(27 days)
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.
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Indications for Use: Same as predicate devices | Same |
| Target Population: Same as predicate devices | Same |
| Design: Same as predicate devices | Same (rectangular shape, spherical radius, tapered, smooth edges, suture holes) |
| Materials: Same as predicate devices | Same (99.99% pure gold) |
| Performance: Same as predicate devices | Same |
| Sterility: Must be sterile | Sterile (validated steam sterilization, SAL 1 x 10-6) |
| Biocompatibility: Same as predicate devices | Same |
| Mechanical Safety: Same as predicate devices | Same |
| Anatomical Site: Same as predicate devices | Same |
| Human Factors: Same as predicate devices | Same |
| Where Used: Same as predicate devices | Same |
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.
§ 886.5700 Eyelid weight.
(a)
Identification. An eyelid weight is a prescription device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye. The device is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure).(1) The external eyelid weight is adhered to the outer skin of the upper eyelid.
(2) The implantable eyelid weight is implanted into the upper eyelid.
(b)
Classification. (1) Class II (special controls) for the external eyelid weight. The external eyelid weight is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. The special controls for the external eyelid weight are:(i) Testing demonstrating the biocompatibility of the device; and
(ii) Labeling must include the following information:
(A) Specific instructions regarding the proper placement, sizing, and removal of the device; and
(B) A warning stating that the patient should be instructed to remove the device prior to entering a magnetic resonance environment.
(2) Class II (special controls) for the implantable eyelid weight. The special controls for the implantable eyelid weight are:
(i) Testing demonstrating the biocompatibility of the device;
(ii) Testing demonstrating the sterility and shelf life of the device;
(iii) Nonclinical testing evaluating the compatibility of the device in a magnetic resonance environment.
(iv) Patient labeling to convey information regarding the safety and compatibility of the device in a magnetic resonance environment, the conditions under which a patient with the device can be safely scanned, and a mechanism for a healthcare provider to obtain detailed information about magnetic resonance safety and compatibility if needed.