(130 days)
Sharpoint® UltraPlug™ Extended Wear Plug may be used in the treatment of dry eve syndrome and the dry eye components of various ocular surface diseases. When indicated, UltraPlug™ Extended Wear Plugs may be used after ocular surgery to prevent complications due to dry eye and to enhance the retention of ocular medications. Patients experiencing dry eye related contact lens problems also may be aided by UltraPlug™ Extended Wear Plugs.
The Sharpoint UltraPlug Extended Wear Plug is made from absorbable suture material. The plugs are available in two lengths 1.6mm and 2.0mm, and in three diameters: 0.2mm, 0.3mm and 0.4mm
The provided text is a 510(k) summary for the Sharpoint® UltraPlug™ Extended Wear Punctum Plug. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about a study that proves the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, accuracy, or other quantitative measures typically associated with AI/ML device performance.
This is a medical device clearance for a physical product (a punctum plug), not a software or AI/ML-based device that would typically undergo performance testing and report on metrics like those listed in your prompt. The "acceptance criteria" for such a device primarily revolve around material properties, biocompatibility, and functional equivalence to similar already-marketed devices (predicates).
Therefore, I cannot fulfill most of your request directly from the provided text because it's not applicable to this type of medical device submission.
Here's what I can extract and extrapolate based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (from text) |
|---|---|
| Material Composition and Safety | Made from PCL Absorbable Synthetic Suture material, ε-Caprolactone-L-Lactide Copolymer. This material has been approved for ophthalmic usage (SSC's 510(k) K003015) and well characterized through absorption and biocompatibility studies. |
| Absorption Profile (Duration of Occlusion) | "PCL Plugs are a synthetic absorbable suture material, which will dissolve in 180 days (reference 510(k) K003015 data)." This distinguishes it from Collagen Plugs (7-10 days) and Silicone Plugs (permanent). |
| Physical Dimensions and Availability | Available in two lengths: 1.6mm and 2.0mm; and three diameters: 0.2mm, 0.3mm, and 0.4mm. |
| Intended Use (Clinical Conditions it addresses) | Intended for temporary use with patients experiencing dry eye symptoms (redness, burning, reflex tearing, itching, foreign body sensations). Also used in treatment of dry eye syndrome and components of various ocular surface diseases (e.g., corneal ulcers, conjunctivitis, pterygium, blepharitis, keratitis, red lid erosion, filamentary keratitis). May be used post-surgery to prevent dry eye and enhance ocular medication retention. AIDS patients with dry eye related contact lens problems. |
| Substantial Equivalence to Predicate Devices | Determined substantially equivalent to legally marketed predicate devices for stated indications for use. Specifically compares material to Eagle Vision Temporary Intracanalicular Collagen Insert. |
| Biocompatibility | Material has been well characterized through biocompatibility studies (per reference to K003015). |
The following items (2-9) are not applicable or cannot be answered from the provided text, as they pertain to performance studies of AI/ML algorithms, not a physical medical device like a punctum plug.
- Sample size used for the test set and the data provenance: Not applicable. This document refers to the physical properties and intended use of a punctum plug, not a data-driven algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML performance studies is not relevant here. The "ground truth" for a physical device is its material composition, physical dimensions, and biocompatibility, which are verified through manufacturing and testing standards rather than expert consensus on a test set.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" for its characteristics (e.g., dissolution time, material properties) would be based on validated material science testing, chemical analysis, and potentially in-vivo or in-vitro degradation studies referenced in the predicate device's data (K003015).
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
In summary, the 510(k) submission for the Sharpoint® UltraPlug™ Extended Wear Punctum Plug focuses on demonstrating substantial equivalence to predicate devices based on material composition, absorption characteristics, physical dimensions, and intended use, rather than performance metrics derived from data analysis by an AI/ML algorithm.
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