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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 <5°C for implants during 15 min scan). Adherence to ASTM F2182-11a. | Gold (2.8g): Max temperature rise of +2.0°C after 15 min. Platinum (2.8g): Max temperature rise of +2.3°C after 15 min. |
| MRI-Related Artifact | Image artifact extension to be reported. Adherence to ASTM F2119-07. | Gold (2.8g): Artifact extends ~5mm from device with gradient echo, 3T MR. Platinum (2.8g): Artifact extends ~10mm from device with gradient echo, 3T MR. |
| Biocompatibility | Meets requirements of ISO 10993 standards (e.g., no cytotoxicity, acceptable leachable levels, etc.). | Established through review of existing data, chemical characterization (leachable test), and cytotoxicity testing per ISO 10993-1, -5, -18. (Results implied as favorable for clearance). |
| Sterility | Sterility Assurance Level (SAL) of 10⁻⁶. Ethylene Oxide (EO) residuals within acceptable limits. Meets ISO 11135-1:2007. Bioburden specification. | SAL 10⁻⁶ achieved via Ethylene Oxide sterilization. EO Residuals: EO 4.0µg/device, ECH 5.8 µg/device. Bioburden: < 100 CFU/device. |
| Shelf-Life | Functional performance maintained, and package integrity preserved over the claimed shelf life (e.g., 5 years) following accelerated aging. Adherence to ASTM standards for package integrity. | 5 years established via accelerated aging. Functional performance (dimensional, visual inspection) verified. Package integrity (visual, peel, dye, bubble leak) confirmed per ASTM F1929, F1886, F88/F88M, F2096. |
2. Sample Size for Test Set and Data Provenance
- MRI Safety: The testing was conducted using the largest sizes available in the market (2.8g) for both Gold and Platinum Eyelid Weight Implants. While the specific number of individual implants tested for each condition (force, heating, artifact) is not explicitly stated, it implies at least one sample of each type and weight was used for the respective tests. The provenance of the data is from non-clinical laboratory testing specific to the device.
- Biocompatibility: Not directly referenced as a "test set" in the traditional sense for diagnostic performance. It involved chemical characterization and cytotoxicity testing. The sample size for these tests (e.g., number of replicates, specimens) is not specified but would follow the requirements of the ISO 10993 standards. Data provenance is from laboratory testing.
- Sterility and Shelf-Life: The testing involved validation protocols based on standards like ISO 11135-1 and ASTM standards for package integrity. The sample sizes for these validation activities are not explicitly detailed but are typically defined by the respective standards (e.g., for bioburden, sterility validation, accelerated aging studies). Data provenance is from laboratory testing (in-house or contract sterilizer).
3. Number of Experts and Qualifications for Ground Truth
This document does not pertain to the diagnostic performance of an AI/ML device or a device requiring expert interpretation for its primary function. Therefore, there were no "experts used to establish ground truth" in the context of clinical outcomes or diagnostic accuracy. The ground truth for the non-clinical tests is based on objective measurements and adherence to established engineering and material science standards and protocols.
4. Adjudication Method
Not applicable, as this is not a study requiring human adjudication of clinical or diagnostic outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable, as this is not a study assessing human reader performance.
6. Standalone (Algorithm Only) Performance
Not applicable, as this is a physical medical implant, not an AI/ML algorithm.
7. Type of Ground Truth Used
The ground truth for the non-clinical tests described is based on:
- Objective Measurements: For MRI safety (deflection angles, temperature changes, artifact dimensions), sterility (SAL, residual levels), and shelf-life (dimensional stability, package integrity).
- Established Standards and Protocols: Adherence to international standards (ISO, ASTM) for methods, acceptance criteria, and measurement techniques.
- Material Characterization: For biocompatibility, the ground truth is based on the chemical composition of the materials and their known biological responses, validated by specific in-vitro tests (cytotoxicity, leachable tests).
8. Sample Size for Training Set
Not applicable, as this is not an AI/ML algorithm requiring a training set.
9. How Ground Truth for Training Set Was Established
Not applicable, as this is not an AI/ML algorithm requiring a training set.
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