Search Results

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:

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.

Ask a specific question about this device

VisiPlugST provide temporary occlusion of the tear drainage system. VisiPlugST may be used as a diagnostic aid to determine the potential effectiveness of long-term occlusion, to temporarily enhance the efficacy of topical medication or ocular lubricants, after surgery to prevent complications due to dry eyes, to evaluate treatment of ocular dryness secondary to contact lens use, and to evaluate the dry eye component of ocular surface diseases (OSD).

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 horizontal canaliculus to restrict the natural lubricating tears from being pumped off the eye.

VisiPlugST provides temporary occlusion of the tear drainage system. The device may be used as a diagnostic aid to determine the potential effectiveness of long-term occlusion, to temporarily enhance the efficacy of topical medications or ocular lubricants, after surgery to prevent complications due to dry eyes, to evaluate treatment of ocular dryness secondary to contact lens use, and to evaluate the dry eye component of ocular surface diseases (OSD).

VisiPlugST plugs are cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. Each plug is cut from a monofilament strand of Glycoprene® MG23, a synthetic surgical grade polymer composed of poly(glycolide-co-trimethylene carbonate-co-caprolactone). The monofilament is dyed with an approved color additive, Green D & C 6 (CAS# 128-80-3; 0.1% by weight). Titanium dioxide is added to the polymer to make the plugs opaque, providing a satisfactory means with which to determine the plug's presence or absence following insertion by a practitioner.

The VisiPlugST is a punctum plug designed for temporary occlusion of the tear drainage system.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VisiPlugST were based on comparing its material properties to an existing predicate device (Collagen Plugs for the Lacrimal Efficiency Test, K895342) and referenced predicate devices (Maxon, Sterile Synthetic Absorbable Sutures K990951 and CaproSyn Suture K032586). The primary performance characteristics evaluated were strength retention and mass loss degradation rates.

2. Sample Size and Data Provenance

The document does not explicitly state a separate "test set" and a "training set" in the context of an algorithm or image analysis. The data provided refers to nonclinical tests conducted to assess the material properties of the VisiPlugST (Glycoprene® MG23) against its predicate device (gut suture).

• Sample Size for Test Set: Not explicitly stated for each test, but studies were conducted to compare strength and mass loss degradation rates.
• Data Provenance: The studies were nonclinical tests comparing material properties. The country of origin and whether it was retrospective or prospective is not specified, but it refers to laboratory testing of materials.

3. Number of Experts and Qualifications for Ground Truth Establishment

This device is not an AI/ML device that requires expert review for ground truth establishment. The performance data is based on laboratory physical and chemical testing of the device material.

4. Adjudication Method for Test Set

Not applicable as this is not a diagnostic device requiring human reader adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI-assisted diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the nonclinical tests was established through laboratory measurements and scientific analysis of the material properties (strength retention, mass loss) and biocompatibility of the Glycoprene® MG23 material, compared against established values and properties of the predicate device's material (gut suture).

8. Sample Size for the Training Set

Not applicable, as this device does not involve a "training set" in the context of an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Ask a specific question about this device

The Lacrimedics Dissolvable Opaque Herrick Lacrimal Plug® is intended to block the canaliculus for the relief of dry eye syndrome.

Dissolvable Opaque Herrick Lacrimal Plug® may be used:

• As a diagnostic aid to determine the potential effectiveness of Occlusion Therapy with non-dissolvable plugs.
• To temporarily enhance the efficacy of topical medications or ocular lubricants.
• After ocular surgery to prevent complications due to dry eyes.
• To evaluate treatment of ocular dryness secondary to contact lens use.
• In the treatment of Dry Eye Syndrome and the dry eye components of varying Ocular Surface Diseases.

The Lacrimedics Dissolvable Opaque Herrick Lacrimal Plug® provides temporary occlusion of the tear drainage system. The plug is supplied in various sizes ranging from 0.2 mm to 0.5mm in diameter. The length is approximately 1.75 mm. The dissolvable (suture material) plug is composed of any one of the following: (1) a copolymer of L-lactide and epsilon -caprolactone (PCL); (2) polydioxanone (PDO); (3) copolymers of glycolic acid and trimethylene carbonate.

The proposed device is supplied as a single use component for use in treatment of dry eye syndrome. The device is supplied sterile and is intended for SINGLE USE ONLY.

The provided text describes a Summary of Safety and Effectiveness for the Lacrimedics Dissolvable Opaque Herrick Lacrimal Plug® device and a 510(k) clearance letter. It does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or reader improvement.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices already on the market, which is the basis for 510(k) clearance. This means the new device shares similar technological characteristics and intended uses with a legally marketed device.

Therefore, many of the requested categories for a study's acceptance criteria and performance cannot be directly extracted from this document, as a formal performance study with these elements is not presented.

Here's a breakdown of what can be inferred or stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. The "performance" described is in terms of its intended use and compliance with manufacturing standards, assuming equivalence to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a clinical study with a test set of subjects/patients to evaluate performance. The 510(k) clearance is primarily based on a comparison of technological characteristics and intended use to predicate devices, not on new clinical trial data that would require a "test set" in the context of device performance metrics.

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)

Not applicable. No test set requiring expert-established ground truth is described in the provided documents for device performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set adjudication is described.

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

Not applicable. This device is not an AI-assisted diagnostic tool or an imaging device, so an MRMC study is irrelevant to its premarket notification.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device (lacrimal plug), not an algorithm or software requiring standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. There is no performance study described that would involve establishing a "ground truth" for diagnostic accuracy or similar metrics. The "ground truth" for 510(k) substantial equivalence relies on regulatory compliance and the established safety and effectiveness of predicate devices.

8. The sample size for the training set

Not applicable. No training set is described as this is not a machine learning/AI device.

9. How the ground truth for the training set was established

Not applicable. No training set is described.

Ask a specific question about this device

OPAQUE Herrick Lacrimal Plugs may be used in the treatment of:
· Dry Eye symptoms:dryness, redness, itching, burning, intermittont tearing or foreign body sensation.
· For treatment of ocular dryness secondary to contact lens use.
· To enhance the efficacy of topical ocular medications.
· After surgery to provent complications due to Dry Fye.
· For the Dry Eye component of: conjunctivitis, keratitis, corncal ulcer, pterygium blepharitis, red lid margins, recurrent chalazion. corneal erosion, filamentary keratitis and other eye diseases.
OPAQUE Horrick Lacrimal Plugs are indicated by the patient's positive response to The Lacrimal Efficiency Test TM with dissolvable plugs (Lacrimedics).

Not Found

The provided document is a 510(k) premarket notification letter from the FDA regarding the "Opaque Herrick Lacrimal Plug®". This type of document declares that a device is substantially equivalent to a predicate device already on the market and does not contain specific acceptance criteria, detailed study designs, or performance data in the way a clinical trial report or a comprehensive device submission would.

Therefore, based solely on the provided text, I cannot extract the information required to answer your request. The document informs Lacrimedics, Inc. that their device is cleared for marketing due to substantial equivalence, but it does not detail the studies or performance data used to determine that equivalence.

The information you are asking for (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, etc.) would typically be found in the actual 510(k) submission itself, or in related study reports, which are not included in this FDA clearance letter.

Ask a specific question about this device

Ask a specific question about this device

Used to enhance retention of eye fluids by occlusion of one or more punctum, reducing lacrimal flow. Useful for treatment of dry eye and other conditions where enhancement of tear retention is indicated

A flexible silicone ophthalmic device designed to fit and be retained in the punctum.

The provided document is a 510(k) Notification Summary for the Herrick Ultimate Punctum Plug. It does not contain information about acceptance criteria or specific studies proving device performance beyond a comparison to predicate devices and a statement that no clinical tests were performed.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document explicitly states "Clinical tests: None" and "Adverse S&E information: None," indicating that no performance studies of the type described in the request were conducted or reported for this submission. The basis for clearance appears to be substantial equivalence to predicate devices based on indications, function, design (dimensions), and material.

Ask a specific question about this device

Used to enhance retention of eye fluids by occlusion of one or more punctum, reducing lacrimal flow. Useful for treatment of dry eye and other conditions where enhancement of tear retention is indicated.

A flexible silicone ophthalmic device designed to fit and be retained in the punctum.

K963708, a 510(k) premarket notification for the Herrick Ultimate Punctum Plug, does not contain information related to acceptance criteria or studies proving the device meets said criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than detailing performance studies and acceptance criteria as a standalone device.

Specifically, the document states "Clinical tests: None" and "Adverse S&E information: None", indicating that no clinical studies were performed or are being presented in this submission. The comparison table focuses on features, indications, function, design (length, diameter), and material between the Herrick Ultimate Punctum Plug and predicate devices to establish substantial equivalence.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device