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The Family of IRIDEX® IQ Laser Systems (IQ 532 [532nm], IQ 630-670 [630nm-670mm], IQ 810 [810mm] [IRIDEX Cyclo G6 Laser System]) and the hand pieces & accessories that are used with them to deliver laser energy in either CW-pulse, MicroPulse™ mode. Intended for soft and fibrous tissue, including osseous tissue incision, excision, coagulation, vaporization, ablation and vessel hemostasis in the medical specialties of, dermatology, ear, nose and throat (ENT)/ otolaryngology, and ophthalmology as follows:

810nm (The IRIDEX Cyclo G6 Laser System)

Ophthalmology:

The IRIDEX® Cyclo G6™ Laser System and Probe Delivery Devices (G-Probe Illuminate, & MicroPulse® P3) are used to deliver laser energy in either CW-Pulse (CW) or MicroPulse (uP) treatment mode and indicated for the treatment of Glaucoma:

MicroPulse P3 Device: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment (Intended Use): Transscleral Cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: μP

G-Probe & G-Probe Illuminate: For the treatment of Glaucoma including: • Primary Open-Angle • Closed-Angle • Refractory. Treatment (Intended Use): Transscleral cyclophotocoagulation (TSCPC) of the ciliary processes. Mode: CW

The Iridex Cyclo G6 is an 810nm (diode) ophthalmic laser comprised of the following main components:

• Main console containing the major electrical components, including:
  • Control Panel including control knobs (power, interval, duration or software assigned function), treat/standby button, and display;
  • Two delivery device fiber-optic connector ports (only one active at a time);
  • LIO illumination connection;
  • Smart key port for detecting/operating safety filters and/or accessory identification;
  • Emergency stop switch;
  • Key switch;
  • Connector ports for the footswitch, remote control, and power cord;
• A treatment Footswitch (either wired, wireless, or wireless with PowerAdjust);
• A Wired Remote Control that duplicates the control panel;
• Delivery Accessories including G-Probe and MicroPulse P3 probe Handpieces, and the G-Probe Illuminate
• Optional Cart/Stand

The laser system automatically enters the "Standby" mode after it is turned on and completes its internal "selftest". Laser emission is not possible until the user attaches the proper delivery device, selects the desired treatment settings, verifies eye safety filter status, places the system into "Ready", and depresses the footswitch.

The system has a primary display screen (power, interval, duration, pulse mode, aiming beam brightness, illumination brightness, treatment/standby toggle, counter reset) and additional screens for ancillary options (system volume, display contrast/brightness, preset selection (user defined/generated), aiming beam settings).

The user may adjust power, treatment duration, treatment interval, type of laser output mode (CW-pulse, MicroPulse), aiming beam brightness, illumination brightness, and reset the laser shot counter. Additionally, for some delivery devices the user may optionally select the on/off operation of the countdown timer on the display screen as well as the on/off function of the voice countdown.

The G-Probe Illuminate that is the subject of this 510(k) is a handheld fiber optic delivery device. It is intended to be used to perform transscleral cyclophotocoagulation of the ciliary processes. It is differentiated from the G-Probe described in earlier submissions by the incorporation of two additional optical fibers to provide white light transillumination of the optic globe. Such transillumination can aid probe placement by revealing the location of internal ocular structures such as the ciliary processes. The incorporation of this transillumination function into a multifunction probe offers the user similar functionality as a separate handheld transilluminator, with a more convenient setup that requires fewer hands or assistants to operate. It is provided as a sterile, single-use device.

The provided document is a 510(k) Premarket Notification for the Iridex Cyclo G6 Laser System and G-Probe Illuminate. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the manner one might find for a novel AI/software medical device.

Therefore, the typical acceptance criteria and study design for "device performance" in terms of accuracy, sensitivity, or specificity against a ground truth (e.g., for an AI diagnostic algorithm) are not applicable or present in this document. Instead, the document discusses the equivalence of the proposed device to a legally marketed predicate device based on technical characteristics and safety testing.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

As this is a 510(k) demonstrating substantial equivalence for a physical laser system and its probe (with an added illumination feature), there are no "acceptance criteria" presented in the measurable performance metrics typical for an AI/diagnostic software. Instead, the "performance" is demonstrated through successful completion of various engineering, sterility, and biocompatibility tests, and the "acceptance criterion" is essentially demonstrating that the modified device (Iridex Cyclo G6 Laser System with G-Probe Illuminate) performs safely and effectively at least as well as the predicate device.

The study that "proves" the device meets acceptance criteria is the sum of the conformance to various standards and the comparison of technological characteristics to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a clinical performance study with a "test set" in the context of diagnostic performance (e.g., images for an AI algorithm). The "testing" involved engineering and safety validation of the physical device and its components, not an evaluation of diagnostic accuracy using a dataset. Therefore, terms like "sample size for test set" or "data provenance" (country/retrospective/prospective) are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. As noted above, there is no diagnostic "test set" requiring expert-established ground truth. The assessments are against engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for the same reasons as above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a laser surgical instrument, not an AI-assisted diagnostic tool for human readers. "Clinical trial data was not required for this product change" as stated in Section VI. Performance Testing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" equivalent in this context would be the established international and national standards for medical device safety, sterility, biocompatibility, and illumination (e.g., ISO 11135, ISO 10993 series, ISO 15004-2, ASTM F1980, etc.). The device's performance was compared against the requirements stipulated by these standards and against the technical specifications of its predicate device, rather than against clinical outcomes data or expert consensus on patient cases.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable for the same reasons as above.

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