(357 days)
For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
The Retraction Paste is a medium viscosity substance that contains aluminium chloride hexahydrate in a water-based kaolin (clay) inert carrier. The kaolin/water paste provides physical displacement of the gingiva as the material is placed into the sulcus via a manual dispensing syringe. The aluminium chloride hexahydrate component has hygroscopic and astringent properties, which produce a hemostatic/drying effect, and assist in temporarily shrinking the gingival tissue and holding it slightly away (retracted) from the tooth surface, thereby allowing complete access of the impression material.
This device, called "Retraction Paste," is a medical product used in dentistry for temporary retraction and hemostasis of the gingival margin. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way one might see for a novel AI or diagnostic device.
Therefore, many of the requested fields regarding detailed study design, sample sizes, expert qualifications, and AI-specific metrics (like MRMC studies) are not applicable to this type of submission. The "acceptance criteria" here are primarily about demonstrating that the new device shares fundamental characteristics and performance with an already legally marketed device.
Here's the breakdown based on the provided text, with explanations for why certain information is not present:
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Indications for Use | Identical to predicate device | "For the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam." (Identical to predicate) |
| Physical Properties | pH, viscosity comparable to predicate | Not explicitly quantified as meeting a specific range, but stated as being "identical to the predicate device in terms of these technological characteristics." |
| Chemical Composition | Identical to predicate device | "Aluminum chloride hexahydrate in a water-based kaolin paste." (Identical to predicate) |
| Operating Principle | Identical to predicate device | "Kaolin-based paste physically displaces gingival tissue; aluminum chloride hexahydrate provides gingival tissue retraction, hemostasis and drying of other fluids. Resulting gingival sulcus exposes margin." (Identical to predicate) |
| How Supplied | Identical to predicate device | "Pre-filled cartridge used with dispensing gun; product applied through disposable syringe tips attached to cartridge." (Identical to predicate) |
Study Proving Acceptance Criteria:
The "study" proving the device meets its (implied) acceptance criteria is the 510(k) Substantial Equivalence comparison provided in the document. This is a non-clinical comparison, not a human clinical trial or a performance study with a test set in the traditional sense for AI.
Detailed Study Information:
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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 is a 510(k) premarket notification for a dental retraction paste, not a diagnostic device involving a "test set" of data or patient cases in the context of AI or imaging. The "test" here is a comparison of product specifications and characteristics to a predicate device.
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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. No "ground truth" was established by experts for a test set in the context of this 510(k) submission. The comparison is based on the chemical, physical, and functional properties of the device itself and its predicate.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or expert adjudication was performed for this 510(k) submission.
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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 device is a manual dental paste, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a manual dental paste, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For this 510(k) submission, "ground truth" is established by the known characteristics and performance of the legally marketed predicate device, as well as the intrinsic properties (pH, viscosity, chemical composition) of the submitted device. There is no biological or diagnostic "ground truth" in the AI sense.
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The sample size for the training set:
- Not Applicable. No training set was used, as this is not an AI or machine learning device.
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How the ground truth for the training set was established:
- Not Applicable. No training set was used.
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