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The subject F65 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:

The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for:

• o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles)
• o Cutaneous lesions, including warts, scars and striae
• o Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
• o Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
• o Mild to moderate inflammatory Acne (Acne vulgaris)

The Nd: YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd: YAG) is indicated for:

• o The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg
• o The removal of unwanted hair and to effect table long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
• o The non-ablative treatment of facial wrinkles

The F65 module and handpiece, with wavelength of 1565 nm, are indicated for:

• o Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue
• o Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV who are seeking treatment for hair loss.

The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for:
o Removal of dark tattoos
o Treatment of pigmented lesions

*Note
Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.

The Lumenis Be F65 Laser System is intended to be used for the new indication for Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV seeking treatment for hair loss, as well as, for the identical set of functions as the predicate device. The description here is limited to the system module required to support the new indication which is the subject of this 510(k):

• The laser console includes a power supply unit, a Laser module (+ aiming beam), a control unit and a PC module. The laser beam is transferred to the handpiece via fiber optics.
• . The handpiece includes a scanner module – built of two mirrors that are controlled by two motors directing the Laser beam to desired target tissue.
• . The handpiece uses a tip (user may choose from two types) to align the Laser beam focus with the target tissue, enabling a treatment shape size and a tip thermo-electric cooler (TEC).

The F65 is intended for professional use only.

The provided FDA 510(k) summary only describes the clinical studies for the F65 module and handpiece with 1565 nm wavelength, specifically for the new indication of "Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV who are seeking treatment for hair loss." It does not provide detailed acceptance criteria and performance data for all the device's indications, nor does it present the information in a clear table format for acceptance criteria vs. device performance.

Based on the information provided for the 1565nm module and its new indication:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new indication ("Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV who are seeking treatment for hair loss") are implicitly derived from the study results presented in the document. The document states a primary efficacy endpoint of "demonstrating improvement in more than 70% of subjects" for the retrospective study.

2. Sample Sizes and Data Provenance

• Preclinical Study (Animal Testing): Sample size for the preclinical study is not specified, only that it "was conducted to evaluate the Lumenis F65 subject module for hair follicle regeneration capabilities using both Low Level Laser Therapy (LLLT) and untreated controls."
• Clinical Studies:
  • Prospective, Single Arm Study:
    • Sample Size: 32 subjects enrolled, 25 completed.
    • Diagnosis Breakdown: 18 with Androgenic Alopecia, 7 with other diagnoses (evaluated separately).
    • Hair Count Data: 5 male subjects with androgenic alopecia, 18 female subjects with androgenic alopecia.
    • Data Provenance: Not explicitly stated, but clinical studies are generally prospective. No country of origin is mentioned.
  • Retrospective, Single Arm Study:
    • Sample Size: 98 subjects evaluated for performance.
    • Diagnosis Breakdown: 44 with confirmed Androgenic Alopecia, 54 with no documented diagnosis (presumably hair loss but not specifically diagnosed as androgenic alopecia).
    • Data Provenance: Retrospective. No country of origin is mentioned.

3. Number of Experts and Qualifications for Ground Truth

• Retrospective Study: "a group of 3 blinded reviewers" were used for the assessment of improvement in scalp hair appearance.
• Qualifications of Experts: The specific qualifications (e.g., dermatologist, years of experience) of these 3 blinded reviewers are not specified in the provided document. They are only referred to as "reviewers."

4. Adjudication Method for the Test Set

• For the retrospective study, where 3 blinded reviewers assessed improvement, the adjudication method is not explicitly stated. It's mentioned they "yielded a correct identification" in a certain percentage of cases. This implies either:
  • All 3 reviewers had to agree (unlikely for such high percentages given typical inter-reader variability without prior agreement).
  • A majority vote (2 out of 3) was used.
  • One expert's assessment was deemed primary, or they collectively discussed and reached a consensus.
    The document does not detail the process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done comparing human readers with AI assistance vs. without AI assistance.
• The studies described are for the device's direct effect on hair growth, not for evaluating human reader performance with or without an AI. The "blinded reviewers" in the retrospective study were assessing the clinical outcome (improvement in scalp hair appearance), not the performance of an AI algorithm.

6. Standalone (Algorithm Only) Performance

• This document describes a medical device (laser system) that directly treats patients, not an AI algorithm. Therefore, there was no standalone (algorithm only) performance study as it's not an AI device. The "performance" refers to the clinical outcome achieved by the laser system.

7. Type of Ground Truth Used

• For the clinical studies, particularly the retrospective study, the "ground truth" for showing improvement in scalp hair appearance was established by expert consensus/review (3 blinded reviewers).
• For the prospective study, quantifiable metrics like mean increase in hair count per cm² from baseline were reported, which can be considered objective outcomes data.

8. Sample Size for the Training Set

• This document describes physical medical device studies (laser system) for a 510(k) submission, not an AI model requiring a training set. Therefore, there is no concept of a "training set" in the context of this submission. The "training" here refers to the device's design and manufacturing through engineering principles and prior knowledge, not machine learning.

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

• As there is no AI model or "training set" in the context of this device submission, this question is not applicable.

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