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The MDK Multi-Applications Platform is laser surgical instrument for use in general and plastic surgery and in dermatology (GEX).

The MDK Multi-Applications Platform is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation the medical specialties of dermatology, general and plastic surgery, in endoscopic/laparoscopic general surgery, gastroenterology, gynecology, neurosurgery, otorhinolaryngology (ENT), oculoplastic, oral surgery, ophthalmology (skin around eyes), orthopedics, podiatry, pulmonary/thoracic surgery and urology for surgical and aestetic applications.

For intended use in Dermatology for the coagulation and hemostasis of benign vascular leasion such as, but not limited to, rosacea, poikiloderma of civatte, and treatment of benign cutaneous lesions such as warts, scars and straie. Also intended for treatment of wrinkles as, but not limited to, periocular and perioral wrinckles.

For intended use on all skin types (Fitzpateick I-VI), including tanned skin.

Nd:YAG 1064nm Q-switched and 532nm Q-switched: The MDK Mull-Applications Platform is intention of vacular lesions, pigmented teslons, and for hair, tattoo removel and the incision, excision, ablation, vaporization of soft tissue.

Nd: YAG 1064nm (long & short pulse): The MDK Multi-Applications Platorn is interest surgical applications; dermatoryplastic surgen; andoscopic - laprosecopic surgery; general surgery; gynecology; ENT; hemostmaly; occuloplasios; putmonary surgery; thoracle surgery; and orthopsdics.

Nd:YAG 1320nm: Indicated for use in general surgery and dematology for the incision, ablation, vaporization, coagulation and haemostasis of soft tosue. It is also indicated for the treatment of perioral wrinkles, fine lines and wrinkles, and the beathers of back acne and strophic acne scars.

Alexandrite 755 mm: Intention for coagulation and hemostasions and the removal and permanent reduction of unwanted hair in Fitzpatick skin types I-VI, beluding suntamed skin indicated for pigmented tesions and writtings. Parmanent hair roduction is defined as the long-larm, stable reduction in the number of halm measured at 6. 9, and 12 months after the campletion of a treatment regime.

Nd:YAG 532nm (Long pulse): For the coagulation and hemostasis of vascular lesions.

IPL 590-1200nm; 625-1200nm; 650-1200nm: Indicated for permanent hair removal.

IPL 550-1200nm; 570-1200nm: Indicated for phoboxagulation of dermanlogical vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (restment of facial and leg veins), and treatment of benign pigmented lesions.

IPL 400-1200nm: Indicated for inflammatory acne (acne vulgaris).

Integrated Skin Cooler: The intended use of the integrated cooling system in the MDK Multi-Applications Platorm hand-piece is to provide cooling of the skin prior to laser treatment, for the reduction of painting laser treatment, to allow for the use of higher flucinces such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.

The MDK Multi-Applications Platform is laser surgical instrument for use in general and plastic surgery and in dermatology (GEX). The device includes a Q-Switched Nd:YAG laser source emitting at 1064 nm and 532 nm wavelengths, and/or an Nd:YAG laser source emitting at 1064 nm (short and long pulse) and/or at 1320 nm and/or at 532 nm, and/or an Alexandrite laser source emitting at 755 nm (long pulse) and/or an intense pulsed light (Twain IPL Handpiece).

The optical delivery system for the Q-Switched Nd:YAG laser source (1064nm and 532nm) is an articulated arm with fixed handpieces. The optical delivery system for the Nd:YAG laser source ( 1064nm long/short pulse, 755 nm long pulse, 532 nm long pulse and 1320 nm long pulse) is an optical fiber with focusing handpieces up to 12mm spot size. The optical delivery system for the IPL system is an handpiece (Twain IPL) with interchangeable light filter at different wavelengths.

The MDK Multi-Applications Platform control software allows to work only one laser source or IPL at time: it means that the laser sources works separately and indipendently. Moreover the Intense Pulse Light cannot work with any laser sources. Combined (simultaneously or sequentially) operations of different laser sources and/or IPL is not allowed.

The MDK Multi-Applications Platform architecture is based on the following main subsystems: (1) an high voltage power supply, which converts and rectifies the AC mains current to provide requlated power for the flash-lamps, simmer current and main triggering pulse; (2) a cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger; (3) a Q-switched Nd:YAG laser source, capable of generating very short pulses at 1064nm and at 532 nm through a suitable (4) KTP SGH crystal. capable of converting light pulses at 1064nm into light pulses at 532nm: (5) a Nd:YAG laser source, capable of generating laser pulses at 1064nm or 1320nm wavelength and at 532 nm through a suitable (6) KTP SGH crystal, capable of converting light pulses at 1064nm into light pulses at 532nm: (7) an Alexandrite laser source, capable of generating laser pulses at 755nm with frequency up to 1,5 Hz; (8) an Intense Pulsed Light handpiece system (Twain IPL), capable of generating light pulses at a frequency of 0.5 Hz; (9) the microprocessor based controller, which requilates the functions of the laser and allows parameter selection by the user; (10) an optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing hand piece; (11) an optical delivery system, interfacing the energy from the laser to the patient via an optical fiber and focusing hand piece: and (12) an integral skin cooler.

The MDK Multi-Applications Platform is controlled via a touch screen display hosted in the front of the device where are also located the key switch, the emergency red push button and the operation led. On the rear panel the footswitch connector, the remote interlock and the power switch are located.

The provided text is a 510(k) summary for the MDK Multi-Applications Platform. It describes the device, its intended uses, and asserts substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria or the details of a study proving the device meets those criteria, as typically found in clinical performance studies.

The document is a regulatory submission for device clearance, focusing on demonstrating equivalence to already marketed devices rather than presenting novel performance data against specific, quantifiable acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. The document states, "There are no mandatory performance standards for this device." It relies on substantial equivalence to predicate devices, meaning its performance is considered acceptable if its technological characteristics and intended use are similar to those already cleared. No specific, quantifiable acceptance criteria or related performance results are reported.

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

• Cannot be provided. The document does not describe any specific testing or clinical study with a test set. It mentions the device's technical specifications and how they compare to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. No clinical test set or ground truth establishment is described.

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

• Cannot be provided. No clinical test set or adjudication process is described.

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

• Cannot be provided. The device is a laser surgical instrument, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

• Cannot be provided. This question is not applicable as the device is a physical laser platform for surgical and aesthetic applications, not a standalone algorithm.

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

• Cannot be provided. No explicit ground truth is mentioned as no specific performance study against such a standard is detailed. The basis for clearance is "substantial equivalence" to predicate devices, meaning the relevant "ground truth" implicitly relates to the established safety and effectiveness of those predicates.

8. The sample size for the training set

• Cannot be provided. This device is a laser system, not an AI algorithm requiring a training set in the conventional sense.

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

• Cannot be provided. Not applicable for this type of device.

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