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Labtician Lid Load External Eyelid Sizing Weights are used by the physician to determine the correct gold eyelid weight to be implanted in the treatment of lagophthalmos.

Labtician Lid Load External Eyelid Sizing Weights are used by the physician who affixes a succession of external eyelid weights to the outer surface of the eyelid using until the proper eyelid closure is attained. Because the levator muscle seems to strengthen after the weight is added, the optimal weight for implantation is ususally that which holds lid about 1.0 mm lower than the normal lid as the patient looks straight ahead.

The corresponding implantable gold eyelid weight is then prescribed for implantation.

Sizing weights are not designed to be implanted, and are provided nonsterile and are re-usable following cleaning with soap and water and/or alcohol and rinsing with tap water.

Labtician Lid Load External Eyelid Sizing Weights are spherically radiused strips of pure tantalum (99.5%), constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments.

A Labtician Lid Load External Eyelid Sizing Weight is attached to the outer skin of the upper eyelid with a double coated adhesive tape strip or other suitable adhesive.

The physical specifications and materials used in the construction of Labtician Iid Load External Eyelid Sizing Weights are identical to the EyeClose External Eyelid Weights, with the exception that Labtician Lid Load External Eyelid Sizing Weights are unpainted.

Labtician Lid Load External Eyelid Sizing Weights are constructed of pure tantalum (99.5%). The weights are designed in a rectangular shape with a spherical radius of curvature of 12.7 mm which conforms to the shape of the eye. All edges are smoothly rounded.

This document is a 510(k) Summary for the Labtician Lid Load External Eyelid Sizing Weights. It describes the device, its intended use, and claims substantial equivalence to a predicate device, the EyeClose External Eyelid Weights (K940974).

No specific acceptance criteria or details of a study demonstrating the device meets such criteria are provided in the provided text. The submission focuses on establishing substantial equivalence based on similar design, materials, and intended use as the predicate device, rather than presenting a performance study with defined acceptance criteria.

The information requested in the prompt, such as sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, is not available in this 510(k) summary. This type of regulatory submission typically does not involve clinical performance studies with detailed statistical analysis as would be required for novel devices or those demonstrating significant technological differences. The claim of substantial equivalence implies that the device is as safe and effective as the predicate device, obviating the need for extensive new performance data.

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Labtician Lid Load Gold Eyelid Weight Implants, surgically implanted in the upper eyelid, work by gravity to restore a functional blink mechanism in the patient with lagophthalmos resulting from temporary or permanent facial paralysis, specifically the orbicularis oculi muscle. This paralysis may be the result of Bell's palsy or from surgical trauma to the facial nerve.

Functional defects which may be corrected or avoided with the use of Labtician lid Load Gold Eyelid Weight Implants include inadequate eyelid closure, corneal exposure, serious keratopathy such as ocular irritation, keratitis, corneal abrasion or ulceration. These conditions may result in decreased vision.

The Labtician Lid Load Gold Eyelid Weight Implants are spherically radiused strips of pure gold (99.99%), constructed in twelve sizes ranging from 0.6 grams to 2.8 grams in 0.2 gram increments. All product specifications are substantially equivalent to the predicate device, the Series 3000 Gold Evelid Implant, produced by MedDev Corporation, with the exception that Labtician Lid Load Gold Eyelid Weight Implants are supplied sterile, whereas the predicate device is supplied nonsterile and designed to be sterilized prior to surgery by the end user.

Labtician Lid Load Gold Evelid Weight Implants are constructed of pure gold (99.99%). The weights are designed in a rectangular shape with a spherical radius of curvature of 12.7 mm which conforms to the shape of the eye. All edges are smoothly rounded. Suture holes are placed in the implant to allow the surgeon to secure it to the tarsus or orbital septum.

The provided text describes a 510(k) premarket notification for the Labtician Lid Load™ Gold Eyelid Weight Implants and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific performance acceptance criteria.

Therefore, many of the requested categories for acceptance criteria and study details cannot be extracted from the provided text because such a study was not performed or detailed. The submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Series 3000 Gold Eyelid Implants by MedDev Corporation) rather than new clinical performance data.

Here's a breakdown of what can and cannot be answered 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" for device performance in the typical sense (e.g., a specific sensitivity or specificity). Instead, it establishes "substantial equivalence" based on qualitative characteristics.

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

Not applicable. No new test set or clinical study data was presented to demonstrate performance against acceptance criteria. The submission relies on substantial equivalence to the predicate device.

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

Not applicable. No new test set requiring expert ground truth was created.

4. Adjudication method for the test set

Not applicable. No new test set requiring adjudication was created.

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 a physical implant, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical implant, not a standalone algorithm.

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

The "ground truth" for the substantial equivalence claim is the established safety and effectiveness of the predicate device, the Series 3000 Gold Eyelid Implants. This is based on its pre-amendment status and long-standing use.

8. The sample size for the training set

Not applicable. There is no machine learning model or training set involved.

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

Not applicable. There is no machine learning model or training set involved.

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