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The Finebeam Dual is a surgical laser instrument intended to provide laser energy in two different operation modes (Qswitched (QSW) and long pulse (LPS)) with 1064nm or 532 nm wavelength per use in a variety of dermatological procedures. Each function is intended for:

• 1. QSW mode with 1064nm single or 1064nm photoacoustic double pulse (PDP) function

• Removal dark ink (black, blue, and brown) tattoos;

• Treatment melasma, treatment nevus of Ota;

• Treatment common nevi;

• Removal of lightening of unwanted hair; and

• Skin resurfacing procedures for the treatment of acne scars and wrinkles

• 2. QSW mode with 532nm single function

• Removal of light ink (red, tan, purple, and orange) tattoos;

• Treatment of vascular lesions including, but not limited to port-wine stains, spider angioma, cherry angioma;

• Treatment of pigmented lesions including, but not limited to cafe-au-Lait birthmarks, solar lentigines, Becker's nevi, freckles, common nevi, and nevus spilus;

• Treatment of seborrheic keratosis:

• Treatment of post-inflammatory hyperpigmentation; and

• Skin resurfacing procedures for the treatment of acne scars and wrinkles in the QSW mode function; 3) QSW mode with 1064nm Non-Q function

• Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of Pseudofolliculitis Barbae (PFB). The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin;

• Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, Coagulation and hemostasis of soft tissue; and

• Treatment of wrinkles

4. LPS mode

• Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin;

• Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins;

• Coagulation and hemostasis of soft tissue:

• Treatment of wrinkles and acne vulgaris

The Finebeam Dual is designed to use neodymium-doped yttrium aluminum garnet (Nd:YAG) to transform and generate high voltage sources for the optical resonator, and the atoms in the source are activated to amplify and emit laser light.

The provided text is a 510(k) summary for the SNJ Co., Ltd. Finebeam Dual laser system. This document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a study with specific acceptance criteria and performance data for the Finebeam Dual itself.

Therefore, the document does not contain the acceptance criteria and a study that proves the device meets those criteria in the traditional sense of a clinical or analytical performance study.

Instead, the submission argues that the Finebeam Dual is substantially equivalent to previously cleared devices (predicates) because it shares similar technological characteristics and has comparable intended uses. The "performance" discussed primarily refers to its compliance with international safety and electrical standards, and a comparison of its technical specifications with those of the predicate devices.

Here's an breakdown based on the information available in the document, and what is missing:

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

   • Acceptance Criteria: Not explicitly stated as pass/fail criteria for a specific device performance study. The "acceptance" is implicitly related to demonstrating substantial equivalence to predicate devices, meaning its technical specifications and intended uses are similar enough not to raise new questions of safety or effectiveness.
   • Reported Device Performance: Instead of a performance study with specific metrics, the document provides a table comparing the Finebeam Dual's technical characteristics (wavelength, pulse frequency, pulse duration, energy, spot size, aiming laser, beam delivery, user interface) with those of its predicate devices in sections 9.1 through 9.5 and 14. For instance, in Q-switched mode, it lists:
     • Wavelength: 532nm and 1064nm (Same as predicates)
     • Pulse frequency: 1-10 Hz (Same as predicates)
     • Pulse duration: 1064nm Q-switched mode: < 25ns, 532nm Q-switched mode: < 25ns, PDP mode: < 25ns, non-Q switched mode: 0.3ms. (Compared to predicates' ranges like 5-20ns for Q-switched, 0.25ms for non-Q)
     • Energy (max): 1600mJ at 1064nm, 500mJ at 532nm, 2200mJ at PTP, 3500mJ at Non-Q. (Compared to predicates' values like 1600mJ at 1064nm, 600mJ at 532nm, 5000mJ at Non-Q for Fotona QX; 1300mJ at 1064nm, 500mJ at 532nm, 1600mJ at PTP, 3500mJ at Non-Q for Pastelle)
     • Similar comparisons are provided for the Long Pulse mode.

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

   • Not Applicable. The document describes a 510(k) submission based on comparison to predicate devices and non-clinical bench testing for safety standards. It does not mention a "test set" in the context of clinical performance data for the Finebeam Dual device for its indicated uses. The non-clinical tests were conducted to verify compliance with safety standards (IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) (page 7). The results demonstrated compliance, but do not involve patient data or specific sample sizes.

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 there's no clinical performance test set, there are no experts establishing ground truth for such a set within this document.

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

   • Not Applicable. No clinical test set is described.

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 device is a laser system, not an AI-powered diagnostic imaging device that involves human readers.

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

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

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

   • Not Applicable. No clinical ground truth data for this device's performance study is presented. The "ground truth" for the 510(k) submission is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

   • Not Applicable. This document is for a medical device (laser system), not an AI algorithm requiring a training set.

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

   • Not Applicable. There is no training set for an AI algorithm.

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