Search Results

Punctum plugs are indicated for the treatment of dry eye disorder. A condition caused by insufficient moisture in the eye. As a result, one may experience some irritation and discomfort to the eyes. Patients that may benefit from the use of punctum plugs are: sufferers of allergies, cataracts, dry eye disorder secondary to contact lens use, and others who experience dry eye disorders. Specific treatment to stop the outflow of tears via a punctal opening (upper/lower) in order to increase tear flow on the surface of the eye.

Not Found

This FDA letter is a 510(k) premarket notification for the Delta Punctum Plug, a medical device. This type of document primarily confirms that a new device is substantially equivalent to existing legally marketed predicate devices, allowing it to proceed to market. It typically does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, etc.) that would be found in a clinical study report or a more comprehensive regulatory submission.

Therefore,Based on the provided text, I cannot answer the questions regarding acceptance criteria and the study proving the device meets those criteria. The document is a 510(k) clearance letter, which confirms substantial equivalence to a predicate device but does not detail performance studies or specific acceptance criteria for a new device's performance.

To answer these questions, I would need access to the actual 510(k) submission packet, which would include performance data, test methods, and acceptance criteria if such information was required for the substantial equivalence determination for this particular device (e.g., if it involved novel technology or significant design changes that necessitated new performance testing).

Ask a specific question about this device