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Super SiliPlugs™ Ear Plugs are used to block water from entering the ear canal.

Super SiliPlugs™ Ear Plugs

I am sorry, but the provided text from the FDA 510(k) K972923 for "Super SiliPlugs™ Ear Plugs" does not contain information regarding detailed acceptance criteria or a study proving the device meets specific performance criteria.

The document is a clearance letter from the FDA, stating that the device is "substantially equivalent for the indications for use" to devices marketed prior to May 28, 1976. This indicates that the device's acceptable performance is based on its similarity to existing legally marketed devices, rather than a specific set of new performance metrics and a study to achieve them.

Therefore, I cannot provide the requested table or the detailed study information because it is not present in the given text. The clearance process for this type of device, particularly in 1997, often relied on substantial equivalence demonstration rather than extensive novel performance studies.

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The catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may also be used as a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.

Epistaxis Catheter

The provided FDA letter and "Indications for Use" statement pertain to a medical device called the "Vyker Silicone Epistaxis Catheter V-27030" (K972922).

Based on the content, this document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a predicate device. This type of clearance does not typically involve specific acceptance criteria and detailed clinical study results in the same way a Premarket Approval (PMA) would.

The crucial information missing for your request is a detailed performance study with acceptance criteria. For 510(k) submissions, the focus is on substantial equivalence to a legally marketed predicate device rather than de novo clinical efficacy and safety studies with predefined acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone (algorithm only) performance was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document only states the device's intended use: "The catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may also be used as a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures."

To obtain the kind of data you are asking for, one would typically need access to the full 510(k) submission, specifically the sections detailing the performance data and comparison to the predicate device. This letter is merely the FDA's decision based on that submission.

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