(155 days)
LacriPro plugs may be used to:
- Treat Dry Eye Syndrome
- Treat ocular dryness secondary to contact lens use
- Enhance the efficacy of topical ocular medications
- Prevent complications due to dry eyes after surgery
- Treat the Dry Eye component of ocular surface diseases
The proposed device is an ophthalmic device commonly referred to as a punctum plug. It is designed to be placed by a practitioner into the punctal opening (upper/lower) to restrict the natural lubricating tears from being pumped off the surface of the eye. This treatment is prescribed for long-term treatment of certain eye conditions collectively referred to as Dry Eye Disease, as well as the dry eye component of ocular surface diseases and other conditions of tear insufficiency. LacriPro Punctum Plugs have a distal tip, a proximal cap and a body (tubular shaft) connecting the tip to the cap. The cap is designed to rest on the opening of the puncta after the tip and body are inserted into the canalicular canal. The cap has one or more recesses (depending on diameter) for retaining tear fluid. The plug has a passage extending in the distal direction from an opening in the proximal cap to facilitate mounting on an insertion tool. The LacriPro Punctum Plugs are available in the following models, diameters and lengths: Model # 1833 0.6mm (1.42mm length) x-small; Model # 1835 0.7mm (1.52mm length) Small; Model # 1837 0.8mm (1.60mm length) Medium; Model # 1839 0.9mm (1.78mm length) Large. The device is made from silicone liquid rubber MED 4870 by Nusil, Inc. The plugs are clear, or translucent.
This document, K161673, describes the LacriPro Punctum Plug, a device used to treat dry eye conditions, and seeks FDA 510(k) clearance by demonstrating substantial equivalence to a predicate device, the AquaFlo Punctum Plug (K021936).
The document does not contain information related to software-based AI/ML devices, nor does it describe a study involving algorithms, human readers, or diagnostic performance metrics typically associated with such devices (e.g., sensitivity, specificity, AUC). Instead, it focuses on non-clinical performance data for a physical medical device.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies that prove the device meets these criteria in the context of an AI/ML device.
However, I can extract the non-clinical performance data and findings that were used to demonstrate substantial equivalence for this physical medical device.
Non-clinical Performance Data and Conclusions for LacriPro Punctum Plug:
The performance data provided is for a physical medical device, not an AI/ML system. Therefore, the "acceptance criteria" discussed are related to the physical properties, safety, and functionality of the punctum plug, not diagnostic performance metrics.
1. Table of Acceptance Criteria (Implied) and Reported Device Performance:
| Implied Acceptance Criterion | Reported Device Performance/Finding |
|---|---|
| Sterilization Efficacy | LacriPro and AquaFlo use the same method: VDmax25 Gamma Sterilization. |
| Package Integrity (5-year shelf life) | A five-year accelerated aging study and a five-year real-time aging study were performed. Tray seals were challenged using the Burst Test method. Sterility tests were performed on both accelerated and real-time aging samples. |
| Shipping and Handling Robustness | A Shipping and Handling Study was performed to support the seal of the pouch up to five years under normal shipping and handling conditions. |
| Biocompatibility | Results of Biocompatibility Studies indicate LacriPro Punctum Plug is a safe device. |
| Material Equivalence | Made from silicone liquid rubber MED 4870 by Nusil, Inc., which is the same as the predicate device. |
| Design Equivalence | The proposed device has the same design as the Predicate Device. |
| Technological Characteristics Equivalence | No technological differences from the predicate device (both are molded using injection molding, no software/energy source, biologics, drugs, coatings, or additives). |
| Indications for Use (Substantial Equivalence) | Similar to the predicate device, with additional indications (enhancing efficacy of topical ocular medications, preventing complications after surgery) deemed supported by clinical evidence, and one indication (treating allergies) removed due to lack of sufficient clinical evidence for LacriPro. |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in a similar manner to an AI/ML study. The document refers to "studies" for sterilization, package integrity, shipping, and biocompatibility. The specific number of units tested in these non-clinical studies is not detailed.
- Data Provenance: The studies were conducted on the LacriPro Punctum Plug itself. No information on country of origin for such tests is typically included in this type of document. They are non-clinical, laboratory-based tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This is not applicable as there is no "ground truth" to establish in the context of a diagnostic AI/ML device. The performance data relates to engineering and biocompatibility testing.
4. Adjudication Method:
Not applicable as this is not a clinical study involving human judgment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is for a physical medical device.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is for a physical medical device.
7. Type of Ground Truth Used:
Not applicable. The "ground truth" for non-clinical studies typically refers to established standards, specifications, and test methods (e.g., ISO standards for biocompatibility, ASTM methods for package integrity).
8. Sample Size for the Training Set:
Not applicable as there is no AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
In summary: The provided document is for the 510(k) clearance of a physical medical device (punctum plug). The "performance data" refers to non-clinical tests demonstrating safety, function, and equivalence to a predicate device, rather than the diagnostic performance of an AI/ML algorithm.
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