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510(k) Data Aggregation
(70 days)
Sil-Flow is indicated for
[A] Temporary inlay and onlay treatments of the cavity
[B] Sealing of openings for implant screws
[C] Relining material for temporary crowns and bridges
[D] Block-out material for retentive areas in the dental arch, e.g. before taking impressions
[E] Covering of the gingival margin
[F] Fixing of resin matrix during filling placement
[G] Temporary filling of cavities
Sil-Flow is a flowable light-cured temporary filling material used for filling and sealing.
The provided FDA Premarket Notification (510(k)) for the Sil-Flow device is for a Tooth Shade Resin Material and NOT an AI/Software as a Medical Device (SaMD) product. Therefore, the information typically found in such a submission regarding AI device performance, such as:
- Acceptance Criteria for AI performance metrics (e.g., sensitivity, specificity, AUC)
- Study design for AI performance evaluation (e.g., standalone, human-in-the-loop, MRMC)
- Sample size and data provenance for AI test sets
- Ground truth establishment (number/qualifications of experts, adjudication methods)
- Training set details for AI models
- Effect size of AI assistance for human readers
are not present in this document.
This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (Clip Flow) based on physical and chemical properties, biocompatibility, and intended use for a dental material.
Here's a breakdown of the requested information based on the provided document, highlighting what is present and what is absent from the perspective of an AI/SaMD device:
Acceptance Criteria and Study Proving Device Meets Criteria (for Dental Material)
The acceptance criteria and supporting study for Sil-Flow relate to its physical, chemical, and biological properties as a tooth shade resin material, demonstrating its safety and performance for its indicated uses.
1. A table of acceptance criteria and the reported device performance
| Test Parameter | Acceptance Criteria (from ISO 4049 Protocol) | Reported Device Performance | Comments |
|---|---|---|---|
| Physical/Chemical Properties | |||
| Visual Appearance | (Implied to meet standard) | Met criteria | "All test results met the criteria in the standard." |
| Depth of Cure (mm) | Not explicitly stated (but referenced ISO 4049) | 3.1 mm | Predicate device (Clip Flow) reported 11mm, suggesting a difference. However, "Both the subject devices and the predicate device have physical parameters which meet the requirements of the relevant ISO standards," implying 3.1mm is acceptable per the standard for Sil-Flow. |
| Shor Hardness D | Not explicitly stated | 52 Shor D | Predicate (Clip Flow) reported 90 Shore A. Note the difference in Shore scale (D vs. A), making direct comparison difficult without a conversion or further context, but still stated to meet relevant ISO standard. |
| Sensitivity to Ambient Light | (Implied to meet standard) | Met criteria | "All test results met the criteria in the standard." |
| Water Sorption (µg/mm³) | <40 µg/mm³ (from predicate) | <40 µg/mm³ | Explicitly stated and met. |
| Water Solubility (µg/mm³) | <7.5 µg/mm³ (from predicate) | <7.5 µg/mm³ | Explicitly stated and met. |
| Color Stability | (Implied to meet standard) | Met criteria | "All test results met the criteria in the standard." |
| Shade Stability | (Implied to meet standard) | Met criteria | "All test results met the criteria in the standard." |
| Biocompatibility Testing | |||
| Cytotoxicity | Pass (according to ISO 10993-05) | Passed | Explicitly stated. |
| Irritation | Pass (according to ISO 10993-10) | Passed | Explicitly stated. |
| Sensitization | Pass (according to ISO 10993-10) | Passed | Explicitly stated. |
| Acute Systemic Toxicity | Pass (according to ISO 10993-11) | Passed | Explicitly stated. |
| Stability (Shelf Life) | |||
| Shelf Life | Demonstrated at 3 years | 3 years | "All shelf life determinations use the same testing protocols as the characterization testing which are based on ISO 4049." |
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the document. The testing summary refers to "protocols based on ISO 4049," which would define the number of samples for each test (e.g., number of specimens for depth of cure, water sorption, etc.), but the exact numbers are not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the testing is in vitro (laboratory testing of the material itself) and biocompatibility testing on biological models, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a dental material, "ground truth" is established through standardized laboratory measurements and validated biological tests, not human expert interpretation of clinical images or data in a diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3. This concept applies to human-reviewed clinical data, not material property testing.
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 not an AI/SaMD device. No MRMC study was performed as it's typically for assessing the impact of AI on diagnostic accuracy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/SaMD device. "Standalone performance" refers to an AI algorithm's performance without human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Laboratory Standard Measurements and Biocompatibility Test Results: The "ground truth" for this device is derived from the results of standardized physical property tests (e.g., specific gravity measurements for water sorption, calibrated hardness testers for Shor hardness, optical measurements for depth of cure) and the results of validated biocompatibility assays following ISO 10993 standards.
8. The sample size for the training set
- Not Applicable. This is not an AI/SaMD device. There is no "training set" in the context of an AI model for this dental material. The material itself is manufactured and tested.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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