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Oculostat is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized.

The Oculostat by Laser Center Development Corporation consists of a scleral vacuum suction ring attached to a medical quality plastic ophihalmic speculum. After retracting the eyelids and inserting the lid margins into the speculum portion of the Oculostat, the suction-vacuum ring is attached to the sclera by sequentially contering, depressing, and enguing low vacuum (30mm Hg or less) by pump or spring-loaded syringe. The frictional forces between the eyelids and speculum, together with the vacuum ring, hold the eye steady despite extraocular muscle activity.

The provided text is a 510(k) summary for the Oculostat, an ophthalmic speculum. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for assessing device performance.

This type of submission (510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data with performance metrics against acceptance criteria. For devices like the Oculostat (Class I ophthalmic speculum), a detailed clinical study with performance endpoints and defined acceptance criteria is typically not required for 510(k) clearance.

Therefore, I cannot populate the requested table or provide information on the study details because the provided document does not contain this information.

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