(222 days)
The Hydrogel Canalicular Plug is intended for use in patients experiencing dry eye symptoms such as redness, burning, reflex tearing, itching, or foreign body sensations, which can be relieved by blocking of the punctum.
The Hydrogel Canalicular Plug may be used in the treatment of dry eye syndrome and the dry eye component of various ocular surface diseases.
When indicated, the Hydrogel Canalicular Plug may be used after surgery of the eye to prevent complications due to dry eye and to enhance the retention of ocular medications on the eye. Patients experiencing dry eye related contact lens problems may also be aided by the Hydrogel Canalicular Plug.
The Hydrogel Canalicular Plug is a very high water content hydrogel plug which, when exposed to lacrimal fluids, expands to approximately three times its size to form a gel which blocks the canaliculus. In its dry state, the Hydrogel Canalicular Plug measures approximately 0.3mm diameter by 2.5 mm long. It is supplied loaded in a disposable Inserter to assist the doctor in placement of the plug through the punctal opening. After the plug is inserted into the canaliculus, the dry hydrogel will absorb lacrimal fluids and swell. The fully hydrated plug has approximately a 95% water content. At this water content, the plug becomes a gel having about the same consistency as mucus. The gel easily deforms and takes the shape of the inside of the canaliculus.
This document is a 510(k) premarket notification for the Form Fit™ Hydrogel Canalicular Plug. It appears to be an unclassified device. The document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical study for diagnostic accuracy would be presented.
Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for many medical devices in the US. The "study" mentioned is not a performance study against acceptance criteria, but rather a comparison to justify equivalence.
Here's a breakdown of the requested information based on the provided text, noting where specific details are absent due to the nature of a 510(k) submission for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific quantitative acceptance criteria or a performance study with numerical results against those criteria in the way a diagnostic device might. The "performance" described relates to its physical characteristics and how it achieves its intended function, as well as its similarity to predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Expansion upon hydration: Designed to expand to block the canaliculus effectively. | Expands to approximately three times its size to form a gel with approximately 95% water content. |
| Shape conformity: Needs to conform to the canaliculus. | The gel easily deforms and takes the shape of the inside of the canaliculus. |
| Removal mechanism: Should be easily removable if needed. | Can be easily flushed from the canaliculus using a stream of saline. |
| Size (dry state): Comparable to predicate devices. | Measures approximately 0.35mm diameter by 2.5mm long (similar to predicate Medennium Smart Plug). |
| Expanded size: Comparable to predicate devices. | Increases to approximately 1mm diameter after insertion and hydration (similar to predicate Medennium Smart Plug). |
| Intended Use Equivalence: Match the intended use ofpredicate devices. | Intended use matches Medennium Smart Plug and Oasis Medical collagen plugs. |
| Method of Operation Equivalence: Similar mechanism of action to predicate devices. | Similar one-size-fits-all design, changes shape upon insertion, absorbs lacrimal fluids, hydrates and swells to block fluid flow. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a 510(k) premarket notification based on substantial equivalence, not a clinical performance study with a test set of patient data. The "test set" here refers to a comparison of device characteristics and intended use against predicate devices. There is no mention of country of origin or retrospective/prospective data as it relates to patient outcomes or device performance testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This type of submission relies on comparing physical and functional characteristics to legally marketed devices, rather than establishing "ground truth" through expert consensus on a test set.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication method as there is no "test set" in the context of expert review for performance against ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No. An MRMC comparative effectiveness study is not indicated or mentioned for this type of device (canalicular plug) or regulatory submission (510(k) for substantial equivalence).
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This device is a physical medical device (a plug), not a software algorithm. Therefore, "standalone" performance in the context of AI algorithms is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is established by the characteristics and intended use of legally marketed predicate devices. The device's "performance" is judged against its ability to be substantially equivalent to these existing devices.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for one.
Summary of the Document's Approach:
The provided document describes a medical device seeking 510(k) clearance by demonstrating substantial equivalence to predicate devices. This regulatory pathway does not typically involve extensive clinical performance studies with acceptance criteria, test sets, or ground truth established by experts in the same way a diagnostic device might. Instead, the focus is on comparing the device's physical properties, mechanism of action, and intended use to existing, cleared devices. The "study" here is essentially the detailed comparison provided in the 510(k) summary (e.g., "Comparison to Predicate" section).
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