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The Profile 1064 Laser Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.

Dermatology:

Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. 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.

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.

The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal protection and 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.

Surgical Applications:

Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.

Profile Laser System is an Nd:YAG laser producing emission at a wavelength of 1064nm. It consists of a laser console, internal computer, control panel and display, an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.

The provided text describes a 510(k) submission for the Sciton Profile 1064 Laser System, demonstrating its substantial equivalence to previously marketed predicate devices. This type of submission generally relies on demonstrating equivalence rather than conducting new clinical studies with defined acceptance criteria and performance metrics.

Therefore, this document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 as it is a regulatory submission focused on substantial equivalence rather than a study report detailing specific performance criteria, test sets, or training sets for an AI/ML device.

Here's why the information is not present based on the provided text:

• Acceptance Criteria and Reported Device Performance (1): The submission focuses on substantial equivalence to predicate devices, meaning its performance is considered acceptable if it is similar to those already on the market. There are no explicit acceptance criteria or a quantitative performance table mentioned.
• Sample Size, Data Provenance (2): No new clinical study data with test sets, sample sizes, or data provenance is presented. The argument is based on the similarity of the device's technological characteristics and intended use to existing devices.
• Experts, Qualifications, Adjudication (3, 4): These details are relevant for studies establishing ground truth, which is not the primary mechanism of this 510(k) submission.
• MRMC Study (5): The submission does not mention an MRMC study or any assessment of human reader improvement with AI assistance, as the device is a laser system, not an AI-assisted diagnostic tool.
• Standalone Performance (6): Similar to the above, this concept applies to AI/ML devices, not a laser system.
• Type of Ground Truth (7): Ground truth is not established in this context as new clinical validation is not the basis of the submission.
• Training Set Sample Size/Ground Truth (8, 9): These concepts are applicable to AI/ML model development. This submission is for a physical medical device (laser system), not an AI algorithm.

In summary, the provided 510(k) summary focuses on demonstrating that the "Profile 1064 Laser System" is substantially equivalent to other legally marketed Nd:YAG laser systems based on shared indications for use and technological characteristics. It is not a report of a study designed to establish new performance criteria or to validate an AI/ML algorithm against a ground truth dataset.

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The DEPILASE YAG LASE PLUS Laser System is intended for the coagulation and haemostasis of vascular lesions and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types.

The DEPILASE YAG LASE PLUS Laser System is based on Nd: YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of a flashlamp. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an optical fibre delivery system to a focusing handpiece. The laser is used in a non-contact mode.

The DEPILASE YAG LASE PLUS Laser System is designed with 5 major sub-systems:
a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 3 Hz
d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

The provided text is a 510(k) Summary for the DEPILASE YAG LASE PLUS Laser System. This document focuses on establishing substantial equivalence to previously cleared devices rather than on presenting results from clinical trials with specific acceptance criteria and performance data in the format requested.

Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be fulfilled from the provided text. The document describes the device, its intended use, and argues for its substantial equivalence to predicate devices (Laserscope Lyra K990718 and Altus Medical Aesthetic CoolGlide K991798). It does not contain information about new studies conducted to prove the performance of the DEPILASE YAG LASE PLUS Laser System against specific acceptance criteria.

Here's an attempt to address the request based only on the provided information, noting where information is absent:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable/not provided. The submission is based on substantial equivalence to predicate devices, not on a new clinical study with a test set of patients.
• Data Provenance: Not applicable/not provided for a new clinical study. The "data" referenced relates to the established safety and effectiveness of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable/not provided. No new test set data requiring expert-established ground truth is presented in this 510(k) summary.
• Qualifications of Experts: Not applicable/not provided.

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

• Adjudication Method: Not applicable/not provided.

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

• MRMC Study: No. This device is a laser system, not an AI-assisted diagnostic or imaging device used by human readers in the context of an MRMC study.

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

• Standalone Study: Not applicable. This is a medical device (laser system), not an algorithm.

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

• Type of Ground Truth: Not applicable for this device's submission in the provided text. The submission relies on the established safety and effectiveness track record (implied outcomes data, clinical experience, and regulatory clearance) of the predicate devices.

8. The sample size for the training set

• Sample Size: Not applicable/not provided. This document does not describe the development or training of an algorithm.

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

• Ground Truth Establishment: Not applicable/not provided.

Summary of what the document does provide regarding its "proof":

The "study" in this context is a substantial equivalence argument to predicate devices cleared by the FDA. The proof is based on demonstrating:

• Identical Intended Use: The DEPILASE YAG LASE PLUS Laser System has the same indications for use as the predicate devices (coagulation and haemostasis of vascular lesions, and permanent reduction of unwanted hair in Fitzpatrick skin types I-VI, including suntanned skin).
• Similar Technological Characteristics: All utilize flashlamp pumped Nd:YAG laser rods, generating light at 1064nm, delivered via optical fiber and focusing handpiece, microprocessor controlled, use Class I aiming beams, and internal closed-loop water-air heat exchange for cooling.
• Comparable Performance (Implied): The output characteristics are "very similar" to predicate devices, and risks and benefits are comparable.

Therefore, the "proof" is a regulatory argument for equivalence rather than a detailed report of a new clinical investigation with quantifiable acceptance criteria.

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