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Punctal Occluders (plugs) are indicated for the treatment of "dry eye" syndrome.

This device, made of medical grade silicone, titanium dioxide as a colorant and utilizing a proprietary surface treatment made under current good manufacturing practices, is a small, generally "plug" shaped design. Punctal Occluders are intended for the treatment of "dry eve" conditions through partial occlusion of individual punctual openings.

This 510(k) summary (K090938) describes a Micro Flow Punctal Occluder, a medical device intended for the treatment of "dry eye" conditions. The submission makes a case for substantial equivalence to a predicate device (Odyssey Punctal Occluder, K970631) rather than directly presenting a study to prove new acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study to prove the device meets them is not explicitly available in the provided text. The document focuses on demonstrating that the new device is substantially equivalent to a previously cleared device.

Here's an explanation based on the provided text:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in the form of measurable acceptance criteria or performance metrics derived from a study. The submission asserts substantial equivalence based on material, design, and intended use.
• Study Details: There is no description of a study conducted to demonstrate the device's performance against specific acceptance criteria.

Key points from the 510(k) summary regarding the device and its comparison to the predicate:

• Device Description: The Micro Flow Punctal Occluder is made of medical grade silicone with titanium dioxide as a colorant and a proprietary surface treatment. It's a small, "plug" shaped design.
• Intended Use: Treatment of "dry eye" conditions through partial occlusion of individual punctal openings.
• Predicate Device: Odyssey Punctal Occluder (K970631).
• Differences from Predicate (Micro-Flow vs. Original Odyssey Plug):
  • Original: Larger angle nose, no through hole, shorter length.
  • Micro-Flow (New):
    • Has a through hole for partial occlusion.
    • A 0.002 ridge on the nose to support the through hole.
    • Smaller angle on the nose (tip).
• Safety and Reversibility: The document highlights that the submitted method is functionally safe and fully reversible, unlike some alternative methods that are permanent or difficult to reverse, or risk damaging intact tissue.

In summary, the provided document does not contain the details of a study with acceptance criteria, sample sizes, expert qualifications, or adjudication methods as requested. It is a 510(k) submission relying on substantial equivalence to a predicate device.

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Odyssey's L.E.D. provides a sterile adhesive surgical barrier for a variety of ophthalmic procedures, including LASIK. Prepare and drape the patient in the normal ophthalmic fashion. Hold back the eyelashes from the visual field as required. Care should be taken when removing the drape from the adhesive backing not to tear or damage the device. Apply the L.E.D. in the required area to provide proper occlusion and maintain a clean and dry sterile field. The Lasik Eyelid Drape is designed to drape the eyebrow, completely drape the perimeter of the eye or provide complete occlusion of the eyelid. It can also be trimmed to aid in retracting lashes without obstructing the surgical site. While the adhesive holds the drape securely in place, removal is easy and painless for patients. A non-adhesive red tab is located on each side of the drape to aid in removal.

This device, made of medical grade polyethylene tape and coated with a pressure sensitive acrylate adhesive, is designed to support LASIK surgery, as well as a variety of other ophthalmic procedures by promoting a clean and dry sterile field. The LASIK Evelid Drape is intended by design to drape the eyebrow, completely drape the eye or provide complete occlusion of the eyelid. In addition, it can be trimmed to aid in retracting lashes without obstructing the surgical site.

The provided text describes a 510(k) premarket notification for a medical device called the "LASIK Eyelid Drape" (or "LASIK Eye Drape"). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or safety through extensive clinical trials with acceptance criteria and statistical analysis as would be required for a PMA (Premarket Approval).

Therefore, the provided document does not contain the information requested regarding acceptance criteria studies, sample sizes, expert involvement, adjudication methods, or comparative effectiveness studies (MRMC or standalone).

Here's why the requested information is not present and what the document does provide:

• Acceptance Criteria and Reported Device Performance: This document states the device's design, material, and intended use, and claims it is substantially equivalent to a predicate device (BD Visiflex incise Drape). There are no specific performance metrics or acceptance criteria listed for the LASIK Eyelid Drape that are backed by a study in this document. The only "performance" characteristics mentioned for the Odyssey product are anecdotal: "reportedly easy to apply and conformable with good adhesion to skin."
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): None of these elements are present because a 510(k) submission primarily relies on demonstrating equivalence to an existing device, often through bench testing, material comparisons, and a comparison of intended use, rather than de novo clinical studies. There is no mention of a clinical study, test set, training set, or expert involvement for establishing ground truth.
• Type of Ground Truth: Not applicable, as there's no clinical study described. The "ground truth" for a 510(k) is essentially the established safety and efficacy of the predicate device.
• Training Set Sample Size and Ground Truth Establishment (for training set): Not applicable, as there's no machine learning algorithm or training set for performance evaluation described in this document.

Summary of relevant information from the document:

This document is a 510(k) premarket notification (K042977) for the LASIK Eyelid Drape. The core of a 510(k) is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective as the predicate. It does not typically involve extensive clinical trials with acceptance criteria like those requested.

The predicate device identified is the BD Visiflex incise Drape (Becton, Dickinson, and Company).

The equivalence is based on:

• Intended Use: Both are designed to promote a clean and dry sterile field, secured by pressure-sensitive adhesive, indicated for refractive and general ophthalmic procedures, universal for left/right eye, and for complete/partial coverage and eyelid retraction.
• Design: Both use pressure-sensitive adhesive.
• Sterilization: Both are supplied sterile via Gamma Irradiation.
• Materials: The LASIK Eyelid Drape uses "Transparent Polyethylene Medical Tape". The material of the predicate is "unknown at this time" to the submitter, but the functional equivalence is still claimed.

The FDA's letter (pages 2-3) confirms the "substantial equivalence" determination, allowing the device to be marketed. This determination is not an approval of efficacy or a finding that the device meets specific performance criteria established through controlled studies, but rather that it is comparable to an already legally marketed device.

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Punctal Occluders (plugs) are indicated for the treatment of "dry eye" syndrome. "dry eye being a condition where there is insufficient lubrication in the eye and the conjunctive becomes much less moist than normal. This produces pain and discomfort in the eyes. This may occur in any condition that causes scars of the cornea, such as erythema multiforme, trachoma, or corneal burns;" ... etc. Other patients that may benefit are: cataract patients, patients with arthritis, patients medicated for hypertension, contact wearers of any age, seasonal allergy sufferers, patients who live in dry climates, or spend extended periods in air conditioning, and any others who suffer from dry eye irritation. Treatment is to stop tear outflow via a specific punctum to enhance tear contact time in certain dry eye conditions. It is also reasonable that eye drops of many kinds would be more effective if retained on the surface of the eye, rather than drained into the sinus.

This device, made of medical grade silicone, titanium dioxide as a colorant and utilizing a propritary surface treatment made under current good manufacturing practices, is a small, generally "plug" shaped design. Punctal Occluders are intended for the treatment of "dry eye" conditions through the total occlusion of individual punctal openings.

The provided text describes a 510(k) premarket notification for a Punctal Occluder device (K972523), comparing it to a previously marketed Odyssey Punctal Occluder. The submission focuses on demonstrating substantial equivalence.

Based on the provided text, the following information regarding acceptance criteria and a study to prove it can be extracted or inferred:

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

The document does not explicitly present a table of acceptance criteria with numerical performance metrics as would be seen in a clinical study for a new device. Instead, the acceptance criterion for this 510(k) submission is the demonstration of substantial equivalence to a predicate device.

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

The provided text does not include information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) summary focuses on design and material comparisons, and a statement about biocompatibility testing, rather than a clinical performance study using a defined test set of patients.

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

This information is not present in the provided document. As there's no mention of a clinical test set with patient outcomes, there's no need for experts to establish ground truth in the context of this 510(k) summary.

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

This information is not present in the provided document.

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 present in the provided document. The device is a physical punctal occluder, not an AI-powered diagnostic or assistive technology for human readers.

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

This information is not present in the provided document. The device is a physical medical device and does not involve algorithms or AI.

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

The concept of "ground truth" as typically applied to diagnostic algorithms or AI models is not directly relevant here. For this 510(k) submission, the "truth" being established is the substantial equivalence of the new device to the predicate device in terms of materials, design, intended use, and safety. This is established through the manufacturer's self-declaration and substantiation, reviewed by the FDA. The biocompatibility statement suggests in vitro or in vivo testing, but the nature of the "ground truth" (e.g., specific assays, observed reactions) is not detailed.

8. The sample size for the training set:

This information is not present in the provided document. As it is a physical device, there is no "training set" in the context of machine learning or AI.

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

This information is not present in the provided document, for the same reason as point 8.

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Punctal Occluders are intended for the treatment of "dry eye" conditions through the total occlusion of individual punctal openings.

This device, made of medical grade silicone and titanium dioxide as a colorant under current good manufacturing practices, is a small, generally "plug" shaped design.

The provided text is a 510(k) summary for a medical device called the "Odyssey Punctal Occluder." This document is for regulatory submission and does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth, or adjudication methods.

Therefore, I cannot provide the requested information based on the input document. The document describes the device, its intended use, and argues for its substantial equivalence to a pre-amendment device, but it does not detail any performance studies that would typically include acceptance criteria or the other study-related metrics you've asked for.

Ask a specific question about this device