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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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• 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.
Injectable Root Canal Bioceramic Sealer is suitable for use in the single cone and lateral condensation technique.

NRSP 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. NRSP is an insoluble, radiopaque and aluminum-free material based on a strontium silicates composition, which requires the presence of water to set and harden. NRSP does not shrink during setting and demonstrates excellent physical properties. NRSP is packaged in a preloaded syringe and is supplied with disposable Intra Canal tips. NRSP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods. NRSP Injectable Root Canal Bioceramic Sealer is available in three preloaded syringe mode that provide different in specification in5g,3g,2g,1g and 0.5g. The only difference between the types are the net weight.
Root canal filling paste is a pre mixed paste material consisting of an inorganic powder system and an organic mixed liquid. It can solidify in a humoral environment, effectively seal the root tip, and has good biocompatibility; The curing time is stable and less affected by root canal moisture and humidity; It has excellent X-ray resistance, fluidity, antibacterial properties, non staining of teeth, and no irritation.

The provided document is a 510(k) premarket notification for a medical device called "Injectable Root Canal Bioceramic Sealer." It does not contain information about an AI/ML powered device or study results related to AI/ML performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI-powered device. The document primarily focuses on non-clinical bench testing and biocompatibility testing for a traditional medical device (root canal sealer) to demonstrate its substantial equivalence to a predicate device.

The tables and information presented are for the non-AI root canal sealer, for example:

• Table 1: Comparison to Predicate Device lists characteristics of the proposed device and its predicate, showing "Same" for many attributes like product code, regulation number, class, indications for use, chemical composition, and performance standard conformance.
• Table 2: Biocompatibility testing details various biocompatibility tests performed on the device (e.g., In Vitro Cytotoxicity, Skin sensitization, Ames test, Acute Systemic Toxicity Test, Bone implant test, Endodontic usage Test), all of which resulted in "Pass" for the "Proposed device."

Since the request is specifically about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML, and the document describes a non-AI medical device, I cannot fulfill the request as phrased.

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

C-Root 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. C-Root SP is an insoluble, radiopaque and aluminum-free material based on a strontium silicates composition, which requires the presence of water to set and harden. C-Root SP does not shrink during setting and demonstrates excellent physical properties. C-Root SP is packaged in a preloaded syringe and is supplied with disposable Intra Canal tips. C-Root SP may be delivered into the canal via the disposable tips or it can be delivered via traditional methods.
C-Root SP Injectable Root Canal Bioceramic Sealer is available in three preloaded syringe mode that provide different in specification in2g; 1g; 0.5g. The only difference between the types are the net weight.

Based on the provided text, the device in question is an "Injectable Root Canal Bioceramic Sealer" and the submission is for a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device, not necessarily a claim of improved performance or a direct clinical efficacy study. Therefore, a significant portion of the requested information, particularly regarding AI performance, MRMC studies, and detailed ground truth establishment for a diagnostic AI, is not applicable to this type of medical device submission.

Here's the breakdown of the information that can be extracted and applied, with N/A for criteria that are not relevant to this submission:

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

For a 510(k) submission, "acceptance criteria" are typically defined by recognized standards (like ISO 6876:2012) and comparability to the predicate device. The performance is assessed through non-clinical testing.

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 applicable as the provided document details a 510(k) submission for a root canal sealer, which relies on non-clinical performance and biocompatibility testing, not a clinical study involving human patient data or a diagnostic AI's test set. The tests performed are laboratory-based assays on the material itself.

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. Ground truth establishment by experts relates to diagnostic device performance evaluation, particularly for AI/image analysis. This document describes a material-based device.

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

This is not applicable as there is no diagnostic 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

This is not applicable. This submission is for a material (root canal sealer), not an AI-assisted diagnostic device.

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

This is not applicable. There is no algorithm or standalone AI performance to evaluate.

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

For this device, "ground truth" refers to the established scientific and engineering principles and the performance standards outlined in ISO 6876:2012, as well as biocompatibility standards (e.g., ISO 10993 series). The "truth" is whether the material meets these specified physical, chemical, and biological properties in laboratory settings.

8. The sample size for the training set

This is not applicable. There is no machine learning model or "training set" for this type of device.

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

This is not applicable. There is no machine learning model or "training set" for this type of device.

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