(61 days)
The Kasha Visual Field System should be used to test the visual field of the human eye.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter for the "Kasha Visual Field System" from the FDA, dated May 28, 1997.
This letter primarily states that the device has been found substantially equivalent to a predicate device and can, therefore, be marketed. It does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, or study design.
- Information on expert ground truth establishment, adjudication methods, or MRMC studies.
- Details about standalone algorithm performance.
- The type of ground truth used.
- Sample size or ground truth establishment for the training set.
The document focuses on the regulatory clearance based on substantial equivalence, rather than providing the performance study details for the device.
§ 886.1605 Perimeter.
(a)
Identification. A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.(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 § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.