(77 days)
The SURGISIS Ocular Graft is intended for implantation to reinforce and support the reconstruction of the soft tissue of the eyelid.
The SURGISIS Ocular Graft is intended for implantation to reinforce and aid reconstruction of the eyelid and is labeled for single use.
The SURGISIS Ocular Graft is derived from porcine small intestinal submucosa (SIS). The material is prepared into sheets of various sizes and thicknesses appropriate for the reconstruction and repair of soft tissues. The device is supplied sterile in a dry lyophilized state sealed in a double peel pouch system
The provided text describes the SURGISIS Ocular Graft, an ophthalmic implant made from processed porcine small intestinal submucosa. It details the device's description, indications for use, and a summary that it is identical in material composition to predicate Surgisis devices and has undergone extensive biocompatibility, viral inactivation, and mechanical testing. The text states that these outcomes demonstrate safety and efficacy for soft tissue reconstruction and repair.
However, the provided text does not contain the specific information requested about acceptance criteria and the study that proves the device meets those criteria. The information regarding acceptance criteria, reported performance, sample sizes for test sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, and how training set ground truth was established is not present in the provided document.
The document focuses on establishing substantial equivalence to predicate devices, listing the predicate devices and their characteristics, rather than detailing the specifics of a study evaluating the performance against predefined acceptance criteria for the SURGISIS Ocular Graft itself in the manner requested. The "Summary of Testing" section is very high-level and does not provide quantitative results or detailed study methodology.
§ 886.3130 Ophthalmic conformer.
(a)
Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ](b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.