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510(k) Data Aggregation
(186 days)
Gold and Platinum Tapered Weight Eyelid Implants are intended for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
The Gold and Platinum Tapered Weight Eyelid Implants are implantable devices for the gravityassisted treatment of lagophthalmos by the addition of weight to the upper eyelid. The device is made of either 99.99% purity gold or platinum. Platinum devices can be implanted in patients who are allergic to gold. The Gold and Platinum Tapered Weight Eyelid Implants come in two thicknesses (thin and normal profiles) and in seven different weights ranging from 0.6 g to 1.8 g (in 0.2 g increments). The Gold and Platinum Tapered Weight Eyelid Implants are each provided as a sterilized product.
This document describes the premarket notification (510(k)) for Gold and Platinum Tapered Weight Eyelid Implants. It focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed clinical study for novel device acceptance criteria. Therefore, much of the requested information regarding clinical study design, ground truth, expert opinions, and sample sizes for diagnostic performance is not directly applicable or available in this document.
However, based on the provided text, I can extract and infer information relevant to the non-clinical acceptance criteria and the studies performed to meet them.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission focused on substantial equivalence to an existing device, the "acceptance criteria" are primarily established by demonstrating that the new device shares fundamental technological characteristics and performance (or equivalent performance) with the predicate device, especially considering any differences. The key performance metrics evaluated are MRI safety, biocompatibility, and sterility/shelf-life.
| Category | Acceptance Criteria (typically from established standards or predicate performance) | Reported Device Performance (FCI Gold/Platinum Eyelid Implants) |
|---|---|---|
| MRI Safety | Device is "MR Conditional" under specified conditions (e.g., static field ≤ 3T, spatial gradient ≤ 4000 Gauss/cm, SAR ≤ 4 W/kg for 15 min). | MR Conditional: meets these conditions. |
| MRI-Related Force | Negligible deflection/torque in a 3T MR system. (e.g., 2° deflection or "0" on a 0-4 torque scale). Adherence to ASTM F2052-06. | Gold: 2° deflection, Torque "0". |
| Platinum: 2° deflection, Torque "0". | ||
| MRI-Related Heating | Maximum temperature rise ≤ acceptable limits (e.g., usually |
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