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The InteliPORT® Occluding Device 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 occluding the lacrimal drainage system in order to increase tear volume.

The InteliPORT® Occluding Device may be used in the treatment of dry eye syndrome and the dry eye components of various ocular surface diseases.

Other patients that may benefit are: patients with arthritis, patients taking systemic or topical medications known to produce dry eyes, contact wearers who experience dry eye related problems, and patients who live in dry climates, or spend extended periods of time in low humidity environments (such as air conditioning). Topical eye drops may be more effective with punctal occlusion because tear drainage will be retarded, and tear breakup time extended.

The InteliPORT® Occluding Device is designed to deliver a custom fit plug through the punctal opening to block tear drainage. The self-forming plug (Intelimer Occluding Material*) is heated and inserted through the punctal opening into the proximal canaliculus as a melted viscous liquid. It rapidly solidifies to conform to the shape of the ampulla and canaliculus. The InteliPORT® Occluding Device is composed of a transitional and continuous block of Intelimer Occluding Material (matrix) which is adequate for delivering two doses in a single patient use applicator and is provided in a sealed, sterilized package. The Intelimer Occluding Material is liquefied in the applicator by warming it a few degrees above body temperature via an internal 1.5 volt battery and a heating coil. The narrow applicator tip is then inserted into the punctal opening and the plunger is pushed to deliver the Intelimer Occluding Material. Once inside the duct, the material cools to form a customized plug that conforms to the shape of the individual's ampulla and canaliculus. The volume of material delivered, approximately 4-7 micro liters, is controlled so as to flow into the common ampulla and canaliculus. Restoration of patency may be accomplished by irrigation with warm sterile saline.

The provided text is for a 510(k) premarket notification for a medical device (InteliPORT® Occluding Device), not an AI/ML device. Therefore, the questions about acceptance criteria, study design for AI evaluation (sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth) are not applicable.

The document describes the safety and effectiveness of the InteliPORT® Occluding Device based on non-clinical and clinical data, comparing it to a predicate device for substantial equivalence.

Here's an overview of the safety and effectiveness information provided, structured to best fit the spirit of the request, acknowledging the non-AI nature of the device:

Acceptance Criteria and Device Performance (Interpreted for a non-AI medical device submission)

For a device like the InteliPORT® Occluding Device, "acceptance criteria" are not framed as statistical thresholds for AI metrics. Instead, they are implicitly defined by the demonstration of safety, biocompatibility, and clinical effectiveness similar to a legally marketed predicate device, with an acceptable risk profile for its intended use. The "reported device performance" refers to the findings from the non-clinical and clinical studies that support these claims.

Table: Summary of Safety and Effectiveness Findings (Non-AI Device)

Given the nature of the submission (510(k) for a punctal plug, not an AI/ML device), the following points are not directly applicable or are interpreted within the context of non-AI device evaluation:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Clinical Study: 107 patients.
• Data Provenance: "Multicenter, randomized well-controlled clinical trial," implying prospective clinical data. Country of origin not specified, but typically US-based for FDA 510(k) submissions unless stated otherwise.
• Non-Clinical Studies: Rabbits were used for chronic irritation study (30 rabbits with multiple evaluations), and other in-vitro tests cited.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as this is not an AI study comparing against expert ground truth. Clinical outcomes and observations (e.g., dry eye symptoms, tear retention, corneal staining, adverse events like canaliculitis) were measured, likely by ophthalmologists or trained clinical staff.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable for a non-AI device clinical trial measuring patient outcomes. Standard clinical trial procedures for data collection and adverse event reporting would have been followed.

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

• Not applicable as this is not an AI device. The clinical study evaluated the device's direct effect on patients, not its assistance to human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable as this is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the clinical study: "Outcomes data" such as reductions in dry eye symptoms, increased tear retention, increased tear break-up time, and reduction in corneal fluorescein staining were measured directly from patients. Adverse events like canaliculitis were also observed and reported.
• For non-clinical studies: Histopathological evaluations, in-vitro test results (biocompatibility, cytotoxicity), and direct observations in animal models.

8. The sample size for the training set

• Not applicable as this is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

• Not applicable as this is not an AI algorithm requiring a training set.

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