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The Alma Veil 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 Alma Veil is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, spider veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scars, striae, and psoriasis. The lasers are also intended 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, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques.

Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

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

The Alma Veil is indicated for temporary and permanent hair reduction. 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 Alma Veil is also indicated for the treatment for pseudofolliculitis barbae.

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

The Alma Veil is also indicated for treatment of mild to moderate inflammatory acne vulgaris.

The intended use of the cooling system in the Alma Veil 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 hair 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, hemangiomas (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 Alma Veil is a Nd:YAG laser operating at wavelengths of 1,064 nm and 532 nm. The Alma Veil consists of the main body, optical fiber cable, user-undetachable laser 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 nm.

Let's break down the acceptance criteria and study information for the Alma Veil Laser System based on the provided FDA 510(k) clearance letter.

It's important to note that this document is an FDA 510(k) Clearance Letter and a 510(k) Summary. 510(k) submissions typically rely on demonstrating substantial equivalence to a previously cleared predicate device, rather than requiring extensive de novo clinical trials to prove safety and effectiveness from scratch. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical and, if applicable, clinical data demonstrating that the new device performs as intended and is as safe and effective as the predicate device.

From the provided text, the Alma Veil is a laser system, not an AI/Software as a Medical Device (SaMD) that typically involves complex AI model validation studies with expert ground truth and MRMC studies. The "acceptance criteria" here relate to the device's physical and functional specifications and its safety and performance standards.

Here's the information extracted and organized:

Acceptance Criteria and Device Performance for Alma Veil Laser System

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a laser system and not an AI/imaging device, the "acceptance criteria" are primarily related to meeting recognized performance and safety standards, and demonstrating physical and functional equivalence to the predicate device. The performance is reported by stating compliance with these standards and matching the predicate's parameters.

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The 'Oligio X' is intended for use in dermatologic and general surgical procedures for non-invasive electrocoagulation and hemostasis of soft tissue.

Oligio X is a radio frequency therapy system. The radio frequency output of the device is 6.78 MHz, and the maximum power is 200 W. Oligio X consists of a main body including touch LCD monitor, a RF handpiece, return pads, a return pad cable, non-sterile treatment tips, cooling fluids, footswitch and a power cable. Oligio X RF System delivers radio frequency energy for selective coagulation of tissue while conductively cooling the epidermis. Oligio X delivers energy form the disposable tip to the patient, and employs radio frequency turning to provide radio frequency energy across a range of impedances for delivery to the patient through the tip.

The provided text does not contain information about a study proving the device meets acceptance criteria in the context of a clinical performance study with human subjects, expert adjudication, or ground truth establishment as would be typical for an AI/software-as-a-medical-device (SaMD) submission.

Instead, the document is a 510(k) premarket notification for a physical medical device, the "Oligio X," which is a radio frequency therapy system for dermatologic and general surgical procedures. The substantial equivalence determination is based on comparisons to a predicate device and non-clinical testing, primarily focused on electrical safety, electromagnetic compatibility, software validation, and biocompatibility.

Specifically, the document states: "No clinical studies were considered necessary and performed." This indicates that for this particular device submission, a clinical performance study (which would typically involve the elements you've asked about, such as ground truth, experts, and human-in-the-loop performance) was not required by the FDA.

Therefore, I cannot populate the table or answer the specific questions related to a clinical study and AI performance, as that information is not present in the provided text.

However, I can extract the "performance testing" details that were reported from non-clinical bench tests:

Acceptance Criteria and Reported Device Performance (Non-Clinical Bench Tests)

For the rest of your questions, based on the provided text:

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. No clinical test set or human data is mentioned. The "test set" for the reported performance was likely conducted on the device itself as part of bench testing.
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. No expert review or ground truth establishment for a test set (involving clinical data) was performed or mentioned.
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 not an AI/SaMD product that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This device does not use a training set for machine learning.
9. How the ground truth for the training set was established: Not applicable.

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Lavieen is indicated for use in dermatological procedures requiring 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).

Lavieen is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 mm) 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. Lavieen is equipped with a 658 nm aiming beam.

The provided text is a 510(k) summary for the Lavieen laser device. It outlines the device's characteristics, intended use, and its substantial equivalence to a predicate device. Medical device 510(k) summaries, by their nature, focus heavily on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive de novo clinical study data.

Based on the provided text, there is no information provided regarding acceptance criteria for an AI/algorithm-driven device, nor is there a study described that proves an AI/algorithm meets such criteria.

Here's a breakdown of why the requested information cannot be found in the provided text:

• Device Type: The Lavieen is described as a "thulium laser, producing a pulsed beam of coherent near-infrared light." It is a physical laser surgical instrument, not an AI/algorithm-driven diagnostic or therapeutic device.
• Software Validation: While the document mentions "Software Validation" and that Lavieen contains "Basic Documentation Level software," this refers to the software controlling the laser's hardware functions (e.g., controlling power, pulse duration, repetition rate) and ensuring its safe operation, not an AI or machine learning algorithm for diagnostic or treatment planning purposes. The software validation is in accordance with FDA guidance for device software functions, which is distinct from AI/ML-specific guidance.
• Clinical Studies: The document explicitly states: "No clinical studies were considered necessary and performed." This further confirms that no clinical performance study, including one for an AI component, was conducted or presented.
• Comparison to Predicate: The substantial equivalence argument relies on comparing the technical specifications of the Lavieen laser (e.g., laser type, wavelength, power, spot size) to another legally marketed laser device (the predicate device K223727), which also appears to be a physical laser device, not an AI.

Therefore, I cannot provide the requested table or describe a study proving an AI/algorithm-driven device meets acceptance criteria because the provided text is about a physical laser device and does not contain information about an AI/algorithm or its performance study.

The prompt asks for information that is not present in the provided document. If you have a document describing an AI/algorithm-driven device and its performance study, please provide that text.

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The PICOCAREMAJESTY is indicated for the following at the specified wavelength:

· 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I - VI) to treat the following tattoo colors: black,brown, green, blue and purple.

· 532 nm: Removal of tattoos for Fitzpatrick skin types I · III to treat the following tattoo colors: red, yellow and orange.

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

The PICOCAREMAJESTY is the solid state laser capable of delivering energy at wavelengths of 1064mm or 532nm at short durations. The device system consists of a main unit, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm delivery system terminated by the handpiece. The fluence (energy density) and frequency 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 treatmented is provided in the user Manual) The energy is changed automatically in accordance with the selected fluence (down) button and then, the fluence is increased / decreased by 0.1 J/cm2.

The selectable fluence values are 0.2 to 10.0 J/cm2 at 1064nm and 0.1 to 2.5 J/cm2 at 532nm

The provided text is a 510(k) summary for the WON TECH Co., Ltd. Picosecond Nd:YAG Laser (PICOCAREMAJESTY). This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for a novel device, especially not data related to complex AI algorithms or diagnostic accuracy studies.

Therefore, many of the specific details requested in your prompt, particularly those related to AI algorithm performance, human-in-the-loop studies, ground truth establishment, and training/test set sample sizes, are not present in this document. The device in question is a laser for tattoo and pigmented lesion removal, which typically undergoes performance testing based on physical parameters, and electrical/software safety, rather than diagnostic accuracy studies with expert readers.

However, I can extract information related to what is available in the document:

Acceptance Criteria and Device Performance (Based on provided documentation's summary of testing):

The document primarily relies on comparisons to predicate devices and adherence to established safety and performance standards for laser surgical instruments. It doesn't present "acceptance criteria" in the sense of a statistical threshold for diagnostic accuracy for a new AI algorithm, but rather lists the device's technical specifications and verifies compliance with recognized standards.

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The PICOANDY is indicated for the following at the specified wavelength:

· 1064 mm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.

· 532 nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

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

The PICOANDY is the solid state laser capable of delivering energy at wavelengths of 1064nm or 532nm at short durations. The device system consists of a main unit, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm delivery system terminated by the handpiece. The fluence (energy density) and frequency 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 provided document lists information for a medical device called PICOANDY (Q-Switched Nd:YAG Laser), which is a laser surgical instrument. It includes a 510(k) summary for FDA clearance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a table format with specific target values for performance in the context of a clinical study or effectiveness evaluation. Instead, it details the technical specifications of the PICOANDY device and compares them against a predicate device (PICOHIGH), claiming "substantial equivalence."

However, we can infer performance specifications from the "Performance Testing" section and the comparison to the predicate device.

• Zoom 532nm: 10 ~ 200mJ ±10%
• Collimation Mode: 38 ~ 500mJ ±10%
• MLA (1064nm): 30 ~ 550mJ ±10%
• MLA (532nm): 10 ~ 200mJ ±10%
• 1064nm DOE: 30 ~ 550mJ ±10%
• 532nm DOE: 20 ~ 200mJ ±10% | Reported within these ranges. | Similar (Predicate range for handpiece output is only slightly different, including error range) |
  | Spot Size: | 2 to 10 mm (by 1mm step) | 1064nm mode: (2 to 10mm) step: 1mm, 532nm mode: (2 to 10mm) step: 1mm | Similar (Proposed device range included in predicate) |
  | Pulse Repetition Rate: | Max. 10Hz | 1064nm mode: 1-10Hz, 532nm mode: 1-10Hz | Same |
  | Laser Delivery Type: | Articulated Arm with Handpiece | Articulated Arm with Handpiece | Same |
  | Handpiece Types: | Zoom, Collimated, MLA, DOE | Zoom, Collimated, MLA, DOE | Same |
  | Patient Contact Material: | Aluminum Powder (Handpiece) | Aluminum Powder (Handpiece) | Same |

The "acceptance criteria" here are implicitly the specifications of the device and its demonstrated ability to perform within those specifications, and critically, to be "substantially equivalent" to a legally marketed predicate device.

Study Type and Details to Prove Acceptance:

The document states: "No clinical studies were considered necessary and performed." This indicates that the device's clearance was based on non-clinical data and comparison to a predicate device.

Therefore, the following information is not applicable or extractable from the provided document as no clinical or comparative effectiveness study was conducted:

• Sample size used for the test set and data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• Multi Reader Multi Case (MRMC) comparative effectiveness study
• Effect size of human readers improving with AI vs. without AI assistance
• Standalone (algorithm only) performance study

Here's what was used to prove the device meets acceptance criteria (i.e., substantial equivalence):

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

• Not applicable / Not provided. No clinical test set. The evaluation relies on bench tests and comparison to a predicate device.

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

• Not applicable / Not provided. No ground truth established by experts for a clinical test set since no clinical studies were performed.

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

• Not applicable / Not provided. No clinical test set requiring adjudication.

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

• No. An MRMC study was not done. This device is a laser system, not an AI-assisted diagnostic tool.

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 a software algorithm for standalone performance. "Software Validation" refers to the internal software controlling the device, not a standalone diagnostic algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" implicitly refers to the engineering specifications and established safety and performance standards (e.g., IEC standards) and the characteristics of the predicate device. Compliance with these standards and demonstrating similar functionality to a predicate forms the basis of "truth" for substantial equivalence.

8. The sample size for the training set:

• Not applicable / Not provided. There is no "training set" in the context of an AI/ML algorithm for this device. The software validation mentioned is for the device's operational software, not for an AI model trained on data.

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

• Not applicable / Not provided. As there's no training set for an AI/ML algorithm described.

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The 'Oligio X' is intended for use in dermatologic and general surgical procedures for non-invasive electrocoagulation and hemostasis of soft tissue.

Not Found

This document is a 510(k) premarket notification acceptance letter for the device "Oligio X". It does not describe acceptance criteria for device performance, nor does it present a study proving the device meets performance criteria.

It confirms that the "Oligio X" device is substantially equivalent to a previously cleared predicate device ("Oligio" K221989) and outlines the regulatory requirements the device must meet.

Therefore, I cannot provide the requested information from the given text. The text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample size for a test set or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about standalone algorithm-only performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The central point of this document is the FDA's determination of substantial equivalence, which is based on the device having the "same electrification, principle, method, indication for use, and same components" as the predicate device, with differences limited to the color of the main body, handpiece, handpiece tip, and the GUI (Graphical User Interface) of the device.

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The Hair Boom Air is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of - II, males who have Norwood-Hamilton Classifications of Ila - V and for both. Fitzpatrick Classification of Skin Phototypes I to IV.

The Hair Boom Air diode laser is configured within an outer helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.

The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria. Instead, it is an FDA 510(k) clearance letter and summary for a device called "Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom".

The document primarily focuses on establishing substantial equivalence to a previously cleared predicate device (K223862), also named "Hair Boom Air, Hair Boom 69, Ulike Hair UpUp". The changes to the device are described as minor (controller design change, new timer mode, and color changes for helmet and controller).

Therefore, I cannot provide the requested information. The document explicitly states:

• "No clinical studies were considered necessary and performed."
• The determination of substantial equivalence relies on the device being "substantially equivalent to this device in design, function, and technical characteristics" to the predicate.

This means there is no new study described in this document that would establish acceptance criteria or demonstrate performance against such criteria for the current submission. The provided text is a regulatory clearance document, not a clinical study report.

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The WONTECH Air Gap Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 980 - 2200 nanometers have received regulatory clearance. The Air Gap Fiber delivery devices are intended for use with any surgical laser configured with an SMA-905 connector.

The WONTECH Air Gap Fibers are available in 3 sizes. These are 272, 365 and 550 microns and designated as hard clad silica material. These sizes refer to the core diameters of the silica. All fibers are Low OH (hydroxide), especially adapted to delivering wavelengths of laser that are highly absorbed by water. However, for those wavelengths in which water absorption is not a limiting factor, Low OH fiber optic cables may be used as well. The fiber assemblies are configured with standardized SMA-905 connectors, which are the most commonly found connectors in use today. These Air Gap fibers are packaged in sterile, single use, peel away pouches for direct use in operating theaters. The Air Gap fibers are indicated for soft and hard tissue contact and prepared with a polished, flat distal end. The Air Gap fibers is standardized at 3 meters. These Air Gap Fibers may be used with laser outputs from 1-120 watts. The Air Gap Fibers are intended for use in laser surgical procedures including open, laparoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable.

The provided text describes specific details about WONTECH Air Gap Fibers in the context of an FDA 510(k) submission, primarily focusing on its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance details from a study, sample sizes, expert qualifications, adjudication methods, or MRMC studies for AI devices. The text explicitly states "No clinical studies were considered necessary and performed" and "There is no software available for this device."

Therefore, I cannot provide the requested information for an AI-based device, as the provided document is for a physical medical device (laser fiber) and does not involve AI or related performance metrics that would typically come from a clinical or standalone study as described in your prompt.

The document focuses on non-clinical bench tests for sterilization, biocompatibility, and packaging, which are relevant to the physical characteristics and safety of the laser fiber itself, not its performance in an analytical or diagnostic task for which AI might be used.

I can, however, extract the non-clinical test summary information regarding product validation:

Non-Clinical Test Summary (from the provided document):

• Sterilization: Bench tests demonstrated compliance with ISO 11737-2 2019, ISO 11737-1:2018, ASTM F1980-21, and ISO 11135:2014/Amd 1:2018.
• Software Validation: "There is no software available for this device."
• Biocompatibility: The Silica Core fiber, with limited patient contact (

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

Lavieen is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 mm) 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. Lavieen is equipped with a 658 nm aiming beam.

The provided text is a 510(k) Summary for the Lavieen laser system. This document focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML-based medical devices or new clinical claims, are largely not present in this document. No clinical studies were deemed necessary or performed for this device.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

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

This document does not specify "acceptance criteria" in the sense of predefined thresholds for clinical performance outcomes. Instead, it demonstrates substantial equivalence to predicate devices by comparing technical characteristics and intended use.

Comparison Table for Substantial Equivalence (summarized from the document):

Reported Device Performance (from "Non-Clinical Test Summary"):

• Max output power: 10 W (This is a design specification, not a performance metric from a clinical study).
• Electrical Safety & EMC: Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1.
• Software Validation: Designed and developed according to a software development process, verified and validated.
• Biocompatibility: Handpiece Tip (ABS) in contact with intact skin for

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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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