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The Youlaser PRIME family laser devices (Youlaser PRIME, Youlaser PRIME CO2, Youlaser PRIME MT) and accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).

Surgical Handpieces
Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with surgical handpieces are indicated for use for the particular indications as follows:

Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:

• · laser skin resurfacing
• · laser derm-abrasion
• · laser burn debridement.

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts.

OptiScan PRIME Scanner
Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with OptiScan PRIME scanner are indicated for:
·Laser skin resurfacing (ablation and/or vaporization) of soft tissue

Youlaser PRIME and Youlaser PRIME MT with wavelength of 1550nm used in combination with OptiScan PRIME scanner, are indicated for:
· Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue

Youlaser PRIME MT with wavelengths of 10600nm & 1550nm used in combination with OptiScan PRIME is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

The models of the Youlaser PRIME family are medical laser emitting at 10600nm (CO2 laser source), 1550nm, plus combined configurations.

The 1550nm laser source is a fiber laser, this wavelength lies in the invisible infrared part of the electromagnetic spectrum.

The CO2 laser source is an RF driven sealed gas tube emitting laser radiation both in continuous and pulsed mode in the invisible far-infrared part of the electromagnetic spectrum (10600nm).

The beam delivery system is an articulated arm with a handpiece or a scanner on its end.

The laser device is equipped with a display with a graphical user interface (GUI) for user-device interaction (e.g. laser parameters settings).

The scanner is also provided with a touchscreen display to select the scan pattern, shape, dimension,...etc. Laser emission is controlled via the external footswitch has an activation pedal which enables laser emission.

The provided text describes a 510(k) premarket notification for a laser surgical instrument. It details the device's technical specifications and compares them to predicate devices to demonstrate substantial equivalence. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of a human-in-the-loop or algorithm-only performance study as typically seen for AI/ML-based medical devices.

The "study" mentioned is an in vivo animal study (on minipigs) for the 1550nm fiber laser source to demonstrate safety and effectiveness, specifically regarding its ability to cause ablation and coagulation in tissue. This is a pre-clinical safety/performance study, not a clinical study assessing diagnostic or assistive performance against ground truth and acceptance criteria in the way an AI/ML device would be evaluated.

Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance is not present in the provided document.

Here's what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance goals for a diagnostic algorithm. The document focuses on demonstrating substantial equivalence to predicate devices in terms of technical characteristics and intended use, and safety and effectiveness through non-clinical (animal) testing.
• Reported Device Performance:
  • In vivo minipig study (for 1550nm fiber laser):
    • Outcome: "Testing was performed safely on the test animals, and the histology results complied with the FDA requirements, from 0 to 14 days."
    • "Re-epithelization was observed three days after radiation in all specimens."
    • "Slight erythema was noted as the primary side effect in higher energy settings, but it was transient and resolved within days."
    • "No cases of oedema were observed, and overall, the healing process was uncomplicated."
    • "Histologic analysis performed with H&E staining at various time points (days 1, 4, and 14) revealed predictable levels of ablation and coagulation depending on the energy settings used, with the fiber laser causing predominantly coagulation while the CO2 laser focused on ablation."
    • "By day 4, re-epithelization of the skin was already evident, and by day 14, the skin had fully healed."
  • Conclusion: "The Youlaser PRIME device demonstrates predictable and controlled skin ablation and coagulation, ensuring patient safety and clinical efficacy." and "The findings confirm that the device is equivalent to other approved technologies, with precise control over energy output and microspot density to facilitate rapid healing and minimize side effects."

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

• Test Set (for the in vivo study): "Three animals were used in this study."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It's an in vivo animal study, not human clinical data.

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

• Experts: Not explicitly stated. The document mentions "histologic analysis performed with H&E staining," which implies expert pathological assessment, but the number and qualifications of the pathologists are not provided.
• Ground truth context: For this type of device, "ground truth" would be the observed biological effects (ablation, coagulation, healing) in the animal tissue, as assessed histologically.

4. Adjudication method for the test set

• Not applicable/Not mentioned, as this was an evaluation of physical effects on tissue, not a diagnostic decision process requiring adjudication.

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. This type of study is for AI-assisted diagnostic devices. The Youlaser PRIME is a laser surgical instrument, and the evaluation presented is a non-clinical (animal) study of its physical effects, not a human-reader study.

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

• No. This is not an AI/algorithm-only device. The "study" refers to the laser's physical interaction with tissue.

7. The type of ground truth used

• For the in vivo animal study: Histology results (e.g., H&E staining at various time points) examining ablation, coagulation, and re-epithelialization in minipig skin tissue.

8. The sample size for the 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

• Not applicable. No training set for an AI/ML model.

Summary of Device and its Evaluation:

The Youlaser PRIME family devices are laser surgical instruments. The "study" mentioned in the document is an in vivo non-clinical study on minipigs designed to demonstrate the safety and effectiveness of the 1550nm fiber laser source by evaluating the biological response (ablation, coagulation, healing) in animal tissue. This type of evaluation is standard for surgical devices that interact directly with tissue, focusing on physical parameters and biological outcomes rather than diagnostic performance or human-AI interaction. The document's primary purpose is to establish substantial equivalence to legally marketed predicate devices, which is achieved by comparing technical specifications and demonstrating comparable safety and effectiveness through non-clinical testing.

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General intended use: Suprema Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.

Indications for use:
1064 nm (pulsed): Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The laser is also indicated for the treatment of facial wrinkles. Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as 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. It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The laser is also 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. It is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

532 nm (pulsed): Intended for the coagulation and hemostasis of vascular lesions. For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including but not limited to the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or ex-tremities telangiectasias, venous anomalies, leg veins]; benign pigmented lesions (nevi, lentigines, chloasma, cafe au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, flattening, reduction of lesion size).

755 nm (pulsed): Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs re-growing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

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

IPL 550-1200nm; 570-1200nm: Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment 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 Suprema Family is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.

Suprema family includes medical laser devices for dermatology and aesthetic medicine. It is used by health care professionals (dermatologists) in professional healthcare environments for the treatment of different skin conditions and hair removal. Suprema models differ for the installed laser sources only according to Table 1. Suprema devices are transportable mobile electrical equipment with a graphical user interface (GUI) for user-device interaction. Laser radiation is delivered through optical fibers connected to handpieces having fix or variable spot dimension. The device can be optionally equipped with an integrated skin cooler. In this case, a specific housing called Skin Cooler handpiece is provided to provide skin cooling the laser handpiece at the same time. Configurations without optional integrated skin cooler, can be used in conjunction with Cryo 6 skin cooler manufactured by Zimmer GmbH (K060395). In this case, an optional housing is provided which is called Skin Cryo handpiece. Laser handpieces cannot be used alone but only in conjunction to Skin Cooler and Skin Cryo handpieces. Laser emission can be activated by the footswitch or by a finger-switch placed on Skin Cooler and Skin Cryo handpieces. The device can be divided into four main sections: Power electronics, Control electronics, Cooling system, Optical bench. Suprema devices can be used in conjunction with Twain 2940 devices. Twain IPL and Twain 2940 are already FDA cleared (K202503, K173002, respectively).

This document describes a 510(k) premarket notification for a family of laser surgical instruments (Duetto Suprema, Domino Suprema, Suprema VT, Suprema VT+, Suprema 4V) for use in general and plastic surgery and in dermatology. The submission demonstrates substantial equivalence to predicate devices (Evo Platform K192160 and Chrome K202503).

Here's an analysis of the provided text in terms of acceptance criteria and the study that proves the device meets them:

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

The document does not present a formal table of quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for a diagnostic device) and then report performance against these criteria. Instead, it relies on demonstrating that the subject device's technical specifications and intended uses are comparable to those of already cleared predicate devices. The "acceptance criteria" here are implicitly that the new device's performance, as measured by its specifications and safety/efficacy profile, is substantially equivalent to the predicate devices.

The comparison table provided (Table 3 on pages 6-8) is the closest equivalent to reporting device performance relative to a benchmark.

• 1064nm & 755nm: Subject device max spot area 7% larger. Justified by lower energy/fluence for larger spots and no new thermal concerns.
• 532nm: Subject device max spot area 12x larger. Justified by 28x lower fluence for largest spots and equivalence of maximum fluence in small spots. |
  | Repetition Rate (max) | @1064 nm: 10 Hz
  @532 nm: 5 Hz
  @755 nm: 10 Hz | The same | Identical repetition rates. |
  | Skin Cooling | Three cooling levels | The same | Identical skin cooling capabilities. |
  | Twain IPL (Predicate: Chrome K202503) | (Specific IPL wavelengths for Chrome) | Same IPL wavelengths as Chrome | The Twain IPL accessory is identical to the Chrome family's. |
  | Twain IPL Pulse width (max) | 40 ms | The same | Identical pulse width for IPL. |
  | Twain IPL Spot size | 48mm x 13mm, 25mm x 13mm | The same | Identical spot sizes for IPL. |
  | Twain IPL Fluence (max) | 25 J/cm² | The same | Identical maximum fluence for IPL. |
  | Twain IPL Repetition rate | 3 Hz | The same | Identical repetition rate for IPL. |
  | Twain IPL Cooled waveguides | Three cooling levels | The same | Identical cooling for IPL waveguides. |
  | Indications for Use | Broad range of dermatological and surgical applications (vascular, pigmented lesions, hair reduction, wrinkles, acne for IPL) | The same | Indications for use are identical to the predicate device, across all wavelengths and IPL. |
  | Non-clinical testing | Compliance with various IEC/ISO standards | Compliance with various IEC/ISO standards | Tests (electrical safety, EMC, usability, software, laser safety, biocompatibility) were repeated for the subject device due to minor hardware/software changes or specific component differences. |

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

This submission is for a laser surgical instrument, and the provided text does not mention any clinical study involving patient data or a test set of clinical cases. The evaluation is based entirely on non-clinical testing (engineering verification and validation, performance testing against standards, and comparison of specifications to predicate devices). Therefore, there is no sample size for a test set or data provenance in the context of clinical performance.

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

Not applicable. As noted above, there was no clinical test set or ground truth established by experts in a clinical context. The evaluation relies on engineering standards and comparison to a predicate.

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

Not applicable, as there was no clinical test set requiring expert adjudication.

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 device is a laser surgical instrument, not an AI-assisted diagnostic or imaging device that would typically involve human readers or MRMC studies.

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

Not applicable. This is not an algorithm-only device. Its performance is related to its physical parameters (wavelength, fluence, spot size, etc.) and its electrical/mechanical safety and functionality.

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

For the non-clinical testing, the "ground truth" is defined by the technical specifications outlined in the predicate device's clearance and by compliance with recognized international standards (e.g., IEC 60601 series, IEC 60825-1, ISO 10993-1). The device's performance is measured against these engineering and safety standards, rather than clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning device that requires a training set.

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

Not applicable. There is no training set for this device.

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General intended use

The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.

Indications for use

1064 & 532 nm (Q-Switched, nanosecond mode)

The Discovery Pico Family is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:

532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:

Removal of light ink (red. sky blue, green, tan, purple, and orange) tattoos

Treatment of benign vascular lesions including, but not limited to:

• port wine birthmarks
• telangiectasias
• spider angiomaa
• Cherry angioma
• Spider nevi
• Treatment of benign pigmented lesions including, but not limited to:
• cafe-au-Iait birthmarks
• Ephalides, solar lentigines
• senile lentigines
• Becker's nevi
• freckles
• common nevi
• nevus spilus
• Ota Nevus
• Treatment of seborrheic keratosis

Treatment of post inflammatory hyperpigmentation

Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:

Removal of dark ink (black, blue and brown) tattoos

Removal of benign pigmented lesions including;

• nevus of Ota
• Café au lait spot
• Ephalides, solar lentigo (lentigines)
• Becker Nevus
• Nevus spilus
• Treatment of common nevi

Removal or lightening of unwanted hair

Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064 nm (non Q-Switched - free running mode)

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin.

Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.

Coagulation and hemostasis of soft tissue.

Treatment of wrinkles.

Treatment of mild to moderate inflammatory acne vulgaris.

532 nm (picosecond mode), also with fractional and microbeam handpieces:

Indicated for the removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.

Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV

1064 nm (picosecond mode), also with fractional and microbeam handpieces:

Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.

Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV

Only with fractional handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V

694 nm (O-Switched), including microbeam handpieces

Indicated for:

Tattoo removal: Suggested for blue, sky blue, black, green and violet ink Pigmented lesion removal (benign):

• Cafe au lait spot
• Ephalides, solar lentigo lentigines)
• Becker Nevus
• Ota and Ito Nevus
• Nevus spilus
• Mongolian spot

694 nm (non q-switch - free running mode)

Intended to remove benign dermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

IPL 590-1200nm; 625-1200nm; 650-1200nm

Indicated for permanent hair removal.

Permanent hair reduction 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

IPL 550-1200nm; 570-1200nm

Indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.

IPL 400-1200nm

Indicated for inflammatory acne (mild to moderate acne vulgaris).

Integrated Skin Cooler

The intended use of the integrated cooling system in the laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and benign vascular lesson, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.

The Discovery Pico Family is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at one or more of the following wavelengths: 532 nm, 1064 nm, 694 nm (Ruby laser)

The Discovery Pico Family systems, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm.

lt can also be connected to Er:YAG handpieces cleared under K173002.

The Discovery Pico Family systems, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems.

The optical delivery system is an articulated arm with fixed handpieces. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths.

All the models belonging to the Discovery Pico Family have the same components and the same controlling software. The only difference between different models is the optical bench that depends on the sources installed.

The Discovery Pico Family is controlled via a touch screen display housed in the front of the device.

Emission is triggered by means of a footswitch.

The provided text is a 510(k) summary for the Discovery Pico Family laser device, submitted to the FDA. It details a modification to an already cleared device, primarily the addition of microbeam handpieces. As such, the acceptance criteria and performance data presented are focused on engineering and safety performance, rather than clinical efficacy or diagnostic accuracy as would be the case for an AI/ML-driven diagnostic device.

Therefore, many of the requested fields related to clinical studies, human reader performance, ground truth establishment for clinical data, and training set information are not applicable to this type of device submission.

Here's the information derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not applicable / Not specified. The performance data described are related to engineering and safety bench tests (e.g., electrical safety, EMC, output measurements on microbeam handpieces) and software validation. These do not typically involve patient-specific test sets in the same way clinical diagnostic studies do. The phrase "Bench testing measurements were done" implies testing on physical units/components, not patient data.

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

• Not applicable. For engineering and safety tests, the "ground truth" is typically established by objective measurements against predefined specifications and recognized standards, not by expert human interpretation of clinical data.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in a clinical study. This device's testing involves objective measurements against engineering standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI-assisted diagnostic device, but a physical laser device for surgical and aesthetic applications. Therefore, an MRMC study and AI assistance effect size are not relevant.

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

• No. This is a physical laser device, not an algorithm. The software verification and validation are for controlling the device, not for making independent diagnostic or therapeutic decisions.

7. The type of ground truth used:

• For electrical safety, EMC, and laser safety: Compliance with recognized consensus standards (e.g., IEC 60601 series, IEC 60825-1).
• For microbeam handpiece output: Physical bench measurements to confirm output against design specifications.
• For software: Verification and validation against software requirements as per FDA guidance.
• For biocompatibility: Reference to the predicate device.

8. The sample size for the training set:

• Not applicable. As this is not an AI/ML device, there is no "training set" in the context of machine learning.

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

• Not applicable. No training set was used for an AI/ML algorithm.

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The EVO Platform is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.

Indications for use

1064 & 532 nm (O-Switched, nanosecond mode) The EVO Platform is intended for treatment of vascular lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:

532 nm (Q-Switched, nanosecond mode)

Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos

Treatment of vascular lesions including, but not limited to:

• port wine birthmarks
• telangiectasias
• spider angiomaa
• Cherry angioma
• Spider nevi

Treatment of benign pigmented lesions including, but not limited to:

• cafe-au-Iait birthmarks
• Ephalides, solar lentigines
• senile lentigines
• Becker's nevi
• freckles
• common nevi
• nevus spilus
• Ota Nevus

Treatment of seborrheic keratosis

Treatment of post inflammatory hyperpigmentation

Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (O-Switched, nanosecond mode)

Removal of dark ink (black, blue and brown) tattoos

Removal of benign pigmented lesions including;

• nevus of Ota
• Café au lait spot
• Ephalides, solar lentigo (lentigines)
• Becker Nevus
• Nevus spilus

Treatment of common nevi

Removal or lightening of unwanted hair

Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064 nm (non O-Switched - free running mode)

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin.

Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to port wine stains,

hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.

Coagulation and hemostasis of soft tissue.

Treatment of wrinkles.

Treatment of mild to moderate inflammatory acne vulgaris.

1064 nm (pulsed)

Dermatology/Plastic Surgery:

Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis.

The laser is also intended for the treatment of benign pigmented lessons such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, verrucae, skin tags, keratosis and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The laser is also indicated for the treatment of facial wrinkles.

Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as 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.

It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The laser is also indicated for pigmented 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.

It is indicated for use on all skin types (Fitzpatrick I-VI ) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

532 nm (pulsed)

Intended for the coagulation and hemostasis of vascular lesions.

Dermatology/Plastic Surgery:

For photocoagulation and hemostasis of vascular and cutaneous lesions in dermatology including but not limited to the following general categories: vascular lesions [angiomas (port wine), telangiectasia (facial or ex-tremities telangiectasias, venous anomalies, leg veins]; benign pigmented lesions (nevi, lentigines, chloasma, cafe au- lait, tattoos (red and green ink), verrucae, skin tags, keratoses, plaques, cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).

694 nm (Q-Switched)

Indicated for:

Tattoo removal: Suggested for blue, sky blue, black, green and violet ink

Pigmented lesion removal (benign):

• Cafe au lait spot
• Ephalides, solar lentigo lentigines)
• Becker Nevus
• Ota and Ito Nevus
• Nevus spilus
• Mongolian spot

694 nm (non q-switch – free running mode)

Intended to remove benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

755 nm (pulsed)

Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

1320 nm (pulsed)

Indicated for use in general surgery and dermatology for the incision, ablation, vaporization, coagulation and haemostasis of soft tissue. It is also indicated for the treatment of perioral wrinkles, fine lines and wrinkles, and the treatment of back acne and atrophic acne scars.

IPL 590-1200nm; 625-1200nm; 650-1200nm

Indicated for permanent hair removal.

Permanent hair reduction 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

IPL 550-1200nm; 570-1200nm

Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment 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 EVO Platform is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.

The EVO Platform is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.

The provided text is an FDA 510(k) clearance letter for the Quanta System S.p.A. EVO Platform, a laser surgical instrument. It details the device's indications for use.

Crucially, it does not contain any information regarding acceptance criteria, study methodologies, or performance data for proving that the device meets specific acceptance criteria.

The document focuses on:

• The FDA's determination of substantial equivalence to a predicate device.
• Regulatory classifications and requirements.
• Detailed indications for use for various wavelengths (1064 nm, 532 nm, 694 nm, 755 nm, 1320 nm), IPL (590-1200nm, 625-1200nm, 650-1200nm, 550-1200nm, 570-1200nm, 400-1200nm), and an integrated skin cooler, across different aesthetic and surgical applications.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance: This data is not present.
2. Sample size used for the test set and its data provenance: This information is not present.
3. Number of experts and their qualifications for ground truth: This information is not present.
4. Adjudication method for the test set: This information is not present.
5. MRMC comparative effectiveness study details: This information is not present.
6. Standalone performance details: This information is not present.
7. Type of ground truth used: This information is not present.
8. Training set sample size: This information is not present.
9. How ground truth for the training set was established: This information is not present.

The FDA 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring the submission of detailed clinical performance study results unless specifically requested by the FDA (e.g., for novel technologies or significant changes in indications). This document is a clearance letter, not a study report.

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2940 nm Er: Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) 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). With microbeam end piece it is indicated for Skin resurfacing.

2940nm Er:YAG handpiece is the same as the one cleared with Quanta Forte platform (K152714), with the addition of a microbeam end piece. 2940nm Er:YAG is an handpiece that can work in conjunction with Quanta System FDA cleared devices (Quanta Forte and EVO and Discovery Pico Platform) provided with a suitable connector for recognizing and controlling the handpiece. Its emission is triggered by means of a footswitch connected to the console of the device it is used with.

The provided document is a 510(k) Pre-market Notification from the FDA for a medical device called the "2940 nm Er:Yag Laser Handpiece." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or meeting specific performance criteria through novel studies.

Therefore, the document does not contain the acceptance criteria and study details that would typically be associated with performance evaluation for a new, innovative device proving clinical effectiveness. Instead, it relies on demonstrating that the new handpiece is sufficiently similar in technology and intended use to existing cleared devices to be considered safe and effective.

Here's a breakdown of why the requested information is not available in the provided text:

• Acceptance Criteria for Performance: The document states, "There are no mandatory performance standards for this device." This means there aren't pre-defined quantitative thresholds (like sensitivity, specificity, or image quality metrics) that the device must meet. The FDA's evaluation for a 510(k) is primarily about substantial equivalence.
• Study Proving Device Meets Acceptance Criteria: Since no specific performance acceptance criteria are defined, there is no corresponding study designed to prove the device meets those criteria in the way one might expect for a diagnostic or novel therapeutic device.

However, the document does contain information about performance data provided in support of the substantial equivalence determination. This includes:

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

   Characteristic	Acceptance Criteria (Not explicitly stated as such, but rather characteristics for substantial equivalence comparison)	Reported Device Performance (2940 nm Er:YAG Laser Handpiece)
   Safety & EMC	Compliance with IEC 60601-1, IEC 60601-2-22, IEC 60601-1-2	Complies with IEC 60601-1, IEC 60601-2-22 (safety) and IEC 60601-1-2 (EMC)
   Software V&V	Verification and Validation according to FDA Guidance for Software in Medical Devices	Successfully underwent verification and validation testing, documentation provided as recommended by FDA guidance.
   Histological Performance	Substantially equivalent skin resurfacing effects to predicate devices with a microlens array.	Histological performance data are provided to demonstrate substantially equivalent skin resurfacing effects to its predicate devices with a microlens array.
   Biocompatibility	Established based on predicate devices.	Biocompatibility established based on predicate devices.
   Technological Similarities to Predicates	(Various parameters listed in the "Summary of technological similarities and differences" table)	See the detailed table below for comparison to primary and additional predicates.

   Technological Comparison Table from Document (Summarized):

   Specifications	Subject Device (2940 nm Er:YAG Laser Handpiece)	Primary Predicate (Quanta Forte - K152714)	Additional Predicate (Fotona F-22/FS-01 Laser Handpiece - K132806)	Additional Predicate (MicroSpot Handpiece - K152153)
   Laser medium	Er:YAG	Er:YAG	Er:YAG	Er:YAG
   Wavelength [nm]	2940	2940	2940	2940
   Energy, max [J]	3	3	3	2.5
   Fluence [J/cm²]	Up to 95 (non-microbeam); Up to 121 (with stacking – microbeam)	Up to 95 (non-microbeam)	Up to 300 (stacking – microbeam)	Up to 51 (stacking – microbeam with 600 µm dots); Up to 150 (stacking – microbeam with 300 µm dots)
   Pulse duration [ms]	0.3 to 1.5 ms	1 to 1.5 ms	0.1 to 1.5 ms	0.1 - 1.0 ms
   Repetition rate, max [Hz]	6	5	50	20
   Spot size	Ø 2, 4, 9mm; Ø 9mm dots array	Ø 2, 4, 9mm	13x13 mm dots array	13x13 mm dots array

2. Sample size used for the test set and the data provenance: This information is not provided in the document. The document refers to "histological performance data" but does not detail the study design, sample size, or data provenance (e.g., country, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. As there's no mention of a clinical "test set" with expert adjudicated ground truth the way you'd find for an AI diagnostic device, these details are absent.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided for the same reasons as point 3.

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: This type of study is completely irrelevant to the device described (a laser handpiece for dermatological procedures) and is therefore not mentioned or performed. This is not an AI diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This device is a surgical laser handpiece; it does not operate as a standalone algorithm. Its performance is directly tied to its physical interaction with tissue under human control. Therefore, this concept is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The document mentions "histological performance data" for skin resurfacing effects. This implies that the ground truth for evaluating the laser's effect on tissue would likely be pathology/histology reports or visual assessment of tissue changes, compared to the effects achieved by predicate devices. However, the exact nature of this "ground truth" and how it was established for the comparison is not detailed.

8. The sample size for the training set: This device is a physical medical instrument, not an AI model that requires a training set. Therefore, this question is not applicable.

9. How the ground truth for the training set was established: This question is not applicable as there is no AI training set for this device.

In summary:

The provided FDA 510(k) document is for a physical medical device (laser handpiece), not an AI diagnostic tool. Therefore, many of the questions related to AI performance metrics, expert adjudication, and training/test sets are not applicable or detailed in this type of submission. The "study" mentioned mainly involves demonstrating compliance with electrical safety, EMC standards, and providing histological data to show comparable effects to predicate devices, thereby establishing substantial equivalence.

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The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery. Specific indications include treatment of benign vascular lesions, benign pigmented lesions, hair removal, tattoo removal, skin resurfacing for acne scars and wrinkles, photocoagulation and hemostasis of benign pigmented and benign vascular lesions, coagulation and hemostasis of soft tissue, treatment of wrinkles, and treatment of mild to moderate inflammatory acne vulgaris.

The Discovery Pico Family is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at one or more of the following wavelengths: 532 nm, 1064 nm, 694 nm (Ruby laser). The systems can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm. The systems, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems. The optical delivery system is an articulated arm with fixed handpieces or a handpiece (Twain IPL) with fixed or interchangeable light filters. All models have the same components and control software, differing only in the installed optical bench. The device is controlled via a touch screen display and emission is triggered by a footswitch.

The provided FDA 510(k) summary for the Discovery Pico Family laser system focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for clinical efficacy through a standalone study.

Therefore, many of the requested details about acceptance criteria, clinical study specifics, and ground truth establishment are not present in this document. The document primarily relies on engineering performance standards and a comparative analysis with predicate devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria for clinical performance (e.g., specific percentages of tattoo clearance or lesion removal). Instead, it states compliance with recognized engineering performance standards and "thermal-histology performance data for fractional handpieces." It also asserts that "the device performs as intended" and is "substantially equivalent to the predicate devices."

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

• Sample Size for Test Set: Not applicable/Not provided. The document does not describe a clinical test set with human subjects for efficacy evaluation beyond what might be implied by "thermal-histology performance data."
• Data Provenance: Not applicable/Not provided for clinical efficacy. The engineering standards compliance refers to internal company testing.

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

• Not applicable. There is no mention of a ground truth established by experts for clinical performance, as the submission focuses on substantial equivalence based on technical characteristics and predicate devices, rather than a clinical trial with a defined ground truth.

4. Adjudication Method

• Not applicable. No clinical study with a read-out or adjudication method is described.

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

• No. An MRMC study was not done, as this is a laser device and not an imaging AI diagnostic tool that would typically involve multiple readers. The document implicitly compares the new device's capabilities to predicate devices, but not in a formal MRMC study format.

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

• Not applicable. This is a physical laser device, not an algorithm, so the concept of "standalone performance" in the context of AI algorithms doesn't directly apply. The device's standalone performance is assessed through its compliance with engineering standards.

7. The Type of Ground Truth Used

• The ground truth used for relevant aspects where data is mentioned would be:
  • Engineering Standards: Compliance with established safety and performance requirements set by IEC standards.
  • Thermal-histology data: This would typically involve histological analysis of treated tissue in an experimental setting (e.g., animal or ex vivo human tissue) to assess the thermal impact, which serves as a form of ground truth for tissue response. Details are not provided.
  • Biocompatibility: Established by reference to predicate device characteristics.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a training set in the typical sense.

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

• Not applicable. No training set is used for this type of medical device submission.

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The device is intended for treatment of benign vascular and benign pigmented lesions.

585 is a diode laser device used mainly for dermatology. It includes a main panel with the touch screen display, the optical fiber connector (SMA 905) and the status LEDs. On the rear panel the connectors for footswitch, remote interlock and power supply cable are located. The key switch and the emergency knob are located on the upper part of the device. The laser system is composed of an opto-mechanical block containing the laser source and heat dissipation system, aiming beam, control system and power electronics. The power electrical system is composed of a power supply. The control electronics, based on a microcontroller, manages power electronics, thermalization of the laser source and controls the user interface. Emission is triggered by means of a footswitch.

This FDA 510(k) summary provides information for a laser surgical instrument (585) for dermatological use. However, it does not contain the specific details required to answer your questions about acceptance criteria and a study proving those criteria are met, especially in the context of an AI/algorithm-based device.

The document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device. This means the performance data supplied is primarily related to the physical and electrical safety and characteristics of the laser, not the analytical or clinical performance of an AI model.

Here's a breakdown of why and what information is missing:

• No AI/Algorithm Component: The device described (Quanta System S.p.A. 585) is a physical laser surgical instrument. There is no mention of it containing any AI, algorithm, or software that performs diagnostic, prognostic, or treatment planning functions requiring a "test set," "ground truth," "experts," or "MRMC studies." The "Software Verification and Validation Testing" mentioned refers to the control software for the laser device itself, not an AI component analyzing images or data.
• Performance Data Type: The "Performance data" section refers to:
  • Safety and electromagnetic compatibility (EMC): Compliance with IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 62366, IEC 60601-2-22, and IEC 60825-1). This is about the electrical and physical safety of the laser, not its analytical performance in identifying lesions.
  • Software Verification and Validation Testing: This pertains to the internal control software of the laser device, ensuring it operates correctly, not an AI model.
  • Biocompatibility: Established based on predicate devices, ensuring materials are safe for biological contact. This is also not related to AI performance.
• Substantial Equivalence: The primary argument for approval is "substantial equivalence" to existing laser devices, meaning it has similar intended use, indications for use, and technological characteristics (laser type, wavelength, pulse width, frequency, spot size). This comparison doesn't involve AI performance metrics.

Therefore, I cannot populate the table or answer the specific questions you've asked because the provided document does not describe an AI or algorithm-based device, nor does it contain the type of performance study details requested.

To answer your questions, I would need a 510(k) summary or an FDA approval document for a medical device that incorporates an AI or algorithm component for which clinical performance data, ground truth establishment, and expert review are relevant.

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The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.

Indications for use

1064 & 532 nm (Q-Switched, nanosecond mode)

The Discovery Pico Family is intended for treatment of vascular lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:

532 nm (Q-Switched, nanosecond mode)

Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos

Treatment of vascular lesions including, but not limited to:

• port wine birthmarks
• telangiectasias
• spider angiomaa
• Cherry angioma
• Spider nevi

Treatment of benign pigmented lesions including, but not limited to:

• cafe-au-Iait birthmarks
• Ephalides, solar lentigines
• senile lentigines
• Becker's nevi
• freckles
• common nevi
• nevus spilus
• Ota Nevus

Treatment of seborrheic keratosis

Treatment of post inflammatory hyperpigmentation

Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (Q-Switched, nanosecond mode)

Removal of dark ink (black, blue and brown) tattoos

Removal of benign pigmented lesions including;

• nevus of Ota
• Café au lait spot
• Ephalides, solar lentigo (lentigines)
• Becker Nevus
• Nevus spilus
• Treatment of common nevi

Removal or lightening of unwanted hair

Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064 nm (non Q-Switched - free running mode)

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin.

Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to port wine stains,

hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.

Coagulation and hemostasis of soft tissue.

Treatment of wrinkles.

Treatment of mild to moderate inflammatory acne vulgaris.

532 nm (picosecond mode) . also with fractional handpiece

Indicated for the removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.

1064 nm (picosecond mode), also with fractional handpiece

Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.

694 nm (Q-Switched)

Indicated for:

Tattoo removal: Suggested for blue, sky blue, black, green and violet ink

Pigmented lesion removal (benign):

• Cafe au lait spot
• Ephalides, solar lentigo lentigines)
• Becker Nevus
• Ota and Ito Nevus
• Nevus spilus
• Mongolian spot

694 nm (non q-switch - free running mode)

Intended to remove benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.

IPL 590-1200nm; 625-1200nm; 650-1200nm

Indicated for permanent hair removal.

Permanent hair reduction 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

IPL 550-1200nm; 570-1200nm

Indicated for photocoagulation of dermatological vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment 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 laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.

The Discovery Pico Family is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at one or more of the following wavelengths: 532 nm, 1064 nm, 694 nm (Ruby laser). The Discovery Pico Family systems, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm. The Discovery Pico Family systems, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems. The optical delivery system is an articulated arm with fixed handpieces. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths. All the models belonging to the Discovery Pico Family have the same components and the same control software. The only difference between different models is the optical bench that depends on the sources installed. The Discovery Pico Family is controlled via a touch screen display housed in the front of the device. Emission is triggered by means of a footswitch.

The provided document is a 510(k) summary for the Discovery Pico Family laser system, which describes its modifications and substantial equivalence to predicate devices. It does not contain information about acceptance criteria, specific device performance metrics, or a study design in the way typically expected for a clinical validation or AI-based device. Instead, it focuses on regulatory compliance and the safety/effectiveness of a modified laser device.

However, I can extract the relevant information that is present in the document which aligns with some of your requested categories, and indicate where the requested information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "There are no mandatory performance standards for this device." Instead of specific numerical acceptance criteria for clinical performance, the approval is based on compliance with electrical and safety standards, and equivalence to predicate devices.

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

Not applicable. This document describes a medical device clearance based on substantial equivalence and compliance with engineering standards, not a clinical study involving a test set of data. The "test set" in this context refers to engineering and safety performance tests of the device itself, not a dataset for evaluating an algorithm's diagnostic or predictive performance.

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

Not applicable. (See explanation for point 2).

4. Adjudication method for the test set

Not applicable. (See explanation for point 2).

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 not an AI-based diagnostic or imaging device. It is a laser surgical instrument.

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

Not applicable. This device is a laser system, not an algorithm.

7. The type of ground truth used

For the engineering and safety performance tests mentioned, the "ground truth" would be established by validated test methods and measurements against established engineering and safety standards. For example, laser power output would be measured with calibrated equipment, and electrical safety would be verified according to IEC standards.

8. The sample size for the training set

Not applicable. (See explanation for point 2).

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

Not applicable. (See explanation for point 2).

Summary of Study (Based on the provided document):

The "study" described in this 510(k) summary is a regulatory submission demonstrating the substantial equivalence of the modified Discovery Pico Family laser system to previously cleared predicate devices. The primary focus is on proving that the modified device (with added fractional handpieces) maintains the same intended use, indications for use, and fundamental scientific technology as its unmodified predecessor (K163222), and that any differences do not raise new questions of safety or effectiveness.

The document highlights compliance with several recognized consensus standards (IEC 60601-2-22, IEC 60825-1, IEC 60601-1, IEC 60601-1-2) which cover general safety, laser safety, and electromagnetic compatibility for medical electrical equipment. It also mentions "Thermal-histology performance data for fractional handpieces" as being provided, which would involve laboratory/bench testing. Software verification and validation testing were also conducted.

There is no mention of clinical trials, human reader studies, or AI algorithm performance evaluations because the device is a laser system whose safety and effectiveness are established through compliance with existing standards and comparison to legally marketed predicate devices, rather than through novel diagnostic performance.

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The THUNDER Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.

1064 nm (pulsed)
Dermatology/Plastic Surgery:
Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis.
The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The laser is also indicated for the treatment of facial wrinkles.
Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months affer the completion of a treatment regime.
It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The laser is also 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.
It is indicated for use on all skin types (Fitzpatrick I-VI ) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

755 nm (pulsed)
Indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured 6, 9, or 12 months after the completion of a treatment regime. It is used for all skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

Skin Cooler
The intended use of the integrated cooling system in the Thunder family is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesion, and to reduce the potential side effects of laser treatments.

This Special 510(k) of the modified device Thunder family is submitted due to Device Modifications of the already cleared device EVO family (K160368) due to hardware and software change, together with a broadening of the range of some laser emission parameters.

This document details a 510(k) premarket notification for the "Thunder" family of laser devices, focusing on modifications made to an already cleared device, the "EVO family" (K160368). The submission aims to demonstrate substantial equivalence to the predicate device despite hardware and software changes and a broadening of laser emission parameters.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "There are no mandatory performance standards for this device." This implies that specific quantitative acceptance criteria in terms of device accuracy, sensitivity, or specificity (as one might find for diagnostic AI models) are not applicable or provided within this submission.

Instead, the acceptance criteria are framed in terms of compliance with established safety and performance standards for medical electrical equipment and laser products. The reported "performance" is that the modified device "successfully passed" these tests.

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

No information is provided regarding a "test set" in the context of clinical data or patient samples. The testing described is against engineering and safety standards, not a clinical dataset. Therefore, there is no mention of sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). This device is a laser system for surgical/dermatological applications, not a diagnostic AI device requiring clinical ground truth for validation.

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

Not applicable. The "ground truth" for this device revolves around its compliance with safety and performance engineering standards, not medical diagnoses. Therefore, there's no mention of experts establishing a clinical ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable, as there is no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

Not applicable. This device is a laser system for treatment, not a diagnostic tool that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

Not applicable in the typical sense of an AI algorithm. The device, as a laser system, operates "standalone" in that its hardware and software functions are tested independently of a human operator making a diagnostic decision. However, its intended use is always with a human operator. The performance testing focuses on the device's adherence to engineering specifications and safety standards as an independent unit.

7. The Type of Ground Truth Used:

The ground truth used for this device is compliance with established international and harmonized engineering and safety standards (e.g., IEC 60601 series, IEC 60825-1). This is a technical "ground truth" as opposed to a clinical or pathological ground truth:

• Safety Standards: Adherence to defined limits for electrical safety, EMI/EMC, laser output, etc.
• Performance Standards: The device meets its specified technical parameters (e.g., laser wavelength, power, pulse duration) within acceptable tolerances, which is evaluated during performance testing.
• Usability Standards: The device's user interface and operational aspects meet usability requirements.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device (laser system), not an AI model trained on a dataset. There is no concept of a "training set" for the device itself or its modifications as described in this 510(k) summary.

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

Not applicable, as there is no training set for this type of device.

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INTENDED USE

The device Litho including a fiber optic delivery system is intended to be used in surgical procedures such as open. laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones.

INDICATIONS FOR USE

The device Litho including a fiber optic delivery system is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones in medical specialties including, but not limited to:

• Urology
• Gastroenterology
• Arthroscopy
• Neurosurgery
• Pulmonary
• Gynecology
• ENT
• Dermatology
• Plastic Surgery
• General Surgery

The modified device Litho is a Laser surgical instrument for use in general and plastic surgery and in dermatology (GEX). Both devices are Pulsed Holmium: YAG laser with a maximum output power of 30 W @ 2.1 um. The device Litho including a fiber optic delivery system is intended to surgical procedures such as open, laparoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones.

The provided text is a 510(k) summary for the Quanta Litho device, which details modifications made to an already cleared laser surgical instrument. This document does NOT contain a study that proves the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device after minor modifications and an update to regulatory standards.

Therefore, many of the requested sections about acceptance criteria, device performance studies, sample sizes, expert involvement, and ground truth establishment cannot be answered from the provided text. The document states "There are no mandatory performance standards for this device," indicating a lack of explicitly defined performance-based acceptance criteria in the context of this submission.

Here's what can be extracted and what cannot:

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

Missing/Not Applicable from the document: Specific quantitative (e.g., accuracy, sensitivity, specificity, or surgical outcome metrics) acceptance criteria typically found in performance studies for new or significantly modified devices. This submission is for incremental changes and regulatory updates, not a new performance claim.

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

• Not applicable / Not mentioned. The document describes device modifications and regulatory updates, not a clinical or performance study involving a "test set" of data or patients. "Verification and validation activities" are mentioned, but no details on their methodology or sample size are provided.

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 mentioned. No information about experts or ground truth establishment for a test set is present. The document mentions "physicians' feedbacks" for GUI changes and laser parameter combinations, but this is not related to establishing ground truth for a performance study.

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

• Not applicable / Not mentioned. There is no "test set" or 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

• No. This device is a laser surgical instrument, not an AI or diagnostic imaging device. Therefore, an MRMC study is not relevant and was not performed.

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

• No. This is a physical laser surgical instrument. The concept of "standalone algorithm performance" is not applicable.

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

• Not applicable / Not mentioned. As no performance study with a "test set" is described, no ground truth type is specified. The modifications relate to safety, electrical standards, and usability improvements, not clinical performance metrics requiring ground truth.

8. The sample size for the training set

• Not applicable / Not mentioned. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable / Not mentioned. Same as above, no training set or ground truth establishment for such a set.

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