not a clinical study with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant here.

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. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical test set. For the non-clinical tests, the "ground truth" would be the specifications and requirements defined by the ISO and USP standards.

8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

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• 1. all direct restorations
• 2. all indirect restorations
• 3. intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, metals, glass ceramics, tooth structure, and composites)
• 4. desensitizing/sealing of tooth structure
• 5. protective varnish for glass ionomer fillings
• 6. priming of enamel for orthodontic use

The Hi-Bond Universal is a light-curing dentin adhesive system composed of several resin monomers, inorganic fillers, polymerization-related initiators and accelerators, ethyl alcohol, and antioxidants. The Hi-Bond Universal is a light-curing type dental adhesive offering etching. priming, and bonding at once. The Hi-Bond Universal is packaged in a bottle made of polyethylene and polypropylene, and then packaged in a box.

The document provided is a 510(k) Premarket Notification from the FDA for a dental bonding agent named "Hi-Bond Universal." It primarily focuses on demonstrating substantial equivalence to a predicate device ("All-Bond Universal w/ BAC") rather than providing a detailed report of a study designed to meet specific acceptance criteria for a new AI/software device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for an AI/software device cannot be extracted from this document, as it pertains to a traditional medical device (dental adhesive) and not an AI-powered one.

However, I can provide the "Performance Data (Non-Clinical)" which lists the types of tests performed on the device to support its substantial equivalence. This section serves as the closest equivalent to "acceptance criteria and reported device performance" for this specific product.

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

The document lists the following non-clinical performance tests that were performed to support substantial equivalence. While it doesn't explicitly state "acceptance criteria" and "reported device performance" in a quantitative table for all tests, it implies that the results of these tests met the necessary standards to demonstrate equivalence to the predicate device.

Note: For "Film Thickness," a specific value (12 µm) is reported for the subject device. The predicate device's film thickness is listed as 3.4 µm. The document states that the "difference is in chemical compositions; however, the test results of biocompatibility and performance tests supports that the subject device is substantially equivalent to the predicate device." This suggests that despite the difference in this particular metric, it was deemed acceptable within the context of substantial equivalence. For other tests where no specific measurement is given, "Acceptable" is inferred because the conclusion states that the test results support substantial equivalence.

Regarding the remaining requested information (2-9):

The provided document does not contain any of the following information:

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 describe a "test set" in the context of an AI/software device. The performance tests are for a physical dental material.
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, as the device is not an AI/software device requiring expert adjudicated ground truth.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be defined by standard material testing protocols and physical/chemical properties, not clinical outcomes or expert labels in the way asked for an AI device.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

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