(237 days)
The Soft Plug® Extended Duration 180 Canalicular Plugs are 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.
The OASIS Medical SOFT PLUG® Extended Duration 180 Canalicular Plug is a mid-term implant 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 absorbable polydioxanone monofilament colored violet with D&C No. 2. The plugs are 2.0mm long and available in 0.2mm, 0.3mm, 0.4mm, and 0.5mm diameters.
The provided text is a 510(k) premarket notification for a medical device called "Soft Plug Extended Duration 180 Canalicular Plug." This document focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria for a novel technology through a clinical study with defined endpoints like accuracy, sensitivity, or specificity.
Therefore, the information typically requested in your prompt regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not present in this type of regulatory submission.
This 510(k) summary primarily discusses:
- Device Description: What the device is (a mid-term absorbable plug for tear drainage), its material (polydioxanone monofilament), dimensions, and how it's used.
- Intended Use: The temporary treatment of dry eye, enhancement of topical medications, treatment of contact lens intolerance, treatment of dry eye after ocular surgery, and determination of potential effectiveness of permanent occlusion.
- Comparison to Predicate Device: It states "There are no differences in the material used for these devices," "There are no differences in the design of these devices," and "There are no differences in the function of these devices." This is the core of its claim for substantial equivalence.
- Non-Clinical Testing: This section details engineering and biocompatibility testing rather than clinical performance metrics. These tests include:
- Shelf life testing: Demonstrated 9% loss of tensile strength after two years equivalent storage, noting a 20% loss would shorten absorption time by 10-15%.
- Chemical characterization and biocompatibility testing: Performed according to ISO 10993-18:2005 and ISO 10993-1:2009, concluding that exposure levels of compounds are safe.
- Product adoption study: For sterilization according to ANSI/AAMI/ISO 11135:2014, with ethylene oxide residuals reduced per ISO 10993-7:2008.
- Bacterial endotoxin testing: Below 20 EU/device.
- Shipping study: In accordance with ISO 11607:2016, ASTM D4169-13, and ISTA 2A 2011, showing no damage to pouched product despite minor carton damage.
In summary, the provided document does not contain the information required to fill out your requested table or answer most of your detailed questions because it's a 510(k) summary for a substantial equivalence claim, relying on non-clinical testing and direct comparison to a predicate device, not on a clinical performance study with AI or diagnostic accuracy metrics.
Therefore, I cannot provide the requested table or answer the specific questions about clinical performance, AI, or human reader studies. The document states that "No additional questions of safety and effectiveness are raised due to material, design, or function," and that non-clinical performance tests "demonstrate that the SOFT PLUG® Extended Duration 180 Canalicular Plug is as safe and effective as the predicate device, and is substantially equivalent to the predicate device." This is the "proof" provided within this type of regulatory submission.
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