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755nm

The Nobleen Long Pulsed Alexandrite & Nd:YAG Laser is indicated for temporary hair reduction.

Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re growing after a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of benign pigmented lesions.

Treatment of wrinkles.

The photocoagulation of dermatological vascular lesions (such as port-wine stains,

hemangiomas, telangiectasias).

1064nm

The Nobleen Long Pulsed Alexandrite & Nd: YAG Laser is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB.

Permanent hair reduction is defined as the 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. 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, hemangioma, warts, telangiectasia, rosacea. Venus lake, leg veins and spider veins.

Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratosis. nevi, chloasma, verrucae, skin tags, keratos (signi flcant reduction in the intensity of black and/or blue-black tattoos) and plaques.

The laser is indicated for pigmented 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 laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.

The Nobleen Long pulsed Alexandrite & Nd: Y AG Laser System contains two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 mm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Rapid Cooling System (RCS) protects the upper layers of the skin with a cooling burst of cryogen.

The provided text describes the regulatory clearance of the "Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System" by the FDA. However, it explicitly states that no clinical studies were needed or performed to support this 510(k) Premarket Notification because of the device's substantial equivalence to a legally marketed predicate device (Candela GentleMax Family of Laser Systems K133283).

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance, as these elements are typically part of clinical validation studies, which were not conducted for this specific device clearance.

The document focuses on non-clinical performance data to establish substantial equivalence, primarily through bench testing, electrical safety, electromagnetic compatibility (EMC), and software verification.

Here's what the document does provide in relation to "acceptance criteria" and "device performance" in the context of a 510(k) without clinical studies:

1. A table of pseudo-acceptance criteria (based on equivalence to predicate) and reported device performance:

• Same maximum delivered energy.
• Similar spot size.
• Identical 1000 µ optical fiber handpiece delivery system.
• Similar operating principles.
• Both use a short burst of cryogen spray (Rapid Cooling System - RCS) for skin cooling. Bench testing confirmed performance specifications were "identical to the predicate device" and that the Nobelenn system performs "according to specifications and functions as intended." |
  | - Software Performance | - Software verification testing conducted; results found acceptable for software release, performed per FDA guidance ("Guidance for the Content of Premarket Submission for Software Contained in Medical Devices"). |

Remaining points (2-9) cannot be answered from the provided text as they relate to clinical studies that were explicitly stated as not performed:

2. Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.
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 a laser system, not an AI diagnostic device, and no clinical studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a laser system, not an AI diagnostic device, and no clinical studies were performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No clinical ground truth was established as no clinical studies were needed.
8. The sample size for the training set: Not applicable. No training set for clinical data was mentioned as no clinical studies were needed.
9. How the ground truth for the training set was established: Not applicable.

In summary, the FDA clearance for the "Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System" relied on demonstrating substantial equivalence to an existing predicate device through non-clinical performance testing and compliance with recognized standards, rather than new clinical efficacy or safety studies.

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