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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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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.

Vista BC Sealer is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. Vista BC Sealer is an insoluble, radiopaque material based on a calcium phosphosilicate and calcium aluminate cement composition, which requires the presence of water to set and harden. Vista BC Sealer does not appreciably shrink during setting and demonstrates excellent physical properties. Vista BC Sealer is packaged in a preloaded syringe and supplied with disposable single use application tips.

The provided text describes the 510(k) submission for the Vista BC Sealer, a root canal filling material. It details non-clinical performance testing but does not include information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/ML algorithm or a typical clinical study with a test set, ground truth, or expert involvement. The submission focuses on demonstrating substantial equivalence to predicate devices through physical, chemical, and biocompatibility testing.

Therefore, many of the requested fields regarding acceptance criteria, study design for AI/ML, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies cannot be answered from the provided document as they are not relevant to this type of device clearance.

However, I can extract the information related to the performance demonstrated by the non-clinical tests.

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

The document does not explicitly state numerical acceptance criteria for many of the tests in a table format, but it does state compliance with ISO standards and favorable comparison to the predicate device. Where specific values or qualitative outcomes are mentioned, they are included below.

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Permanent obturation of the root canal following root canal treatment.

Sonendo Material A is a single component injectable paste material intended for permanent obturation of the root canal following root canal treatment. The device is comprised of alginate and a calcium containing compound which crosslinks in the presence of water to form an insoluble polymer. The placement into the root canal can be accomplished with or without the use a root canal point. The material is radiopaque and has physical properties such that it is suitable for root canal obturation. The material is packaged in either a syringe with single use dispensing tips or in a single dose capsule.

The provided text describes Sonendo Material A, a root canal filling resin, and its FDA 510(k) clearance based on substantial equivalence to a predicate device, iRoot SP Root Canal Sealer (K080917).

However, the document does not contain any information about an AI/ML powered device, nor does it provide details about acceptance criteria for an AI/ML product, performance metrics typically associated with AI/ML (e.g., accuracy, sensitivity, specificity, AUC), or studies involving human readers or ground truth established by experts/pathology for an AI model.

The "Performance Data" section of the document refers to bench testing to demonstrate physical-chemical properties and biocompatibility, which are standard for medical devices like root canal filling resins, not AI/ML software.

Therefore, I cannot fulfill your request for information related to AI/ML device acceptance criteria and study details. The input document pertains to a traditional medical device (root canal filling resin) and its regulatory clearance process.

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Permanent sealing of root canal

Well-Root™ ST is a convenient premixed ready-to use 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 describes the regulatory clearance of a root canal filling resin, Well-Root™ ST, and its substantial equivalence to predicate devices. It does not present a study with acceptance criteria and reported device performance in the context of diagnostic accuracy, clinical outcomes, or human-in-the-loop performance, as implied by the request. Instead, the "performance data" section refers to bench testing against ISO standards and biocompatibility tests. These are typically used to demonstrate the physical, chemical, and biological safety of a material, not to evaluate the diagnostic or clinical efficacy of an AI-powered medical device.

Therefore, many of the requested items, particularly those related to diagnostic accuracy, a test set, ground truth, experts, and comparative effectiveness studies, cannot be answered from the provided text.

Here's an attempt to answer the questions based only on the information available in the provided text, highlighting where the information is not present or not applicable to the context of AI device studies:

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

The document lists performance standards it conformed to (ISO 6876 and ISO 10993 series), and mentions that "the test result of the subject device satisfies the requirement of the ISO 6876" and "the results of the bench and the biocompatibility tests performed demonstrates that any of these differences do not raise a new question as to safety and effectiveness." However, specific numerical acceptance criteria and reported performance values for these tests are not detailed in the provided text.

The document mentions compliance with the following ISO standards and specific tests within them:

Note: The text explicitly states, "the test result of the subject device satisfies the requirement of the ISO 6876 and does not raise an issue of safety and/or performance." It also mentions for shelf life "Appearance, ISO 6876 tests (Flow, Setting Time, Film Thickness)" were conducted, implying compliance.

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/Not provided. This document describes physical, chemical, and biocompatibility testing of a root canal filling resin, not an AI-powered diagnostic device that would typically have a "test set" of data (e.g., images, patient records). The testing methods for ISO standards usually involve a defined number of samples for each test (e.g., N=3 or N=5 for flow, setting time, etc.), but these specific numbers are not given in this summary.

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/Not provided. Ground truth, in the context of diagnostic AI, refers to the confirmed correct diagnosis or outcome. For a physical device like a root canal sealer, "ground truth" would relate to the validated methods of the ISO standards themselves, not expert judgment on cases.

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

Not applicable/Not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations (e.g., in reading medical images) for establishing ground truth, which is not the type of study described here.

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. This is not a study involving human readers or AI assistance. It is a submission for a physical medical device.

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

No. This is not an algorithm or AI device.

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

For the ISO and biocompatibility tests: The "ground truth" is established by the specified methodologies and criteria outlined within the respective ISO standards (e.g., ISO 6876 for physical properties of root canal filling materials, ISO 10993 series for biocompatibility). These standards define the acceptable range or characteristics for the device's performance.

8. The sample size for the training set

Not applicable/Not provided. As this is not an AI device, there is no "training set."

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

Not applicable/Not provided. As this is not an AI device, there is no "training set" or corresponding ground truth establishment in that context.

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DRFP propoint obturation points are designed for permanent sealing of root canals when used with DRFP smartpaste Dental Sealer or Brasseler USA EndoSequence® BC Sealer following established endodontic procedures by qualified healthcare professionals.

The propoints are identical to the points cleared for marketing with K100248. They are made of a radiopaque core and an opaque hydrophilic coating of cross-linked hydrophilic polymers that have been used in the contact lens industry for more than 20 years.

propoints are offered in the traditional 4% and 6% sizes and for use with variable taper files (such as ProTaper™ and Sendoline S5™). They are biocompatible and fully opaque. The hydrophilic coating expands radially to push the sealer into irregularities and voids present in the root canal system for a tight mechanical seal with the dentine. The coating only expands into available space and does not exert pressure on tooth structures. Dimensional length stability is maintained.

The points are packaged in clean room conditions and come individually wrapped to prevent cross-contamination. They can be cut to exact tip size and length.

No heating or compression equipment is required. Post insertion can commence immediately after root canal has been filled. The hydrophilic properties of the device allow extraction without softeners in revision procedures.

propoints are

• coated with DRFP smartpaste prior to insertion into the root canal . (K100248) or
• inserted after the root canal has been filled with EndoSequence® BC. .

This report describes the acceptance criteria and study that proves the device meets the acceptance criteria for DRFP Ltd.'s Propoints with iRoot SP Sealer.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Approximately 2000 treatments were reviewed for clinical performance.
• Data Provenance: The clinical data is retrospective, derived from the "DRFP User Panel of practicing dentists". The country of origin for the data is not explicitly stated, but the submission is from DRFP Ltd. in the United Kingdom and their "User Panel" is mentioned, implying data collected from dental practices.

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

• Number of Experts: A "DRFP User Panel of practicing dentists" was used. The exact number of dentists on this panel is not specified.
• Qualifications of Experts: They are described as "practicing dentists." Their specific qualifications (e.g., years of experience, specialization) are not detailed in the provided text.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The failure rate and clinical observations appear to be reported directly by the "DRFP User Panel of practicing dentists."

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

There is no mention of an MRMC comparative effectiveness study, nor is AI involved in this device. This submission is for a conventional medical device (root canal obturation points and sealer).

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

This question is not applicable as the device is a physical medical device (root canal obturation system), not an algorithm or AI.

7. The Type of Ground Truth Used

• For Clinical Performance: The ground truth for clinical performance (failure rate, healing, bonding effectiveness) was established through observations and reporting by a "DRFP User Panel of practicing dentists" and confirmed through "clinical x-rays."
• For Bench Tests: The ground truth for bench tests (dye penetration, sodium hypochlorite/EDTA interaction, radiopacity) was based on laboratory measurements and visual assessment (e.g., microscopic assessment for dye ingress).
• For Biocompatibility: Ground truth was established by testing according to ISO 10993 and ISO 7405 standards.

8. The Sample Size for the Training Set

There is no mention of a "training set" in the context of an algorithm or AI. This submission is for a physical medical device, not an AI/ML product.

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

This question is not applicable as there is no "training set" for an algorithm.

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

iRoot BP Injectable Root Canal Repair Filling Material (iRoot BP) is a convenient ready-to-use white hydraulic premixed injectable BioAggregate paste developed for permanent root canal repair and filling applications. iRoot 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. iRoot BP does not shrink during setting and demonstrates excellent physical properties. iRoot BP is packaged in a preloaded syringe and is supplied with disposable tips.

The device in question, iRoot BP Injectable Root Canal Repair Filling Material, is a dental product and theprovided text describes its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific clinical acceptance criteria in the way an AI/ML device would.

Therefore, the following information is not applicable or not provided in the given text:

• Acceptance criteria and reported device performance in a table (as this is not an AI/ML device with quantifiable performance metrics like accuracy, sensitivity, etc.).
• Sample size for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone performance (without human-in-the-loop).
• 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.

Instead, the documentation focuses on non-clinical tests to establish substantial equivalence.

Here's an analysis of the provided information, framed as closely as possible to your request, while acknowledging the limitations for a non-AI/ML device:

Device: iRoot BP Injectable Root Canal Repair Filling Material

1. Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are generally related to demonstrating substantial equivalence to existing predicate devices through comparable chemical, physical, and biocompatible properties, as well as similar performance specifications. The "reported device performance" are the results of these non-clinical tests compared to the established properties of the predicates.

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

This information is not provided in the document. The testing described is primarily laboratory bench testing and biocompatibility assessment, not a clinical trial with a "test set" in the context of patient data.

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

This is not applicable as the evaluation is based on non-clinical laboratory tests and established properties of predicate devices, not expert interpretation of clinical cases.

4. Adjudication Method for the Test Set

This is not applicable, as there isn't a test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI/ML system and does not involve human readers for interpretation.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For physio-chemical properties and performance specifications, the "ground truth" is derived from established standards for dental materials and the known, FDA-accepted properties of the predicate devices (BioAggregate, iRoot SP, Jeltrate® Plus™ Impression Material, Clearfil™ Ceramic Primer).
For biocompatibility, the "ground truth" comes from standard biocompatibility testing protocols and the established safety profiles of the chemical components present in the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device does not use a training set for machine learning.

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

Not applicable. There is no training set mentioned or implied for this device.

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