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The Nd: Yag 1064 Laser Handpiece (Long Pulsed) is intended for:
-treatment of benign vascular lesions such as but not limited to port wine stains, hemangiomas, telangiectasias, rosacea. venus lake, facial and leg veins;
-treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques;
-tattoos (significant reduction in the intensity of black and/or blue-black tattoos);
verrucae, skin tags, seborrheic keratosis;

• reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar;
• coagulation and hemostasis of soft tissue;
  -the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Nd: Yag 1064 Laser Handpiece (Short Pulsed) is intended for:
Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions
Laser skin treatment procedures for the treatment of: Acne scars, Wrinkles

The Nd:YAG Q-Switched Handpieces (1064 nm) are indicated for treatment of:

• Benign vascular lesions such as, but not limited to treatment of:
  Port wine stains; Hemangiomas; Warts; Superficial and deep telangiectasias; Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas
  -Benign cutaneous lesions, such as, but not limited to:
  Warts; Scars; Striae; Psoriasis
  -Benign pigmented lesions such as, but not limited to:
  Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Seborrheic keratoses; Nevi and nevus of Ota; Chloasma; Verrucae; Skin tags; Keratoses; The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos); Plaques
• Pigmented benign 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.
• The non-ablative treatment of facial wrinkles, such as, but not limited to:
  Periocular wrinkles; Perioral wrinkles;
  -Laser skin resurfacing procedures for the treatment of:
  Acne scars; Wrinkles
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Nd:YAG Q-Switched Handpieces (532 nm) are indicated for treatment of:

• Incision, excision, ablation, vaporization of soft tissue.
• Tattoo removal: Light blue; Yellow; Red; Green
• Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider, hemangiomas); Angiomas (cherry, spider); Telangiectasia; Spider nevi
  -Benign pigmented lesions: Cafe-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus; Nevus of Ota ;Becker's Nevi
  -Other benign pigmented cutaneous lesions: Verrucae; Skin tags; Keratoses; Plaques

The 2940 nm Er:YAG Laser Module handpiece is indicated for:
Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes). Laser skin resurfacing procedures for the treatment of:
A. Acne scars

• Acne scars . . Wrinkles

The 2940 nm Er: Yag Fractional tips are indicated for:
Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Keratoses; Scar revision (including acne scars).

The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

IPL 400-1200 run handpiece is indicated for:
· The treatment of moderate inflammatory acne vulgaris.
· The treatment of benign pigmented epidermal lesions including dyschromia,
hyperpigmentation, melasma, and ephelides (freckles).
· The treatment of benign 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, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.
·Use on all skin types (Fitzpatrick I-VI).

IPL500-1200 nm handpiece is indicated for:
· The treatment of moderate inflammatory acne (acne vulgaris).
· The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars, striae,
dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, and cafe..au-lait macules. · The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6. 9, and 12 months after the completion of a treatment regime.
•Use on Fitzpatrick skin types I-V.

IPL 550-1200 nm handpiece is indicated for:
· The treatment of moderate inflammatory acne Vulgans.
· The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).

• · The treatment of face and body vascular and pigmented lesions.
  · The treatment of cutaneous lesions, including scars and striae.
  · The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
  · The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
  · Use on all skin types (Fitzpatrick I-VI).

IPL 580-1200 run handpiece is indicated for:
· The treatment of moderate inflammatory acne vulgaris.
· The treatment of benign pigmented esions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).
· The treatment of face and body vascular and pigmented lesions.
· The treatment of cutaneous lesions, including scars and striae.
· The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
· Use on all skin types (Fitzpatrick I-VI).

IPL 620-1200 nm handpiece is iodicated for:
· The treatment of tattoos.
· The treatment of moderate inflammatory acne vulgaris.
· The treatment of benign pigmented epidermal lesions includiog dyschromia, hyperpiementation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and ca!e-au-lait.
· The treatment of cutaneous lesions including warts, scars and striae.
· The treatment of benign cutaneous vascular lesions includiog port wine stains, hemangiomas, facial. truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
: The removal of unwanted hair and to effect stable long-term or permanent reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction io the number of hairs regrowiog when measured at 6. 9, and 12 months after the completion of a treatment regime.
· Use on all skin types (Fitzpatrick I-VI), iocludiog tanned skin.

IPL 755-1200 nm handpiece is indicated for:
• The treatment of tattoos.
· The treatment of moderate ioflammatory acne vulgaris.
· The treatment of benign pigmented epidermal lesions includiog dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
· The treatment of cutaneous lesions iocluding warts, scars and striae.
· The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
· The treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis.
· The treatment of pseudofolliculitis barbae (PFB).
· The removal of unwanted hair to effect stable long-term or permanent hair reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
·Use on all skin types (Fitzpatrick I-VI), including tanned skin.

The portable device SUPERBIUM, is a multilaser and pulsed light system, designated to act on some common conditions of face and body (as specified in detail in Section 4). The equipment is designed as an expandable system for dermatologic and general surgery procedures, composed of a modular platform, which contains the entire electronics of the system and the cooling circuit, and a series of interchangeable handpieces to be connected on the platform, intended to treat specific groups of imperfections. A quick connection enables the quick and easy replacement of the various hand pieces that can be mounted on the modular platform.

This document is a 510(k) summary for the "SUPERBIUM" medical laser system. It compares the device to several predicate devices to demonstrate substantial equivalence, rather than providing a performance study with specific acceptance criteria against a defined ground truth.

Therefore, many of the requested sections about acceptance criteria and study details cannot be fully answered from this document. However, I can extract the relevant information regarding the device's technical characteristics and the comparison to predicate devices, which serves the purpose of demonstrating equivalence.

Here's a summary of the available information based on the provided text:

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

Since this is a 510(k) submission showing substantial equivalence to predicate devices, there isn't a table of explicit acceptance criteria for the study's outcome in the traditional sense of a clinical trial. Instead, the "acceptance criteria" are implied by demonstrating that the SUPERBIUM device's technological characteristics and intended uses are "substantially equivalent" to the listed predicate devices. The "reported device performance" is essentially a comparison of these characteristics.

The tables within the document (e.g., "B) Nd:Yag Handpiece Long Pulse", "C) Nd:Yag Handpiece - Short Pulse", etc.) serve as the core of this comparison. For each handpiece, the SUPERBIUM's specifications (Wavelength, Output power, Max energy per pulse, Beam diameter, Fluence, Pulse duration, Emission frequency, and Intended Use) are presented alongside those of the predicate devices.

Example of "Acceptance Criteria" (Implicit for Substantial Equivalence) and "Reported Device Performance" (Comparison to Predicates):

Note: The document states "Any differences are considered minor and do not raise new issues of the safety and effectiveness of the SUPERBIUM device when compared to the predicate devices." This is the ultimate "acceptance" for a 510(k).

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 explicitly states: "Animal and clinical studies were not necessary to demonstrate that the permormances are comparable to the predicate devices." Instead, the submission relies on direct comparison of technological characteristics. Therefore, there is no test set sample size or clinical data provenance to report. The data provenance for the comparison itself is simply from the regulatory submissions of the 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)

Not applicable, as no clinical study with a test set requiring expert ground truth was conducted for this 510(k) submission.

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

Not applicable, as no clinical study with a test set requiring adjudication was conducted.

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, as this is a medical laser system for various dermatological and surgical applications, not an AI-powered diagnostic device, and no MRMC study was performed.

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

Not applicable, as this is a medical laser system, not an algorithm.

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

Not applicable, as no clinical study requiring a specific ground truth was conducted. The ground for the submission is the regulatory information and technical specifications of the predicate devices.

8. The sample size for the training set

Not applicable, as this is a physical medical device and not a machine learning model.

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

Not applicable, as this is a physical medical device and not a machine learning model.

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The Venus Versa System is a multi-application device intended to be used in aesthetic procedures. The SR515 and SR580 IPL applicators are indicated for the following:

Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.

Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins and venous malformations.

The HR650, HR690, HR650XL, and HR690XL IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris.

The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for the non-invasive treatment of moderate to severe facial wrinkles and rtides in Fitzpatrick skin types I-IV.

The Viva applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.

The Venus Versa System is comprised of a console (controller/CPU) and ten detachable handpieces (applicators). The system can deliver three types of energies to the patient's skin using the associated applicators:

• Intense Pulsed Light (IPL); ●
• Radiofrequency (RF); .
• Magnetic Pulse (MP2). .

The following ten handpieces are included with the device system: SR515, SR580, HR650, HR690, HR650XL, HR690XL, ACDUAL, Diamondpolar, Octipolar, and Viva.

The provided document is a 510(k) summary for the Venus Versa System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific clinical acceptance criteria through a standalone study with a predefined ground truth and expert adjudication. Therefore, much of the requested information (like specific acceptance criteria based on clinical efficacy, sample sizes for training/test sets, expert qualifications, or MRMC comparative effectiveness studies) is not typically found or required in a 510(k) summary for this class of device and type of submission.

The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and bench testing (system verification testing) rather than clinical performance data against specific endpoints.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria described are largely related to technical specifications and safety, not clinical efficacy. The reported performance refers to the device meeting these technical specifications.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe "test sets" in the context of clinical data for performance evaluation. The "testing" mentioned refers to engineering and safety verification on the device itself. Therefore, specific sample sizes for clinical test sets or data provenance (country, retrospective/prospective) are not applicable to the information provided for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable as the document describes technical verification and safety testing, not clinical studies requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The submission relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety (bench testing), not comparative clinical efficacy with human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

This information is not applicable as the Venus Versa System is a physical device (multi-application aesthetic system), not an AI algorithm. Its performance is inherent in its operation, not an "algorithm only" in the sense of AI.

7. Type of Ground Truth Used

The "ground truth" for the performance evaluation described would be engineering and manufacturing specifications/standards. For example, the "truth" for fluence measurement is the expected fluence value, and the "truth" for biocompatibility is conformance to ISO 10993-5. There is no clinical or pathological "ground truth" established from patient data mentioned in this submission for proving performance.

8. Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as the device is a physical system, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above.

Summary of Device Acceptance and Study:

The Venus Versa System gained acceptance (clearance) through the 510(k) pathway by demonstrating substantial equivalence to previously cleared predicate devices. The "study" proving this involves:

• Comparison of Technical Characteristics: Showing that the Venus Versa System's intended use, indications for use, technological characteristics (energy type, IPL spectrum, frequency, spot size, pulse duration, energy density), and principles of operation are similar to its predicate devices, with minor differences that do not raise new safety or effectiveness concerns.
• Bench Testing / System Verification: Conducting a series of engineering, safety, and performance evaluations on the device itself. This included:
  • Electromagnetic Compatibility (EMC) testing.
  • Electrical Safety testing.
  • Biocompatibility testing of patient-contacting materials.
  • Validation of cleaning, disinfection, and sterilization parameters.
  • Software validation.
  • Specific system verification for each applicator type (IPL, Bipolar RF & PMF, Fractional RF) to ensure measured outputs (e.g., fluence, RF voltage, output power, temperature) met predefined technical specifications and expected values.

In essence, the "acceptance criteria" were regulatory requirements for safety and performance equivalence to predicate devices, and the "study" was a combination of documentation outlining feature similarity and rigorous engineering verification testing. Clinical efficacy for specific indications, while implied by equivalence to predicates, was not proven through new clinical trials with patient cohorts described in this document.

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The Alma Lasers ALEX755 Module to be used with the Harmony XL™ Multi-Application Platform is indicated for permanent hair reduction. Also indicated for the treatment of vascular lesions and benign pigmented lesions.

The Alma Lasers ALEX755 Module is an additional module to the existing Alma Lasers. Ltd. Harmony XLTM Multi-Application Platform (previously cleared under K072564). The pistol-shaped Alex755 laser module incorporates a solid state Alexandrite rod laser medium and a xenon flash lamp as the heart of the optical bench. The flash lamp pumped Alexandrite rod emits light through an aperture located on the module tip. The laser beam is delivered when the operator presses both the footswitch, and the handpiece trieger. The Alma Lasers ALEX755 Module is comprised of the following components; An 'umbilical' cable and connector, that is permanently attached to the ALEX755 module body and semi-permanently attached to the laser system. Electrical cables (to provide power to the light source and to connect to a memory device that identifies the module). A supply and return water line (to remove the heat generated). Module body (shells) housing the module internals and connecting to the umbilical. The operator holds the handpiece by its handle in order to position the module tip against the patient's skin. Optional air-cooling can be provided.

This 510(k) summary describes a medical device, the Alma Lasers ALEX755 Module. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. The document focuses on regulatory approval based on substantial equivalence to predicate devices, rather than performance studies with defined acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or what is explicitly missing:

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

• Cannot be provided. This document does not describe specific acceptance criteria (e.g., a certain percentage of hair reduction, lesion clearance rate) or any performance data from a study. The approval is based on substantial equivalence, implying that its performance is expected to be similar to its predicates without explicit new performance data provided in this summary.

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

• Cannot be provided. No test set or clinical study data is reported in this document.

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

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

4. Adjudication method for the test set

• Cannot be provided. No test set or adjudication 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. This device is a laser module for treatment, not an AI-assisted diagnostic or interpretation system. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

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

• Cannot be provided. This device is a hardware laser module operated by a human. The concept of "standalone algorithm performance" doesn't apply.

7. The type of ground truth used

• Cannot be provided. No ground truth is described as no performance study is detailed.

8. The sample size for the training set

• Cannot be provided. No training set is described as no new algorithm development or performance study is detailed.

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

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

In summary, the provided text is a 510(k) summary for regulatory clearance based on substantial equivalence, not a report of a device performance study with acceptance criteria.

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The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology.

The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family with 415 - 950 nm wavelengths (with and without contact-cooling) are indicated for:

• Hair removal in all skin types (I-VI) to the Fitzpatrick scale. Permanent Hair Reduction. - Recommended wavelengths in the range of 635-950 nm or 580-950 nm
• Treatment of Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale -Recommended wavelength in the range of 535-950 nm
• Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm
• Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 415-950 nm

The proposed BEAMAX/ FORMAX family system is a pulsed light energy device based on a filtered, Xenon flashlamp.

The total emission spectrum of a Xenon flashlamp is from around 300 nm in the UV to 1000 nm in the near IR. The light emitted from the lamp is collected by a reflector and focused into a rectangular, waveguide. Prior to entering the waveguide, the light is transmitted through a longpass optical filter which blocks all wavelengths below the "cut-off" wavelength of the filter. Thus when a 635nm filter is used, only light of wavelengths above 635 nm is emitted. Since the lamp is surrounded by a water cooling jacket, actual wavelength emission is up to about 950 nm, due to water absorption of longer wavelengths.

The BEAMAX/FORMAX family system is equipped with four different handpieces which can be attached for different clinical applications. These handpieces differ in the optical filter applied, hence in the optical spectrum emitted, as well as in the time duration of the pulses emitted. A microprocessor based system controller is used to monitor and direct all system functions and Man Machine Interface.

The provided document is a 510(k) summary for the BEAMAX/ FORMAX Pulsed Light Device Family. This document focuses on demonstrating substantial equivalence to predicate devices rather than conducting a new clinical study to establish acceptance criteria and device performance from scratch. Therefore, many of the typical elements of a study that prove a device meets acceptance criteria are not present.

However, based on the information provided, here's an attempt to answer the request by interpreting "acceptance criteria" as the criteria for substantial equivalence, and "study" as the comparison to predicate devices:

Acceptance Criteria and Device Performance Study for BEAMAX/FORMAX Pulsed Light Device Family

Overview

The BEAMAX/FORMAX Pulsed Light Device Family sought 510(k) clearance by demonstrating substantial equivalence to legally marketed predicate devices, as opposed to conducting a de novo clinical trial with new performance acceptance criteria. The "acceptance criteria" here therefore refer to the criteria for substantial equivalence, and the "reported device performance" is framed by its similarity to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence submission, the "acceptance criteria" are the conditions under which the device is considered substantially equivalent to already cleared devices. The "reported device performance" is essentially that it matches or is comparable to these predicate devices for the specified indications.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Test Set: Not applicable in the context of a 510(k) substantial equivalence submission, as direct human clinical outcome data from a "test set" for the new device is not provided. The "test" here is the comparison against the characteristics and established safety/effectiveness of predicate devices already on the market.
• Data Provenance: The "data" for comparison comes from the regulatory filings and established performance of the identified predicate devices, which are already marketed in the US. There is no mention of country of origin for new clinical data, nor is there a distinction between retrospective or prospective data for a newly conducted study for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable. Ground truth, in the context of a 510(k) for substantial equivalence, is established by the FDA's prior clearance of the predicate devices based on their safety and effectiveness. No new expert consensus panel was convened for this specific submission to establish a "ground truth" for a new test set.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since there's no new test set with human subject data requiring expert review and adjudication for this submission, no adjudication method like 2+1 or 3+1 was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The documentation focuses on technological and indications-for-use equivalence rather than human reader performance with or without AI assistance. The device is a pulsed light system, not an AI diagnostic tool that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This device is an energy-based medical device (pulsed light system), not an algorithm or AI system. Its performance is inherent in its physical operation and energy delivery for therapeutic purposes.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The new device's characteristics, intended use, and indications are compared against these established "truths" to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable. As there is no training set for an AI/ML algorithm for this device, there is no ground truth established for such a set.

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