Search Results

Sealapex/Sealapex Xpress is a calcium hydroxide, polymeric resin, root canal filling material that is used in conjunction with gutta percha or silver endodontic points.

Sealapex/Sealapex Xpress is a non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material. It is indicated for use as a root canal sealing and filling material, and is used during an endodontic procedure to seal off the prepared root canal apical foramen and tubules from blood, exudates, and infection. The proposed is a two-part, base/catalyst - paste/paste system that is mixed in equal portions. Then, the mixture is carried to the root canal with endodontic obturation points or directly dispensed in the root canal depending on delivery method, e.g. tube or dual-barrel syringe.

The proposed is available packaged in tubes (Sealapex) and dual-barrel syringes (Sealapex Xpress) used with single-use automix tips. The tubes are dispensed onto a mixing pad, hand mixed and then applied to the canal with an endodontic point. Sealapex Xpress has the same formulation and indications for use as Sealapex, but is branded as "Sealapex Xpress" since it offers the convenience of single-use automix tips that remove the need for hand mixing. The dual-barrel and single-use automix tips allow the dental professional to deliver the desired volume of Sealapex Xpress directly into the prepped root canal.

Here's an analysis of the provided text regarding the acceptance criteria and study for Sealapex/Sealapex Xpress:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied to be adherence to the ISO 6876:2012 standard for "Dentistry - Root Canal Sealing Materials" and substantial equivalence to the predicate device, Sealapex 4 (K010940).

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

The document does not explicitly state the sample sizes for the performance tests. It mentions "Performance testing on stability, work time, set time and slump were performed on the modified formula." and "The sealer was tested to meet ISO 6876:2012 standard." and "The predicate and proposed devices produced Flow results..." This implies that samples were tested, but the number of samples tested for each characteristic is not provided.

The data provenance is from non-clinical bench testing. It doesn't specify the country of origin for the data generation, but the manufacturing location for the proposed device is noted as Scafati Salerno, Italy. The predicate device's tests would have been performed by Kerr Corporation in Romulus, MI, USA. The current testing was performed on the "modified formula" which has been on the EU market for several years.

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

This document describes a material science/bench testing study, not a clinical study involving experts establishing ground truth for a diagnostic device. Therefore, this information is not applicable to this submission. The "ground truth" for this study is defined by the objective, measurable standards set by ISO 6876:2012.

4. Adjudication Method for the Test Set

As this is a bench testing study evaluating physical and mechanical properties against an international standard (ISO 6876:2012) and comparison to a predicate device, an adjudication method for a "test set" in the human-reader sense is not applicable. The results are quantitative measurements against predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This submission is for a root canal filling material, and the evaluation focuses on its physical and mechanical properties, not on diagnostic accuracy involving human readers.

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

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a material, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this study is based on:

• International Standard Specifications: Specifically, ISO 6876:2012 for "Dentistry - Root Canal Sealing Materials."
• Predicate Device Performance: The performance characteristics of the legally marketed Sealapex 4 (K010940) served as a benchmark for comparison to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This type of study for a material science device does not involve a "training set" as would be used for an AI/ML algorithm. Therefore, this question is not applicable.

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

As there is no "training set" in the context of this material science submission, this question is not applicable.

Ask a specific question about this device

Ask a specific question about this device

Kerr Modified Sealapex Root Canal Sealer is a two- paste, non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material. It is intended for use as a root canal sealer to be used in conjunction with gutta percha or silver endodontic points.

Kerr Modified Sealapex Root Canal Sealer is a two- paste, non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material.

This document describes a 510(k) submission for a modified root canal sealer, not an AI/ML powered device. Therefore, a table of acceptance criteria and reported device performance and other AI/ML specific information cannot be extracted from the document. The document describes changes to a root canal sealer formulation and provides evidence of substantial equivalence to a predicate device.

However, I can provide a summary of the provided information regarding the modified Sealapex Root Canal Sealer to address the intent of understanding the device's validation.

Device: Kerr Modified Sealapex Root Canal Sealer

Purpose of Submission: To gain market clearance for an updated formulation of Sealapex Root Canal Sealer with two modifications:

1. Substitution of poly(methylene methyl salicylate) resin with Neopentyl glycol disalicylate/trimethylol propane trisalicylate (NPG-TMP salicylate) resin to remove formaldehyde from the manufacturing process.
2. Addition of bismuth trioxide to increase radiopacity by fifty percent.

Study Type: This is a 510(k) submission for a medical device (root canal sealer), demonstrating substantial equivalence, not a study of an AI/ML system. The "studies" mentioned are related to the chemical and biological properties of the material.

Acceptance Criteria and Device Performance (Based on the provided text):

Since this is not an AI/ML device, the typical acceptance criteria for AI/ML performance metrics (e.g., AUC, sensitivity, specificity) are not applicable. Instead, the "acceptance criteria" can be inferred from the regulatory requirements for substantial equivalence and the performance standards for dental root canal sealing materials.

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

• Test Set Sample Size: Not specified in the provided text. The "test set" here refers to the materials and animals used in the histopathology studies and the samples used for ISO 6876 testing.
• Data Provenance: The animal histopathology studies are internal ("Copies of reports of these studies are included elsewhere in this submission"). Comparison testing to ISO 6876 is also internal. Country of origin is thus likely the USA where Kerr is based, but not explicitly stated. These were prospective studies designed to evaluate the new formulation.

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

• Number of Experts: Not explicitly stated. For animal histopathology, typically veterinary pathologists would interpret the tissue samples. For ISO standard testing, laboratory personnel and potentially experts in dental material science would perform and interpret the tests.
• Qualifications: Not specified, but implied to be appropriately qualified professionals for histopathology and dental material testing.

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

• Not applicable/Not specified for this type of device submission. Adjudication methods are typically used in clinical trials for endpoint determination or in image interpretation studies.

4. 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/ML device, so no MRMC study or AI assistance is relevant.

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

• Not applicable. This is not an AI/ML device.

6. The type of ground truth used:

• For Safety: Histopathology (evidence of biocompatibility, tissue response, hard tissue formation).
• For Efficacy/Performance: Results from objective laboratory tests conforming to ISO International Standard 6876 for Dental root canal sealing materials (e.g., flow, film thickness, working time, setting time, solubility, dimensional stability, radiopacity).
• For Substantial Equivalence: Comparison of material properties and biological performance to legally marketed predicate devices that meet FDA requirements.

7. The sample size for the training set:

• Not applicable for this type of device. The term "training set" is used for AI/ML models. For this device, the "training" can be considered the cumulative knowledge and testing from prior formulations and predicate devices, as well as the newly conducted studies.

8. How the ground truth for the training set was established:

• Not applicable for this type of device.

Ask a specific question about this device