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XLase Plus is indicated for use as follows:

Diode 808/760 nm 4000W ALEX PRO Handpiece: Indicated for the treatment of hair removal with static and dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
· Treatment of Pseudofolliculitis barbae (PFB)
· Use on all skin types (Fitzpatrick I-VI).

SLP ND:YAG 1064 nm Handpiece: Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of benign pigmented and benign vascular lesions, treatment of benign pigmented lesions, such as but not limited to warts, telangiectasia, leg veins and spider veins.

Q Switch ND:YAG 1064 nm Handpiece: Indicated for removal of dark tattoos and treatment of benign pigmented lesions.

CPL Handpiece: Indicated for use Fitzpatrick skin types I – IV, as shown in the table below. Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Photocoagulation of benign vascular lesions, photo thermolysis of blood vessels, treatment of benign pigmented lesions.

ERBIUM:YAG FRACTIONAL 2940 nm Handpiece: Indicated for procedure requiring resurfacing of soft tissue with fractionated handpiece.

Diode 2800W 810nm Handpiece: Indicated for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin. Indicated for:

• the treatment of benign vascular and benign pigmented lesions,
• permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Diode 1200W 810nm Handpiece:
Indicated for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
Indicated for the treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudo folliculitis barbae.
Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Indicated for the treatment of benign pigmented lesions and leg veins.

ALEX 755nm Handpiece: Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of benign pigmented lesions. Treatment of wrinkles and the photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). On all skin types (Fitzpatrick I- VI) including tanned skin.

XLase Plus, laser for medical applications. It features two models: XLase Plus Standing (with wheels) and XLase Plus Table (tabletop).

The two medical devices are identical, contain the same electronic boards and the same critical components, use the same software and are able to perform the same aesthetic treatments. The generic components of XLase Plus Table are a subset of those of XLase Plus Standing. The difference between the two devices is that XLase Plus Standing is built on wheels while XLase Plus Table has no wheels but can be easily placed on a table due to its low weight. The device is for prescription use only.

The XLase Plus Standing and XLase Plus Table medical devices consists of:

• . System Console
• Operator control panel .
• . Touch screen monitor
• Power cable
• Accessories and components .

Based on the provided text, the device in question is the "XLase Plus," a medical laser and pulsed light platform. The document is a 510(k) premarket notification summary submitted to the FDA, indicating that it aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving novel clinical effectiveness through a new clinical study with specific acceptance criteria related to disease diagnosis or treatment efficacy per se.

Therefore, the acceptance criteria and supporting "study" (in the context of this 510(k) submission) are focused on non-clinical performance and substantial equivalence to existing devices, rather than on the direct clinical performance of an AI algorithm in a diagnostic or treatment outcome context.

Here's an breakdown based on the provided document:

Device: XLase Plus (Medical Laser and Pulsed Light Platform)

Overall Goal of the Submission: To demonstrate Substantial Equivalence (SE) to legally marketed predicate devices. This means proving that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety and effectiveness.

Acceptance Criteria and Reported Device Performance (Non-Clinical Focus):

Since this is a 510(k) for a laser/pulsed light platform, the "acceptance criteria" are not related to diagnostic accuracy (like sensitivity/specificity for an AI) but rather to the device's technical specifications and safety/performance standards compared to predicates.

• For various handpieces (Diode, SLP ND:YAG, Q Switch ND:YAG, CPL, ERBIUM:YAG, ALEX 755nm): Laser Wavelength, Fluence (J/cm2), Pulse Duration (ms/ns), Pulse Repetition Rate (Hz), Handpiece Spot Size (mm), Cooling Temperature (specific values provided for some). These parameters are compared against those of predicate/reference devices to establish substantial equivalence. |
  | Pulsed Light Wavelength Ranges | Conformance to specified operational wavelength ranges for different indications and skin types (Fitzpatrick I-IV). | The document provides two tables (Table 1: Predicate Device Wavelength Ranges; Table 2: CPL – Subject Device Wavelength Range) showing comparable wavelength ranges for hair reduction, benign vascular lesions, blood vessels, and benign pigmented lesions across different skin types. This comparative data implicitly shows the XLase Plus (Subject Device) operates within ranges acceptable for its intended uses, similar to the predicate. |

Since the submission is a 510(k) for a physical device (laser/pulsed light platform) and not an AI/ML medical device, many of the typical categories for AI software are not applicable. Here's how the other points are addressed:

2. Sample sizes used for the test set and the data provenance:
   This is not applicable in the context of this 510(k) for a physical device, as it did not involve a clinical "test set" of patient data for an AI algorithm. The "test set" here refers to the actual physical device units undergoing non-clinical testing. The document doesn't specify the number of devices tested but implies standard product testing.
   Data provenance (country of origin, retrospective/prospective) is also not applicable for this type of non-clinical device testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. Ground truth, in the AI context, refers to expert annotations or pathological confirmation. For a laser device, "ground truth" is established by manufacturing tolerances and measurement standards/equipment to ensure the device performs according to its specifications (e.g., emits the correct energy, pulse duration). This is a technical validation process, not one involving expert human interpreters for diagnoses.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable, as there is no "test set" of patient cases requiring adjudication of interpretations.

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 treatment device, not a diagnostic AI assistance tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. While the device has software, it's an embedded system controlling a hardware device. Its "performance" is assessed by its ability to deliver specified energy parameters, not by its ability to independently diagnose or interpret clinical images. The "standalone" performance is its electrical, mechanical, and software functionality in producing the desired laser/light output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the non-clinical testing of the device's performance, the "ground truth" would be engineering specifications, verified by calibrated measurement equipment and adherence to international standards (e.g., ISO, IEC). For example, a power meter would provide the "ground truth" for laser energy output, or an oscilloscope for pulse duration.

8. The sample size for the training set:
   Not applicable. There is no AI model being trained on patient data for this device. The software is a control system for the hardware.

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set for an AI model.

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