(274 days)
The VeraPlug™ Punctal Plug is for use in patients with dry eye syndromes.
The VeraPlug™ Punctal Plug is designed to provide reduction or elimination of tear drainage through the inferior or superior puncta, thus maintaining lubricating tears on the surface of the eye. Each VeraPlug™ Punctal Plug is molded from medical grade silicone. The VeraPlug™ Punctal Plug is available in 3 sizes (small, medium, and large) and is packaged 2 per/box. Each plug is sterile and preloaded on an inserter.
The inserter is manufactured using medical grade ABS (acrylonitrile butadiene styrene), and 304 stainless steel.
Here's the analysis of the provided text regarding the acceptance criteria and supporting study for the VeraPlug™ Punctal Plug:
This document is a 510(k) premarket notification for a medical device called the VeraPlug™ Punctal Plug. It aims to demonstrate substantial equivalence to a predicate device, not necessarily to establish de novo acceptance criteria for a novel device. Therefore, the "acceptance criteria" discussed relate to demonstrating this equivalence rather than setting performance thresholds for a new technological concept.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (VeraPlug™ Punctal Plug) |
|---|---|---|
| Intended Use | "For use in patients with dry eye syndromes," consistent with the predicate device which treats "dry eye" syndrome to enhance tear contact time and make eye drops more effective. | The VeraPlug™ Punctal Plug is for use in patients with dry eye syndromes. (Matches predicate) |
| Material | Medical Grade Silicone | Medical Grade Silicone (Matches predicate) |
| Sterility | Device must be sterile. | Yes (Matches predicate); Sterility testing completed via validated ETO sterilization cycle. |
| Design (Shape) | Similar design shape with a conical shaped nose (distal end), a shaft, and a dome-shaped proximal end, comparable to the predicate. | Has a similar design shape with a conical shaped nose (distal end), a shaft, and a dome shaped proximal end. (Comparable to predicate) |
| Design (Nose Diameter) | Within cleared nose diameter ranges of the predicate device (Small: 0.75mm, Medium: 0.88mm, Large: 1.01mm). | Small: 0.76mm, Medium: 0.89mm, Large: 1.02mm (All within ~0.01mm of predicate, deemed "within cleared nose diameter ranges") |
| Design (Overall Length) | Within cleared overall length ranges of the predicate device (Small: 1.63mm, Medium: 1.80mm, Large: 1.93mm). | Small: 1.65mm, Medium: 1.83mm, Large: 2.00mm (All within ~0.02-0.07mm of predicate, deemed "within cleared overall length ranges") |
| Mechanical Performance | Must pass a simulated implantation stretch test, similar to the predicate device. | Passed (Matches predicate) |
| Biocompatibility | Must be biocompatible for its intended use. | Biocompatibility testing was deemed unnecessary as the material (medical grade silicone) has a long-standing history of biocompatibility for punctal occluders. |
| ETO Residuals | Ethylene Oxide residuals must meet safety standards. | Testing performed and demonstrated safety. |
| Microorganisms | The product must meet standards for the population of microorganisms (bioburden). | Testing performed and demonstrated safety. |
| Packaging Validation | Post-accelerated aging packaging must maintain integrity and sterility (e.g., Bubble Test, Dye Penetration). | Testing performed and demonstrated safety. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a clinical "test set" in the sense of patient data being collected for evaluation of the device. The non-clinical tests involved laboratory and bench testing of the device itself and its manufacturing processes.
- Sample Size: Not specified for individual tests, but implicitly refers to a sufficient number of devices for bench and lab testing (e.g., for sterility, stretch tests, and packaging validation).
- Data Provenance: The data is generated from non-clinical bench and laboratory testing of the manufacturing processes and device properties. It is not derived from human subjects or patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this submission. The "ground truth" for the non-clinical tests is established by adherence to recognized international standards (ISO, ASTM) and internal validation protocols for manufacturing processes (e.g., ETO sterilization validation). There is no "test set" that requires human expert adjudication for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. Since there is no "test set" involving human interpretation or subjective evaluation, no adjudication method is described or required.
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, an MRMC comparative effectiveness study was not done. This device is a physical medical implant (a punctal plug), not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers improve with AI" is not relevant here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Established industry standards and regulations: Adherence to ISO and ASTM standards for sterilization, biocompatibility, and packaging.
- Laboratory test results: Objective measurements demonstrating physical and biological properties (e.g., passing a stretch test, meeting ETO residual limits, adequate bioburden reduction, package integrity).
- Substantial equivalence: The comparative data with the legally marketed predicate device regarding materials, dimensions, and intended use serves as a form of "ground truth" for demonstrating safety and effectiveness based on equivalence.
8. The Sample Size for the Training Set
This information is not applicable. Since this is a physical medical device and not an AI algorithm, there is no concept of a "training set" in this context. The manufacturing processes are validated, and devices are tested, but not in the sense of training a model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this device.
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