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The Alma Veil laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

1064 nm:
Dermatology:

The Alma Veil is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, spider veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques.

Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

The Alma Veil is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.

The Alma Veil is indicated for temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.

The Alma Veil is also indicated for the treatment for pseudofolliculitis barbae.

The Alma Veil is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The Alma Veil is also indicated for treatment of mild to moderate inflammatory acne vulgaris.

The intended use of the cooling system in the Alma Veil handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as hair removal and vascular lesions; and to reduce the potential side effects of laser treatments.

532 nm:

For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).

The Alma Veil is a Nd:YAG laser operating at wavelengths of 1,064 nm and 532 nm. The Alma Veil consists of the main body, optical fiber cable, user-undetachable laser handpiece, handpiece tip, footswitch, and handpiece cable cradle. The laser output is delivered through the optical fiber terminated by the handpiece. The fluence (energy density), frequency and pulse are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

For treatment, the user can select the appropriate fluence value. The energy is changed automatically in accordance with the selected fluence value and selected spot size. The user can change the fluence value by pressing (up) and/or (down) button.

The selectable fluence values are 2 to 300 J/cm² at 1064 nm and 1.8 to 42 J/cm² at 532 nm.

Let's break down the acceptance criteria and study information for the Alma Veil Laser System based on the provided FDA 510(k) clearance letter.

It's important to note that this document is an FDA 510(k) Clearance Letter and a 510(k) Summary. 510(k) submissions typically rely on demonstrating substantial equivalence to a previously cleared predicate device, rather than requiring extensive de novo clinical trials to prove safety and effectiveness from scratch. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical and, if applicable, clinical data demonstrating that the new device performs as intended and is as safe and effective as the predicate device.

From the provided text, the Alma Veil is a laser system, not an AI/Software as a Medical Device (SaMD) that typically involves complex AI model validation studies with expert ground truth and MRMC studies. The "acceptance criteria" here relate to the device's physical and functional specifications and its safety and performance standards.

Here's the information extracted and organized:

Acceptance Criteria and Device Performance for Alma Veil Laser System

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a laser system and not an AI/imaging device, the "acceptance criteria" are primarily related to meeting recognized performance and safety standards, and demonstrating physical and functional equivalence to the predicate device. The performance is reported by stating compliance with these standards and matching the predicate's parameters.

2. Sample Sizes Used for the Test Set and Data Provenance

For this laser device, the "test set" primarily refers to the physical device itself undergoing testing against established engineering and safety standards.

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of patient data. For device testing against standards, it implies testing of the device (or a representative sample during manufacture) to ensure it performs according to specifications.
• Data Provenance: The document does not refer to patient data or clinical data provenance in this section. The testing is non-clinical, proving device compliance with standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable in the context of device performance testing against engineering standards. Experts might be involved in the creation and interpretation of the standards themselves (e.g., IEC, ANSI AAMI committees), but not for adjudicating "ground truth" on test data in the way one would for diagnostic imaging.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Device performance is measured against quantifiable engineering specifications and safety requirements defined by the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No. MRMC studies are typically for diagnostic devices or AI algorithms where human interpretation of medical images or data is involved. This is a therapeutic laser device, not a diagnostic one or an AI-assisted interpretation tool. The 510(k) pathway for this device type does not typically require an MRMC study.
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed or required.

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

• Standalone Performance: Not applicable. This is a physical laser device, not an algorithm, and its operation is always human-in-the-loop. The safety and performance are evaluated based on the device's technical specifications and adherence to safety standards.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the Alma Veil laser system is its conformity to established international and national performance and safety standards (e.g., IEC 60601 series, IEC 60825-1). These standards define the "truth" for safe and effective operation of medical laser devices. For biocompatibility, the ground truth is established through adherence to ISO 10993-1.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a hardware laser device, not an AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device.

In summary, the provided document highlights that the Alma Veil Laser System received 510(k) clearance by demonstrating substantial equivalence to a predicate device (V-Laser). The "acceptance criteria" are met by detailed non-clinical testing confirming the device conforms to relevant electrical, electromagnetic, usability, and laser-specific safety and performance standards. No clinical studies, MRMC studies, or AI algorithm performance evaluations were deemed necessary for this type of device under the 510(k) pathway, as the changes from the predicate device were primarily aesthetic/marketing-driven and did not alter fundamental safety or efficacy.

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