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The XERF is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

XERF is an electrosurgical unit which uses high frequency electrical currents for treatment. When high frequency is irradiated on the skin, the treated skin tissue is heated, resulting in coagulation. This equipment generates high frequency of 2 MHz and 6.78 MHz and is delivered non-invasively into skin through the tip of the handpiece. There are a total of 12 types of active electrode tips compatible with the handpiece; the different tips are intended for various applications and treatment zones. The system also includes a return pad corresponding to the neutral electrode which is intended to be attached to the patient's back to disperse the generated energy. For adjustment of treatment parameter, data can be used by adjusting the operator interface through LCD touch screen. Treatment is conducted using foot switch or finger switch after ready when applied treatment parameter is output to the tissue.

The provided FDA 510(k) Clearance Letter for the XERF device does not contain the kind of detailed information about acceptance criteria and a study proving the device meets them that your request outlines. This document is a clearance letter, which means the FDA has already assessed the sufficiency of the submitted information, including performance data, and found the device substantially equivalent to a predicate.

Specifically, the document states:

• "No clinical tests were included as part of this submission." This immediately tells us there was no study involving human subjects to demonstrate the device meets acceptance criteria in a clinical setting.
• The "Performance" section describes ex-vivo thermal studies. While these are performance tests, they are not clinical studies with acceptance criteria based on human outcomes or expert assessment of clinical images, as typically implied by your request.

Therefore, for aspects like "Table of acceptance criteria and reported device performance," "Sample size used for the test set," "Number of experts," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Type of ground truth," "Sample size for training set," and "How ground truth for training set was established," the provided text does not contain this information. These details would typically be found in the more comprehensive 510(k) submission itself, rather than in the final clearance letter summary.

However, I can extract the available information from the "Performance" section regarding the ex-vivo studies.

Summary of Device Performance and Related Information from the Provided Text:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria (Implicit from study goal): Achieving coagulation, uniform coagulation, and thermal performance equivalent to predicate device.
• Reported Device Performance:
  • Study 1 (Ex-vivo thermal study - tissue effects): "Coagulation was observed when treatment was performed with five stacked pulses with the interval of 200ms (within the same treatment spot without moving the tip). Coagulation surface correlated to the perimeter of the RF tip treatment surface. Uniform coagulation at entire perimeter and depth was observed in tested tissues."
  • Study 2 (Ex-vivo thermal study - temperature-time curves): "The ex-vivo dermal temperature testing confirmed that the XERF device's thermal performance is equivalent to that of the Thermage FLX device in terms of time-dependent heating and cooling behavior."

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

• Sample Size: Not explicitly stated for the ex-vivo studies.
• Data Provenance: Ex-vivo (not human/clinical) tissues: kidney, liver, and skin. No country of origin mentioned for the tissues.

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

• Not applicable as no clinical ground truth was established. The tissue analysis involved standard H&E histology performed on biopsy samples. The expertise of those analyzing the histology (e.g., pathologist) is not specified.

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

• Not applicable as no clinical ground truth was established by experts.

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 MRMC study was done. This device is an electrosurgical unit, not an AI diagnostic/imaging device.

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

• Not applicable. This is a medical device, not an algorithm, and its performance was assessed ex-vivo.

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

• For the ex-vivo tissue study: Histology (H&E staining and analysis under light microscope) was used to assess coagulation.
• For the ex-vivo thermal curve study: Direct temperature measurements using fiber optic sensors.

8. The sample size for the training set:

• Not applicable. The device is not an AI/ML algorithm that requires a training set in the conventional sense. The studies described are performance validation tests for the device itself.

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

• Not applicable.

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The eCO2 3D Laser System with fractional handpieces is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.

The eCO2 3D Laser System using the non-fractional handpieces (F100, F50, Zoom, and 500 micron tip) is also indicated for use in skin resurfacing and surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, and podiatry.

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
• Treatment of wrinkles, rhytids and furrows
• Ablation and/or vaporization of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, skin tags, solar/actinic elastosis, actinic cheilitis, lentigines, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous and basal cell carcinoma, spider and epidermal naevi, xanthelasma palpebrarum, syringoma, and verrucae and seborrhoecae vulgares (warts); laser derm-ablation; and laser burn debridement.

Dermatology, Plastic Surgery & General Surgery: Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery, including the performance of blepharoplasty and for the creation of recipient sites for hair transplantation, treatment of hemorrhoids, atheroma, cysts, abscesses, and all other soft tissue applications.

Podiatry:
Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares.

The eCO2 3D Laser System consists of a self-contained console, with a 10.6μm wavelength delivered through an articulated arm. The emitted laser beam is then irradiated to the treatment area through a handpiece and a tip connected to the handpiece.

The eCO2 3D is used by a trained physician for procedures requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue.

The eCO2 3D Laser System utilizes an articulated arm to generate a laser beam with a wavelength of 10.6μm by applying patented chaos scanning technology. It radiates a micro-laser beam with an aiming beam of 520nm to the surgical area. Micro laser beams are radiated onto the treatment area, generating MAC (Micro Ablative Column), which improves the skin condition as it recovers. By changing the handpiece according to various application areas, the user can change the beam spot size to optimize the treatment effect. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece tip.

The system console is the heart of the eCO2 3D Laser System and contains the Touch LCD, handpieces, system control module, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the Touch LCD. There are 4 casters in the console base that can be used when moving the system.

This FDA 510(k) clearance letter pertains to the eCO2 3D Laser System, an ablative laser, not an AI/Software as a Medical Device (SaMD). Therefore, the typical acceptance criteria and study designs associated with AI/SaMDs (such as sensitivity, specificity, MRMC studies, ground truth establishment, etc.) are not applicable to this document.

The document describes the device's technical specifications and compares them to predicate devices to demonstrate substantial equivalence, as is standard for a 510(k) submission for a physical medical device. It explicitly states: "No clinical tests were performed for this submission." This means there is no data provided within this document regarding device performance against typical AI/SaMD acceptance criteria.

However, I can extract the information that is relevant to the device's clearance and structure it to address your request as best as possible within the limitations of the provided text.

Analysis of the Provided Document for Acceptance Criteria and Study Proof:

The eCO2 3D Laser System is a physical medical device (laser system) for dermatological and surgical procedures. The 510(k) clearance process for such a device primarily relies on demonstrating substantial equivalence to predicate devices through technical characteristics, safety standards compliance, and intended use alignment, rather than performance metrics on a 'test set' as would be seen for an AI diagnostic algorithm.

Therefore, many of the requested categories (related to AI performance metrics, test sets, ground truth, and human reader studies) are explicitly not present in this document because they are not relevant to the 510(k) clearance of this type of device.

Here's a breakdown based on the provided text, indicating where information is present and where it's not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are primarily related to safety, electrical performance, laser specifications, and functional equivalence to predicate devices. There are no performance metrics like sensitivity/specificity for a diagnostic AI.

Since this is not an AI/SaMD, the following sections are Not Applicable (N/A) based on the provided document:

2. Sample size used for the test set and the data provenance: N/A (No clinical test set described for performance evaluation; clearance based on substantial equivalence to predicate device specifications and non-clinical testing for safety/electrical performance).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No external 'ground truth' establishment for diagnostic performance).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No adjudication required for this type of device clearance).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (Not an AI-assisted device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI algorithm).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A (No diagnostic ground truth needed).
8. The sample size for the training set: N/A (No AI training set).
9. How the ground truth for the training set was established: N/A (No AI training set).

Conclusion from the Document:

The acceptance for the eCO2 3D Laser System is based on demonstrating substantial equivalence to its predicate device (Lutronic eCO2 Plus, K100610) and a reference device (SNJ Finexel, K213557). This demonstration relies on comparing technical specifications and compliance with relevant national and international safety and performance standards (as listed in 807.92(b)(1)). The document explicitly states: "No clinical tests were performed for this submission." Therefore, there is no performance study data in the context of diagnostic accuracy, human reader improvement, or algorithm-specific metrics available in this 510(k) clearance letter.

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CoreLevée is indicated to be used for:

• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
• Strengthening, toning and firming of buttocks and thighs.

CoreLevée is a non-invasive electromagnetic muscle stimulator that applies high-intensity electromagnetic field to the treatable body areas through two applicators. The coil enclosed in each applicator produces a magnetic field that induces electric currents within neuromuscular tissues. At its optimal level, these electric currents depolarize neuromuscular tissues causing effective muscle contraction.
CoreLevée consists of a Main Body, a software integrated color-touch LCD screen, two applicators, three applicator fixing belts, and a patient switch. The Main Body allows the proper operation of the entire system. The LCD screen works as a control panel and displays step-by-step guides through the entire therapy procedure. The therapeutic parameters such as treatment time, location, and stimulation frequency and intensity are easily set using the touch screen and the dial knob on the device. The micro-controller within the software continuously monitors the device system for its operation and functional normalcies. Two applicators can be used alone or together on top of clothing.
The device is a mobile standalone equipment with four wheels. The device housing protects the patient from electrical shock and mechanical injuries.

The provided document is a 510(k) summary for the CoreLevée device. It details the device's characteristics, indications for use, and a comparison to a predicate device (BTL 799-2). However, it does not contain a study that establishes acceptance criteria for clinical performance and demonstrates the device meets those criteria, nor does it provide a table of acceptance criteria and reported device performance in a clinical context.

The "Performance Data" section primarily focuses on:

• Biocompatibility: Stating it's not applicable as the device doesn't directly contact the skin.
• Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Listing compliance with various IEC standards.
• Sterilization and Shelf-Life: Stating it's not sterile and is reusable with a 5-year expected service life.
• Software Validation and Verification Testing: Classifying the software as "moderate" level of concern and confirming validation.
• Performance Bench Testing: Confirming magnetic field intensity, oscilloscopic characterization, pulse repetition/duration, and theoretically derived induced current in tissues are within specifications and comparable to the predicate.

This document describes technical and safety performance, but not clinical acceptance criteria or a clinical study proving efficacy against such criteria. The 510(k) process relies on demonstrating "substantial equivalence" to a predicate device, which often means showing similar technological characteristics and performance (including safety and, in some cases, limited clinical data if specifically required for a new question of safety/effectiveness). In this case, the manufacturer primarily relies on a comparison of technological characteristics and bench testing to demonstrate substantial equivalence, rather than a separate clinical study with predefined acceptance criteria for patient outcomes.

Therefore, I cannot provide the requested table of acceptance criteria and the study proving the device meets those criteria because the provided text does not contain this information. The document focuses on demonstrating substantial equivalence through technical specifications and bench testing, not clinical efficacy trials with specific acceptance metrics.

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The HOLLYWOOD SPECTRA System is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatological and general surgical procedures for coagulation and hemostasis.

1064nm in nanosecond mode, including microbeam handpieces:

• Tattoo removal: dark ink (black, blue, and brown)
• Removal of Nevus of Ota
• Removal or lightening of unwanted hair with or without adjuvant preparation
• Treatment of Common Nevi
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Treatment of melasma

1064nm in Spectra (long-pulse) mode:

• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris

532mm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 585 nm and 650 mm with optional dye handpieces):

• Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
• Removal of Epidermal Pigmented Lesions
• Removal of Minor Vascular Lesions including but not limited to telangiectasias
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
• Treatment of Lentigines
• Treatment of Café-au-Lait
• Treatment of Seborrheic Keratoses
• Treatment of Post Inflammatory Hyperpigmentation
• Treatment of Becker's Nevi, Freckles, and Nevi spilus

The HOLLYWOOD SPECTRA Laser System contains a Nd: YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates Q-switched and/or pulsed laser sources at the nominal wavelength of 1064 nm and 532 nm using KTP. The outputs of each laser generator and the aiming beam (655 nm) are delivered by articulated arm to a fixed (collimated), or focusing variable (zoom) spot handpiece, or a dual focused dots microbeam handpiece, or a 585nm/650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam into a 585 nm or 650 nm wavelengths, correspondingly.

When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid, highly localized temperature increase to the target chromophores such as melanin and tattoo particles. This increases localized temperature of the chromophores. The instantaneous temperature-increase causes fragmentation of the chromophores to smaller particles. By directing the beam onto specific tissue locations, using different handpieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam.

The user activates laser emission by means of a footswitch. All handpieces are equipped with sensors for automatic detection of a handpiece type and the spot size. The HOLLYWOOD SPECTRA laser system is controlled via a touchscreen guided user interface in the front of the device.

The provided text is a 510(k) summary for the HOLLYWOOD SPECTRA Laser System. This document focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and indications for use, rather than presenting performance data from clinical studies directly.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and performance data from a study that proves the device meets those criteria.

Specifically:

• 1. A table of acceptance criteria and the reported device performance: This information is not present. The tables provided (Table 1 and Table 2) are "Technical Characteristics Comparison" tables, comparing the proposed device's specifications to those of predicate devices. These are not acceptance criteria tables from a performance study.
• 2. Sample sized used for the test set and the data provenance: Not applicable, as no performance study with a test set is described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 system, not an AI-assisted diagnostic tool for human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

The "PERFORMANCE DATA" section (Page 13) of the summary lists various types of engineering and safety testing performed (Biocompatibility, Sterilization and Shelf-Life, Electrical Safety and EMC, Software Verification and Validation, Performance Bench Testing). However, these are bench tests and safety compliance tests, not clinical performance studies with acceptance criteria for specific medical outcomes or diagnostic accuracy. The purpose of these tests is to show that the device is safe and functions according to its design specifications, and is substantially equivalent to existing devices, not to demonstrate clinical efficacy against pre-defined acceptance criteria in a patient population.

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1064 nm

The DermaV Laser System is indicated for stable long term or permanent hair reduction and for treatment of PFB (Pseudofolliculitis Barbae) on all skin types, Fitzpatrick I – VI, including tanned skin. 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.

The 1064 nm laser is also indicated for coagulation and hemostasis of vasular lesions of vascular lesions such as but not limited to port wine stains, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The 1064 mm laser system is also indicated for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, sebortheic keratoses, nevi, chloasma, verucae, skin tags, keratoses, (significant reduction in the intensity of black and/or blue- black tattoos) and plaques. The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

532 nm

For coagulation 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 extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).

The DermaV laser system contains a Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelengths of 1064 mm and 532 nm using KTP. The outputs of each laser generator and the aiming beam (635 nm) are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system for either the 532 nm or 1064 nm wavelength.

The control panel is equipped with an LCD touch screen so that users can easily adjust parameters for optimal settings. The software included provides all the function which is necessary to use the device.

The DermaV laser system is comprised of three main components: system main body, optical fiber with handpiece, and footswitch.

The DermaV laser system emits laser energy at 532 nm via a handpiece attached to an optical fiber. The DermaV laser system can be configured with an ICD (Intelligent Cooling Device) skin cooling device. The pulsed beam is directed to the treatment zone through a lenscoupled optical fiber attached to a handpiece. When the beam contacts human tissue, the energy of the beam is absorbed by the tissue, resulting in a very rapid and highly localized temperature increase in the target. The short but swift temperature increase causes selective heating and destroys of the target materials into smaller particles.

The DermaV Laser System did not have specific acceptance criteria for clinical performance explicitly stated in this document. The document states "Clinical performance testing was not needed for this submission; therefore, no clinical tests were submitted." This implies that regulatory clearance was sought based on substantial equivalence to predicate devices and non-clinical performance testing.

Therefore, the following information cannot be provided from the given document:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone (algorithm only) performance was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc).
• The sample size for the training set.
• How the ground truth for the training set was established.

Instead, the document details non-clinical performance testing, which serves as the "study that proves the device meets (non-clinical) acceptance criteria":

Non-clinical Performance Testing:

The DermaV Laser System underwent several non-clinical tests to demonstrate its safety and conformance with relevant standards. These tests effectively serve as the "acceptance criteria" for its non-clinical performance.

• Electrical Safety: The device was tested and found to be in conformance with IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance).
• Electromagnetic Compatibility (EMC): The device was found to be in conformance with IEC 60601-1-2 (Medical electrical equipment Part 1-2 General requirements for basic safety and essential performance- Collateral standard: Electromagnetic Disturbances-Requirements and tests).
• Laser Safety: The device was tested and found in conformance with IEC 60825-1 (Safety of laser products-Part 1: Equipment classification and requirements).
• Biocompatibility: The device was tested and found to be in conformance with:
  • ISO 10993-1 ("Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process")
  • ISO 10993-5 ("Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity")
  • ISO 10993-10 ("Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization")

Comparison to Predicate Devices (Substantial Equivalence):

The primary method for establishing equivalence and, by extension, the acceptability of the device for its intended use, was through comparison with predicate devices. This comparison focused on:

• Intended Use: The DermaV Laser System's 1064 nm functions were compared to the Lutronic Corporation CLARITY II Laser System (K183566), and its 532 nm functions were compared to the Cutera Family of Coolglide Aesthetic Lasers (K153671). The document states that the proposed device and predicates have the "same intended use."
• Technological Characteristics: The document provides detailed tables (Table 1 and Table 2) comparing various technical characteristics such as:
  • Manufacturer
  • 510(k) Number
  • Product Code
  • Laser Wavelength
  • Indications for Use
  • Laser Type
  • Beam Delivery
  • Aiming Beam
  • Pulse Energy
  • Pulse Width
  • Max Fluence (J/cm²)
  • Pulse Rate
  • CDRH Laser Class
  • User Interface
  • Spot Size
  • Emission Control
  • Integrated Cooling

The conclusion drawn from this comparison is that "Differences in the proposed device's technical features, such as software, biocompatibility, and laser output parameters, do not raise new types of questions regarding the device's safety and efficacy for its indications for use."

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755 nm: The CLARITY II 755 nm Laser System is indicated for temporary hair reduction and stable long-term or permanent reduction through selective targeting of melanin in hair follicles. 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 on all skin types (Fitzpatrick 1-VI) including tanned skin. The 755 nm laser is also indicated for treatment of benign pigmented lesions, vascular lesions and wrinkles.

1064 nm: The CLARITY II 1064 nm Laser System is indicated for stable long term or permanent hair reduction and for treatment of PFB (Pseudofolliculitis Barbae) on all skin types, Fitzpatrick I -VI, including tanned skin. 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. The 1064 nm laser is also indicated for coagulation and hemostasis of soft tissue, for hemostasis of vascular lesions such as but not limited to port wine stains, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The 1064 nm laser system is also indicated for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, (significant reduction in the intensity of black and/or blue- black tattoos) and plaques. The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

The CLARITY II Laser System contains two separate resonators, an Alexandrite resonator and an Nd: YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelength 755 nm and 1064 nm, respectively. The outputs of each laser generator and the aiming beam are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system for either the 755 nm or 1064 nm wavelength. It is a medical device, designed for specific clinical applications, emitting laser energy via a handpiece and controlled by the user with a handpiece finger switch or optional footswitch. The CLARITY II Laser System consists of a system main body with an LCD touch screen, optical fiber with an AC or ICD handpiece.

The provided text is a 510(k) summary for the CLARITY II Laser System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed performance studies with acceptance criteria, ground truth, or statistical analysis typical for a de novo or PMA submission of an AI-powered diagnostic device.

Therefore, the specific information requested in the prompt about acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training is not present in this document. The device in question is a laser system for dermatological treatments, not an AI diagnostic tool.

However, I can extract the information that is available and clarify what is missing based on your prompt.

Summary of Device Performance and Equivalence

The CLARITY II Laser System is being submitted as substantially equivalent to the CLARITY LPC Laser System (K130199) and the Elite + Laser (K141425). Substantial equivalence means that the device has the same intended use and technological characteristics as the predicate device, or if there are differences, they do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are inferred to be the characteristics of the predicate devices which the CLARITY II aims to match or demonstrate non-significant difference from, to achieve substantial equivalence. No explicit performance metrics or thresholds are stated as "acceptance criteria."

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 Provided. The submission states: "No performance data has been provided since the CLARITY II Laser System is equivalent to the previously cleared predicate devices with no new issues regarding safety and effectiveness." This indicates that no new clinical study with a test set was conducted for this 510(k) submission.

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 Provided. No clinical test set or ground truth determination is described in this submission.

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

• Not Applicable / Not Provided. No clinical test set or adjudication method 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 / Not Provided. This device is a laser system and not an AI diagnostic tool that would typically undergo an MRMC study related to human reader performance with AI assistance.

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

• Not Applicable / Not Provided. This device is a physical laser system, not an algorithm, so "standalone performance" in the context of an algorithm is not relevant.

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

• Not Applicable / Not Provided. No clinical ground truth determination is described as no new clinical studies were submitted.

8. The sample size for the training set

• Not Applicable / Not Provided. This submission does not describe a training set as it's not an AI/ML algorithm submission.

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

• Not Applicable / Not Provided. As no training set is described, no ground truth establishment for it is mentioned.

Additional Information from the Document:

• Bench Testing: The device complies with applicable standards: ISO 13485:2016, ISO 60601-1 (electrical safety), and IEC 60601-1-2 (electromagnetic compatibility). These are considered part of the performance data to demonstrate safety and effectiveness for substantial equivalence.
• Clinical Testing: The document explicitly states: "No performance data has been provided since the CLARITY II Laser System is equivalent to the previously cleared predicate devices with no new issues regarding safety and effectiveness." This means the submission relies on the established safety and effectiveness of the predicate devices.
• Differences from Predicates: The CLARITY II includes a skin temperature monitoring feature (for informational purposes only) and an Intelligent Tracking Tip (ensures selectable overlap of contiguous pulses). The submission argues these differences "do not affect the safety and effectiveness of the subject device."

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The LUTRONIC GENIUS Radiofrequency System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The LUTRONIC GENIUS Radiofrequency System consists of the system control module and RF power supply in a main body on locking castor wheels, a handpiece equipped with disposable handpiece tips with microneedle array, footswitch, handpiece hanger and holder, and an LCD touch screen control panel. The sterilized handpiece tips include the tip body containing the microneedle array and a protective cap. The treatment parameters are entered via a touchscreen console that also displays system output information during treatment. The microneedles come in light contact with the epidermis of the patient and minimally penetrate the epidermis during the treatment. Needle depth, Power level and Duration (Power x Duration = RF Energy), are userselectable via the GUI console. The RF Power output is controlled to insure for a given Duration that a determinate RF Energy is delivered to the 7x7 bipolar microneedle array of the handpiece tips. The handpiece is held at right angles to the target tissue. As the RF energy passes into the skin via the needles, it generates an electro-thermal reaction capable of coagulating the tissue surrounding the uninsulated portion of the needles.

The provided text describes the LUTRONIC GENIUS Radiofrequency System, a medical device, and its comparison to a predicate device for FDA 510(k) clearance. The focus of the study to prove the device meets acceptance criteria is primarily on demonstrating substantial equivalence to the predicate device, the INFINI Radiofrequency System (K121481), rather than a study against a pre-defined set of clinical performance metrics. Therefore, the information provided does not fully align with the typical structure of an AI/ML-based medical device performance study, especially concerning elements like multi-reader multi-case studies, ground truth establishment for a test set, and detailed acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity).

However, I can extract the relevant information from the document to describe the acceptance criteria and the study that proves the LUTRONIC GENIUS Radiofrequency System's equivalence to its predicate, as this is the primary method of acceptance described in the 510(k) summary.

Acceptance Criteria and Study for LUTRONIC GENIUS Radiofrequency System

The LUTRONIC GENIUS Radiofrequency System sought 510(k) clearance by demonstrating "substantial equivalence" to a legally marketed predicate device, the INFINI Radiofrequency System (K121481). The acceptance criteria were centered around demonstrating that the modified device's technological characteristics and performance are sufficiently similar to the predicate device such that it raises no new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

• Frequency: GENIUS: 460 KHz; INFINI: 1 MHz (Change, but deemed minor).
• Max Output Power: Both 50W.
• Operation Mode: Both Microneedle Fractional RF.
• Treatment Duration (Time): Both 10 - 1000 msec.
• Tip (Microneedle array, depth adjustment): Both 49 tip, 7x7 microneedles; 10x10 mm; depth 0.5 - 3.5 mm.
• Needle Diameter: Both 200 micrometers. Other differences in dimensions, electrical requirements, GUI, packaging, shelf life, and needle coating were evaluated. |
  | Performance Data: No significant differences in biological effects or safety outcomes. | Ex Vivo Animal Study Findings: Porcine tissue model. No statistically significant differences in the coagulation profiles (height, width, volume of thermal coagulative zones) between the two systems as per ANOVA and student t-tests. The LUTRONIC GENIUS fell within the 95% confidence interval of the INFINI for coagulation profile height, width, and volume at each setting.
  Additional Safety Data: Biocompatibility, Sterilization Validation, Electrical Safety & EMC, Software V&V, Cleaning & Disinfection Testing were all conducted and met relevant standards. |

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

• Test Set (Ex Vivo Animal Study): The document states "an ex vivo animal study utilized a porcine tissue model." It does not specify the exact number of porcine tissue samples or animal subjects used.
• Data Provenance: The ex vivo animal study was conducted to compare the LUTRONIC GENIUS with the INFINI Radiofrequency System. The data is prospective for this comparison study, specifically designed for this submission. The country of origin of the data is not explicitly stated, but the submitter is Lutronic Corporation, Republic of Korea, with a contact person in Massachusetts, USA.

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

• This question is not applicable in the context of this 510(k) submission as described. The "ground truth" for the performance comparison was the quantitative measurement of thermal coagulative zones in the ex vivo animal study, not expert consensus on medical images or patient outcomes. The evaluation involved scientific measurement and statistical analysis.

4. Adjudication Method for the Test Set

• This is not applicable. The ex vivo animal study data was quantitative (height, width, and volume of thermal coagulative zones) and analyzed statistically (ANOVA, student t-tests, 95% confidence intervals). There was no subjective assessment 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 Multi-Reader Multi-Case (MRMC) study was done. This device is a direct energy delivery system, not an AI-assisted diagnostic tool. Therefore, human reader improvement with AI assistance is not relevant to this submission.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This is a hardware medical device, not an algorithm/software-only device intended for standalone performance evaluation in diagnosis or prediction.
• Software verification and validation testing were conducted, and the software was considered a "major" level of concern, indicating a thorough V&V process for the embedded software controlling the device.

7. The Type of Ground Truth Used

• The "ground truth" for the performance comparison was quantitative measurements of physical effects (height, width, and volume of thermal coagulative zones) on porcine tissue, obtained through standardized H&E staining techniques. This is a scientific and objective measure rather than expert consensus, pathology, or outcomes data in the traditional sense for diagnostic devices.

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware medical device with embedded software. It is not an AI/Machine Learning device that undergoes a "training" phase on a dataset in the conventional sense. The "training set" concept is relevant for AI models, not for traditional medical devices undergoing performance testing for substantial equivalence.

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

• Not applicable. As stated above, there is no "training set" as this is not an AI/ML device in the context of data-driven model training.

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The PICOPLUS Laser System is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery as follows:

The 1064 nm wavelength and 450 pico-second pulse width of the PICOPLUS system is indicated for:

· Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.

· Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

The 532 nm wavelength and 450 pico-second pulse width of the PICOPLUS system is indicated for:

• · Removal of tattoos for Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
• · Treatment of benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

The 1064 nm wavelength and nanosecond pulse width of the PICOPLUS system is indicated for:

• · Treatment of benign pigmented lesions on Fitzpatrick skin type I-VI
• Removal of dark and multi-colored tattoos containing dark colored tattoo inks on Fitzpatrick skin types 1-VI

The 532 nm wavelength and nanosecond pulse width of the PICOPLUS system is indicated for:

• · Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV
• Removal of lighter colored tattoo inks, including red and yellow inks, on Fitzpatrick skin types I-III

The PICOPLUS Laser System is a surgical laser instrument. The PICOPLUS Laser System is designed and manufactured in accordance with 21 CFR 820 (with emphasis on 820.30) and 21 CFR 1040 for medical devices in order to insure user safety and durability of use.

The PICOPLUS Laser System is a laser system, delivering energy at wavelengths of 1064 nm and 532 nm, both at pulse durations of 450 picoseconds (ps) and 2 nanoseconds (ns). The laser system console, an articulated arm and attached handpieces.

The provided text describes a 510(k) premarket notification for the PICOPLUS Laser System and asserts its substantial equivalence to predicate devices. However, it explicitly states that no clinical performance data was provided for the PICOPLUS Laser System itself because it is considered equivalent to previously cleared predicate devices. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria for the PICOPLUS Laser System is largely unavailable in the provided document.

Here's a breakdown of the available information:

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

• Acceptance Criteria: Not explicitly stated as specific, measurable criteria for the PICOPLUS Laser System. The acceptance is based on substantial equivalence to predicate devices.
• Reported Device Performance: No clinical performance data is reported for the PICOPLUS Laser System. The document states: "No performance data has been provided since the PICOPLUS Laser System is equivalent to the previously cleared predicate devices with no new issues regarding safety and effectiveness."

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

• Sample Size for Test Set: Not applicable, as no clinical performance data was provided for the PICOPLUS Laser System itself.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable, as no clinical performance data was provided.

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

• Not applicable, as no clinical performance data was provided.

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. The PICOPLUS Laser System is a laser surgical instrument, not an AI-assisted diagnostic tool involving human readers.

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

• Not applicable, as this is a physical medical device, not an algorithm.

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

• Not applicable, as no clinical performance data was provided.

8. The sample size for the training set

• Not applicable, as no clinical performance data was provided, and the device is not an AI algorithm requiring a training set in the conventional sense.

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

• Not applicable.

Summary based on the provided text:

The PICOPLUS Laser System's acceptance is based on a claim of substantial equivalence to two legally marketed predicate devices: the Cutera Enlighten III Laser System (K172077) and the Quanta System S.P.A. Discovery Pico Family (K163222). The applicant argues that the PICOPLUS device shares the "same intended use and Indications for Use statement" and that technological differences are "minor."

The documentation states that the PICOPLUS Laser System passed bench testing for compliance with applicable standards, including ISO 13485:2003, ISO 60601-1 for electrical safety, and IEC 60601-1-2 for electromagnetic compatibility. However, no clinical performance data was submitted for the PICOPLUS Laser System itself. The FDA's determination of substantial equivalence implies that the agency found the device to be as safe and effective as the predicate devices without requiring new clinical studies for this specific device.

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The LASEMD Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).

The LASEMD Laser System is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The LASEMD Laser System is equipped with a 658 nm aiming beam.

This document is a 510(k) Summary for the LASEMD Laser System, detailing its substantial equivalence to a predicate device. It primarily focuses on comparing the new device to an already approved one, rather than providing a detailed study of the device's performance against specific acceptance criteria in a clinical setting.

Therefore, many of the requested items, such as a table of acceptance criteria, sample sizes for test and training sets, expert qualifications, and ground truth establishment methods, are not explicitly provided in the document as it's not a clinical performance study report for the LASEMD Laser System itself. Instead, the document relies on the equivalence to a previously cleared device.

However, I can extract information related to the device's technical specifications and how its performance was assessed in comparison to the predicate.

Here's a breakdown of the available information:

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

The document does not explicitly state "acceptance criteria" for the LASEMD Laser System's clinical performance in the same way a standalone study would. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device (Fraxel DUAL Laser System, K130193) in terms of:

• Intended Use and Indications for Use: Must be the same.
• Technological Characteristics: Differences must be minor and not raise new questions of safety or effectiveness.
• Performance (Safety and Effectiveness): Must be as safe and effective as the predicate.

The reported device performance for substantial equivalence is primarily based on:

• Bench Testing: Compliance with electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards.
• Animal Testing: Histology confirming the treatment skin effect is the same as the predicate when used at the same energy settings.
• Clinical Testing: No new clinical data was provided for the LASEMD system itself, as it was deemed equivalent to the predicate.

Table of Device Performance (focused on comparison to predicate):

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

• Test Set Sample Size: Not applicable for a traditional clinical "test set" in this context. The animal study (histology) involved an unspecified number of animals (sample size not given).
• Data Provenance: The manufacturer, Lutronic Corporation, is based in the Republic of Korea. The animal testing location and nature (retrospective/prospective) are not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as the document does not describe a clinical study for the LASEMD Laser System that would require expert ground truth establishment for a diagnostic test. The animal histology would likely be interpreted by veterinary pathologists, but details are not provided.

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

• Not applicable.

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 system, not an AI-based diagnostic tool for which MRMC studies would typically be conducted.

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

• Not applicable. This is a physical medical device (laser system), not an algorithm.

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

• For the animal study, the "ground truth" was histology for confirming the treatment skin effect.
• For the overall substantial equivalence, the "ground truth" is that the predicate device is legally marketed and generally accepted as safe and effective for its indicated uses.

8. The sample size for the training set

• Not applicable. There's no machine learning algorithm being "trained" on a dataset for this device.

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

• Not applicable.

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The ACTION II Laser System is indicated for: coagulation, vaporization or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes).

The ACTION II Laser Module Fractional Handpiece is indicated for: use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and Plastic Surgery: skin resurfacing treatment of wrinkles; epidermal nevi; telangiectasia; spider veins; actinic chelitis; keloids; verrucae; skin tags; keratoses; scar revision (including acne scars).

The ACTION II Laser System produces a pulsed beam of coherent near-infrared (2940 nm) light upon activation by a footswitch. The beam is then directed to the treatment zone by means of an articulated arm coupled to a handpiece. An integrated LCD touch screen gives the user control over the necessary laser system parameters. An aiming beam is coincident with the 2940 nm main laser beam.

This document outlines the FDA's 510(k) clearance for the Lutronic ACTION II Laser System. The acceptance criteria and supporting study information are not applicable in the context of this FDA clearance letter, as this is a medical device and not an AI/ML powered device.

This document pertains to a medical laser system and its clearance by the FDA based on substantial equivalence to existing predicate devices. It does not involve AI/ML technology, thus the requested information regarding acceptance criteria, performance metrics, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, or MRMC studies is not present.

The clearance is based on non-clinical performance data and a comparison to predicate devices, which is common for traditional medical devices. No clinical performance data was required for this 510(k) submission.

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