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510(k) Data Aggregation
(311 days)
Stasis Gel
STASIS Gel is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. STASIS Gel facilitates the insertion of the cord into the sulcus.
Stasis Gel is a 15.5% Ferric Sulfate in a water-based, viscous gel that facilitates sulcus retraction. When applied to the sulcus, the product provides physical displacement of the gingival tissue from the tooth, which in turn, provides a physical barrier to prevent gingival bleeding and oozing from following procedures. Stasis Gel is supplied in a 30 ml or 1.2 ml plastic syringe. The 30 ml syringe is used for bulk storage and 1.2 ml plastic syringe is used for delivery the gel to the sulcus.
This document is a 510(k) summary for the STASIS Gel, a dental device intended for sulcus retraction and control of bleeding/gingival oozing. It primarily focuses on demonstrating substantial equivalence to a predicate device (Vista FS) rather than presenting a detailed study with acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI device testing (e.g., sample size for test set, expert qualifications, MRMC study, standalone performance) is not applicable or provided in this document.
However, based on the provided text, I can extract information related to the device's characteristics and the non-clinical testing performed to support its substantial equivalence.
Here's the information that can be extracted, and where the requested information is not applicable, it is noted.
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a medical device (STASIS Gel) and not an AI/software device, the acceptance criteria are based on demonstrating similarity to a predicate device in terms of chemical characteristics, indications for use, and safety. The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense for a software algorithm, but rather compares key attributes.
| Criteria/Characteristic (for comparison with Predicate) | Predicate Device (Vista FS / Vista FS Liquid) Performance | Subject Device (Stasis Gel) Performance |
|---|---|---|
| Indications for Use | Sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. Facilitates the insertion of the cord into the sulcus. | Sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. Facilitates the insertion of the cord into the sulcus. |
| Chemical Characteristics | 20% Ferric Sulfate (Vista FS), 15.5% Ferric Sulfate (Vista FS Liquid) | 15.5% Ferric Sulfate |
| Mechanism of Action | Physical displacement of gingival tissue by viscous gel; facilitates cord insertion. | Physical displacement of gingival tissue by viscous gel; facilitates cord insertion. |
| Viscosity | Unknown | ≥ 55,000 cps |
| pH | 1-3 | 1-3 |
| Biocompatibility | Cytotoxicity | Cytotoxicity, Skin Sensitization, Skin Irritation (all demonstrated low risk) |
| Ferric Sulfate Content | Not explicitly stated for performance, but implied by 15.5% / 20%. | Tested and found similar to predicate device. |
| Shelf-Life | 18 months | 24 months (based on accelerated testing, real-time ongoing) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document describes the non-clinical testing of a physical medical device (STASIS Gel), not an AI/software device. There is no "test set" in the context of clinical images or patient data for AI performance evaluation. The "testing" refers to bench testing and biocompatibility studies.
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 is for a physical medical device, not an AI/software device requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or human adjudication process as this is not an AI/software device.
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 for a physical medical device, not an AI/software device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the physical characteristics and safety:
- Biocompatibility: In-vitro and in-vivo testing according to ISO 10993-1 standards, which serve as objective ground truth for safety assessments.
- Chemical Characteristics (Ferric Sulfate content, pH): Laboratory analytical methods that provide objective measurements.
- Viscosity: Laboratory rheometry methods that provide objective measurements.
- Shelf-Life: Accelerated aging studies and ongoing real-time aging studies, which provide objective data on product stability over time.
8. The sample size for the training set
Not applicable. This is not an AI/software device that uses "training sets."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/software device.
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