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Tear Pool Dissolvable Punctum Plugs are designed to provide for temporary occlusion of the tear drainage system.

Punctum Plugs are indicated for:

• • As a diagnostic aid to determine the potential effectiveness of long term occlusion
• • To temporarily enhance the efficacy of topical medications or ocular lubricants
• • After ocular surgery to prevent complications due to dry eyes
• • To evaluate treatment of ocular dryness
• • To evaluate the dry eye component of ocular surface diseases

The Tear Pool Dissolvable Punctum Plug is an ophthalmic device commonly referred to as a punctum plug. It is designed to be inserted by a practitioner into the canaliculus to temporarily restrict the natural lubricating tears from draining off the surface of the eye.

This treatment is prescribed for temporary occlusion in the treatment of certain eye conditions collectively referred to as dry eye disease, as well as the dry eye component of ocular surface diseases and other conditions of tear insufficiency.

Tear Pool Dissolvable Punctum Plugs are cylindrical in shape. Approximately 2.0mm in length and are available in two sizes: 0.4mm and 0.5mm. Each plug is composed of polydioxanone(PDO). The plug is dyed with an approved color additive, D & C Violet No. 2.

A Tear Pool Dissolvable Punctum Plug is mounted on a specially designed insertion tool and placed into a plastic tray then sealed with a Tyvek® cover. The primary package is sent to the sterilizer for Ethylene Oxide sterilization. Two sterile trays, one IFU, two chart labels and one silica gel packet are sealed in a pouch and placed in a shelf box.

The Pre-Loaded Tear Pool Dissolvable Punctum Plugs are available in the following models and diameters and are 2.0mm in length
Model# 20-5304 0.4mm
Model# 20-5305 0.5mm

The device is make from Polydioxanone(PDO). The plugs are violet in color.

The provided text describes a 510(k) premarket notification for a medical device called "Tear Pool Dissolvable Punctum Plugs." This document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies typical for novel or higher-risk devices. As such, the information needed to answer many of your questions regarding acceptance criteria and study detailed performance evaluation for an AI/CAD-like device is not present in this document.

The document primarily discusses:

• Device Description: What the punctum plugs are, their materials (polydioxanone), sizes, and sterilization method (Ethylene Oxide).
• Indications for Use: Temporary occlusion of the tear drainage system for various dry eye-related conditions.
• Technological Characteristics: Highlighting similarities to the predicate device and the absence of software, energy sources, biologics, drugs, coatings, or additives.
• Performance Data (Non-clinical): Biocompatibility testing (cytotoxicity, irritation, sensitization, material testing), sterilization validation (EO residuals, bacterial endotoxin), and insertion tool testing (simulated use deployment).

There is no mention of an AI/CAD device, or any kind of software component that would require acceptance criteria related to AI performance metrics (like sensitivity, specificity, AUC). The device is a physical, dissolvable punctum plug.

Therefore, for most of your questions, the answer will be "Not Applicable" or "Information Not Provided in this Document" because the context of your questions (AI/CAD performance, ground truth establishment, MRMC studies) does not align with the type of device and regulatory submission described in the FDA letter.

However, I can extract the non-clinical performance data and frame it in a way that resembles acceptance criteria based on the information provided, even though it's not for an AI device.

Here's an attempt to answer your questions based only on the provided text, acknowledging its limitations for an AI/CAD context:

Device: Tear Pool Dissolvable Punctum Plugs

Purpose of the Submission: 510(k) Premarket Notification to demonstrate substantial equivalence to a legally marketed predicate device (Dissolvable Opaque Herrick Lacrimal Plug, K030300).

Based on the provided document, the "acceptance criteria" and "study" are focused on demonstrating the safety and effectiveness of a physical medical device (punctum plugs) by showing equivalence to a predicate device, primarily through non-clinical testing. This is not a study of an AI/CAD system.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a physical device and not an AI, the "acceptance criteria" are based on meeting specific biological, chemical, and functional standards for medical devices. The "reported device performance" indicates whether these standards were met.

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

• Sample Size: Not specified for any of the non-clinical tests. The tests are typically performed on a statistically justified sample of the device or its materials, but the exact number isn't in this summary.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would typically be laboratory test data rather than patient data. For in vitro and animal (e.g., skin sensitization in guinea pigs/mice) biocompatibility tests, standardized lab conditions are used. It's safe to assume these are prospective laboratory tests specifically performed for this submission.

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

• Not Applicable. For a physical medical device, "ground truth" for biocompatibility and sterilization is established by adherence to recognized international standards (e.g., ISO, USP) and validated laboratory testing protocols, rather than expert consensus on interpretive data (which applies to AI/CAD). The "experts" would be the qualified laboratory personnel conducting the tests and the personnel overseeing the quality system.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication (e.g., 2+1, 3+1 for discordant reads) is relevant for human interpretation of imaging data or clinical endpoints. For laboratory tests, the results either meet the specified standard/criteria or they do not.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The device is a physical punctum plug for tear drainage occlusion.

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

• No. As there is no algorithm or software component for this medical device, a standalone performance study is not relevant.

7. The Type of Ground Truth Used

• For Biocompatibility/Sterilization: Ground truth is defined by the objective results of validated laboratory tests conducted according to established international and national standards (e.g., ISO 10993 series, USP monographs). This could be considered "laboratory standard" or "validated assay results."
• For Insertion Tool: Ground truth is functional performance (e.g., successful deployment without damage), verified by a "Simulated Use Deployment Test."

8. The Sample Size for the Training Set

• Not Applicable. This device does not have a "training set" as it is not an AI/machine learning product. The design and manufacturing are based on established engineering principles and prior knowledge of the predicate device.

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

• Not Applicable. See point 8.

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