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The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.

MedDev Contour™ and ThinProfile™ Eyelid Weight Implants were designed for the treatment of lagophthalmos, i.e. the inability of the eyelid to fully close. This condition is typically due to a degree of facial paralysis. The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are passive implants surgically placed in the eyelid. The density of their construct material (pure gold or platinum) provides the weight necessary to close the eyelid over the eye. The patient can use their functional orbital musculature to keep their eyes open, but have the gravitational assist from the Implant to close the eyelid.

The provided text describes the acceptance criteria and a study for the MedDev Contour™ and ThinProfile™ Eyelid Weight Implants.

1. Table of Acceptance Criteria and Reported Device Performance:

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The MedDev Contour Design Gold Eyelid Implants intended use is for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.

MedDev's Contour Design Gold Eyelid Implants are spherically radiused parts of gold (at McdDCV S Ource) which conform to the curvature of the eye globe. They are available in twelve sizes ranging from 0.6 grams in 0.2-grams in 0.2-gram increments. All product tworo olzoo ranging trone or substantially equivalent to the predicated devices mentioned Specifications are the barns of Suzen the predicated MedDev devices and the proposed above. The occasion Gold Eyelid Implants is that the devices will now be supplied sterile to end users.

MedDev's Contour Design Gold Eyelid Implants can be implanted into the eyelid using the Medical techniques depicted in the product brochure. This technique is the same or substantially equivalent to techniques used for the predicated devices.

Implants are made of 99.99% pure gold. They are designed in a receinigular onapo with a opners spherical radius of 12.7 mm to conform to the shape of the good. The implant, allowing the surgeon to secure the implant to the tarsus or orbital septum.

The MedDev Contour Design Gold Eyelid Implants are spherically radiused gold implants designed to conform to the curvature of the eye globe. They are used for the gravity-assisted treatment of protracted or permanent lagophthalmos, typically resulting from facial paralysis.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Acceptance Criteria and Reported Device Performance

The submission relies on substantial equivalence to predicate devices rather than defining specific quantitative acceptance criteria or performance metrics for the device itself. The primary change in the proposed device is that it will now be supplied sterile, whereas previous MedDev Contour Design Gold Eyelid Implants were non-sterile.

The acceptance criteria for the re-submitted device are implicitly based on maintaining all other characteristics and performance features of the predicate devices. The study provided focuses on asserting that the proposed device is "the same or substantially equivalent" to the predicate devices across various attributes.

2. Sample Size for Test Set and Data Provenance

No specific test set or clinical study data is referenced in the provided document for the evaluation of the device's functional performance or efficacy. The submission relies on the established safety and effectiveness of its own pre-amendment non-sterile version and the cleared Labtician Lid Load™ Gold Eyelid Weight Implants (K983607).

The "study" presented is a comparison table asserting substantial equivalence. It does not involve a test set of patients or data provenance in the traditional sense of a clinical trial. The data provenance is effectively the regulatory approval of the predicate devices.

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

Not applicable. No ground truth was established by experts for a test set in this submission. The "ground truth" for the claims of equivalence lies in the established properties and regulatory acceptance of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring adjudication in this submission.

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

Not applicable. This device is an implant, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical implant. The concept of an "algorithm only" performance study is not applicable.

7. Type of Ground Truth Used

The ground truth used for this submission is the established safety and effectiveness of the predicate devices (MedDev's own pre-amendment non-sterile Contour Design Gold Eyelid Implants and Labtician Lid Load™ Gold Eyelid Weight Implants). The primary ground truth for the new aspect of the device (sterility) is the validation of the steam sterilization process to achieve a Sterility Assurance Level (SAL) of 1 x 10-6.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device.

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