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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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Indications:

• Indirect pulp capping
• Direct pulp capping
• Pulpotomy, after removal of affected coronal pulp to preserve vitality of remaining pulp tissue

Not Found

The provided text is an FDA 510(k) clearance letter for a dental device called "MTA vpt" (Root Canal Filling Resin). This letter does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The 510(k) clearance process is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy or meet specific performance metrics. Therefore, the details requested in your prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are generally not part of a standard 510(k) submission for this type of device.

To provide information related to your prompt, I would need a different type of document, such as a clinical study report, a performance testing report, or a summary of safety and effectiveness data, which are not included in this FDA clearance letter.

Based on the provided document, it is not possible to answer your request. The letter confirms the device's clearance based on substantial equivalence, but it does not detail the specific performance data or studies you're asking about.

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Permanent obturation of the root canal following vital pulp-extirpation.
Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
Injectable Root Canal Bioceramic Sealer (nRoot SP) is suitable for use in the single cone and lateral condensation technique.

Injectable Root Canal Bioceramic Sealer (nRoot SP) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. nRoot SP is an insoluble, radiopaque on a calcium silicate composition, which requires the presence of water to set and harden. nRoot SP does not shrink during setting and demonstrates excellent physical properties.

nRoot SP is packaged in a preloaded syringe and is supplied with disposable Intra Canal tips. nRoot SP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods. Injectable Root Canal Bioceramic Sealer (nRoot SP) is available in five preloaded syringe mode that provide different in specification in 5g,3g,2g,1g and 0.5g. The only difference between the types are the net weight.

The performance of the Injectable Root Canal Bioceramic Sealer (nRoot SP) conforms to ISO 6876:2012 Dentistry - Root canal sealing materials.

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Injectable Root Canal Bioceramic Sealer (nRoot SP)". This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states that "No clinical study is included in this submission."

Therefore, based only on the provided text, it is not possible to describe the acceptance criteria and a study that proves the device meets those criteria from the perspective of an AI or human-in-the-loop performance evaluation. The device in question is a dental material, not an AI or imaging device that would typically undergo such a study.

The questions you've asked (about sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, ground truth, and training sets) are highly relevant for AI/ML-based medical devices or devices that require human interpretation of data for their function.

Given the content of the provided 510(k) clearance letter, I cannot fulfill your request for details regarding AI/ML-specific acceptance criteria and study designs because the device is a dental material, and the provided document explicitly states no clinical studies were performed.

If you intended to provide a different document related to an AI/ML medical device, please provide that document.

However, to directly address the intent of your questions, and assuming hypothetically that such a device (an AI/ML device) were being submitted and these details would be present in its submission, here's what could be inferred about the type of information that would be necessary to answer your questions, based on typical regulatory submissions for AI/ML devices:

Hypothetical General Information for an AI/ML Medical Device (Not Applicable to the Provided Document)

• Device Type: This type of information (acceptance criteria, test sets, experts, MRMC, etc.) is typically provided for AI/ML-based diagnostic or assistive devices, especially those that analyze medical images (e.g., AI for detecting pneumonia on X-rays, or AI for stroke detection on CT scans).
• Regulatory Pathway: For such devices, a 510(k) submission would typically include a detailed performance study section.

If this were an AI/ML device, the answers to your questions would typically be structured as follows (but again, this is not information present in the provided document):

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

   • Acceptance Criteria Examples (for an AI/ML device): Sensitivity > X%, Specificity > Y%, AUC > Z, F1 score > A, meeting non-inferiority/superiority to a predicate/human experts on certain metrics, etc.
   • Reported Device Performance: The actual measured metrics from the validation study.

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

   • Sample Size: e.g., N=1000 cases.
   • Data Provenance: e.g., Multi-center, retrospective study from hospitals in the US, UK, and Germany. Or, prospective study collected from 3 different clinics in China.

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

   • Number of Experts: e.g., 3 independent board-certified radiologists.
   • Qualifications: e.g., All were board-certified radiologists with at least 5 years of experience in [relevant sub-specialty], specializing in [medical condition] diagnosis.

4. Adjudication method for the test set:

   • Method: e.g., 2+1 (two experts independently read, a third adjudicates disagreements). Or, consensus panel of 3 experts, or majority vote.

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:

   • MRMC study: Yes/No.
   • Effect Size: e.g., "Human readers improved their diagnostic accuracy by an average of 15% (p

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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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Permanent obturation of root canals of the secondary dentition in combination with root canal points.

AH Plus Endodontic Sealer is a two-component paste-paste permanent root canal sealer based on epoxyamine resin. It is available in two delivery forms: AH Plus Endodontic Sealer in tubes, for an easy manual mix, or as AH Plus Jet Endodontic Sealer double-barrel syringe with a disposable mixing tip for intraoral use, offering a more precise, convenient, and faster procedure. It functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus Endodontic Sealer does not stain teeth.

This document is a 510(k) summary for the AH Plus Endodontic Sealer. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving device performance against specific acceptance criteria in the context of an AI-powered diagnostic device.

Therefore, many of the requested categories for AI/digital health devices are not directly applicable or are not explicitly detailed in this type of submission for a traditional medical device like an endodontic sealer.

However, I can extract the information related to performance testing as described for this device, specifically those aspects that function as "acceptance criteria" for the device's physical properties.

Acceptance Criteria and Study for AH Plus Endodontic Sealer (K243546)

1. Table of Acceptance Criteria and 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)

This information is not provided in the document. The document describes non-clinical bench testing, not a clinical study involving patients or data provenance in that sense.

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)

This is not applicable as the ground truth for the performance tests (radiopacity, solubility, etc.) is established by the physical and chemical properties measured against the ISO standard, not by expert interpretation.

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

This is not applicable. The "test set" here refers to samples of the device material undergoing physical and chemical tests, not diagnostic cases 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

This is not applicable. This is a submission for an endodontic sealer, which is a physical material, not an AI-powered diagnostic device. No human reader or AI assistance is involved.

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

This is not applicable. This device is not an algorithm or software.

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

The "ground truth" for the performance tests is the specified limits and methodologies defined within the ISO 6876:2012 standard for dentistry-root canal sealing materials. For biocompatibility, the ground truth is adherence to the specified ISO 10993 series and USP standards.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI model. There is no concept of a "training set."

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

This is not applicable.

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i-MTA BP Bioceramic Root Canal Sealer and Repair Material is developed for permanent root canal sealer and repair and surgical applications.

• Repair of Root Perforation
• Repair of Root Resorption
• Root End Filling
• Apexification
• Pulp Capping

i-MTA BP Bioceramic Root Canal Sealer and Repair Materials is a ready-to-use premixed bioceramic paste developed for permanent root canal sealer and repair and surgical applications. i-MTA BP is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. i-MTA BP does not shrink during setting and demonstrates excellent physical properties. i-MTA BP is packaged in a preloaded syringe.

Here's a breakdown of the acceptance criteria and the study details for the Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP), based on the provided FDA 510(k) summary:

This device is not an AI/ML device, therefore, some of the requested information (like effect size of human readers with vs. without AI, number of experts for ground truth, adjudication methods, details on training set) are not applicable. The information provided relates to a traditional medical device's performance against established standards.

1. Table of Acceptance Criteria and Reported Device Performance

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Permanent obturation of root canals of the permanent teeth in combination with root canal points

VioSeal is the epoxy resin-based root canal sealer in the dual syringe for easy mixing and injection and is mixed with the 1:1 mixing ratio. It contains inorganic fillers which has good biocompatibility, physical and chemical properties and produces a complete obturation. Therefore, VioSeal has good biocompatibility with the root canal tissues.

The provided text does not describe an AI/ML powered medical device or software. It pertains to a dental device, specifically a root canal filling resin. Therefore, the questions regarding acceptance criteria, study details, ground truth, sample sizes, and expert qualifications for an AI/ML device are not applicable to this document.

The document discusses the substantial equivalence of the VioSeal root canal filling resin to a predicate device based on non-clinical tests.

Here's the relevant information found in the document regarding the device's performance:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Study that Proves the Device Meets Acceptance Criteria:

A non-clinical study investigated the performance of VioSeal according to ISO 6876 standards for root canal filling materials.

• Sample size used for the test set and the data provenance: Not explicitly stated, but implies laboratory testing of the material itself. It is a non-clinical study, not a study involving human or image data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a materials science characterization, not an expert-driven ground truth assessment.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI/ML or diagnostic device.
• Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
• Type of ground truth used: The "ground truth" or reference standard for these non-clinical tests is the established methodology and specifications outlined in the ISO 6876 standard.
• Sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
• How the ground truth for the training set was established: Not applicable.

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• Permanent obturation of the root canal following vital pulp-extirpation.
• Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.

i-MTA SP Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and placement of intracanal dressings.

i-MTA SP Injectable Root Canal Bioceramic Sealer is a convenient premixed ready-to-use, injectable white hydraulic bioceramic paste developed for permanent root canal filling and sealing applications. an injectable mineral trioxide aggregate. i-MTA SP is used for root canal sealing and permanent obturation. It is an insoluble and radiopaque material based on a calcium silicates composition, which requires the presence of water to set and harden. i-MTA SP is packaged in an oral irrigator and is supplied with disposable Intra Canal Tips. i-MTA SP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods.

The provided text describes a 510(k) submission for a medical device, the "Injectable Root Canal Bioceramic Sealer (i-MTA SP)". This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets specific acceptance criteria through a clinical study with AI or human readers.

Therefore, the requested information regarding acceptance criteria, AI/human reader performance, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies is not available in the provided text.

The text primarily details:

• Device Name: Injectable Root Canal Bioceramic Sealer (i-MTA SP)
• Regulation Number: 21 CFR 872.3820
• Regulation Name: Root Canal Filling Resin
• Product Code: KIF
• Indications for Use:
  • Permanent obturation of the root canal following vital pulp-extirpation.
  • Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
  • Suitable for use in the single cone and placement of intracanal dressings.
• Comparison to Predicate Devices: The document explicitly states its purpose is to show "substantial equivalence" based on "similar physical and biocompatible properties and demonstrates comparable performance specifications to the predicate devices."
• Performance Data Provided:
  • ISO 6876:2012 Dentistry - Root canal sealing materials.
  • Endodontic usage Test- ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
  • Biocompatibility Assessment per FDA Biocompatibility Guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

No information about AI performance, human reader studies, or the specific criteria for such studies is present in this 510(k) summary. This device is a material used for root canal filling, not a diagnostic or AI-powered device.

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• Repair of Root Perforation
• Repair of Root Resorption
• Root End Filling
• Apexification
• Pulp Capping

Vista BC Putty is a hydraulic, ready-to-use injectable bioceramic, bioactive root repair paste developed for permanent root canal repair of root perforation and root resorption, and root end filling, apexification and pulp capping applications. Vista BC Putty is an insoluble, radiopaque material based on a calcium sodium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Putty does not appreciable shrink during setting and demonstrates excellent physical properties.
1.0g of Vista BC Putty is packaged in a 1.2mL syringe. Vista BC Putty is for prescription use (Rx) only.

The provided text describes the regulatory clearance of a dental root canal filling material, Vista BC Putty. It references non-clinical performance testing but does not include information about clinical studies, expert-based ground truth, or MRMC studies that are typically associated with AI/ML-based medical devices.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from ISO 6876 standards for dental root canal sealing materials. The reported performance indicates compliance with these standards and comparability to predicate devices.

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