(155 days)
The Visant Medical Canalicular Plug is intended to block tear drainage by occlusion of the canalicular system. It is indicated for use, for up to 6 months, in patients experiencing dry eye symptoms.
The Visant Medical Canalicular Plug is designed to temporarily block tear drainage by the occlusion of the canaliculus of one or both eyelids in a given patient, thus maintaining lubricating tears on the surface of the eye. The Visant Plug consists of a transparent hydrogel, manufactured from cross-linked hyaluronic acid, that is designed for insertion into the canaliculus.
The Visant Medical Canalicular Plug is inserted into the lower canaliculus of the patient's eyelid by the healthcare practitioner, using a commercially available lacrimal cannula attached to the 0.6 mL gel-filled syringe which pushes the gel into the lower punctum until the recommended volume of gel (0.2 mL) is inserted.
The Visant Medical Canalicular Plug is a device intended to block tear drainage by occluding the canalicular system for up to 6 months in patients experiencing dry eye symptoms.
The document does not specify quantified acceptance criteria for the device's performance. Instead, it presents results from a comparative clinical trial, implying that equivalence to the predicate device (Form Fit® Hydrogel Canalicular Plug, K040912) in terms of effectiveness and safety constitutes meeting the implicit acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit: Equivalence to Predicate Device) | Reported Device Performance (Visant Medical Canalicular Plug vs. Predicate) |
|---|---|
| Effectiveness (Clinical Performance) | |
| Improvement in Schirmer's Test score at Month 3 | Right eye: Mean change 3.40±7.54 mm (Visant) vs. 1.78±5.44 mm (Control). LS mean between-group difference: 1.19±1.16 mm (95% CI -1.10 to 3.48 mm). |
| Left eye: Mean change 3.38±7.005 mm (Visant) vs. 2.24±5.76 mm (Control). | |
Improvement in OSDI questionnaire score at Month 3 (≥ 4.5 for moderate baseline symptoms or ≥ 7.3 for severe baseline symptoms) | 83.8% (Visant) vs. 84.6% (Control) of participants achieved improvement. Mean proportional difference: -0.028 (95% CI -0.139 to 0.083). |
| Safety (Adverse Events) | |
| Overall Adverse Events (TEAEs) | 57.3% of Visant group reported TEAEs vs. 63.0% of Control group. Most were mild. |
| Severity of TEAEs | Mild: 36.9% (Visant) vs. 44.4% (Control). |
| Moderate: 17.5% (Visant) vs. 16.7% (Control). | |
| Severe: 2.9% (Visant) vs. 1.9% (Control). | |
| Device-related Ocular Severe TEAEs | One Visant-group participant reported excessive tearing. |
| Corneal staining | 36.9% (Visant) vs. 40.7% (Control). |
| Ocular pain | 9.7% (Visant) vs. 0% (Control). |
| Dacryocystitis | One case (Visant) vs. zero (Control). |
| Conjunctivitis | 4.9% (Visant) vs. 1.9% (Control). |
| Epiphora (excessive tearing) | 7.8% (Visant) vs. 5.6% (Control). |
| Premature treatment discontinuation due to AEs | 1 (Visant) vs. 1 (Control). |
| Unplanned device removal due to AEs | 3 (Visant) vs. 1 (Control). |
| Physicochemical and Biocompatibility | |
| Biocompatibility (e.g., Cytotoxicity, Genotoxicity, Systemic Toxicity, Pyrogenicity, Sensitization, Irritation) | All tests generally showed the device to be non-cytotoxic, non-mutagenic, non-pyrogenic, non-sensitizing, and non-irritating (with one noted exception of saline extract causing skin irritation, similar to other commercially available HA products, below a level of concern). Testing on syringe primary packaging also showed non-cytotoxic, non-toxic, non-sensitizing, non-reactive, non-pyrogenic results. |
| Sterility (SAL) | Achieved a Sterility Assurance Level (SAL) of 10-6. |
| Shelf-life stability and performance | Successfully completed. |
| Implantation study (in vivo rabbits) | No subchronic toxicity, chronic toxicity, or tissue irritation observed. |
2. Sample size used for the test set and the data provenance:
- Clinical Test Set Sample Size:
- Total participants randomized: 157
- Safety population: 157 participants (103 in Visant plug group, 54 in control group).
- Intent-to-treat (ITT) population: 156 (103 in Visant plug group, 53 in control group - one Visant participant did not have device successfully applied).
- Per-protocol (PP) population: 151 (99 in Visant plug group, 52 in control group) due to major protocol deviations.
- Data Provenance: The study was a "prospective, multicenter, randomized, double masked, controlled clinical trial," indicating that the data was collected specifically for this study with a pre-defined protocol. The document does not explicitly state the country of origin, but FDA submission implies it was conducted in a region compliant with FDA regulations, likely the US or a country with comparable standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a clinical trial involving patients, where outcomes are measured directly from the patients based on established clinical assessment methods and patient-reported outcomes (e.g., Schirmer's test, OSDI questionnaire, adverse event reporting, physician observations). Therefore, there isn't a "ground truth" established by a panel of independent experts in the same way one might for an AI diagnostic device that interprets medical images. The "truth" is derived from the clinical measurements and observations made by the investigators (ophthalmologists or other healthcare practitioners specializing in eye care) involved in the multicenter trial. Their qualifications are implicitly assumed to be appropriate for conducting such a clinical study, but specific details about their experience (e.g., "radiologist with 10 years of experience") are not provided.
4. Adjudication method for the test set:
Not applicable in the context of this clinical device trial. Adjudication methods like "2+1" typically apply to expert review of diagnostic results (e.g., discrepancies in image interpretations). Here, direct clinical measurements and adverse event reporting were used. Adverse events were likely documented by the site investigators and potentially reviewed by a clinical events committee (though not explicitly detailed in the provided text).
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:
No, this was not an MRMC comparative effectiveness study involving human readers and AI assistance. This was a direct comparison of two medical devices (Visant Medical Canalicular Plug vs. a predicate control plug) for their effects on dry eye symptoms in patients.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this is a physical medical device (canalicular plug), not a software algorithm. Therefore, no standalone algorithm performance study was applicable or performed.
7. The type of ground truth used:
The "ground truth" for evaluating the device's effectiveness and safety was based on:
- Clinical Measurements: Objective metrics like anesthetized Schirmer's test scores, tear meniscus heights, corneal fluorescein staining scores, and tear break-up time (TBUT), measured directly from patients by healthcare professionals.
- Patient-Reported Outcomes (PROs): Subjective data from the Ocular Surface Disease Index (OSDI) questionnaire, completed by the participants.
- Adverse Event Reporting: Documentation of adverse events by clinical investigators, classified by severity and relatedness.
- Investigator Assessments: Observations by investigators regarding ease of insertion and removal, pain during procedure, and patency of the lacrimal drainage system after removal.
8. The sample size for the training set:
Not applicable. This is a physical medical device. There is no "training set" in the context of an algorithm or AI model development. The non-clinical testing and in vivo animal studies could be considered analogous to early developmental or exploratory phases, but not a "training set" in the AI sense.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for a physical device. The non-clinical and in vivo studies serve to establish the safety and preliminary performance characteristics before human clinical trials.
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