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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.

1064 nm:
Dermatology:
The V-Laser is intended for the coagulation ans hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, and poikloderma of civate; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scriae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions, such as, but not limited to, lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques.
Additionally, the lasers are 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.
The V-Laser is also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.
The V-Laser is indicated for temporary and permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The V-Laser is also indicated for the treatment for pseudofolliculitis barbae.
The V-Laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vasularity is an integral part of the scar.
The V-Laser is also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The intended use of the cooling system in the V-Laser handpiece 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 harr removal and vascular lesions; and to reduce the potential side effects of laser treatments.

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 V-Laser is a Nd: YAG laser operating at wavelengths of 1,064 nm and 532 mm. The V-Laser consists of the main body, optical fiber cable, user handpiece, handpiece tip, footswitch, and handpiece cable cradle. The laser output is delivered through 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.
For treatment, the user can select the appropriate fluence value. The energy is changed automatically in accordance with the selected fluence value and selected spot size. The user can change the fluence value by pressing (+ (up) and/or == (down) button.
The selectable fluence values are 2 to 300 J/cm2 at 1064 nm and 1.8 to 42 J/cm2 at 532 mm.

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance criteria beyond general safety and equivalence to predicate devices. The information primarily focuses on the device's indications for use, technical specifications, and non-clinical testing for regulatory conformance.

Here's an analysis of what is and isn't available based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity) or clinical outcomes. Instead, it lists conformance to various international standards for medical electrical equipment, including safety, electromagnetic compatibility, usability, and particular requirements for laser equipment.

The document also provides technical specifications for the V-Laser, which are compared to predicate devices for substantial equivalence. These are not "acceptance criteria" in the sense of a performance study, but rather characteristics for comparison.

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

The document explicitly states: "No clinical studies were considered to be necessary for this pre-market notification." Therefore, there is no test set in the sense of patient data for clinical performance evaluation. The testing performed was non-clinical, focusing on compliance with safety and performance standards for laser 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 studies with patient data requiring expert ground truth were conducted or presented.

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

Not applicable, as no clinical studies with patient data were conducted or presented.

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 V-Laser is a laser surgical instrument, not an AI-assisted diagnostic or interpretive device 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 an algorithm, and is intended for use by a human operator.

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

Not applicable. For the non-clinical tests, the "ground truth" would be the specifications and requirements defined by the relevant international standards (e.g., IEC, ANSI AAMI).

8. The sample size for the training set:

Not applicable, as no machine learning algorithm or AI component is described as being trained.

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

Not applicable, as no machine learning algorithm or AI component is described.

In summary:

The provided 510(k) summary focuses on demonstrating substantial equivalence to previously cleared predicate devices (K221427 and K153671) through a comparison of technological characteristics and adherence to recognized performance and safety standards for laser surgical instruments. It explicitly states that no clinical studies were deemed necessary for this pre-market notification, which means there is no data presented in this document regarding clinical acceptance criteria, patient test sets, expert ground truth, or performance metrics like sensitivity/specificity.

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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 skin through 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.

This document is a 510(k) summary for the WON TECH Co., Ltd. V-Laser, a laser surgical instrument. The document states that no clinical studies were performed, and therefore, it does not contain the information required to fulfill the request.

Here's why the requested information cannot be provided based on the input:

• Acceptance Criteria and Reported Device Performance: The document lists technical specifications for the V-Laser and compares them to a predicate device (K183156). It notes differences in spot size and cooling system and states that these differences do not affect intended use, safety, or effectiveness. However, it does not define specific "acceptance criteria" for clinical performance (e.g., success rates, adverse event rates) or present "reported device performance" against such criteria.
• Sample Size, Data Provenance, Number of Experts, Adjudication Method, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size, Training Set Ground Truth: All these points relate to clinical studies involving human subjects and the evaluation of the device's efficacy and safety in a real-world setting. The document explicitly states: "No clinical studies were considered necessary and performed."

Therefore, all the requested information related to clinical studies and performance metrics based on such studies is absent from this document. The submission focuses solely on demonstrating substantial equivalence to a predicate device through non-clinical testing (electrical safety, EMC, software validation, biocompatibility) and a comparison of technical specifications.

Ask a specific question about this device

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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