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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.

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