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IRIS Pi Q switched Nd YAG laser system is indicated for the Incision, Excision, Ablation Vaporization of soft tissues for general dermatologic and general surgery procedures for Coagulation and Hemostasis

532nm wavelength

Tattoo removal light ink (red, tan, purple, orange, sky blue) Removal of benign epidermal pigmented lesions, Minor benign vascular lesions, Talangietasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi, Freckles. Treatment of Post inflammatory Hyperpigmentation ( PIH)

1064nm wavelength

Tattoo removal dark ink (black, blue, green) Removal of Nevus of Ota, Removal or lightening of unwanted hair, Treatment of Common Nevi, Melasma Skin resurfacing procedures for treatment of Acne Scars, Wrinkle

The IRIS Pi O-Switched Nd:YAG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and using two non-fractional handpieces (Zoom handpiece and 7mm collimated handpiece) is able to control various treatment fluence.

laser tube : placed in the mixed crystals of copper pipe to the heater and produces a laser beam, Resonator : amplifies the beam, through the Xe-gas contained lamp : Xe-gas contains high pressure lamp to increase specific laser beam lamp

This converted light energy creates the Nd: Y AG crystal and exhaust from the crystal is amplified into a specific wave length. Laser energy produced is delivered to the tissue by means of an articulated arm and a specially designed adjustable spot size Hand Piece.

The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.

This system also consist of

Optic main Bench assembly, Articulated Arm Hand pieces, LCD control panel, Cooling system, Foot Pedal Switch

This document is a 510(k) summary for the IRIS Pi Q-switched Nd:YAG laser, comparing it to a predicate device (K171648 BM.IRIS Nd:YAG). It does not describe acceptance criteria or a study proving the device meets said criteria in the way typically expected for an AI/CADe device. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through technical specifications and adherence to general safety and performance standards for laser medical devices.

Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to this type of submission, as it's not for a diagnostic AI/CADe device.

Here's an analysis based on the provided text, addressing the applicable points and explicitly stating when information is not present:

Summary of Acceptance Criteria and Device Performance (Not Applicable - Device is a laser, not AI/CADe)

This submission does not provide acceptance criteria in the typical sense for an AI/CADe or diagnostic device, nor does it report specific device performance metrics against such criteria. The device is a laser system, and its "performance" is assessed by comparing its technical specifications to those of a predicate device and by demonstrating adherence to international safety standards for laser products.

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

As this is a laser surgical instrument, the "acceptance criteria" are primarily related to safety and efficacy as demonstrated through substantial equivalence to a predicate device and compliance with relevant international standards. There are no specific performance metrics like sensitivity, specificity, or AUC mentioned in the context of diagnostic decision-making that would be typically found for an AI/CADe device.

Here's a table based on the comparison to the predicate device, highlighting differences that were reviewed for safety and effectiveness:

Conclusion stated in the document: The differences in Maximum Pulse Energy and Repetition Rate "are not expected to significantly alter the safety and effectiveness of the subject device compared to the predicate device" because "the maximum repetition rate for the subject device is lower than that of the predicate device, the energy delivered by the subject device is lower than or comparable to the predicate device."

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

• Not Applicable. This submission is for a laser surgical instrument, not an AI/CADe device that relies on a "test set" of medical images or patient data to evaluate algorithmic performance. The evaluation is based on technical specifications and adherence to performance standards.
• The document states: "Clinical data is not required in this submission".

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 no clinical data or "test set" was used to evaluate a diagnostic or AI algorithm, there was no need for experts to establish ground truth in this context.

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

• Not Applicable. No test set or human adjudication was performed for this laser device submission.

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 not an AI/CADe device, and therefore no MRMC study or evaluation of human reader improvement with AI assistance was performed or is relevant.

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

• Not Applicable. This is a physical laser device, not an algorithm.

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

• Not Applicable. As no diagnostic claims or AI/CADe functionality are involved, "ground truth" in the traditional sense of medical image analysis is not established for this device. The 'truth' in this context is adherence to fundamental engineering and safety standards for laser devices.

8. The sample size for the training set

• Not Applicable. This is a hardware device, not an AI model, and therefore does not have a "training set."

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

• Not Applicable. No training set was used.

Performance Tests Conducted (from section 8 of the 510(k) Summary):

The device's performance and safety were demonstrated by compliance with the following mandatory and voluntary standards:

• AAMI/ANSI ES60601-1:2005® 2012 And A1:2012: General requirement for basic safety and essential performance.
• IEC60601-1-2: 2014: Electro Magnetic Compatibility test.
• IEC60601-2-22: Part 2, Particular requirements for safety of diagnostic and Therapeutic laser.
• IEC60825-1: 2nd ED: Equipment classification and requirement.
• IEC60601-2 Part 6: General requirements for safety - Collateral Standard: Usability.
• Software Verification and Validation test: Conducted and documentation provided as recommended by FDA guidance and IEC62304. Results found acceptable for software release.
• Biocompatibility: The device uses non-contact mode, and the handpiece tips are made of SS.304, same as the predicate device.

These tests serve as the "study" proving the device's acceptable performance in terms of safety and adherence to recognized standards for laser medical devices, supporting its substantial equivalence claim.

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