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510(k) Data Aggregation
(106 days)
Sealer Solvent, a root canal cleanser, is intended to irrigate, cleanse, and debride root canal systems including the removal of foreign material and debris during root canal therapy.
The Sealer Solvent presents a clinically effective way to aid in removal of bioceramic root canal sealers during endodontic retreatment procedures. Sealer Solvent is an aqueous-based irrigant that is delivered via syringe and needle tip while instrumenting the canal after any gutta percha is removed. Sealer solvent works to soften and dissolve the sealer to be flushed out or removed with files. Although Sealer Solvent has been designed for use as a retreatment irrigant, it may be used during traditional endodontic non-retreatment procedures as an endodontic irrigant (i.e. root canal cleanser) to help remove inorganic solids from canal walls, such as smear layer and calcium hydroxide, prior to obturation.
Analysis of provided document for Acceptance Criteria and Device Performance Study Details:
Based on the provided FDA 510(k) summary for "Sealer Solvent" (K241354), the document extensively details the device's characteristics, comparison to predicate devices, and non-clinical performance testing. However, it explicitly states:
- "Clinical performance testing has not been performed for Sealer Solvent."
Therefore, the document does not contain information about a study that proves the device meets clinical acceptance criteria, nor does it provide details on sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a clinical test set. The focus of the provided information is on non-clinical (laboratory) testing to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the available information in relation to your request, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of acceptance criteria in terms of specific performance metrics for the device (e.g., a specific percentage of material removal, or a target softening time). Instead, it describes various tests performed and implies the device met the requirements for these non-clinical tests to demonstrate substantial equivalence.
Implied Performance and Testing:
| Test Category | Description of Test / Implied Performance |
|---|---|
| Dissolution Testing | Performed to assess the device's ability to dissolve materials. (Specific results not provided, but passing implied for 510(k)). |
| In-Vitro Canal Performance Testing | Performed to evaluate performance within a simulated root canal. (Specific results not provided, but passing implied for 510(k)). |
| Shelf-Life Verification | Verified a shelf life of 36 months. |
| Biocompatibility Analysis | All patient-contacting components evaluated per ISO 7405 / ISO 10993-1. Meets requirements. |
| Cytotoxicity Testing | Performed per ISO 10993-5 (in vitro). Meets requirements. |
| Anti-microbial Testing | Performed. (Specific results not provided, but passing implied for 510(k)). |
| Transit Testing | Performed. (Specific results not provided, but passing implied for 510(k)). |
Comparison to Predicate Device (Technological Characteristics):
The document emphasizes that the Sealer Solvent's technological characteristics are "very similar" to the predicate device (Ultradent Citric Acid Irrigant 20%):
- Same function: Cleanses root canal.
- Active Ingredients: Both contain Citric Acid at 20%.
- Mechanism of Action: Both aim to dissolve inorganic materials.
- Form of Use: Both filled into syringes and delivered via dental irrigation tip.
- Non-sterile.
- External communicating device with limited (≤24 hour) contact time.
- Prescription device.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the non-clinical tests.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be laboratory-based non-clinical tests rather than human clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set with human data requiring expert ground truth establishment was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set with human data requiring adjudication was conducted.
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 medical device (a solvent), not an AI-assisted diagnostic tool or imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" would be established by standard laboratory methods and controls for mechanical/chemical dissolution, biocompatibility, and antimicrobial efficacy testing. It would not involve expert consensus, pathology, or outcomes data in the human clinical sense.
8. The sample size for the training set:
- Not applicable. No AI/machine learning model was developed, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. No AI/machine learning model was developed, so there is no training set or associated ground truth establishment.
In summary, the provided document focuses solely on the non-clinical (laboratory) testing and comparison to a predicate device to establish substantial equivalence for a solvent, without any human clinical performance data or studies involving AI or expert readers.
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