(86 days)
CAPSULO is indicated for photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy.
The Yttrium Aluminum Garnet (YAG) ophthalmic laser system produces short pulses of focused infrared light at a wavelength of 1.064 nm. These pulses can be precisely positioned using a slit lamp microscope and a dual-point aiming system. The energy contained in a short pulse is concentrated by focusing a very small spot (10 um) so that the formation of plasma is at the focal point. The firing causes an acoustic wave that radiates from the focal point and breaks the near tissue which is known as disruptive photo-effect. Once formed, plasma absorbs and further diffuses incident light, protecting deeper structures. Furthermore, the divergence of the beam after the focal point protects the retina from damage that could otherwise occur by the absorption of concentrated energy in the Nd: YAG treatment beam. As the treatment energy is increased, the size of the plasma formed also increases, until a larger and stronger acoustic wave is produced. For increased energy, it is necessary to focus the treatment beam further behind the ocular structure being treated. The Nd: YAG 1064 nm laser operates at a nano-second pulse rate and the laser energy is delivered to the treatment site using the integrated slit lamp.
The provided text is a 510(k) summary for the Quantel Medical CAPSULO device, which is an ophthalmic laser. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria for an AI/ML-driven device.
Therefore, the information required to answer the prompt regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, and training set information for an AI/ML device is not present in the provided document.
The document discusses the following:
- Device Type: Nd: YAG ophthalmic laser (not an AI/ML device).
- Purpose: Photodisruption of ocular tissue (posterior capsulotomy, pupillary membranectomy, iridotomy).
- Equivalence: The submission claims substantial equivalence to a predicate laser device (Quantel Medical Optimis Fusion).
- Performance Data: States non-clinical testing was performed to verify design specifications and substantial equivalence, and lists the standards adhered to (electrical safety, EMC, usability, laser safety, biocompatibility). It also mentions software verification and validation activities for a "Major level of concern," but this refers to the software controlling the laser, not a diagnostic AI algorithm.
In summary, there is no information in the provided text about acceptance criteria for an AI/ML device's performance, nor any study details that would typically be conducted for verifying an AI/ML model's diagnostic accuracy or effectiveness.
§ 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.