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The Pastelle laser system is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic 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 Genesis (long-pulse) mode:

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

532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 595 nm and 660 nm 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 Pastelle laser system consists of an Nd:YAG laser head, a power supply, a cooling system, a delivery system and other electrical components. The laser head contains two Nd:YAG laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed ,in the special adjustable holders composed the laser cavity.

The provided text is a 510(k) clearance letter and summary for the Pastelle Laser System. It details the device's characteristics, indications for use, and a comparison to predicate devices to establish substantial equivalence.

Crucially, the document explicitly states: "No clinical studies were considered necessary and performed." This means there is no section describing clinical performance data, acceptance criteria, sample sizes for test/training sets, expert involvement, or ground truth establishment for clinical efficacy.

The "Performance Testing" section under "Non-Clinical Test Summary" describes the technical specifications of the laser's output, not clinical performance or acceptance criteria related to treating conditions. These are technical parameters of the device itself, verified through bench tests, not measures of patient outcomes.

Therefore, since the 510(k) relies on substantial equivalence to predicate devices and states no clinical studies were performed, there is no information available in the provided text to describe acceptance criteria and the study that proves the device meets those acceptance criteria in a clinical context.

The document focuses on demonstrating that the new Pastelle device is technically similar to already cleared predicate devices, thus inferring that it will perform similarly.

Based on the provided text, the device's acceptance criteria and proven performance related to clinical outcomes cannot be detailed. The data provided pertains to technical specifications and regulatory compliance through bench testing.

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Veincare is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb

The Veincare laser system consists of a Laser Diode module, a power supply and a cooling system. The laser diode module consists of an optical sensor interface, fiber connector for high power SMA fiber, protective glass holder, monitoring interface, cathode and anode. The system delivers laser energy at a wavelength of 1470nm. The output of the laser is delivered to the area of treatment through an optical fiber cable a trigger (Foot switch) controls the delivery of pulses. The user selects the desired energy density and enables or disables the laser at the touched LCD panel.

The provided FDA 510(k) clearance letter for the Veincare Laser System does not contain any information regarding a study specifically proving the device meets acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and non-clinical testing. It explicitly states: "No clinical studies were considered necessary and performed."

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets those criteria from the provided text. The information requested regarding sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are all related to clinical or performance studies, which were not conducted for this submission according to the document.

However, I can extract the "performance" parameters defined for the device based on non-clinical testing, which could be considered a form of acceptance criteria for the device's technical specifications.

Based on the provided text, here's what can be inferred about the "performance" as defined by the manufacturer and accepted by the FDA for this 510(k) clearance:

1. Table of Acceptance Criteria (Technical Performance) and Reported Device Performance:

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

• Sample Size: Not applicable. The document states "No clinical studies were considered necessary and performed." The performance data reported above is based on bench tests (non-clinical testing).
• Data Provenance: Not applicable for clinical data. The non-clinical testing was performed by WONTECH Co., Ltd. in Republic of Korea.

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

• Not applicable. No clinical or human-reader studies were conducted where expert ground truth would be established.

4. Adjudication Method for the Test Set:

• Not applicable.

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

• No. The document explicitly states "No clinical studies were considered necessary and performed."

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

• Not applicable. This is a laser device, not an AI algorithm. Its performance is measured by its physical output parameters, not diagnostic accuracy.

7. The Type of Ground Truth Used:

• The "ground truth" for the technical performance parameters (wavelength, power, pulse duration, frequency) was established through bench test measurements against specified physical and electrical engineering standards (e.g., IEC 60601-1, IEC 60825-1).

8. The Sample Size for the Training Set:

• Not applicable. No AI algorithm or machine learning model was developed or trained.

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

• Not applicable.

Summary of Device Performance Study (as described in the 510(k) submission):

The "study" proving the device meets the acceptance criteria (in this context, technical specifications) was a series of non-clinical bench tests. These tests were conducted to verify that the device's electrical safety, electromagnetic compatibility, and laser output parameters (wavelength, power, pulse duration, frequency) complied with relevant international standards (e.g., IEC 60601-1, IEC 60825-1). The software was also validated as a "MODERATE level of concern" software. The biocompatibility of the optical fiber component was addressed by referencing prior 510(k) clearances for the fiber itself.
No clinical studies involving human subjects were performed or deemed necessary for this 510(k) clearance. The substantial equivalence was demonstrated based on the similarity of the device's technological characteristics and intended use to an existing predicate device, backed by non-clinical performance and safety testing.

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PICOALEX is indicated for tattoo and benign pigmented lesions removal including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma.

The PICOALEX laser system consists of an Alexandrite laser head, a power supply, a cooling system, a delivery system and other electrical components. The laser head contains Alexandrite laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed, in the special adjustable holders composed the laser cavity. To provide energy to the flash lamp, high voltage power supply charges to a storage capacitor. Then, a trieger pulse applied to the flash lamps causes the capacitor to discharge through the flash lamps. The resulting flash excites the Alexandrite laser medium, causing the emission of a pulse of laser energy. Power supply and the laser resonator to the laser resonator is calculated from a power supply to the laser energy is set via the LCD monitor is a certain amount of power. In the laser resonator is a certain amount of electrical energy to the flash lamp by changing the electrical energy into light Alexandrite broiling to momentarily strong light in the laser medium to generate a laser. The generated laser is a laser return to convert heat energy reaches thssue is cut by the heat energy, destruction, removal. The electro-optic modulator with a polarizer introduced into the cavity creates the picoseconds pulse irradiation pulses. The sealed top metal cover protects all optical components from dust and humidity and blocks the visible and invisible scattering light from the laser head. The system delivers laser energy at a wavelength of 755 nm. The output of the laser is delivered to the treatment area through an articulated Arm with a handpiece. A trigger (Foot Switch) controls the user selects and sets the treatment parameters and other functions operated by software on the graphical user interface.

The provided text describes a 510(k) submission for the PICOALEX laser system. It does not include information about acceptance criteria for a study proving device performance, nor does it detail such a study.

Instead, it focuses on demonstrating substantial equivalence to a predicate device (Cynosure, LLC's PicoSure Work Station, K210226) based on non-clinical testing and technical characteristics comparison.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device meets acceptance criteria, as this information is not present in the provided document. The document explicitly states:

• "No clinical studies were considered necessary and performed." (Page 9)

The non-clinical tests mentioned are for electrical safety, electromagnetic compatibility, software validation, and biocompatibility, as well as verification of laser performance specifications against established parameters. These are not a "study that proves the device meets the acceptance criteria" in the way you've outlined, which typically implies a clinical or comparative performance study.

**Here's a breakdown of what is available: **

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

The document presents a comparison to a predicate device, showing that its technical specifications (performance parameters) are either the same or similar, falling within acceptable ranges. These are not "acceptance criteria" in the sense of a performance study with a defined endpoint, but rather design specifications that were verified through bench testing.

Non-Clinical Test Summary (Page 9):
Performance Testing was conducted to define the PICOALEX's parameters:

• Laser wavelength: 755nm
• Laser output power: Max 300mJ ± 20%
• Pulse width: 600-800ps
• Pulse repetition rate: 1-10Hz

The following information is not available in the provided text, as no clinical performance study was conducted:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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WONTECH Surgical Optic Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 532nm - 2200mm have received regulatory clearance. WONTECH Surgical Optic Fibers are intended for use with any cleared surgical laser with an SMA 905 connector.

WT-SMA-400(or BA400)/WT-SMA-600(or BA600)/BA400R/BA600R as surgical laser fiber is indicated for use in general surgical applications of incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non-contact mode with a compatible laser system marketed for use in the desired application. Especially, they are indented for endovascular of blood vessels. WT-SMA-400(or BA400)/WT-SMA-600(or BA600) is bare-typed fiber and BA400R/BA600R is radial-typed fiber. The shape of distal end of fiber is different between bare and radial fiber. Bare fiber distal end is flat to radiate laser straightly, but radial fiber distal end is conical to radially.

Additionally, BA400 and BA600 have same design with the each original model(WT-SMA-400 and WT-SMA-600). The additional model name(BA400 and BA600) and each original model name(WT-SMA-400 and WT-SMA-600) need to be alternatively exchanged and labeled depending on customer requirement.

WT-SMA-400(or BA400)/WT-SMA-600(or BA600)/BA400R/BA600R are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode and output power less than 30 W.

They are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho;YAG, Tm:YAG pulsed and continuous wave CW laser devices. They were designed to be connected with laser medical device consisted with SMA905 connector according to IEC 61754-22 and output power less than 30 W.

The provided document is a 510(k) summary for a medical device (WONTECH Surgical Optic Fibers) seeking clearance from the FDA. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and technical characteristics, rather than clinical studies or studies proving device performance against specific acceptance criteria in a clinical context.

Therefore, the information required to fully answer your request regarding a study proving the device meets acceptance criteria, including details on acceptance criteria with reported performance, sample sizes, expert involvement, ground truth establishment, and MRMC studies, is not present in the provided text.

Specifically:

• No acceptance criteria or reported device performance table is provided. The document focuses on showing the new device is similar enough to a legally marketed predicate device (K220189) that it doesn't raise new questions of safety or effectiveness.
• No details on sample sizes for a test set (clinical data), data provenance, or expert involvement are available. The document states "No clinical studies were considered necessary and performed."
• Adjudication methods, MRMC comparative effectiveness studies, or standalone algorithm performance are not applicable as this is not a software-based AI device and no clinical studies were performed.
• The type of ground truth used is not applicable since clinical studies were not conducted.
• Training set size and ground truth establishment for a training set are not applicable as this is not an AI/machine learning device that requires a training set in the conventional sense.

The document highlights the following non-clinical tests to demonstrate substantial equivalence:

• Sterilization: Bench tests demonstrated compliance with numerous ISO and EN standards related to ethylene oxide sterilization, biological indicators, and packaging sterility. No performance metrics are given beyond "complies."
• Software Validation: "There is no software available for this device," so no software validation was performed.
• Biocompatibility: The material (Silica Core) for the fiber is stated to be biocompatible for limited contact (

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The Pastelle Pro system is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic 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 Genesis (long-pulse) mode:

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

532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 595 nm and 660 nm 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 Pastelle Pro laser system consists of an Nd: YAG laser head, a power supply, a cooling system and other electrical components. The laser head contains two Nd. YAG laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed, in the special adjustable holders composed the laser cavity.

To provide energy to the flash lamp, high voltage power supply charges to a storage capacitor. Then, a trieger pulse applied to the flash lamps causes the capacitor to discharge through the flash lamps. The resulting flash excites the Nd: YAG laser rod, causing the emission of a pulse of laser energy.

The electro-optic modulator with a polarizer introduced into the cavity creates the picoseconds pulse irradiation pulses. The basic frequency of 1064 nm can be doubled by a KTP crystal, which can be inserted to a working area. The sealed top metal cover protects all optical components from dust and humidity and blocks the visible and invisible scattering light from the laser head.

The system delivers laser energy at a wavelength of 1064 nm. 532 nm and 660 nm. The output of the laser is delivered to the area of treatment through an Articulated Arm with a handpiece. A trigger (foot switch) controls the delivery of pulses. The user selects and sets the treatment parameters and other functions operated by software on the graphical user interface.

The provided text is a 510(k) summary for the Pastelle Pro laser system. It details the device's technical specifications and compares them to predicate devices to demonstrate substantial equivalence for regulatory clearance. However, it explicitly states:

"No clinical studies were considered necessary and performed."

This means that the document does not contain information about acceptance criteria, reported device performance from clinical studies, sample size, data provenance, expert adjudication, MRMC studies, standalone performance, or how ground truth was established for clinical data.

Therefore, I cannot provide the requested table and study details. The 510(k) summary focuses on non-clinical bench testing to demonstrate compliance with electrical safety, EMC, software validation, and biocompatibility standards, and on comparing technical characteristics to previously cleared devices.

Based on the provided text, here's what can be stated about the testing and lack of clinical study information:

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

• Cannot be provided. The text explicitly states, "No clinical studies were considered necessary and performed." The performance testing mentioned (Laser wavelength, output power, pulse duration, pulse frequency) are technical specifications and not acceptance criteria or reported performance from a clinical study on human subjects or patient outcomes.

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

• Not applicable for clinical studies.
• For non-clinical bench tests (Electrical Safety, EMC, Performance Testing), the sample sizes are not explicitly mentioned but typically refer to test units of the device itself rather than patient data.
• Data provenance for bench tests would be the manufacturer's testing facilities.

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

• Not applicable. No clinical test set with ground truth established by experts was performed.

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

• Not applicable. No clinical test set requiring adjudication was performed.

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. No clinical studies, and therefore no MRMC studies, were performed. The 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. The device is a physical laser system, not a standalone algorithm.

7. The type of ground truth used:

• Not applicable for clinical ground truth. For non-clinical tests, "ground truth" would be the device's adherence to engineering specifications and safety standards as measured by calibrated test equipment.

8. The sample size for the training set:

• Not applicable. As no clinical studies were performed, there are no training sets of patient data mentioned.

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

• Not applicable. As no clinical studies were performed, there are no training sets or ground truth establishment methods for clinical data mentioned.

Summary of what the document does provide regarding testing:

The manufacturer conducted non-clinical bench tests to demonstrate that the Pastelle Pro device meets design specifications and complies with relevant safety and performance standards:

• Electrical Safety & Electromagnetic Compatibility (EMC) Testing: The device complies with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2.
• Software Validation: The software (classified as MODERATE level of concern) was designed, developed, verified, and validated according to a software development process and FDA guidance (May 11, 2005, for software in medical devices).
• Biocompatibility: The handpiece tip (Aluminum Powder) was assessed for intact skin contact for limited duration (

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Veincare is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb

The Veincare laser system consists of a Laser Diode module, a power supply and a cooling system. The laser diode module consists of an optical sensor interface, fiber connector for high power SMA fiber, protective glass holder, monitoring interface, cathode and anode. The system delivers laser energy at a wavelength of 1470mm. The output of the laser is delivered to the area of treatment through an optical fiber cable a trigger (Foot switch) controls the delivery of pulses. The user selects the desired energy density and enables or disables the laser at the touched LCD panel.

The Veincare device is intended for the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and incompetent refluxing veins in the superficial venous system in the lower limb.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state "acceptance criteria" for clinical performance. Instead, it details the technical specifications of the Veincare device and compares them to predicate devices to demonstrate substantial equivalence. The non-clinical performance section verifies these technical specifications through bench testing.

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

The document states, "No clinical studies were considered necessary and performed." Therefore, there is no test set in the traditional sense of patient data. The evaluation was based on non-clinical (bench) testing of the device's technical specifications and comparison to legally marketed predicate devices.

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

Not applicable, as no clinical test set was used and therefore no ground truth was established by experts for such a set.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

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 Veincare is a laser surgical instrument, not an AI-assisted diagnostic or interpretive device that would involve human readers.

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

Not applicable, as the Veincare is a medical device for treatment, not a standalone algorithm. The "standalone" performance here refers to the device's physical and functional performance, which was evaluated through non-clinical bench tests.

7. The Type of Ground Truth Used:

For the comparisons concerning technical specifications, the "ground truth" is established by the specifications of the legally marketed predicate devices and by international standards (e.g., IEC standards for electrical safety, EMC). For the device's own performance, the "ground truth" is its measured performance per internal design specifications during bench testing.

8. The Sample Size for the Training Set:

Not applicable. This device does not have a "training set" in the context of an AI/machine learning algorithm.

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

Not applicable.

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The V-Laser laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

The V-Laser is a Nd:YAG laser operating at wavelengths of 1,064 nm and 532 nm. The V-Laser consists of the main body, optical fiber cable, user-undetachable laser handpiece tip, footswitch, and handpiece cable cradle. The laser output is delivered to the optical fiber terminated by the handpiece. The fluence (energy density), frequency and pulse are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen.

The provided document is a 510(k) Premarket Notification for the V-Laser system. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence. Crucially, this document does not contain information about acceptance criteria, device performance metrics, or a study proving the device meets acceptance criteria in the context of clinical outcomes or diagnostic accuracy.

The "Clinical Test Summary" section explicitly states: "No clinical studies were considered necessary and performed." This means the device's performance was not evaluated through clinical trials for human use, and therefore, there are no reported device performance metrics against acceptance criteria related to clinical efficacy or safety from such studies.

Instead, the submission focuses on bench tests to verify that the device meets design specifications and complies with non-clinical standards related to electrical safety, electromagnetic compatibility, laser safety, and software validation. It also includes biocompatibility testing for materials that may come into contact with the body.

Here's an attempt to answer your questions based only on the provided document, acknowledging the significant limitations:

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

Based on the provided document, there are no acceptance criteria or reported device performance for clinical efficacy or diagnostic accuracy because "No clinical studies were considered necessary and performed."

The "acceptance criteria" discussed are primarily compliance with international and national standards for medical electrical equipment, electromagnetic compatibility, laser safety, and biocompatibility. The "reported device performance" is that the device "met all design specifications" and "complies with the following standards."

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

This information is not applicable and therefore not provided, as "No clinical studies were considered necessary and performed." The "test set" for non-clinical bench testing would typically refer to the specific laser units, components, or materials tested, not a patient cohort. The document does not specify the number of units or samples subjected to each bench test.

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)

This information is not applicable and therefore not provided, as "No clinical studies were considered necessary and performed." Ground truth established by medical experts is relevant for studies involving human diagnosis or treatment outcomes, which were not conducted for this submission.

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

This information is not applicable and therefore not provided, as "No clinical studies were considered necessary and performed." Adjudication methods are used in clinical trials or diagnostic accuracy studies involving human interpretation.

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 such study was done. The device is a laser system for surgical and aesthetic applications, not an AI-powered diagnostic or assistive tool. "No clinical studies were considered necessary and performed."

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

This question is not applicable to the V-Laser system, as it is a physical laser device, not a standalone AI algorithm. "No clinical studies were considered necessary and performed."

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

This information is not applicable as "No clinical studies were considered necessary and performed." For the non-clinical tests, the "ground truth" would be the specifications and requirements outlined in the various engineering and biocompatibility standards.

8. The sample size for the training set

This information is not applicable. Training sets are relevant for machine learning algorithms. The V-Laser is a hardware device. "No clinical studies were considered necessary and performed."

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

This information is not applicable. "No clinical studies were considered necessary and performed."

Summary of the Study that Proves the Device Meets the Acceptance Criteria (Non-Clinical):

The "study" in this context refers to a series of non-clinical bench tests and validations. The document states:
"Verification and validation activities were conducted to establish the performance and safety characteristics of the V-Laser. The results of these activities show that there are no any new safety and effectiveness issues. Therefore, the V-Laser is considered substantially equivalent to the predicate."

These activities included:

• Electrical Safety, Electromagnetic Compatibility, and Performance Bench Tests: These tests verified that the device met all design specifications and complied with AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1 standards.
• Software Validation: The software, identified as having a MODERATE level of concern, was designed, developed, verified, and validated according to a software development process and FDA guidance.
• Biocompatibility Testing: Tests were performed according to ISO 10993-1 and FDA Blue Book Memo #G95-1, covering cytotoxicity, intracutaneous reactivity, and skin sensitization for materials in contact with the body.

The "proof" that the device meets these non-clinical "acceptance criteria" is the statement that the tests were conducted and the device "complies" with the listed standards and its design specifications. No detailed results, specific measurements, or pass/fail thresholds beyond the general statement of compliance are provided in this summary.

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