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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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The TRANSDERM IONTO System MK 2 is a powered iontophoresis drug delivery system that is for medical purposes and can be used as an alternative to injections. For the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.

The TRANSDERM IONTO System MK 2 consists of a probe, power supply/support, and a disposable drug delivery cap electrode. The TRANSDERM IONTO System MK 2 generates mechanical vibrations that are produced by an electric motor which has an unbalanced weight applied on the device shaft. The vibrations are transmitted by the motor body to a plastic plate that is held in contact with the skin through the disposable drug delivery cap electrode. Electrical pulses are produced by an electronic pulse generator that is able to generate bursts of pulses that are applied to the skin through electrodes applied to a plastic plate (the applicator). The design of the device provides one channel output. The TRANSDERM IONTO System MK 2 requires a DC supply of 9 V, 1.0 A max. This power source is supplied by, the TRANS-BASE module which is connected to mains through a removable supply cord and is equipped with a proper connector receptacle to fit the connector male mounted on TRANSDERM IONTO probe supply cable. The TRANS-BASE is equipped with a 15 w AC-DC switch mode power module. The drug delivery cap electrode is adhered to the patient's skin and then saturated The urug delivery cap electrug delivery cap electrode is affixed to the while solution: "Oneo the artig changes": applicator head can be attached pation internal side of the drug delivery cap electrode.

The provided text is a 510(k) summary for the TRANSDERM IONTO System MK 2, and it describes the device's safety and effectiveness compared to a predicate device. However, it does not include the details of a study with specific acceptance criteria and reported device performance in the manner requested.

Here's a breakdown of why many of your requested points cannot be filled from the provided text:

• No specific acceptance criteria or performance metrics are listed. The document states that "Performance testing and the applicable IFC 60601-1 standards testing including 21 CFR 898 was performed." This refers to general electrical safety and good manufacturing practice standards, not specific clinical or technical performance metrics for drug delivery efficacy or patient perception.
• No detailed study results are present. The document concludes that the device is "substantially equivalent" to legally marketed iontophoretic devices. This is the outcome of the 510(k) process, but not the detailed study results that would typically include an acceptance criteria table.
• No information on sample sizes, ground truth establishment, or expert involvement for a clinical study is provided. The 510(k) summary focuses on comparing the new device's design and intended use to an existing predicate device (TRANSDERM IONTO System K032968), rather than presenting a novel clinical trial with detailed methodology. The "study" mentioned for patient perception is simply stated as "supports that the TRANSDERM IONTO System MK 2 decreases the patient's perception of the electrical currents," without any data, sample size, or methodology.

Therefore, I cannot populate most of the requested fields accurately based on the provided text.

However, I can extract what is available:

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

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

• Sample Size: Not specified.
• Data Provenance: Not specified.

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)

• Not applicable/Not specified. The "ground truth" here is regulatory substantial equivalence, assessed by the FDA.

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

• Not applicable/Not specified. This refers to the FDA's regulatory review process for substantial equivalence, not a clinical trial adjudication method.

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

• No, an MRMC study was not done. This device is an iontophoresis system, not an AI-powered diagnostic imaging tool.

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

• Not applicable. This device is a drug delivery system, not an algorithm.

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

• The primary "ground truth" for a 510(k) is the predicate device (TRANSDERM IONTO System, K032968). The new device is compared to this already legally marketed device to demonstrate substantial equivalence in terms of intended use, technological characteristics, and safety/effectiveness. No specific clinical ground truth (like pathology or outcomes) is detailed from a new study.

8. The sample size for the training set

• Not applicable. No "training set" is mentioned as this is a medical device, not a machine learning algorithm being trained.

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

• Not applicable.

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The TRANSDERM IONTO System is a powered iontophoresis drug delivery system that is indicated for the local administration of ionic drug solutions into the body for medical purposes and can be used as an alternative to injections.

The TRANSDERM IONTO System consists of a probe, power supply/support, and a disposable drug delivery cap clectrode. Flectrical pulses are produced by an electronic pulse generator that is able to generate bursts of pulses that are applied to the skin through electrodes applied to a plastic plate (the applicator). The design of the device provides one channel output. The TRANSDERM IONTO System requires a DC supply of 9 V, 1.0 A max. This power source is supplied by, the TRANS-BASE module which is connected to mains through a removable supply cord and is equipped with a proper connector receptacle to fit the connector malc mounted on TRANSDERM IONTO probe supply cable. The TRANS-BASE is equipped with a 15 w AC-DC switch mode power module. The drug delivery cap electrode is adhered to the patient's skin and then saturated with ionic solution. Once the drug delivery cap electrode is affixed to the patient's skin, the TRANSDERM IONTO probe's applicator head can be attached to the internal side of the drug delivery cap electrode.

This document describes a 510(k) premarket notification for the TRANSDERM IONTO System, an iontophoresis device. It's important to note that 510(k) submissions primarily demonstrate substantial equivalence to a predicate device rather than fulfilling specific, independent performance criteria based on a clinical study where the device's performance would be compared against a 'ground truth' developed by experts. As such, many of the typical acceptance criteria and study details for an AI/ML device (like those related to expert consensus, adjudication, and specific performance metrics like AUC, sensitivity, specificity, and F1 score) are not directly applicable or reported in this type of submission.

Therefore, the following table summarizes the information relevant to a 510(k) for a medical device aiming for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for the test set: Not directly applicable or explicitly stated in this 510(k) summary. Performance testing for a device like this would typically involve engineering and bench testing, potentially some in-vivo animal studies, or very limited human testing for specific parameters, but not a large-scale clinical trial with a "test set" in the sense of AI/ML evaluation.
• Data provenance: Not specified. Testing would likely be conducted in a laboratory or clinical setting, but details like country of origin or retrospective/prospective nature of data are not relevant for this type of submission.

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

• This is not applicable for a 510(k) submission focused on substantial equivalence for an iontophoresis device. Ground truth, in the context of expert consensus, is typically used for diagnostic or screening AI/ML devices where human interpretation is the gold standard. For this device, "ground truth" would relate to objectively measurable physical or electrical parameters.

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

• Not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, often in diagnostic AI/ML contexts to establish a robust ground truth. This type of device's performance is evaluated by objective engineering and safety standards.

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. An MRMC study is relevant for diagnostic or screening devices where human readers (e.g., radiologists, pathologists) interpret cases with and without AI assistance. The TRANSDERM IONTO System is a drug delivery device, not a diagnostic imaging or screening tool.

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

• Not applicable. The TRANSDERM IONTO System is a physical device that delivers medication, not an algorithm. Its performance is inherent to its physical operation and electrical characteristics, rather than a separate "standalone algorithm."

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

• The concept of "ground truth" as typically defined for AI/ML diagnostic studies is not applicable. Instead, the device's performance is assessed against established engineering standards (e.g., IEC 60601-1) and objective physical and electrical specifications derived from predicate devices or general medical device safety requirements. For instance, parameters like current output, voltage, safety mechanisms, and drug delivery capabilities would be measured against predefined benchmarks.

8. The sample size for the training set

• Not applicable. This device is hardware for drug delivery, not an AI/ML system that requires a "training set."

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

• Not applicable. As the device is not an AI/ML system, there is no training set or associated ground truth.

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