(244 days)
This indication for use for the 'Lid Chain Eyelid Weight Implant' is for the "Restoration of dynamic lid closure in paralytic lagophthalmos due to facial nerve paralysis"
Lid Chain Eyelid Weight Implant
The provided document is a 510(k) clearance letter from the FDA for a medical device called "Lid Chain Eyelid Weight Implant." This type of document establishes substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical studies to prove effectiveness and safety with specific acceptance criteria in the same way a PMA (Premarket Approval) would.
Therefore, the document does not contain the information requested regarding acceptance criteria, device performance from a specific study, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.
The 510(k) pathway primarily focuses on demonstrating that a new device is as safe and effective as an already legally marketed device (the predicate device). This often involves:
- Comparison to a predicate device: Showing that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, demonstrating that those differences do not raise new questions of safety or effectiveness.
- Performance data (often non-clinical): This might include bench testing, material characterization, and sometimes small clinical usability studies or animal studies, to support the substantial equivalence claim. However, it's not the same as a large-scale, controlled clinical trial to prove efficacy against pre-defined acceptance criteria.
In summary, based on the provided document, I cannot fulfill your request for the following reasons:
- Acceptance Criteria and Reported Device Performance: This document does not specify acceptance criteria or report performance data from a study for the "Lid Chain Eyelid Weight Implant." It's a clearance letter based on substantial equivalence.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): This information is not present as the device approval pathway (510(k)) does not typically require the detailed clinical study structure implied by these questions.
- Ground Truth Type and Training Set Details: There is no mention of an algorithm or AI model, thus no training set or ground truth establishment for such a model. The device is a physical implant.
§ 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.