(225 days)
VISULAS yag is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye, including Posterior capsulotomy, Iridotomy and Posterior Membranectomy.
This device is for Prescription Use (Rx) only.
VISULAS yag uses a Q-switched, flashlamp-pumped solid-state laser for photodisruption treatments of diseases of the eye, including posterior capsulotomy, iridotomy and membranectomy. Laser radiation is generated by means of a neodymium-doped yttrium aluminum garnet (Nd:YAG) gain medium inside the laser source. The emitted laser radiation with a near-infrared wavelength of = 1064 nm has a pulse duration of
I am sorry, but the provided text is a 510(k) summary for a medical device (VISULAS yag), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study design with acceptance criteria and device performance results as requested.
The document does not contain:
- A table of acceptance criteria and reported device performance for a specific study.
- Information on sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for a clinical study.
- Details regarding training set size or how ground truth was established for a training set.
Instead, the document primarily compares the subject device's indications for use and technical characteristics to two predicate devices (Ellex YAG Laser K212630 and VISULAS YAG III K042139) to establish substantial equivalence. It mentions "Non-Clinical Performance Testing" and "functional and system level testing showed that the system met the defined specifications," and "Software verification and validation testing were conducted... All testing passed," but these are general statements and do not provide the detailed study information you've asked for.
Therefore, I cannot fulfill your request based on the provided text.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.