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The MATTIOLI PULSE TWO/THREE PLUS is an Intense Pulse Light (IPL) device family indicated for use in aesthetic applications (based on selective photothermolysis) , in the treatment of various benign pigmented lesions and hair removal and that produce different effects depending on the applicator that is used:

SA APPLICATOR:

Model SN: Wavelengths from 560 - 1200 nm are indicated for treatment of benign pigmente (epidermal and coutaneous) lesions, including hyperpigmentation, warts, lentigines, nevi, melasma, and cafe-au-lait.

VA APPLICATOR

Model VN: Wavelengths from 510 - 1200 nm are indicated for the treatment of benign vascular lessons including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider anglormas, polkiloderma of civatte; leg veins, facial veins and venous malformations.

HR APPLICATORS indicated for the treatment of unwanted hair (i.e. hair removal). Model HN: Wavelengths from 650-1200 nm for skin types I-IV; Model HF: Wavelengths from 710 - 1200 nm for skin type V

The equipment should only be used under medical supervision.

The MATTIOLI PULSE TWO/THREE Plus Family is an Intense Pulse Light (IPL) generator device producing on the skin different effects depending on the applicator used by the operator:

SR Applicator: its purpose is to stimulate the regenerative process of the skin. It uses the principle of the selective absorption of the different light wavelengths, without damaging the skin structure.

HR Applicator: its purpose is to destroy thermally the hair bulb, due to the absorption of a selected range of radiated wavelength. The selective absorption of different wavelengths is either used by HR to obtain the desired effect without damaging the surrounding skin structures.

VR Applicator: Its purpose is to treat benign pigmented (epidermal and cutaneous) lesions including warts scars abnd striae. It is also intended for treatment of benign (cutaneous) vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangectasias, rosacea, melasmna, angiomas and spider angiomas, polkiloderma of civatte; leg veis, facial veins and venous malformations.

The two systems differ substantially only by the case: it is "desktop" style for MATTIOLI PULSE TWO PLUS device and a standard case, with wheels to allow easy movement on the floor, for PULSE THREE PLUS device.

Both equipments consist of a console, containing the electronic supply system for capacitor bank charge , the computerized control system (CCS) , and one or two hand pieces in which are contained the light generators devices (flash lamp) and the necessary filtered light guide for the selection of the wavelengths range.

The computerized control system (CCS) monitors and controls either the equipment and interfaces with the operator, through an 8.2" colour back lighted LCD screen display and a touch screen panel, displaying all the selected parameters and indications on the status of the machine. The selection of each command and parameter simply occurs by touching the LCD screen.

Each applicator is composed basically by the flash-lamp, a water cooled reflector, a filtered light guide, a light guide cooler, a flash-counter and the pushbutton for the activation of flash emission.

This document is a 510(k) Premarket Notification for the Mattioli Pulse Two/Three Plus Family of Intense Pulsed Light (IPL) systems. It's an application to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving new acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies for a new device is not present in this document.

The document primarily focuses on establishing substantial equivalence to a predicate device (Angelite Family of Intense Pulsed Light Systems) rather than presenting novel performance data.

Here's an analysis of the provided text with respect to your request:

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

This document does not provide a table of acceptance criteria and reported device performance for the Mattioli Pulse Two/Three Plus Family in the way one would for a new device requiring rigorous testing and comparison against defined performance metrics. Instead, it argues for substantial equivalence based on comparable characteristics to a predicate device.

The rationale for substantial equivalence mentions:

• Product specification, functionality, indication for use, and treatment parameters: "are the same or very similar" to the predicate.
• Output characteristics (pulse duration and fluence): "are identical, or very similar, to those of the predicate device."

Without specific numerical ranges or targets for these "similar" characteristics, a formal table of acceptance criteria and reported performance cannot be extracted from this document. The "performance" being demonstrated here is primarily the similarity to the predicate.

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

None. The document explicitly states "Non-Clinical Performance Data: None" and "Clinical Performance Data: None." This means no test set was used or described for evaluating the performance of the Mattioli devices itself. The submission is based on engineering similarity to the predicate.

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)

N/A (Not Applicable). Since no clinical or non-clinical performance data from a test set is provided, there were no experts establishing ground truth for such a set.

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

N/A (Not Applicable). No test set, no adjudication method 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

N/A (Not Applicable). This is a 510(k) for an IPL device, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant here.

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

N/A (Not Applicable). This is an IPL device, which is operated by a human. The concept of "standalone algorithm performance" does not apply.

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

N/A (Not Applicable). As no performance studies were conducted, no ground truth was established for this device's performance. The "ground truth" for the 510(k) submission is the pre-existing FDA clearance of the predicate device, which implies its safety and effectiveness.

8. The sample size for the training set

N/A (Not Applicable). This is not a machine learning device; therefore, there is no training set.

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

N/A (Not Applicable). As no training set exists, no ground truth was established for it.

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