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OPTIMIS FUSION YAG: photodisruption of ocular tissue using light energy emitted by a Nd: YAG Laser, including discission of posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy.
OPTIMIS FUSION SLT: Selective Laser Trabeculoplasty
OPTIMIS FUSION YAG/SLT: photodisruption of ocular tissue using light energy emitted by a Nd: YAG Laser, including discission of posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy; and Selective Laser Trabeculoplasty

The QUANTEL MEDICAL OPTIMIS FUSION is an ophthalmic surgical laser designed for performing photodisruption of ocular tissue using laser energy emitted by a Nd:YAG laser including discission of the posterior capsule of the eye (posterior capsulotomy), discission of the pupillary membranes (pupillary membranectomy), and iridotomy/iridectomy; and selective laser Trabeculoplasty.

The Family of OPTIMIS FUSION Ophthalmic Lasers. Delivery Device and Accessories consists of the following models:

1. OPTIMIS FUSION YAG a Nd: YAG Laser providing-switched laser pulses at a wavelength of 1064 nm for use in photodisruption of ocular tissue (posterior capsulotomy, pupillary membranectomy, iridotomy/iridectomy). The 1064 treatment beam delivers 4 ns, 0.3 -10mJ adjustable and selectable single, double or triple pulse of energy. It is conditioned trough beam shaping optics to generate a photodisruption micro pulse of plasma at a precision adjustable location relative to the visual focal plane (located at slit lamp center of rotation) and along the slit lamp objective lens axis. A twin aiming beam is also focused by the slit lamp objective to a converging 10 um spot located at the focal point of the lens. The focal point of photodisruption is adjustable 150um in the posterior direction and -150um in the anterior direction by the physician relative to this convergence of the twin aiming beams.
2. OPTIMIS FUSION SLT a Nd: YAG Laser providing Q-switched frequency doubled pulses at a wavelength of 532 nm for use in Selective Laser Trabeculoplasty. The treatment beams delivers a 4 nsec. 0.3-2mJ adjustable single pulse of energy. The aiming and treatment beams are coaxial with each other and focussed by the slit lamp objective to a 400um spot at the focal point of the lens.
3. OPTIMIS FUSION YAG/SLT a Nd: YAG Laser providing Q-switched laser pulses at a wavelength of 1064 nanometers for use in photodisruption or O-switched frequency doubled pulses at a wavelength of 532 nm for use in Selective Laser Trabeculoplasty. depending upon the mode selected. The OPTIMIS FUSION YAG/SLT contains two aiming beam modules that produce a single beam for the 532nm mode and a dual beam for the 1064nm mode, respectively.

For each OPTIMIS FUSION model, the physician controls delivery of laser energy from the OPTIMIS FUSION control display unit and activates the treatment laser beam with a footswitch or joystick pushbutton. In addition, a laser slit lamp adaptor may be coupled to each of the above OPTIMIS FUSION models and connected to a currently cleared QUANTEL MEDICAL 532nm photocoagulator (VITRA (K04236), SUPRA (K07776), VITRA MULTISPOT (K122251)) to allow to the physician to use the Slit Lamp Adaptor to deliver 532 nm continuous wave laser energy for retinal photocoagulation.

The OPTIMIS FUSION produces short, individual pulses of focused laser light with wavelengths of either 1064 nm or 532 nm. depending on the selected operational mode. Using a slit lamp microscope and aiming beam, the pulsed light is accurately targeted on a structure within the patient's eye.

When the photodisruptor mode is selected, the treatment wavelength is 1064nm. A twinaiming beam targets the area of tissue disruption. The energy contained within a single short pulse is concentrated by focusing to a very small spot size so that plasma formation occurs at the focal point. This creates an acoustic wave which disrupts nearby tissue.

When the SLT mode is selected, the treatment wavelength is 532nm. A coaxial aiming beam targets the trabecular meshwork via a contact lens. The SLT treatment laser provides a low energy, short pulse of laser light that produces a thermal effect in pigmented cells in the trabecular meshwork.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Quantel Medical OPTIMIS FUSION Ophthalmic Laser Systems:

Disclaimer: This 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving novel clinical efficacy or accuracy against a defined ground truth in a clinical study. Therefore, many of the typical elements sought for evaluating AI/diagnostic device performance will not be explicitly present.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not delineate specific, quantifiable "acceptance criteria" in the format of a diagnostic performance study (e.g., sensitivity, specificity, AUC thresholds). Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices. This means the device is deemed acceptable if its technological characteristics and intended use are similar enough to previously cleared devices that it raises no new questions of safety or effectiveness.

The "device performance" reported is also in terms of technological characteristics and similarity to predicate devices, rather than clinical outcome or diagnostic accuracy metrics.

• Wavelength: 532 nm (Same as Selecta SLT, Solutis)
• Pulse Mode: Single pulse (Same as Selecta SLT, Solutis)
• Energy Range: 0.3-2.0 mJ (Same as Selecta SLT; Solutis is 0.2-2.0 mJ - considered minor difference)
• Spot Size in Air: 400 microns (Same as Selecta SLT, Solutis)
• Focus Angle:

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