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The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, ENT, Radiology. The Dornier Medilas D 1064 Laser model (trade name Medilas D30) is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).

The Dornier Medilas D 1064 Laser is a continuous-wave diode laser emitting laser radiation in the invisible range of 1064 nm. Each is calibrated during the manufacturing process and during service calls. The end-user does not calibrate fibers for this system. The Medilas D 1064 Laser incorporate a graphic display panel, which shows laser operating parameters, application modes, time functions, system status and messages for the user. The Medilas D 1064 Laser features several operating modes, including Standard, Fibertom, LITT and LPS. The laser can be used in contact or non-contact open surgery with or without handpieces.

The provided document is a 510(k) summary for the Dornier Medilas D 1064 Laser. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device meets specific de novo acceptance criteria through rigorous clinical studies for performance metrics like sensitivity, specificity, etc.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/diagnostic device.

Here's why and what information is available:

• Type of Device: The Medilas D 1064 Laser is a surgical laser, not an AI or diagnostic device that would typically have performance metrics like those for image analysis, disease detection, or treatment efficacy quantified by sensitivity, specificity, F1-score, etc.
• Regulatory Pathway: The 510(k) pathway focuses on demonstrating "substantial equivalence" to a predicate device. This means showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to a device already on the market.
• Performance Data (as presented): The "Performance Data" section explicitly states: "While no performance standards have been established for Diode lasers under Section 514 of the Federal Food, Drug, and Cosmetic Act, the Dornier Medilas D 1064 Laser is in compliance with class IV performance standards for light emitting products promulgated under the Radiation Control for Health and Safety Act of 1968... The laser also complies with the applicable requirements of the following voluntary standards: IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and European Medical Device Directive (CE)."
  • This indicates compliance with safety and electrical standards for laser devices, not clinical performance metrics on patient outcomes or AI accuracy.

In summary, the requested information (performance acceptance criteria, study details, sample sizes, ground truth methodology, expert qualifications, MRMC studies, standalone performance) is not applicable to this type of device and regulatory submission.

The document confirms that:

• The Medilas D 1064 Laser emits laser radiation at 1064 nm.
• It operates in continuous-wave mode.
• It is calibrated during manufacturing and service.
• It has a graphic display and several operating modes (Standard, Fibertom, LITT, LPS).
• It can be used in contact or non-contact open surgery, with or without handpieces.
• Its intended use is for cutting, vaporization, ablation, and coagulation of soft tissue in various medical specialties, including with endoscopic equipment, and for treating/removing vascular lesions.

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The Lumenis Family of Intense Pulsed-Light (IPL) systems and combination IPL/Nd:YAG laser systems (and the delivery accessories that are used with them to deliver light and/or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:

Intense Pulsed Light Energy / Wavelengths (515 - 1200 nm):

• The treatment of tattoos and benign pigmented epidermal and cutaneous lesions * including warts, scars and striae;
• • The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
• • The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent1, hair reduction in skin types I-VI through selective targeting of melanin in hair follicles;

Nd:YAG Laser Wavelength (1064 nm):

• • The coagulation and hemostasis of vascular lesions and soft tissue, including:
    • • Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg;
• • The non-ablative treatment of facial wrinkles.

The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:

• • Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
• Reduce discomfort during and/or associated with light or laser treatment; *
• • Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyperand/or hypopigmentation;
• • Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
• • Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems are comprised of the following main components:

• • A light/laser system console (including software and control electronics);
• A control and display panel; and *
• • One or more attached hand-piece(s), which may have integrated skin cooling components.

This is a pre-market notification for a laser system, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies (such as MRMC, standalone performance, ground truth, and sample sizes) is largely not applicable in the context of AI/ML device evaluation.

Here's a breakdown of why this information isn't present in the provided text for an AI/ML context:

• Device Type: The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems are medical devices that physically interact with tissue for surgical, aesthetic, and cosmetic applications. They are not software-based AI/ML devices that provide diagnostic or prognostic insights.
• Approval Process: The document is a 510(k) submission, indicating a substantial equivalence pathway. This pathway compares the new device to existing legally marketed predicate devices to demonstrate that it is as safe and effective. It does not typically involve the rigorous performance metric evaluations (like sensitivity, specificity, AUC) associated with AI/ML devices.
• "Acceptance Criteria" in this context: For this type of device, "acceptance criteria" primarily refer to demonstrating that the device's technical specifications and performance (e.g., fluence, pulse rate, spot size) are comparable to predicate devices and that clinical data supports its safety and effectiveness for its intended use. There are no "reported device performance" metrics in the sense of AI/ML model output.

However, I can provide the available information relevant to the device's evaluation, reinterpreting "acceptance criteria" and "study" for this non-AI/ML context:

1. Table of Acceptance Criteria and Reported Device Performance (Reinterpreted for a Laser System)

Since this is a 510(k) for a laser system, the "acceptance criteria" are implied by its comparison to predicate devices across various technical and functional specifications, and the "reported device performance" is its demonstrated capability to meet those same specifications and achieve the intended clinical effects.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document states: "Clinical data was provided to demonstrate that the Lumenis Family of IPL and IPL/Nd:YAG laser (1064 nm) systems are safe and effective..."
• No specific sample size, data provenance, or retrospective/prospective nature of the clinical data is provided in this summary. This level of detail is typically found in the full study reports, not necessarily in the high-level 510(k) summary.

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

• Not Applicable. For a laser system, "ground truth" isn't established by experts interpreting outputs in the way it is for AI/ML diagnostic tools. The "truth" would be the observed clinical outcome (e.g., hair reduction, lesion clearance, wrinkle reduction) directly from the treatment.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in AI/ML performance evaluation, which is not relevant here.

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 treatment device, not an AI diagnostic/assistant tool. MRMC studies are for evaluating scenarios where humans are interpreting outputs (e.g., medical images) with or without AI assistance, which is not the function of this device.

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

• Not Applicable. Again, this is a physical laser device, not an algorithm. Its performance is always "standalone" in the sense that it performs its function without an AI element, but it requires a human operator for application.

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

• For a medical treatment device like this laser system, the "ground truth" for demonstrating safety and effectiveness would primarily be clinical outcomes data. This includes:
  • Observed clinical efficacy: e.g., photographic evidence of lesion clearance, hair reduction, wrinkle improvement.
  • Patient feedback: on pain reduction, discomfort.
  • Adverse event reporting: to assess safety.
  • These outcomes would be assessed by clinicians.

8. The sample size for the training set

• Not Applicable. This device does not use a "training set" in the AI/ML sense. Its operational parameters are designed and validated through engineering principles and clinical studies, not by training an algorithm on a dataset.

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

• Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established in this context.

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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, the removal and permanent reduction of unwanted hair in Fitzpatrick skin type I - VI and for the use in dermatological applications for the treatment of facial wrinkles.

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 document is a 510(k) summary for the DEPILASE YAG LASE PLUS Laser System. It focuses on demonstrating substantial equivalence to a predicate device and does not contain information about a study to prove adherence to specific performance acceptance criteria for the treatment of facial wrinkles.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, or study methodologies because this information is not present in the document.

The document states:

• Intended Use: The DEPILASE YAG LASE PLUS Laser System is indicated for the use in dermatological applications for the treatment of facial wrinkles.
• Substantial Equivalence: Depilase believes its device is substantially equivalent to the Laserscope Lyra (K020021) Nd: YAG laser, previously cleared for the use in dermatological applications for the treatment of facial wrinkles.

This 510(k) summary relies on demonstrating that the new device has similar technological characteristics, intended use, and comparable risks and benefits to a previously cleared device. It does not describe a new clinical study with specific acceptance criteria to evaluate the effectiveness of the DEPILASE YAG LASE PLUS Laser System for facial wrinkle treatment.

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