(291 days)
Aluminum Chloride impregnated retraction material are for the temporary retraction of the gingival margins and hemostasis procedures. The Retraction Cord is place the gingival tissues for a short period prior to making an impression or for other restorative procedures.
As part of a tissue management procedure, Styptin, Hemogin-L, Hemodettes, and GingiGEL are aluminum chloride containing astringent/ hemostatic solutions and gels that are intended to be supplied with gingival retraction cord or cotton pellets that are either pre-impregnated or for end-user impregnation by soaking the cords or cotton pellets in these solutions. The aluminum chloride impregnated retraction material is then packed into the sulcus to temporarily displace gingival tissue to expose the sub-gingival margins and control sulcular seepage and hemorrhage for impression taking and other restorative treatments. The supplied retraction material is available as an aqueous aluminum chloride solution or gel and either unit-dose 2"-pieces of braided cotton cord, braided cotton-polyester cord, or unit-dose cotton pellets.
The provided document is a 510(k) Pre-market Notification from the FDA for dental retraction materials (Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials). This type of document is focused on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing acceptance criteria and conducting studies to prove performance against those criteria in the way one might for a novel device or software.
Therefore, much of the requested information regarding detailed acceptance criteria and a specific study proving the device meets those criteria (especially clinical performance, AI/ML specific details like sample sizes for training/test sets, expert adjudication, or MRMC studies) is not applicable or not present in an FDA 510(k) summary for this type of device.
Here's a breakdown of what information can be extracted or inferred from the document based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Formal acceptance criteria, as in numerical thresholds for accuracy, sensitivity, or specificity commonly seen for diagnostics, are not presented for this device. Instead, the "acceptance criteria" are implied through demonstration of substantial equivalence to predicate devices, focusing on shared intended use, indications for use, fundamental technological characteristics, and safety profiles. Performance is primarily assessed through non-clinical testing and comparison of characteristics.
| Acceptance Criteria Category (Derived from Substantial Equivalence) | Reported Device Performance (as demonstrated by comparison and non-clinical tests) |
|---|---|
| Intended Use | Same as predicates: Temporary retraction of gingival margins and hemostasis procedures. |
| Indications for Use | Same as predicates: Temporary retraction of gingival margins and hemostasis for impression taking or other restorative procedures. |
| Target Users | Same as predicates: Licensed dental professionals. |
| Primary Mode of Action | Same as predicates: Mechanical displacement of gingival tissues. |
| Astringent/Hemostatic Agent | Aluminum Chloride (similar to reference predicates; primary predicate uses Aluminum Potassium Sulfate). |
| AlCl3 Content (weight/volume %) | GingiGel: 20%; Styptin: 20%; Hemogin-L: 25%; Hemodettes: 20% (Comparable to reference predicates Expa-syl (15%) and ViscoStat Clear (25%)). |
| Contact Time |
N/A