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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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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.

Ask a specific question about this device