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Hello,eyes® BIO Plug is intended to temporarily block tear drainage by the occlusion of the canaliculus in order to

• Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases,
• Temporarily enhance the efficacy of topical medications or ocular lubricants,
• Temporarily treat contact lens intolerance secondary to dry eye,
• Temporarily treat dry eye after ocular surgery, and.
• Determine the potential effectiveness of permanent occlusion.

Intracanalicular Plug named Hello,eyes@BIO Plug consists of lacrimal punctum plug and its holder. The plug is made of polydioxanone per 21 CFR 878.4840. The pigment for the violet dye is D&C Violet No.2 per 21 CFR 74.3602. It is 2.0mm long and available in three diameters: 0.3, 0.4, and 0.5mm which are based on USP synthetic absorbable suture diameters. Hello, eyes@ BIO Plug, the intracanalicular plug is a product sterile by ethylene oxide (EO) gas in accordance with ISO 11135:2014. It is designed to be inserted through the punctal opening and reside in the canaliculus until it is absorbed over time in tissue.

The provided text describes a 510(k) premarket notification for a medical device called "Hello,eyes® BIO Plug". This submission focuses on establishing substantial equivalence to a predicate device ("SOFT PLUG® Extended Duration 180 Canalicular Plug") rather than presenting a performance study with acceptance criteria in the typical sense of accuracy, sensitivity, or specificity for an AI/CADe device.

The "acceptance criteria" here are met by demonstrating that the new device is as safe and effective as the predicate device. The "study" described is a series of non-clinical tests to support this substantial equivalence.

Here's the breakdown of the information as requested, though some categories may not be directly applicable to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical medical device (an intracanalicular plug), the "acceptance criteria" are the standards and design specifications it must meet to be considered safe and effective and comparable to the predicate. The "reported device performance" refers to the results of the non-clinical tests that demonstrate compliance with these standards and the equivalence to the predicate.

2. Sample Size Used for the Test Set and the Data Provenance

This document describes non-clinical laboratory and animal studies, not a "test set" in the context of an AI/CADe clinical trial. The sample sizes and data provenance for each specific test (e.g., sterilization validation, biocompatibility) are not detailed in this summary but would be found in the full test reports referenced (e.g., "Sterilization Validation Report on Hello,eyes® Bio Plug").

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is not an AI/CADe submission requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the non-clinical tests are the established scientific principles and measured outcomes as per the ISO/ANSI standards.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication in the context of this substantial equivalence submission for a physical medical device.

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. This is not an AI/CADe device or a human-in-the-loop study.

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

Not applicable. This is not an algorithm-based device.

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

The "ground truth" for the non-clinical tests is based on:

• Established scientific principles and standards: Compliance with ISO and ANSI standards.
• Direct measurements and observations: Results of laboratory tests for material properties, sterilization, biocompatibility, etc.
• Animal study outcomes: For the implantation study that supported the intended duration.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/Machine Learning device.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no "training set" or associated "ground truth" establishment in the context of an AI/ML model for this device.

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The SOFT PLUG Extended Duration 180 Canalicular Plugs and the SOFT PLUG Extended Duration 180 Tapered Canalicular Plugs are intended to temporarily block tear flow by the occlusion of the canaliculus in order to:

• Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases,
• Temporarily enhance the efficacy of topical medications or ocular lubricants,
• Temporarily treat contact lens intolerance secondary to dry eye,
• Temporarily treat dry eye after ocular surgery, and
• Determine the potential effectiveness of permanent occlusion.

The Oasis Medical SOFT PLUG® Extended Duration 180 Tapered Canalicular Plug is a mid-term duration device designed to be inserted through the punctal opening into the canaliculus in order to block tear drainage through the lacrimal drainage system for approximately 180 days. The plugs are made from degradable polydioxanone monofilament colored violet with D&C No. 2. The plugs are 2.0mm long and have a base diameter of 0.6mm with one end tapered to enable easier placement through the punctal opening.

This is a 510(k) summary for a medical device, the SOFT PLUG® Extended Duration 180 Tapered Canalicular Plug. The document focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a dedicated clinical study with AI or human readers for device performance.

Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this document, as they pertain to clinical studies or AI performance evaluation, which are not detailed here.

However, based on the provided information, I can offer the following:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable way for a primary clinical outcome. Instead, it relies on demonstrating substantial equivalence to a predicate device by showing that the new device is as safe and effective. The "performance" described is primarily related to non-clinical testing confirming that the changes in the device (specifically the tapered geometry) do not negatively impact its fundamental characteristics compared to the predicate.

Relevant Study/Testing:

The study that "proves the device meets the acceptance criteria" (in the context of substantial equivalence) is comprised of non-clinical performance tests detailed in the "Summary of Non-clinical Testing" section. These tests were conducted to confirm that the modification (tapered end) did not alter the fundamental safety and performance characteristics from the predicate device.

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

This information is not provided in the document. The document describes non-clinical testing (biocompatibility, degradation, shipping) but does not specify sample sizes for these tests or their provenance. This type of information is typically not included in the public 510(k) summary but would be found in the full submission.

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)

This information is not applicable as the document does not describe a clinical study involving experts establishing ground truth for diagnostic or interventional performance. The testing described is non-clinical.

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

This information is not applicable as the document does not describe a clinical study requiring adjudication of expert interpretations.

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

This information is not applicable. This document is for a physical medical device (canalicular plug) and does not involve AI or human readers for diagnostic or interventional tasks.

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

This information is not applicable. This document is for a physical medical device and does not involve an algorithm or AI.

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

This information is not applicable as the testing is non-clinical and relies on validated laboratory methods (e.g., ISO 10993-5 for cytotoxicity, ASTM F1635 for degradation, ISO 11607/ASTM D4169/ISTA 2A for shipping) rather than clinical ground truth types.

8. The sample size for the training set

This information is not applicable. This document is for a physical medical device and does not involve machine learning or a training set.

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

This information is not applicable. This document is for a physical medical device and does not involve machine learning or a training set.

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