Search Results

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.

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

INTENDED USE

The device Litho DK30 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 DK30 including a fiber optic delivery system is insurgical 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 DK30 is a Laser surgical instrument for use in general and plastic surgery and in dermatology (GEX). This Special 510(k) of the modified device Litho DK30 is submitted due to Device Modifications of the already cleared device Litho (K091909): Litho DK30 is the desktop version of the already cleared device Litho (K09109). 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 be used in 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 does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for device modifications (Litho DK30) to an already cleared device (Litho). It focuses on demonstrating substantial equivalence to the predicate device due to minor modifications that do not change the fundamental scientific technology or intended use.

This is a regulatory submission for device modifications, not a study evaluating performance against specific acceptance criteria. The device is a "Laser surgical instrument for use in general and plastic surgery and in dermatology," and the modifications are primarily mechanical, electrical and software changes to create a desktop version of an existing device.

Therefore, I cannot provide the requested information as it is not present in the given text.

Ask a specific question about this device

Quanta Systems Surgical Laser Fibers are intended to be used in conjunction with any cleared surgical laser manufactured by Quanta system equipped with SMA 905 connector.

Quanta Systems Surgical Laser Fibers are indicated for use in general surgery applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact mode (with a compatible laser marketed for use in the desired application).

Quanta System Surgical Laser Fibers (surgical fiber optic laser delivery devices) are indicated for use in general surgery, urology, gastroenterology, dermatology, vascular surgery, neurosurgery, plastic surgery. ENT/ololaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.

Quanta System Surgical Laser Fibers are also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated with an approved compatible laser marketed for use in the desired application.

Quanta System Surgical Laser Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue with an approved compatible laser marketed for use in the desired application.

Quanta System Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application.

Quanta System Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode.

Quanta System Surgical Laser Fibers are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho:YAG, Nd;YAG, Tm:YAG pulsed and continuous wave CW laser devices.

Quanta System Surgical Laser Fibers may be used in surgical specially or procedures for which compatible lasers have received regulatory clearance: for a complete information about applications, contraindications, precautions and warnings when using fiber optic it is necessary to refer to the applicable laser device User Manual.

The Quanta System Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber jacketed with ethylene tetraffluoroethylene (ETFE). The devices are 3.0 meters (9.8 ft) in length and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations and various core diameter sizes (150, 200, 272, 365, 400, 800 and 1000 microns) are offered.

The Quanta System Surgical Laser Fibers are single-use sterile medical devices, supplied sterilized by Ethylene Oxide (EtO).

The provided text describes the 510(k) summary for Quanta System Surgical Laser Fibers, focusing on their substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or diagnostic device. As such, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth is not applicable.

However, I can extract information related to the performance and safety testing conducted to support the device's substantial equivalence.

Here's an attempt to answer your questions based on the available information:

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

The document does not explicitly state quantitative "acceptance criteria" for clinical performance that would typically be found in studies for diagnostic or AI devices (e.g., sensitivity, specificity thresholds). Instead, it refers to a "full plan of non-clinical performance tests" to demonstrate safety and effectiveness. The acceptance criteria for these tests would be compliance with the referenced standards and internal methods.

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

Not applicable. This is not a study involving a "test set" of clinical data in the context of an AI or diagnostic device. The performance evaluation is based on non-clinical engineering and biological tests of the device itself.

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's performance is established by compliance with recognized engineering, sterilization, and biocompatibility standards, not by expert consensus on clinical cases.

4. Adjudication method for the test set

Not applicable. There is no clinical "test set" or adjudication process 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

Not applicable. This device is a surgical laser fiber, not an AI or diagnostic tool that assists human readers.

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

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used

For the non-clinical performance tests, the "ground truth" is defined by:

• International Standards: ISO 14971:2009, ISO 10993-1:2008, ISO 11135-1:2007, ISO 11607-1.2009, ISO 17664:2004.
• FDA Guidance Documents: FDA Blue Book Memo G95-1, FDA Sterility Review Guidance K90, FDA MDUFMA Validation Data in 510(k) for Reprocessed single-use medical device.
• Internal Methods: Visual, mechanical, and functional (optical) tests were conducted according to internal methods.

The overall "ground truth" for the 510(k) submission is that the device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device with a training set.

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

Not applicable. As above, there is no training set mentioned.

Ask a specific question about this device

YOULASER CO2 laser when used in traditional, non fractionated mode is indicated for: incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery.

YOULASER CO2 laser when used in fractionated mode (dot scanner) is indicated only for ablative skin resurfacing.

The YOULASER CO2 Laser System includes a single model named YOULASER CO2 emitting a maximum power of 30 Watt at 10.6 µm.

The YOULASER CO2 Laser is composed externally of a metallic shell with a frontal polyurethane panel containing the touch screen display. On this panel the key switch, emergency red push button and the operation led are inserted too. On the rear panel the footswitch connector, the remote interlock, the power switch are located.

The laser system is composed of power supply, CO2 laser source with air cooling system, optical bench, articulated arm with CO2 scanner, the control electronics.

The electronic, based on a microcontroller, manages the voltage power supply and the CO2 laser source.

This submission describes a medical device, the YOULASER CO2 laser system, seeking 510(k) clearance. The device is a Class II laser surgical instrument for use in general and plastic surgery and dermatology. It operates in both traditional (non-fractionated) and fractionated modes.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly state specific quantifiable acceptance criteria for performance metrics. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The performance evaluation is described qualitatively as "safety and effectiveness" and "ablation, coagulation depth and the healing evolution of the skin at the typical settings of use of Youlaser CO2."

   Therefore, a table of acceptance criteria and reported device performance cannot be generated with specific numerical values from this document. The overall acceptance criterion is "substantial equivalence" to the predicate devices. The reported device performance is that it was found to be "as safe as effective as the predicated devices" based on the described non-clinical testing.

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

   The document mentions a "specific non clinical testing was conducted on the proposed YOULASER CO2 device." However, it does not provide details about the sample size used for this test set.

   Regarding data provenance, the testing was conducted on the "proposed YOULASER CO2 device," implying this was a prospective study using the actual device. The country of origin of the data is not explicitly stated, but the applicant/manufacturer is Quanta System SPA, based in Italy.

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

   The document does not mention the use of experts to establish ground truth for the non-clinical testing. The assessment of "ablation, coagulation depth and the healing evolution of the skin" would likely be through objective measurements and potentially histological analysis rather than expert consensus on subjective outcomes.

4. Adjudication Method for the Test Set:

   Since no experts are mentioned for establishing ground truth, there is no adjudication method described. The non-clinical testing appears to be based on objective measurements related to the laser's effects on tissue.

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

   No, an MRMC comparative effectiveness study was not done. The device in question is a surgical laser, not an imaging diagnostic tool that would typically involve multiple readers interpreting cases. The testing described is non-clinical and assesses direct tissue interaction.

6. Standalone (Algorithm Only) Performance Study:

   No, a standalone (algorithm only) performance study was not done. This device is a physical surgical laser, not an AI algorithm. Therefore, "algorithm only" performance is not applicable.

7. Type of Ground Truth Used:

   The "ground truth" for the non-clinical testing appears to be based on objective measurements of tissue response to the laser parameters. This includes "ablation, coagulation depth and the healing evolution of the skin." This would involve direct physical or biological measurements/observations, likely including histological analysis, rather than expert consensus on a subjective interpretation, pathology of a disease state, or patient outcomes data in an extensive clinical trial setting.

8. Sample Size for the Training Set:

   Since this is a physical medical device and the testing focuses on its physical effects rather than an AI algorithm, the concept of a "training set" in the context of machine learning is not applicable or mentioned.

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

   As the concept of a "training set" for an AI algorithm is not applicable, there is no information on how ground truth for a training set was established.

Ask a specific question about this device

YOULASER CO2 Laser is indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery.

YOULASER CO2 Laser with the scanning unit is indicated for full ablative skin resurfacing for the following application: Dyschromia, Atrophic + Acne scars, Hypertrophic scars

The scanning modality is intended for the above described use. In this case the handpiece simply enables a laser-tissue interaction in different positions within a specific area.

The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device

The YOULASER CO2 Laser System includes 1 model: YOULASER CO2 with Wavelength 10.6μm and Laser Power 30W. The YOULASER CO2 Laser is composed externally of a metallic shell with a frontal polyurethane panel containing the touch screen display. On this panel the key switch, emergency red push button and the operation led are inserted too. On the rear panel the footswitch connector, the remote interlock, the power switch are located. The laser system is composed of power supply, CO2 laser source with air cooling system, optical bench, arm with CO2 scanner, the articulated control electronics. The electronic, based on a microcontroller, manages the voltage power supply and the CO2 laser source.

The provided text is a 510(k) summary for the Quanta System YOULASER CO2. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through novel studies. Therefore, much of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication, and MRMC studies is not available in this document.

Here's what can be extracted based on the provided text:

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

This information is not present. The document focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting specific performance metrics that meet defined acceptance criteria. The statement "The Quanta System YOULASER CO2 is as safe and effective as the predicate devices" is a general claim of equivalence, not a report of specific performance against numerical acceptance criteria.

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

No dedicated clinical or performance test set data is described. The 510(k) summary structure for this device does not include such a study.

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

Not applicable, as no dedicated test set requiring expert ground truth is described.

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

Not applicable, as no dedicated test set requiring 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:

Not applicable. This device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers.

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

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

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

Not applicable. No ground truth for device performance is described. The ground for "substantial equivalence" is the predicate device's established safety and effectiveness.

8. The sample size for the training set:

Not applicable, as this is a hardware device (laser surgical instrument) and not a machine learning algorithm that requires a training set.

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

Not applicable, as this is a hardware device and does not involve a training set.

Summary of what the document does state regarding acceptance and proof:

The document states:

• "The Quanta System YOULASER CO2 is as safe and effective as the predicate devices."
• "The YOULASER CO2 has the same intended uses and similar indications, technological characteristics, and principles of operation As its predicate device."
• "The minor technological differences between the YOULASER CO2 and its predicate devices raise no new issues of safety or effectiveness."
• "Thus, the YOULASER CO2 is substantially equivalent."

The proof that the device meets "acceptance criteria" (which in this context is "substantial equivalence") comes from a comparison of its technological characteristics, intended uses, and indications for use to the predicate devices (El.En S.p.A Smart CO2 Laser System (K072159)). The document explicitly states "Performance Data: None" under the Substantial Equivalence section, indicating that no separate performance studies were conducted or provided to demonstrate novel criteria. The acceptance is based on the argument that the new device is fundamentally similar to an already cleared device, implying that the established safety and effectiveness of the predicate device extends to the new device due to these similarities.

Ask a specific question about this device

Nd:YAG (1064nm): The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (blue, black and green tattoo)

Nd: YAG (532nm): The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (red, violet, orange, yellow and brown tattoo)

The device includes a Q-Switched Nd: YAG laser source with 900mJ max energy at 1064 nm and 450mJ max energy at 532 nm wavelengths. The optical delivery system for the two wavelengths is the articulated arm. In addition, the DUOLITE includes a power supply; a cooling system; an optical delivery system; a microprocessor based controller; and safety features to ensure use of the appropriate laser, wavelength and hand piece.

The provided text is a 510(k) summary for the Quanta System DUOLITE laser, which is a predicate device application. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with detailed acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, clinical study specifics, and ground truth establishment are not typically found or required in a 510(k) summary for a predicate device of this nature.

However, I can extract the relevant information that is present in the document.

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

Since this is a 510(k) for a predicate device, explicit "acceptance criteria" in the sense of predefined thresholds for a clinical study endpoint are not presented. Instead, the device's performance is demonstrated through its "Technological Characteristics" being substantially equivalent to the predicate device. The performance comparison is based on technical specifications rather than clinical outcomes.

The "acceptance criteria" for a 510(k) in this context is that the device is "as safe and effective as the predicate devices" and that "Minor technological differences...raise no new issue of safety or effectiveness," leading to a determination of "Substantial Equivalence."

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 does not describe a clinical "test set" with a sample size or data provenance in the way one would for a new clinical study. The equivalence is demonstrated through comparison of technical specifications, not patient data.

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. There was no clinical test set requiring expert ground truth establishment.

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

Not applicable. There was no clinical test set 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

Not applicable. This device is a laser surgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a laser surgical instrument.

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

Not applicable. No clinical ground truth was established for this 510(k) submission. The "ground truth" for demonstrating substantial equivalence lies in the technical specifications, intended uses, and principles of operation being comparable to the predicate device.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning device.

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

Not applicable. There is no "training set."

Ask a specific question about this device

The Quanta System QUANTA Diode Laser Family, including the QUANTA532, QUANTA808, QUANTA940, QUANTA980, QUANTA1064, QUANTA1320, QUANTA1470, and QUANTA1950 (and all their double wavelength combination and their delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery(PLDD), Gastroenterology, Head/neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures. The QUANTA980 and QUANTA1470 Diode Laser are further indicated for laser assisted lipolysis.

The QUANTA Diode Laser Family is designed with 4 major subsystems: (1) an external structure; (2) power electronics; (3) display with control electronics, which controls the power electronics, the user interface and the laser source temperature via a thermostat board: and (4) the laser system with an opto-mechanical block composed of the laser source, the Peltier cooling system with dissipater and fans, the fiber launching system, the red diode aiming beam, and the power calibration system. The fiber is connected to the system through an SMA 905 socket on the front panel. In addition to the four subsystems, the QUANTA Diode Laser Family incorporates several safety features, including a remote interlock, an emergency red push button and a key switch. The external accessories include separate optical fibers and hand pieces for dental, dermatological and surgical applications, or for endovascular applications and laser assisted lipolysis.

The Quanta System QUANTA Diode Laser Family for surgical applications has been recognized as substantially equivalent to various predicate devices (K072034, K083613, K091534, K053604, K090164) and does not have specific acceptance criteria or an analytical study presented in the provided text to demonstrate its performance. Instead, the FDA's 510(k) clearance is based on its substantial equivalence to already marketed devices.

However, based on the provided text, we can describe the intended uses for each laser model, which implicitly sets the performance expectations for these devices.

Acceptance Criteria and Reported Device Performance

Since no specific quantitative acceptance criteria or reported device performance metrics (e.g., accuracy, sensitivity, specificity) were provided in the document, the "performance" here refers to the extensive list of intended uses and indications for which the device is cleared. The device "meets the acceptance criteria" by being substantially equivalent to existing devices and being cleared for the broad range of surgical applications outlined.

Regarding the study that proves the device meets the acceptance criteria:

The provided 510(k) Premarket Notification document does not describe a specific clinical study for the Quanta System QUANTA Diode Laser Family to prove its performance against acceptance criteria in the traditional sense of a new device. Instead, the basis for its market clearance is "Substantial Equivalence" to predicate devices already on the market.

The document explicitly states under "Performance Data": "None".

This means that a new clinical study was not conducted or presented to demonstrate the device's efficacy or safety. The FDA's determination of substantial equivalence (K100558) implies that the new device is as safe and effective as the predicate devices based on similarities in intended use, indications for use, technological characteristics, and principles of operation, and that minor technological differences raise no new issues of safety or effectiveness.

Therefore, the following points cannot be answered from the provided text, as the underlying regulatory pathway for this device did not require such studies or data submission:

1. Sample size used for the test set and the data provenance: Not applicable, as no performance testing using a test set against ground truth was described in this document.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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 a laser surgical device, not an AI-based diagnostic tool relying on human readers.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an AI algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable, as no machine learning or AI component with a training set was mentioned.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device