(112 days)
The OphthaVision Imaging System is intended to be used to capture, archive and manipulate digital images of the eye obtained through the use of an ophthalmic camera.
The OphthaVision Imaging System consists of: (1) a digital camera; (2) an imaging board: (3) a personal computer; (4) a monitor; and (5) MRP Group Inc.'s Microsoft Windows based image processing software. The OphthaVision Imaging System is used in ophthalmic procedures such as digital angiography during which the patient's retina is viewed through a slit lamp or a fundus camera. Images are transferred to the OphthaVision Imaging System's imaging board, located in the OphthaVision Imaging System's personal computer and stored in the computer's Random Access Memory (RAM) and hard drive. As the images accumulate, the user downloads the images from the hard drive onto the computer's Jaz drive, a removable media drive, by using the computer keyboard and mouse to manipulate the software interface.
This 510(k) submission (K980295) for the OphthaVision Imaging System, an ophthalmic camera with a digital imaging system, does not contain a study that establishes performance criteria and demonstrates the device meets those criteria.
Instead, this submission focuses on establishing substantial equivalence to predicate devices based on intended use and technological characteristics. The "Performance Characteristics" section describes the components and functions of the OphthaVision Imaging System but does not present data from a formal study with acceptance criteria.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving their fulfillment. The provided text primarily addresses:
- Intended Use: To capture, archive, and manipulate digital images of the eye obtained through the use of an ophthalmic camera.
- Technological Characteristics Comparison: The device uses a Kodak MegaPlus digital camera, a 1-gigabyte Jaz drive, stores files in TIFF format, operates on Pentium-chip personal computers with Microsoft Windows-based software, and has similar storage capabilities and monitors to predicate devices.
- Software Functions: Similar to predicate devices, providing image acquisition, analysis, storage, and retrieval. Specific functions include printing, extracting/deleting, saving, auto-aligning, image comparison, animation, and stereo imaging, along with image manipulation (magnify, reduce, invert, flip, rotate, brightness, sharpness, contrast, shadow, edge trace, blur).
- Verification and Validation: The document states that "MRP Group, Inc. has performed the software verification and validation. The verification and validation results demonstrate that the device meets the system and software specifications and requirements." However, the details of these verification and validation activities, including specific acceptance criteria or study results, are not included in the provided text.
Without a performance study in the provided text, I cannot populate the table or answer the specific questions related to a study's methodology (sample size, ground truth, experts, adjudication, MRMC, standalone performance, training set).
§ 886.1120 Ophthalmic camera.
(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.