(89 days)
The OrthoPlan System is indicated for the planning of orthopaedic surgeries on a personal computer. The software is intended to read in digitized x-rays and orthopaedic implants, provide a constructed image of this data, and to use this information in conjunction with the provide a constructed images to aid surges to aid surgeons in their planning of orthopaedic surgeries.
Not Found
I am sorry, but the provided text from the FDA 510(k) letters for OrthoPlan does not contain any information about acceptance criteria, study details, or performance metrics of the device.
The letters primarily address a substantial equivalence determination and an administrative correction. They state that the device is a "Template for clinical use" (product code HWT) and describe its indications for use as:
"The OrthoPlan System is indicated for the planning of orthopaedic surgeries on a personal computer. The software is intended to read in digitized x-rays and orthopaedic implants, provide a constructed image of this data, and to use this information in conjunction with the provide a constructed images to aid surges to aid surgeons in their planning of orthopaedic surgeries."
Since the document does not contain the requested information about acceptance criteria and study data, I cannot fulfill your request to describe them.
§ 888.4800 Template for clinical use.
(a)
Identification. A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.