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Hello,eyes® BIO Plug is 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.

Intracanalicular Plug named Hello,eyes@BIO Plug consists of lacrimal punctum plug and its holder. The plug is made of polydioxanone per 21 CFR 878.4840. The pigment for the violet dye is D&C Violet No.2 per 21 CFR 74.3602. It is 2.0mm long and available in three diameters: 0.3, 0.4, and 0.5mm which are based on USP synthetic absorbable suture diameters. Hello, eyes@ BIO Plug, the intracanalicular plug is a product sterile by ethylene oxide (EO) gas in accordance with ISO 11135:2014. It is designed to be inserted through the punctal opening and reside in the canaliculus until it is absorbed over time in tissue.

The provided text describes a 510(k) premarket notification for a medical device called "Hello,eyes® BIO Plug". This submission focuses on establishing substantial equivalence to a predicate device ("SOFT PLUG® Extended Duration 180 Canalicular Plug") rather than presenting a performance study with acceptance criteria in the typical sense of accuracy, sensitivity, or specificity for an AI/CADe device.

The "acceptance criteria" here are met by demonstrating that the new device is as safe and effective as the predicate device. The "study" described is a series of non-clinical tests to support this substantial equivalence.

Here's the breakdown of the information as requested, though some categories may not be directly applicable to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a physical medical device (an intracanalicular plug), the "acceptance criteria" are the standards and design specifications it must meet to be considered safe and effective and comparable to the predicate. The "reported device performance" refers to the results of the non-clinical tests that demonstrate compliance with these standards and the equivalence to the predicate.

2. Sample Size Used for the Test Set and the Data Provenance

This document describes non-clinical laboratory and animal studies, not a "test set" in the context of an AI/CADe clinical trial. The sample sizes and data provenance for each specific test (e.g., sterilization validation, biocompatibility) are not detailed in this summary but would be found in the full test reports referenced (e.g., "Sterilization Validation Report on Hello,eyes® Bio Plug").

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is not an AI/CADe submission requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the non-clinical tests are the established scientific principles and measured outcomes as per the ISO/ANSI standards.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication in the context of this substantial equivalence submission for a physical medical device.

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 is not an AI/CADe device or a human-in-the-loop study.

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

Not applicable. This is not an algorithm-based device.

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

The "ground truth" for the non-clinical tests is based on:

• Established scientific principles and standards: Compliance with ISO and ANSI standards.
• Direct measurements and observations: Results of laboratory tests for material properties, sterilization, biocompatibility, etc.
• Animal study outcomes: For the implantation study that supported the intended duration.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/Machine Learning device.

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

Not applicable. There is no "training set" or associated "ground truth" establishment in the context of an AI/ML model for this device.

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The Visant Medical Canalicular Plug is intended to block tear drainage by occlusion of the canalicular system. It is indicated for use, for up to 6 months, in patients experiencing dry eye symptoms.

The Visant Medical Canalicular Plug is designed to temporarily block tear drainage by the occlusion of the canaliculus of one or both eyelids in a given patient, thus maintaining lubricating tears on the surface of the eye. The Visant Plug consists of a transparent hydrogel, manufactured from cross-linked hyaluronic acid, that is designed for insertion into the canaliculus.

The Visant Medical Canalicular Plug is inserted into the lower canaliculus of the patient's eyelid by the healthcare practitioner, using a commercially available lacrimal cannula attached to the 0.6 mL gel-filled syringe which pushes the gel into the lower punctum until the recommended volume of gel (0.2 mL) is inserted.

The Visant Medical Canalicular Plug is a device intended to block tear drainage by occluding the canalicular system for up to 6 months in patients experiencing dry eye symptoms.

The document does not specify quantified acceptance criteria for the device's performance. Instead, it presents results from a comparative clinical trial, implying that equivalence to the predicate device (Form Fit® Hydrogel Canalicular Plug, K040912) in terms of effectiveness and safety constitutes meeting the implicit acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Clinical Test Set Sample Size:
  • Total participants randomized: 157
  • Safety population: 157 participants (103 in Visant plug group, 54 in control group).
  • Intent-to-treat (ITT) population: 156 (103 in Visant plug group, 53 in control group - one Visant participant did not have device successfully applied).
  • Per-protocol (PP) population: 151 (99 in Visant plug group, 52 in control group) due to major protocol deviations.
• Data Provenance: The study was a "prospective, multicenter, randomized, double masked, controlled clinical trial," indicating that the data was collected specifically for this study with a pre-defined protocol. The document does not explicitly state the country of origin, but FDA submission implies it was conducted in a region compliant with FDA regulations, likely the US or a country with comparable standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is a clinical trial involving patients, where outcomes are measured directly from the patients based on established clinical assessment methods and patient-reported outcomes (e.g., Schirmer's test, OSDI questionnaire, adverse event reporting, physician observations). Therefore, there isn't a "ground truth" established by a panel of independent experts in the same way one might for an AI diagnostic device that interprets medical images. The "truth" is derived from the clinical measurements and observations made by the investigators (ophthalmologists or other healthcare practitioners specializing in eye care) involved in the multicenter trial. Their qualifications are implicitly assumed to be appropriate for conducting such a clinical study, but specific details about their experience (e.g., "radiologist with 10 years of experience") are not provided.

4. Adjudication method for the test set:

Not applicable in the context of this clinical device trial. Adjudication methods like "2+1" typically apply to expert review of diagnostic results (e.g., discrepancies in image interpretations). Here, direct clinical measurements and adverse event reporting were used. Adverse events were likely documented by the site investigators and potentially reviewed by a clinical events committee (though not explicitly detailed in the provided text).

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:

No, this was not an MRMC comparative effectiveness study involving human readers and AI assistance. This was a direct comparison of two medical devices (Visant Medical Canalicular Plug vs. a predicate control plug) for their effects on dry eye symptoms in patients.

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

No, this is a physical medical device (canalicular plug), not a software algorithm. Therefore, no standalone algorithm performance study was applicable or performed.

7. The type of ground truth used:

The "ground truth" for evaluating the device's effectiveness and safety was based on:

• Clinical Measurements: Objective metrics like anesthetized Schirmer's test scores, tear meniscus heights, corneal fluorescein staining scores, and tear break-up time (TBUT), measured directly from patients by healthcare professionals.
• Patient-Reported Outcomes (PROs): Subjective data from the Ocular Surface Disease Index (OSDI) questionnaire, completed by the participants.
• Adverse Event Reporting: Documentation of adverse events by clinical investigators, classified by severity and relatedness.
• Investigator Assessments: Observations by investigators regarding ease of insertion and removal, pain during procedure, and patency of the lacrimal drainage system after removal.

8. The sample size for the training set:

Not applicable. This is a physical medical device. There is no "training set" in the context of an algorithm or AI model development. The non-clinical testing and in vivo animal studies could be considered analogous to early developmental or exploratory phases, but not a "training set" in the AI sense.

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

Not applicable, as there is no training set for a physical device. The non-clinical and in vivo studies serve to establish the safety and preliminary performance characteristics before human clinical trials.

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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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Tear Pool Dissolvable Punctum Plugs are designed to provide for temporary occlusion of the tear drainage system.

Punctum Plugs are indicated for:

• • 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 ocular surgery to prevent complications due to dry eyes
• • To evaluate treatment of ocular dryness
• • To evaluate the dry eye component of ocular surface diseases

The Tear Pool Dissolvable Punctum Plug is an ophthalmic device commonly referred to as a punctum plug. It is designed to be inserted by a practitioner into the canaliculus to temporarily restrict the natural lubricating tears from draining off the surface of the eye.

This treatment is prescribed for temporary occlusion in the 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.

Tear Pool Dissolvable Punctum Plugs are cylindrical in shape. Approximately 2.0mm in length and are available in two sizes: 0.4mm and 0.5mm. Each plug is composed of polydioxanone(PDO). The plug is dyed with an approved color additive, D & C Violet No. 2.

A Tear Pool Dissolvable Punctum Plug is mounted on a specially designed insertion tool and placed into a plastic tray then sealed with a Tyvek® cover. The primary package is sent to the sterilizer for Ethylene Oxide sterilization. Two sterile trays, one IFU, two chart labels and one silica gel packet are sealed in a pouch and placed in a shelf box.

The Pre-Loaded Tear Pool Dissolvable Punctum Plugs are available in the following models and diameters and are 2.0mm in length
Model# 20-5304 0.4mm
Model# 20-5305 0.5mm

The device is make from Polydioxanone(PDO). The plugs are violet in color.

The provided text describes a 510(k) premarket notification for a medical device called "Tear Pool Dissolvable Punctum Plugs." This document focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical performance studies typical for novel or higher-risk devices. As such, the information needed to answer many of your questions regarding acceptance criteria and study detailed performance evaluation for an AI/CAD-like device is not present in this document.

The document primarily discusses:

• Device Description: What the punctum plugs are, their materials (polydioxanone), sizes, and sterilization method (Ethylene Oxide).
• Indications for Use: Temporary occlusion of the tear drainage system for various dry eye-related conditions.
• Technological Characteristics: Highlighting similarities to the predicate device and the absence of software, energy sources, biologics, drugs, coatings, or additives.
• Performance Data (Non-clinical): Biocompatibility testing (cytotoxicity, irritation, sensitization, material testing), sterilization validation (EO residuals, bacterial endotoxin), and insertion tool testing (simulated use deployment).

There is no mention of an AI/CAD device, or any kind of software component that would require acceptance criteria related to AI performance metrics (like sensitivity, specificity, AUC). The device is a physical, dissolvable punctum plug.

Therefore, for most of your questions, the answer will be "Not Applicable" or "Information Not Provided in this Document" because the context of your questions (AI/CAD performance, ground truth establishment, MRMC studies) does not align with the type of device and regulatory submission described in the FDA letter.

However, I can extract the non-clinical performance data and frame it in a way that resembles acceptance criteria based on the information provided, even though it's not for an AI device.

Here's an attempt to answer your questions based only on the provided text, acknowledging its limitations for an AI/CAD context:

Device: Tear Pool Dissolvable Punctum Plugs

Purpose of the Submission: 510(k) Premarket Notification to demonstrate substantial equivalence to a legally marketed predicate device (Dissolvable Opaque Herrick Lacrimal Plug, K030300).

Based on the provided document, the "acceptance criteria" and "study" are focused on demonstrating the safety and effectiveness of a physical medical device (punctum plugs) by showing equivalence to a predicate device, primarily through non-clinical testing. This is not a study of an AI/CAD system.

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a physical device and not an AI, the "acceptance criteria" are based on meeting specific biological, chemical, and functional standards for medical devices. The "reported device performance" indicates whether these standards were met.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified for any of the non-clinical tests. The tests are typically performed on a statistically justified sample of the device or its materials, but the exact number isn't in this summary.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would typically be laboratory test data rather than patient data. For in vitro and animal (e.g., skin sensitization in guinea pigs/mice) biocompatibility tests, standardized lab conditions are used. It's safe to assume these are prospective laboratory tests specifically performed for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. For a physical medical device, "ground truth" for biocompatibility and sterilization is established by adherence to recognized international standards (e.g., ISO, USP) and validated laboratory testing protocols, rather than expert consensus on interpretive data (which applies to AI/CAD). The "experts" would be the qualified laboratory personnel conducting the tests and the personnel overseeing the quality system.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication (e.g., 2+1, 3+1 for discordant reads) is relevant for human interpretation of imaging data or clinical endpoints. For laboratory tests, the results either meet the specified standard/criteria or they do not.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. The device is a physical punctum plug for tear drainage occlusion.

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

• No. As there is no algorithm or software component for this medical device, a standalone performance study is not relevant.

7. The Type of Ground Truth Used

• For Biocompatibility/Sterilization: Ground truth is defined by the objective results of validated laboratory tests conducted according to established international and national standards (e.g., ISO 10993 series, USP monographs). This could be considered "laboratory standard" or "validated assay results."
• For Insertion Tool: Ground truth is functional performance (e.g., successful deployment without damage), verified by a "Simulated Use Deployment Test."

8. The Sample Size for the Training Set

• Not Applicable. This device does not have a "training set" as it is not an AI/machine learning product. The design and manufacturing are based on established engineering principles and prior knowledge of the predicate device.

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

• Not Applicable. See point 8.

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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.

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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.

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The Riverpoint Medical Absorbable Canalicular Plugs are intended to temporarily block tear drainage by the obstruction of the canaliculus in the lacrimal drainage system. The Absorbable Canalicular Plugs are used for the temporary treatment of dry eye syndrome, and the dry eye components of various ocular surface diseases including contact lens intolerance secondary to dry eye. The Absorbable Canalicular Plugs can be used in the treatment of dry eye following ocular surgery or to enhance the efficacy of topical medicines and/or ocular lubricants. The Riverpoint Medical Absorbable Canalicular Plugs may also be used to determine the potential effectiveness of a non-absorbable punctal occlusion device.

The Riverpoint Medical PDO Absorbable Canalicular Plug is a monofilament synthetic absorbable device prepared from poly(p-dioxanone). PDO Absorbable Canalicular Plugs are available undyed or violet. When dyed, only FDA-approved color additives such as D&C Violet No. 2 are used. PDO Absorbable Canalicular Plugs are used to temporarily block tear drainage by the occlusion of the lacrimal canaliculi for approximately 180 days.

The provided document is a 510(k) summary for a medical device (PDO Absorbable Canalicular Plug) seeking substantial equivalence to a predicate device. This type of submission generally focuses on demonstrating equivalence rather than comprehensive clinical studies with detailed acceptance criteria and performance reports in the format requested.

Therefore, the document does not contain specific acceptance criteria, detailed study results proving a device meets these criteria, sample sizes for test sets or training sets, information on expert numbers/qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document primarily states that the device is substantially equivalent to a predicate and that "All acceptance criteria were met" for specific non-clinical performance tests. However, it does not define those acceptance criteria or report the device performance against them in a measurable way that could be tabulated as requested.

Here's what can be extracted based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "All acceptance criteria were met, and the Riverpoint Medical Absorbable Canalicular Plug performed as intended."
However, the specific acceptance criteria and the quantitative or qualitative device performance against those criteria are not detailed in this document. The document lists the types of tests performed (sterilization validation, biocompatibility, stability, usability validation) but does not provide the pass/fail thresholds or the actual results.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not specified for any of the performance tests mentioned.
• Data Provenance: The tests are non-clinical (laboratory/simulated use). Country of origin is not specified.
• Retrospective/Prospective: Not applicable as these are non-clinical performance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. These were non-clinical performance tests (sterilization, biocompatibility, stability, usability validation). No "ground truth" established by experts in a clinical context is described for these tests.

4. Adjudication method for the test set:

• Not applicable. This relates to clinical studies and expert review, which are not detailed for the performance tests described.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:

• No, a MRMC comparative effectiveness study was not done according to this document. The document focuses on demonstrating substantial equivalence through non-clinical performance testing and comparison of technological characteristics.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) study:

• Not applicable. This device is a physical medical implant (canalicular plug), not a software algorithm.

7. Type of ground truth used:

• Not applicable. The performance tests mentioned (sterilization, biocompatibility, stability, usability validation) are evaluated against established standards (e.g., ISO guidelines) and engineering specifications, not clinical "ground truth" like pathology or outcomes data.

8. Sample size for the training set:

• Not applicable. There is no mention of a "training set" as this is a physical device, not an AI/machine learning model.

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

• Not applicable. (See point 8).

In summary, the provided FDA 510(k) summary focuses on demonstrating that a new device is "substantially equivalent" to an existing predicate device through a comparison of technological characteristics and non-clinical performance testing (e.g., sterilization, biocompatibility). It does not include the detailed clinical study information—with specific acceptance criteria, reader performances, and ground truth establishment—that would be expected for a product requiring such extensive evaluation for its primary performance claims.

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The VeraPlug™ Punctal Plug is for use in patients with dry eye syndromes.

The VeraPlug™ Punctal Plug is designed to provide reduction or elimination of tear drainage through the inferior or superior puncta, thus maintaining lubricating tears on the surface of the eye. Each VeraPlug™ Punctal Plug is molded from medical grade silicone. The VeraPlug™ Punctal Plug is available in 3 sizes (small, medium, and large) and is packaged 2 per/box. Each plug is sterile and preloaded on an inserter.

The inserter is manufactured using medical grade ABS (acrylonitrile butadiene styrene), and 304 stainless steel.

Here's the analysis of the provided text regarding the acceptance criteria and supporting study for the VeraPlug™ Punctal Plug:

This document is a 510(k) premarket notification for a medical device called the VeraPlug™ Punctal Plug. It aims to demonstrate substantial equivalence to a predicate device, not necessarily to establish de novo acceptance criteria for a novel device. Therefore, the "acceptance criteria" discussed relate to demonstrating this equivalence rather than setting performance thresholds for a new technological concept.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not describe a clinical "test set" in the sense of patient data being collected for evaluation of the device. The non-clinical tests involved laboratory and bench testing of the device itself and its manufacturing processes.

• Sample Size: Not specified for individual tests, but implicitly refers to a sufficient number of devices for bench and lab testing (e.g., for sterility, stretch tests, and packaging validation).
• Data Provenance: The data is generated from non-clinical bench and laboratory testing of the manufacturing processes and device properties. It is not derived from human subjects or patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not apply.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable to this submission. The "ground truth" for the non-clinical tests is established by adherence to recognized international standards (ISO, ASTM) and internal validation protocols for manufacturing processes (e.g., ETO sterilization validation). There is no "test set" that requires human expert adjudication for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. Since there is no "test set" involving human interpretation or subjective evaluation, no adjudication method is described or required.

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?

No, an MRMC comparative effectiveness study was not done. This device is a physical medical implant (a punctal plug), not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers improve with AI" is not relevant here.

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

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Established industry standards and regulations: Adherence to ISO and ASTM standards for sterilization, biocompatibility, and packaging.
• Laboratory test results: Objective measurements demonstrating physical and biological properties (e.g., passing a stretch test, meeting ETO residual limits, adequate bioburden reduction, package integrity).
• Substantial equivalence: The comparative data with the legally marketed predicate device regarding materials, dimensions, and intended use serves as a form of "ground truth" for demonstrating safety and effectiveness based on equivalence.

8. The Sample Size for the Training Set

This information is not applicable. Since this is a physical medical device and not an AI algorithm, there is no concept of a "training set" in this context. The manufacturing processes are validated, and devices are tested, but not in the sense of training a model.

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

This information is not applicable as there is no training set for this device.

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The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are intended to temporarily block tear drainage by the occlusion of the canaliculus in order to:

• Determine the potential effectiveness of permanent occlusion, .
• 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, and
• Temporarily treat dry eye after ocular surgery.

Comfortear® Lacrisolve™ Absorbable Punctum Plugs are intended to temporarily block tear drainage by occlusion of the canaliculus. The plug is supplied in various sizes ranging from 0.2mm to 0.5mm in diameter and has a length of approximately 1.75mm, see table below. The plug is dyed (D&C Violet No. 2). Comfortear® Lacrisolve™ Absorbable Punctum Plugs are composed of the following absorbable suture materials: polydioxanone (PDO).
The design features of the Comfortear@ Lacrisolve™ Absorbable Punctum Plugs raise no new issues of safety or effectiveness. Comfortear® Lacrisolve™ Absorbable Punctum Plugs consist of a length of monofilament synthetic absorbable suture material. The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are provided sterile. The Comfortear® Lacrisolve™ Absorbable Punctum Plugs are available in various sizes to accommodate different patient physiologies and achieve occlusion of the canaliculus (or punctum). Two plugs are included in each package and there is one package in each box. This device is sub-punctal, to limit contact and possible irritation to the eye.

This document describes a 510(k) premarket notification for the Comfortear® Lacrisolve™ Absorbable Punctum Plug. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study proving the device meets specific acceptance criteria in the clinical performance sense (e.g., diagnostic accuracy or treatment effectiveness).

The "acceptance criteria" discussed in the document are primarily related to safety, material biocompatibility, and manufacturing controls, aligning with the requirements for justifying substantial equivalence.

Here's an analysis of the provided text in relation to your questions:

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

The document doesn't present a table of quantitative acceptance criteria and device performance for clinical effectiveness per se. Instead, it outlines testing performed to ensure safety and manufacturing consistency. The "acceptance criteria" are implied by compliance with established international and FDA standards.

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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.

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