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510(k) Data Aggregation
(125 days)
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:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| MRI Safety Review | MR-Conditional for static magnetic fields of 3-Tesla or less. | Successfully demonstrated MR-Conditional claim. |
| MRI Related force (Torque) | Minimal to no deflection/torque in a 3-Tesla MRI. (Implied: Acceptable deflection for safety, which for this device was 2 degrees, and torque rating of 0 for both axis, indicating no movement after initial 2 degree deflection) | 2° deflection for both gold and platinum samples (2.8g), with a torque rating of 0 (no torque) in both long and short axis for 2.8g Gold and Platinum Contour™ Eyelid Weight Implants. |
| MRI Related Heating | Maximum temperature change (over 15 minutes in a 3T field) within safe limits. (Implied: Typically <2-3°C for small implants unless specifically justified) | Maximum measured temperature change of +2.0°C for 2.8g Gold Contour™ Eyelid Weight Implant and +2.3°C for 2.8g Platinum Contour™ Eyelid Weight Implant. |
| MRI Related artifact | Acceptable artifact size (Implied: limited to a small area around the device, not obscuring critical anatomy). | Image artifact extends approximately 5-mm from the 2.8g Gold Contour™ Eyelid Weight Implant and approximately 10-mm from the 2.8g Platinum Contour™ Eyelid Weight Implant when imaged using a gradient echo pulse sequence and a 3-Tesla MR system. |
| Biocompatibility | Compliant with ISO 10993-1:2009 for the duration of contact. | Concluded that the MedDev Eyelid Weight Implants are biocompatible as defined by ISO 10993-1:2009, based on review of existing data, material review, Cytotoxicity MEM Elution test, and Chemical Characterization (leachable test). |
| Sterility | Sterility Assurance Level (SAL) of 10-6 via moist heat sterilization, validated according to ANSI/AAMI/ISO 17665-1:2006. | Demonstrated that the devices could be moist heat sterilized to a Sterility Assurance Level of 10-6. Validation based on biological indicators (BI Spore Strips) in a half-cycle "overkill" method (includes installation, operational, and performance qualification). |
| Shelf-life (Packaging Integrity) | Packaging integrity maintained for 36 months, protecting sterile barrier. Tested according to ASTM D4169-05, F1886-98, F2096-04, F88-06, and microbial barrier performance (Tyvek) tested by DuPont using ASTM F1608-00(2009) and F2638-12. | Completed testing confirmed the integrity of the sterile barrier and packaging for a period of 36 months. This included real-time aging, distribution simulation, visual inspection, bubble leak testing, and seal strength testing. A seal strength test capability index study and a review of product functionality and physical damage were also conducted. Microbial barrier performance for Tyvek® was supported by DuPont™ testing up to five years. |
2. Sample Size Used for the Test Set and Data Provenance:
- MRI Safety Review: The testing was conducted on "the largest available sizes of 2.8g" for both gold and platinum Contour™ Eyelid Weight Implants. No specific number of samples (implants) is given beyond this, but it implies at least one of each (gold and platinum, 2.8g).
- Data provenance: The tests were conducted according to specific ASTM and internal SOPs. The location (e.g., country of origin) of the testing lab is not specified, but it's presumed to be a controlled laboratory environment. The data is prospective, generated specifically for this submission.
- Biocompatibility: Testing was performed on "the Gold and Platinum Contour™ and ThinProfile™ Eyelid Weight Implants." No specific number of samples is provided.
- Data provenance: Testing was conducted in accordance with ISO standards and Nelson Labs SOPs. The data is prospective.
- Sterility and Shelf-life:
- Sterilization validation: Uses biological indicators (BI Spore Strips). No specific number of BIs or device units is given.
- Shelf-life testing: While real-time aging of 36 months is mentioned, no specific number of packaged units tested is provided.
- Data provenance: Conducted according to ISO and ASTM standards. The data is prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This device is not an AI/diagnostic software. The "acceptance criteria" here refer to engineering and material performance specifications rather than diagnostic performance assessed against a ground truth established by experts.
4. Adjudication Method for the Test Set:
Not applicable. This is not a diagnostic device with an "adjudication method" in the typical sense for clinical studies. The results are objective measurements from laboratory tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a physical implant, not a diagnostic imaging or AI system.
6. Standalone Performance Study (Algorithm Only):
Not applicable. This is a physical implant, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this device's acceptance is based on:
- Standardized laboratory measurements and physical properties (e.g., MRI-induced heating, force, artifact size).
- Compliance with recognized international and national standards (e.g., ISO, ASTM, USP) for biocompatibility, sterility, and packaging.
- Expert interpretation of these test results against established safety and performance thresholds defined in the standards and regulatory guidance.
8. Sample Size for the Training Set:
Not applicable. This is a physical implant; there is no "training set" in the context of AI or machine learning.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
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