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510(k) Data Aggregation
(279 days)
The Tubli-Seal product line (Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress) is used for permanent obturation of the root canal space with the aid of obturating points.
The Tubli-Seal product line (Tubli-Seal Xpress/ Tubli-Seal EWT/ Tubli-Seal EWT Xpress) is a Zinc Oxide Eugenol root canal sealer to be used for permanent obturation of the root canal space in conjunction with obturating points. It is a two-part, base/accelerator, 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 product is available in two (2) working times. Regular and Extended Work Time (EWT) for both delivery options of tubes or dual-barrel syringes.
The proposed is available packaged in tubes (Tubli-Seal and Tubli-Seal EWT) and dualbarrel syringes (Tubli-Seal Xpress and Tubli-Seal EWT 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. Tubli-Seal Xpress has the same formulation and indications for use as Tubli-Seal, and Tubli-Seal EWT Xpress has the same formulation and indications for use as Tubli-Seal EWT. The proposed syringe-delivery products are branded as "Tubli-Seal Xpress" and "Tubli-Seal EWT Xpress" and offer 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 Tubli-Seal Xpress or Tubli-Seal EWT Xpress directly into the prepped root canal.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: Tubli-Seal product line (Tubli-Seal/Tubli-Seal Xpress/Tubli-Seal EWT/Tubli-Seal EWT Xpress)
This submission is for a modified version of an existing root canal sealer (Tubli-Seal/Tubli-Seal EWT). The core of the study is to demonstrate that the modified product line is substantially equivalent to the predicate device, essentially performing as well despite minor formula changes and a manufacturing location change.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are based on the international standard ISO 6876:2012 for Dental - Root Canal Sealing Materials. The reported performance of the proposed device is compared to the predicate device, with the standard as the overarching acceptance benchmark.
| Criterion (ISO 6876:2012) | Predicate Device Performance | Proposed Device Performance | Acceptance Criteria (from ISO 6876:2012) | Does Proposed Device Meet Criteria? |
|---|---|---|---|---|
| Consistency (Flow) | 29 mm | 28 mm | Not explicitly stated in the provided text as a numerical range (for a pass/fail), but is a characteristic measured. The slight difference (1mm) is considered acceptable for substantial equivalence. | Yes (implicitly, as considered substantially equivalent) |
| Film Thickness | 13.04 µm | 17.61 µm | Not more than 50 µm | Yes (17.61 µm < 50 µm) |
| Solubility and Disintegration | 0.70% | 0.46% | Not to exceed 3.0% | Yes (0.46% < 3.0%) |
| Radiopacity | 5 mm Al | 6 mm Al | Not explicitly stated in the provided text as a numerical range (for a pass/fail), but is a characteristic measured. The difference (1mm Al) is considered acceptable for substantial equivalence. | Yes (implicitly, as considered substantially equivalent) |
Notes on Acceptance Criteria:
- For Consistency (Flow) and Radiopacity, the document does not explicitly state the numerical acceptance range from ISO 6876:2012 beyond which the device would fail. Instead, it relies on the direct comparison between the proposed and predicate devices and the conclusion of substantial equivalence based on ISO 6876:2012.
- The key phrase "the proposed products meet the current product specifications and are substantially equivalent to the predicate" indicates that meeting the predicate's performance within acceptable ISO 6876:2012 deviations serves as the acceptance criterion.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not explicitly state the specific number of samples for each test (Consistency, Film Thickness, Solubility, Radiopacity). It mentions "Performance testing on stability, work time, set time and slump were performed on the modified formula," indicating multiple tests were conducted. Standard quality control and testing procedures would typically involve a statistically appropriate number of samples, but the exact count is not provided.
- Data Provenance: The testing was carried out as "Non-Clinical Performance Data" and "Performance Testing - Bench." This suggests the data was generated in a controlled laboratory or benchtop setting. The document also mentions that "The proposed Tubli-Seal product line (...) has successfully been on the EU market for several years without incident," suggesting real-world performance data from Europe, though the specific validation study data is laboratory-based. The manufacturing location is changing to Scafati, Italy, so it's likely the bench testing was done in relation to this manufacturing process and formulation.
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. This study is a bench performance study comparing the physical and mechanical properties of a material (root canal sealer) against an international standard (ISO 6876:2012) and a predicate device. It does not involve human interpretation or clinical endpoints that would require expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As a bench performance study, there is no need for human adjudication of results. The measurements are objective physical properties.
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 is a bench performance study for a dental material, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this study is defined by the objective, measurable physical and mechanical properties of the material as specified by ISO 6876:2012 - Dentistry - Root Canal Sealing Materials. This is a standardized laboratory measurement. The predicate device's performance also serves as a comparative "truth" for demonstrating substantial equivalence.
8. The sample size for the training set
- Not applicable. This is a physical materials performance study, not a machine learning study that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
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