(144 days)
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord are for the temporary retraction of the gingival margins and hemostasis procedures. The Retraction Cord is placed in the sulcus to displace the gingival tissues for a short period prior to making an impression or for other restorative procedures.
Dental retraction materials are used to aid in creating accurate impressions of subgingival margins by temporary gingival displacement, and control of sulcular seepage and hemorrhage. Cords are impregnated with Aluminum Potassium Sulfate. The braided GingiBraid+ and the knitted GingiKnit+ are made of cotton fiber with a different color strand running through the cord for identification of the diameter. Retraction Cords have a yellow background color for medicament identification. The usage is inherently of transient nature. Typical exposure time is less than five minutes. The braided and knitted cord configurations are available in different sizes to fit the sulcus.
This document describes Kerr Corporation's dental retraction cords (GingiKnit+, Gingibraid+, Gingibraid+ Shortcut, and Unibraid+ impregnated Aluminum Potassium Sulfate Retraction Cord) and their substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Non-Clinical Performance Data | Stability: Performed. (No specific results provided, but implied to be acceptable for substantial equivalence determination.) |
| Cutting Test: Performed. (No specific results provided, but implied to be acceptable for substantial equivalence determination.) | |
| Water Contact Test: Performed. (No specific results provided, but implied to be acceptable for substantial equivalence determination.) | |
| Biocompatibility Testing (ISO 10993-1: 2009 & ISO 10993-5:2009): Performed. | |
| - Results: Biocompatibility meets requirements. | |
| Material Compatibility | Biocompatibility meets requirements. (Explicitly stated in Table 8.1 for both Predicate and Proposed Device.) |
| Technological Characteristics | Designs are similar to the predicate KnitPak+. Braided or knitted cotton also contains a surfactant and Aluminum Potassium Sulfate for hemostasis. The braided material is made of cotton fiber and a solid cord for strong physical retraction, not splitting or collapsing. The knitted cord is formed by many tiny loops, places easily without fraying or memory, and conforms to the sulcus with gentle, outward force. Cuts cleanly if touched by a high-speed instrument. (Implied to meet acceptance criteria for substantial equivalence by being "virtually identical" to the predicate in key characteristics.) |
| Intended Use | 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. (Matches the predicate's intended use.) |
| Indications for Use | For the temporary retraction of the gingival margins and hemostasis procedures. The Retraction Cord is placed in the sulcus to displace the gingival tissues for a short period prior to making an impression or for other restorative procedures. (Matches the predicate's indications for use, albeit with a different hemostatic agent mentioned primarily in the description.) |
| Safety and Effectiveness | No new questions of safety or effectiveness raised by noted differences in technological characteristics (specifically the different hemostatic agent, Aluminum Potassium Sulfate vs. Aluminum Chloride, and configuration). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set in the traditional sense for evaluating the device's performance against specific acceptance criteria for diagnostic accuracy or detection. This is a 510(k) submission focused on substantial equivalence to a predicate device.
- Test Set for Non-Clinical Performance Data: The sample sizes for the Stability, Cutting Test, Water Contact Test, and Biocompatibility testing are not specified in the provided text.
- Data Provenance: Not explicitly stated for the non-clinical tests. However, the standards used (ISO 10993-1: 2009 and ISO 10993-5:2009) are international standards. This type of testing is generally performed in laboratory settings.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes non-clinical performance and substantial equivalence, not a study evaluating human interpretation or a diagnostic device where ground truth would be established by experts.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above.
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
This information is not applicable. This device is a dental retraction cord, not an AI software or diagnostic imaging device. No MRMC study was conducted or is relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests mentioned:
- Biocompatibility: The ground truth is established by the specified ISO standards (ISO 10993-1 and ISO 10993-5), which define acceptable biological responses and methodology.
- Other Non-Clinical Tests (Stability, Cutting, Water Contact): The "ground truth" or acceptance criteria for these tests would likely be internal specifications derived from the predicate device's performance or industry standards, ensuring the device functions as intended and safely. Specific criteria are not detailed in the provided text.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated above.
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