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The Eye Prime is intended for ophthalmic imaging when the following conditions are present or suspected:
•Cataracts
•Retinal Detachment (separation of the retina from the middle coat of the eyeball)
•Orbital Lesions
•Tumors
•Foreign Bodies
•Inflammation
•Vascular Irregularities

The Eye Prime is a new, diagnostic ophthalmic ultrasound Track 1 device. Its function is to perform B-mode ultrasound scans. The system consists of 1) A console which supports 12 and 18MHz Posterior B scan probes and Anterior B- Scan. Ultrasound Bio-microscopy (UBM) probes with either 35 or 50MHz transducers. 2) A laptop which performs the image processing requirements of the system; provides the user interface for operating the device and viewing the resultant images. The laptop also provides data storage, export, archiving and networking for the device and includes the connection for footswitch.

The provided text describes the Eye Prime device, which is an ophthalmic ultrasound system. However, the document provided does not contain information about acceptance criteria, device performance metrics, sample sizes, expert adjudication, or clinical study results (MRMC or standalone) for the Eye Prime device itself.

The document primarily focuses on establishing "substantial equivalence" of the Eye Prime device to a predicate device (Eye Cubed Version 4) based on similar indications for use, technological characteristics, and safety testing. It explicitly states in Section IX: "Since the Eye Prime device uses the same technology and principles as the predicate device, clinical data is not required." This implies that no specific clinical study was conducted for the Eye Prime to prove its performance against acceptance criteria in the way a new, non-substantially equivalent device might.

Therefore, I cannot fulfill all parts of your request with the provided information. I can, however, extract details about the acceptance criteria assumed by demonstrating substantial equivalence, and other relevant information present in the document.

Here's a breakdown of what can and cannot be provided based on the input:

Acceptance Criteria and Device Performance

Since no specific performance metrics or acceptance criteria for the Eye Prime device itself are reported, we can infer that the acceptance criteria for this 510(k) submission were likely focused on demonstrating equivalence in safety and general performance characteristics to the predicate device, rather than specific diagnostic accuracy metrics.

Table of Performance (Based on "Substantial Equivalence" claim):

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