Search Results

Pulp Canal Sealer and Pulp Canal Sealer EWT are used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials. They are Zinc Oxide/Eugenol root canal sealants. The products are made up of two separate components, a powder base and a liquid catalyst. to form the final device. The liquid catalyst is the same formulation for both products. Pulp Canal Sealer is a fast setting material, while Pulp Canal Sealer EWT features an extended work time of greater than 6 hours on the pad.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental device, "Pulp Canal Sealer and Pulp Canal Sealer EWT." The submission aims to demonstrate substantial equivalence to a predicate device (K945244). The information focuses on non-clinical performance data and does not include details about Artificial Intelligence (AI) or machine learning algorithms. Therefore, many of the requested points related to AI studies (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance of an algorithm) are not applicable to this document.

However, I can extract information related to the acceptance criteria and non-clinical study for the device's physical and mechanical properties.

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

The acceptance criteria for the physical and mechanical properties are implicitly derived from the predicate device's performance and the ISO 6876 standard for "Dental Root Canal Sealing materials." The reported device performance is compared against the predicate and against the ISO standard's maximum limits where specified.

Property	Acceptance Criteria (Based on Predicate and ISO 6876)	Reported Proposed Device Performance (K152956)
Pulp Canal Sealer
Consistency	Comparable to predicate (29 mm)	28 mm
Solubility	Comparable to predicate (0.09%)	0.34%
Work Time	> 45 Minutes (from predicate)	> 45 Minutes
Set Time	< 60 Minutes Max (from predicate)	< 60 Minutes Max
Film Thickness (µm)	≤ 50 µm (ISO 6876 standard) and comparable to predicate (22.6 µm)	20.66 µm
Safety	Pass (from predicate)	Pass
Pulp Canal Sealer EWT
Consistency	Comparable to predicate (28.5 mm)	25 mm
Solubility	Comparable to predicate (0.47%)	0.36%
Work Time	> 6 Hours (from predicate)	> 6 Hours
Set Time	< 2 Hours Max (from predicate)	< 2 Hours Max
Film Thickness (µm)	≤ 50 µm (ISO 6876 standard) and comparable to predicate (23.6 µm)	33.87 µm
Safety	Pass (from predicate)	Pass

Justification for Acceptance: The document states, "The data analyzed from the various tests substantiate that the Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT are substantially equivalent to the predicate devices." Specifically for film thickness, it notes, "The sealer was tested to meet ISO 6876 standards which state that a sealer shall have a film thickness of not more than 50 um. The Proposed Pulp Canal Sealer and Pulp Canal Sealer EWT is still below the maximum 50 um allowance and will flow sufficiently to fill the voids, as the film thickness remains within the proper specifications of the ISO standard requirements."

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

The document does not specify the sample sizes used for each physical and mechanical test. It only states that "Verification and validation activities were performed in accordance with design control requirements as specified in 21 CFR 820.30, ISO 13485:2012 Medical Devices- Quality Management Systems, and ISO 6876 Dental - Root Canal Sealing Materials."
The data provenance is from non-clinical performance data (laboratory testing) rather than human subject data. The proposed device's manufacturing location is identified as Scafati, Italy, suggesting the testing data may originate from these operations, although it's not explicitly stated. It is a prospective test in the sense that the new formulation was tested to demonstrate equivalence.

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

Not applicable. This is a non-clinical, laboratory-based performance study, not involving expert interpretation of medical images or patient data. The "ground truth" is defined by the physical and mechanical properties of the materials as measured against ISO standards and the predicate device's performance.

4. Adjudication method for the test set

Not applicable. This is a non-clinical, laboratory-based performance study; therefore, no adjudication method for human interpretation was used.

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 document describes a non-clinical study for a dental filling material, not an AI software or a comparative effectiveness study involving human readers.

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

Not applicable. This device is a physical dental material, not an algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical performance tests is based on:

ISO 6876:2012 Dentistry Root canal sealing materials: This international standard specifies the requirements and test methods for root canal sealing materials.
Performance of the legally marketed predicate device (K945244): The performance characteristics of the predicate device serve as a benchmark for comparison.

8. The sample size for the training set

Not applicable. This is a non-clinical study for a physical device, and there is no "training set" as would be used in machine learning.

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

Not applicable. As noted above, there is no training set mentioned in the context of this device's evaluation.

Ask a Question

Ask a specific question about this device

Page 1 of 1