Search Results

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.

Ask a specific question about this device