(80 days)
CordCap™ is intended for the temporary retraction and hemostasis of the gingival margin through mechanical means.
CordCap™ is a compression roll manufactured out of wicking paper and impregnated with natural salts.
The provided text is a 510(k) summary for the CordCap™ device. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with defined performance metrics, sample sizes, and ground truth establishment methods.
Based on the provided text, there is no detailed study information available that describes acceptance criteria and how a device's performance meets those criteria in the way typically expected for a clinical trial or performance study of an AI/imaging device.
Here's an analysis of the submission in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The submission does not present a formal table of acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating substantial equivalence to existing predicate devices. The "criteria" for acceptance are implicitly that the device is "as safe and effective" as the predicate devices.
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Summary from Submission) |
|---|---|
| Safety: | |
| - No adverse biological reactions | - CordCap™ is a mechanical device made of absorbent paper infused with sodium chloride and/or aluminum chloride salts. |
| - Low concentration of salts | - Salt level less than 6mg per 1" x ½" of paper, typically 0.06g - 0.09g of salt per device. |
| - Similar materials to predicate devices | - Materials (wicking paper, natural salts) are similar in nature to components or principles of retraction cords. |
| Effectiveness: | |
| - Temporary retraction of gingival margin | - Intended for temporary retraction of the gingival margin through mechanical means. Compression of gingival tissue over several minutes is commonly known to widen the sulcus. |
| - Hemostasis of gingival margin | - Intended for hemostasis of the gingival margin through mechanical means. Mechanical pressure on the tissue can effect hemostasis, enhanced through natural action of salts. |
| - Similar mechanism of action to predicate devices | - Functions in a physical manner similar to, and is intended for the same use as, predicate devices (Ultrapak NEHA, Stay-Put Impregnated). |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission does not describe a test set in the context of performance metrics for an AI/imaging device. It relies on a comparison of characteristics and intended use to predicate devices already on the market. There were no human subjects or data sets used for validating specific performance claims.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As there was no test set for performance evaluation, there were no experts used to establish ground truth. Substantial equivalence is determined by regulatory bodies based on documented device characteristics and comparison to predicates.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication process for performance was described.
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:
- No. An MRMC study is not relevant for this type of mechanical dental device. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Implicit "Ground Truth" of Predicate Devices: The "ground truth" in a substantial equivalence claim is effectively the established safety and effectiveness of the legally marketed predicate devices (Ultrapak NEHA, Stay-Put Impregnated). The new device is deemed acceptable if it can demonstrate it shares the same intended use and technological characteristics, or is as safe and effective, as these predicates.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
In summary, the provided K091380 document is a 510(k) premarket notification for a mechanical dental device. Its acceptance relies on demonstrating substantial equivalence to already approved predicate devices, not on a detailed clinical study with performance metrics in the way an AI diagnostic device would be evaluated. Therefore, most of the specific questions about acceptance criteria and study details for an AI-like device are not applicable to this submission.
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