Search Results

1,064nm:

The Vbeam® Prima Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus, spider veins, and poikiloderma of civatte and treatment of benign cutaneous lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots), cafe au lait manules, sebortheic keratoses, nevi, chloasma, verrucea, skin tags, and keratoses. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.

595 nm:

General Surgery: Photocoagulation of benign cutaneous vascular lesions and benign cutaneous lesions.

Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesions, such as facial and leg telangiectasia, rosacea, port wine stains, hemangioma, spider angioma, poikiloderma of civatte, and benign cutaneous lesions, such as warts, scars, striae, psoriasis and the treatment of benign epidermal pigmented lesions. Treatment of inflammatory acne vulgaris.

Gynecology: Photocoagulation of benign cutaneous lesions and benign vascular lesions in gynecology.

Podiatry: Treatment of benign cutaneous lesions, such as warts.

The Vbeam Prima Laser system is designed as a transportable device that delivers laser energy at wavelengths of 595 nm (pulse-dye) or 1064 nm (Nd: YAG). The device is comprised of a main console, power supply, controlled electronics, firmware, software, cooling system, and handpieces. There is also an internal calibration port with an internal meter located in the system. The handpiece offers a set of distance gauges available in the following spot ranges: 3-7 mm, 11-15 mm, and 3 X 10 mm. The user selects treatment settings, such as fluence, number of pulses, and spot size selection via a color touch screen. The handpiece incorporates a Dynamic Cooling Device (DCD) into its handpiece that is designed to cool the skin surface during treatment, which consists of an electrically controlled spray nozzle, cryogen reservoir canister and an electronic control circuitry. The Vbeam Prima Laser System also offers an optional EverCool Delivery System Handpiece for skin cooling during treatment.

The Vbeam Prima Laser System (K183452) is a laser surgical instrument. As stated in section 9, "no clinical studies were needed to support this 510(k) Premarket Notification." Therefore, no specific acceptance criteria or "study that proves the device meets the acceptance criteria" in terms of clinical performance are provided in the document.

The document focuses on demonstrating substantial equivalence to predicate devices (Candela Vbeam Prima Laser System (K180593) and Candela GentleMAX Family of Pulse Dye Laser Systems (K140122)) through non-clinical performance data.

Here's a breakdown of the information requested, based on the provided text:

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

Since no clinical acceptance criteria or performance metrics were reported for this specific 510(k), this table cannot be populated as requested. The document emphasizes equivalence to predicate devices based on:

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, as no clinical human subject test set was used for this 510(k) submission. Performance data primarily comes from engineering and software 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, as no clinical human subject test set requiring expert ground truth assessment was conducted.

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

Not applicable, as no clinical human subject test set was conducted.

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, as the device is a laser system, not an AI diagnostic tool, and no clinical studies, including MRMC studies, were performed for this submission.

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

Not applicable, as the device is a laser system, not an algorithm.

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

Not applicable, as no clinical studies with a defined ground truth were provided in this 510(k). The "ground truth" for the non-clinical performance data would be adherence to established engineering and software standards.

8. The sample size for the training set

Not applicable, as no machine learning algorithm was evaluated, and therefore no training set was used.

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

Not applicable, as no training set was used.

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The GentleLASE Family of Laser Systems is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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.

Treatment of benign pigmented lesions.

Treatment of wrinkles.

The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

The Candela GentleLASE Family of Laser Systems contains an alexandrite laser head, which produces laser energy emitted at nominal wavelength of 755 nm. The output of the energy is then delivered to the skin through an optical fiber delivery system which also cools the surface of the skin through either air or cryogen cooling. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen. The GentleLase Pro and GentleLase Pro LE laser systems both have the same technological and performance specifications, the same indications for use, the same principles of operation, and the same energy type. The only difference between these two systems is the color of the side panels.

The provided text describes the acceptance criteria and a study for the Candela GentleLASE Family of Laser Systems, but it is a 510(k) summary for a software update for an already cleared device, not an initial clearance document. Therefore, the information typically found in an initial clearance study (like detailed performance data from a clinical trial demonstrating efficacy against a specific acceptance criterion for a medical condition) is not present.

The focus of this document is on demonstrating that a software update to an existing device (GentleLASE Pro and GentleLASE Pro LE Laser Systems) does not negatively impact its safety or effectiveness compared to its predicate device (GentleMAX Family of Laser Systems, K133283).

Here's an analysis based on the provided text, highlighting what is available and what is explicitly stated as not required or not applicable in this context.

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

The document does not present a table of specific acceptance criteria in the way one might expect for a primary efficacy study (e.g., "X% reduction in hair"). Instead, the "acceptance criteria" here are implicitly tied to the device performing "according to specifications and functions as intended" after the software update, and maintaining substantial equivalence to the predicate device.

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

• Sample Size: Not applicable/not provided. The study mentioned is "software verification and validation" and "performance testing" to standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22). This typically involves engineering and functional testing of the device itself, rather than testing on a "test set" of patients or cases.
• Data Provenance: Not applicable, as this was not a clinical study on human subjects or patient data. It was technical testing of the device.

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

• This is not applicable as there was no clinical "test set" requiring ground truth establishment by experts for medical conditions. The testing was technical verification and validation of the device's functional performance.

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

• This is not applicable as there was no clinical "test set" requiring adjudication.

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

• This is not applicable. The device is a laser system, not an AI diagnostic tool, and this submission is for a software update, not a new device clearance or an AI assistance study.

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

• This is not applicable. The device is a laser system which operates with human involvement.

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

• This is not applicable. For engineering performance testing, the "ground truth" would be the device's design specifications and the requirements of the relevant IEC standards.

8. The sample size for the training set

• This is not applicable as this is a software update for a laser system, not an AI/machine learning model that typically undergoes "training."

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

• This is not applicable for the reasons mentioned in point 8.

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The GentleMAX Family of Laser Systems is indicated for the following at the specified wavelength:

755mm
Temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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 I- VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

1064nm
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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 lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
The laser is 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.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.

1064nm
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

The Candela GentleMAX Family of Laser Systems contains two separate laser heads (Alexandrite and Nd: YAG), which produce laser light outputs of 755 nm and 1064 nm. respectively. The output of each laser head is 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 which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen.

Here's a breakdown of the acceptance criteria and study information based on the provided text, focused on the GentleMAX Family of Laser Systems for its primary indications (hair reduction, pigmented lesions, wrinkles, vascular lesions) and the new indication (onychomycosis) which is the focus of this 510(k) submission:

Acceptance Criteria and Device Performance

The provided document is a 510(k) summary for the GentleMAX Family of Laser Systems, specifically regarding a modification that includes a new indication for onychomycosis. For the existing indications (hair reduction, pigmented lesions, wrinkles, vascular lesions), the submission asserts substantial equivalence to previously cleared devices. For the new onychomycosis indication, the substantial equivalence is drawn against the Cutera GenesisPlus Laser (K122493).

The "acceptance criteria" in this context are primarily based on demonstrating substantial equivalence to existing predicate devices, meaning the device performs as safely and effectively as a legally marketed device without raising new questions of safety or effectiveness. For medical devices, this is often assessed through bench testing, device specifications, and sometimes clinical data.

For the existing indications (Hair Reduction, Benign Pigmented Lesions, Wrinkles, Vascular Lesions):

The acceptance criteria are implicitly met by demonstrating that the Modified GentleMAX Family of Laser Systems maintains the same technological characteristics and intended uses as the GentleMAX Family of Laser Systems (K133283). The "reported device performance" in this context is that its performance specifications (wavelength, pulse duration, fluence, spot size, repetition rate, etc.) are identical to the predicate.

For the new indication (Temporary increase of clear nail in patients with onychomycosis at 1064nm):

The acceptance criteria are established by comparing to the Cutera GenesisPlus Laser System (K122493).

Study Information

The document explicitly states: "No clinical data was required." This is a key piece of information. The "study" proving the device meets acceptance criteria primarily relies on bench testing and the demonstration of substantial equivalence through comparison of technological characteristics and intended uses with predicate devices.

1. Sample size used for the test set and the data provenance:
* Test Set Sample Size: Not applicable. The submission states "No clinical data was required," indicating there was no clinical test set of patients or anonymized data sets from patients used for this 510(k) submission.
* Data Provenance: Not applicable for a clinical test set. The data provenance would be from internal bench testing (laboratory-generated) and comparison of specifications from the predicate devices' publicly available 510(k) information.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable as no clinical test set was used. Ground truth for device specifications would be based on engineering and manufacturing standards.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable as no clinical test set requiring expert adjudication was used.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* Not applicable. This device is a laser system for dermatology, not an AI-assisted diagnostic or imaging system that would involve human readers interpreting cases.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. This is a physical medical device, not an algorithm or software-only device. Performance is evaluated based on its physical characteristics and functionality.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* The "ground truth" for this submission is based on engineering specifications and performance data collected during bench testing (e.g., laser output measurements, pulse duration, fluence, spot size consistency). For the new onychomycosis indication, the ground truth for equivalence is the performance specifications of the predicate device (Cutera GenesisPlus Laser System K122493).

7. The sample size for the training set:
* Not applicable. This is a medical device clearance based on substantial equivalence and bench testing, not a machine learning or AI-driven device requiring training data.

8. How the ground truth for the training set was established:
* Not applicable as no training set was used.

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755nm
The GentleMAX Family of Laser Systems is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias.

1064nm
The GentleMAX Family of Laser Systems is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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 lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to. lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.
The laser is 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 laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.

The Candela GentleMAX Family of Laser Systems contains two separate laser heads (Alexandrite and Nd: YAG), which produce laser light outputs of 755 nm and 1064 nm, respectively. The output of each laser head is 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 which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen.

1. Acceptance Criteria and Device Performance:

Detailed Indications for Use (both predicate and modified device):

• 755nm:
  • Temporary hair reduction.
  • Stable long-term or permanent hair reduction (defined as long-term, stable reduction in the number of hairs regrowing at 6, 9, and 12 months post-treatment) on all skin types (Fitzpatrick I-VI) including tanned skin.
  • Treatment of benign pigmented lesions.
  • Treatment of wrinkles.
  • Photocoagulation of dermatological vascular lesions (e.g., port-wine stains, hemangiomas, telangiectasias).
• 1064nm:
  • Removal of unwanted hair, stable long-term or permanent hair reduction, and treatment of PFB (defined as long-term, stable reduction in the number of hairs regrowing at 6, 9, and 12 months post-treatment) on all skin types Fitzpatrick I-VI including tanned skin.
  • Photocoagulation and hemostasis of pigmented and vascular lesions such as port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins.
  • Coagulation and hemostasis of soft tissue.
  • Benign pigmented lesions (e.g., lentigos, solar lentigos, café au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos - significant reduction in black and/or blue-black tattoos, and plaques).
  • Indicated for pigmented lesions to reduce lesion size, for patients benefiting from aggressive treatment, and for patients not responding to other laser treatments.
  • Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
  • Treatment of wrinkles.

2. Sample Size and Data Provenance:

• Sample size for the test set: Not applicable. The submission states "No clinical data was required for these modifications." The evaluation was based on non-clinical performance data and a comparison to a predicate device.
• Data provenance: Not explicitly stated as clinical data was not required. However, the non-clinical tests (EMC, electrical safety, software verification and validation) would have been performed by the manufacturer, Candela Corporation. This indicates prospective testing of the modified device's performance against established specifications. The original predicate device's performance would be historical (retrospective) for comparison.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable for this submission. No clinical studies requiring expert ground truth were conducted for these modifications. The evaluation focused on comparing technical specifications and performance data to a predicate device, not on clinical outcomes assessed by experts.

4. Adjudication Method for the Test Set:

• Not applicable as no clinical test set requiring adjudication by experts was used. The assessment appears to be based on engineering and safety testing.

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

• No. The document explicitly states, "No clinical data was required for these modifications." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

6. Standalone Performance Study:

• Yes, in a non-clinical context. The "Performance Data" section indicates that "All performance testing demonstrated that the GentleMax Pro Laser System performs according to specifications and functions as intended." This refers to electromagnetic compatibility (EMC), electrical safety, and software verification and validation tests run on the device itself. This can be considered a standalone performance evaluation of the device's technical functionality, distinct from clinical efficacy.

7. Type of Ground Truth Used:

• For the non-clinical testing of the modified device, the "ground truth" was the pre-defined engineering specifications, safety standards (e.g., EMC, electrical safety), and validated software requirements.
• For the overall substantial equivalence claim, the "ground truth" or reference was the performance and safety profile of the legally marketed predicate device (K112715). The modified device was deemed substantially equivalent because its non-clinical tests confirmed it performed "as well as the predicate device" and raised no new safety or effectiveness issues.

8. Sample Size for the Training Set:

• Not applicable. This submission describes modifications to an existing laser system and relies on non-clinical testing and comparison to a predicate device, not the development or training of an AI algorithm or statistical model that would require a training set of data.

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

• Not applicable, as no training set was used.

Ask a specific question about this device

The GentleMAX Family of Laser Systems is indicated for temporary hair reduction. Stable longterm or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. On all skin types (Fitzpatrick I-VI) including tanned skin.

Treatment of benign pigmented lesions.

Treatment of wrinkles.

The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias)

1064nm

The GentleMAX Family of Laser Systems is indicated for the removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.

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

Treatment of wrinkles.

The Candela GentleMAX Family of Lasers contains two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 nm, respectively. The output of each laser head is 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 which can output either 755 nm or 1064 nm wavelengths.

Each laser head contains the appropriate solid state laser rod and high intensity xenon flashlamps to excite the laser medium. The laser heads are water cooled with a self contained circulating water system that includes a water to air heat exchanger so the system can be fully air-cooled. The temperature of the laser heads are regulated by the circulation of distilled water at a controlled temperature.

A high voltage power supply is used to charge a storage capacitor which provides energy to the flashlamps. An IGBT (high voltage switch) is used to discharge the capacitor through the flashlamp. Each laser head has its own dedicated IGBT switch which is how the system controls which wavelength is produced. The resulting flash of the flashlamp excites the laser rod which causes emission of a pulse of laser energy.

The Candela GentleMAX Laser System delivers laser energy with various pulse durations from 0.25 milliseconds to 300 milliseconds. The output of this laser is delivered to the area of reamment by means of a lens coupled user replaceable optical fiber with a treatment her and are artacted to its distal end. A trigger switch (fingerswitch or footswitch) is used to control the delivery of laser pulses. The user may choose to deliver a single pulse each time the trigger switch is depressed, or pulses may be delivered repetitively as long as the switch is depressed, at repetition rates up to 10 pulses per second (depending on the chosen pulse duration).

Energy from the laser is directed to the target area via optical fiber handpiece delivery system. The Dynamic Cooling Device provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 1.5, 3, 6, 8, 10, 12, 15 and 18 millimeters on the skin. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece.

A microprocessor based system controller is used to monitor and direct all system functions. Operators of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via a touch screen and display panel. The touch screen panel can also be used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system, such as the number of pulses delivered or spot size selected.

The GentleMAX Family of Laser Systems are designed with six major components:

• 1. High voltage power supply and modulator system
• 2. Optical laser head
• 3. Circulator system
• 4. Optical delivery system
• S. Software control system
• 6. Dynamic cooling device

The Candela GentleMAX Family of Laser Systems are equipped with safety interlock systems to protect patients and operators.

The Candela GentleMAX Family of Laser Systems is a medical device for dermatological treatments. The 510(k) summary indicates that the device has comparable performance to its predicate devices, but it does not contain a study or data that assesses its performance against specific acceptance criteria.

The provided document is a 510(k) premarket notification. For devices cleared through the 510(k) pathway, the primary mechanism for demonstrating safety and efficacy is to show substantial equivalence to a legally marketed predicate device. This typically involves demonstrating that the new device has similar intended uses, technological characteristics, and performs as safely and effectively as the predicate without raising new questions of safety or effectiveness. Often, comparison to predicate device specifications and existing performance data for predicate devices is used rather than new, extensive clinical studies with specified acceptance criteria as might be seen for a PMA (Premarket Approval) submission.

Therefore, many of the requested details about acceptance criteria, study methodologies, and ground truth establishment are not typically found in a 510(k) summary that relies on substantial equivalence.

Here's a breakdown of the information as it relates to your request, indicating where information is present or absent based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The 510(k) summary does not describe a specific clinical "test set" with a sample size or data provenance because it relies on substantial equivalence to predicate devices, rather than new, independent clinical performance data. The "testing" section primarily refers to compliance with laser and electrical safety standards.

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

This information is not applicable or provided. The submission does not detail a study that required expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable or provided. There is no described test set requiring an adjudication method.

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

This information is not applicable or provided. The device is a laser system for dermatological treatments and not an AI-assisted diagnostic device, so an MRMC study with human readers/AI assistance is not relevant to this 510(k) submission.

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

This information is not applicable or provided. The device is a physical laser system, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable or provided as there is no specific performance study against a ground truth described in the document. Substantial equivalence relies on comparing the device's characteristics and intended use to those of already approved predicate devices.

8. The Sample Size for the Training Set

This information is not applicable or provided. The device is a physical laser system, and the submission does not mention any machine learning or AI components that would require a "training set."

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

This information is not applicable or provided for the reasons stated in point 8.

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The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

The Candela GentleLASE Family of Lasers utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed to the target area via optical fiber handpiece delivery system. The Dynamic Cooling Device provides a short burst of cryogen spray prior to firing the laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 6, 8, 10, 12, 15, 18 millimeters on the skin. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece. The GentleLASE Family of Laser Systems are designed with six major components:

1. High voltage power supply and modulator system
2. Optical laser head
3. Circulator system
4. Optical delivery system
5. Software control system
6. Dynamic cooling device
   The Candela GentleLASE Family of Laser Systems are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.

The provided text is a 510(k) summary for the Candela GentleLASE Family of Laser Systems, seeking clearance based on substantial equivalence to predicate devices. It does not contain information about a study that establishes acceptance criteria and then proves the device meets those criteria in the way described in the prompt's request.

Instead, this document focuses on demonstrating substantial equivalence to existing, legally marketed devices, rather than establishing and meeting novel performance acceptance criteria through clinical studies designed for that purpose.

Therefore, most of the requested information cannot be extracted from the provided text. Here's a breakdown of what can be inferred or directly stated, and what information is missing:

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

Not applicable. The submission focuses on demonstrating substantial equivalence to predicate devices based on shared intended uses, operating principles, and key design aspects (spot size, wavelength, maximum delivered fluence). No specific performance metrics for novel "acceptance criteria" are provided.

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

Not applicable. No "test set" in the context of a performance study is described. The submission relies on comparisons to predicate devices.

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 "ground truth" establishment for a performance study is described.

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

Not applicable. No "test set" or adjudication method for a performance study 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. The device is a laser system for dermatological use, 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

This question is not relevant as the device is a laser system, not an algorithm.

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

Not applicable. No ground truth for a performance study is described. The "ground truth" in this context is the safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set.

Summary of Device Acceptance/Equivalence from the Provided Text:

The acceptance of the device is based on its substantial equivalence to previously cleared predicate devices. The study, in this case, is a comparison against these predicates, highlighting similarities in design and principle.

Key Information from the Document regarding "Acceptance":

• Acceptance Criteria (Implicit for 510(k) submission): The device must be "substantially equivalent" to predicate devices. This is demonstrated by showing:

  • Same intended uses (photocoagulation of dermatological vascular lesions).
  • Similar operating principles (Alexandrite rod, 755nm pulsed energy, optical fiber handpiece delivery, Dynamic Cooling Device).
  • Matches key design aspects (similar spot size, same wavelength, same maximum delivered fluence as predicate devices).
  • Conforms to relevant safety standards (Laser Performance Standard (21 CFR 1040), IEC (EN) 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22).

• Reported Device Performance (as demonstrated for equivalence):
  The Candela GentleLASE Family of Laser Systems has the same intended uses, utilizes similar operating principles, and matches key design aspects (including similar spot size, the same wavelength, and the same maximum delivered fluence) as the predicate devices (GentleLASE Family of Laser Systems K024371, K024335, K024260, and previous models K994260, K981351, K974381, K972767). The device also conforms to various laser and medical electrical equipment safety standards.

The FDA's letter (K11144) ultimately states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... You may, therefore, market the device." This constitutes the "acceptance" based on the provided evidence of equivalence.

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The Candela Family of Q-Switched Alexandrite Lasers are indicated for treatment in the following uses:
Pigmented Lesions Tattoos

The Candela Q-Switched Alexandrite Laser consists of an Alexandrite laser head, power supply and deionized water circulator The laser head contains cavity mirrors, pockels cell, solid state laser medium (the Alexandrite rod), and two high intensity xenon flashlamps which excite the laser medium. A calibration port with an internal meter is located on the control panel, which is used to verify the transmission of the optical fiber and handpiece, and to calibrate the output of the handpiece at selected fluence levels. The temperature of the laser head is regulated by the circulation of distilled water at a controlled temperature.

The Candela Q-Switched Alexandrite Laser delivers laser energy at a wavelength of 755 nm and pulse duration between 50 and 120 microseconds. When the Q-switching mechanism is disabled the system has the capability of producing a laser pulse duration of 0.050 - 0.120 milliseconds. The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch is used to control the delivery of pulses.

A microprocessor based system controller is used to monitor and direct all system functions. Users of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via electronic controls and a display panel. The control panel is also used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Candela Q-Switched Alexandrite Laser supports 2mm, 3mm, and 5mm nominal spot sizes.

The provided text is a 510(k) summary for the Candela Q-Switched Alexandrite Laser. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

It is crucial to understand that 510(k) summaries, especially for older or non-AI/software devices, often do not contain the type of detailed clinical study information requested. The purpose of a 510(k) is to show substantial equivalence, not necessarily to prove new high-level efficacy or to conduct comprehensive clinical trials with the rigor you're asking about (e.g., MRMC studies, specific acceptance criteria for performance metrics like sensitivity/specificity).

Based on the provided text, I can answer some of your questions, but many will be marked as "Not Applicable" or "Not Provided" because the document does not contain that information, consistent with the nature of a 510(k) for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. The 510(k) summary does not present specific quantitative performance metrics (like sensitivity, specificity, accuracy) or formal acceptance criteria for these metrics for the Candela Q-Switched Alexandrite Laser. The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological features, and design aspects, rather than proving a new level of clinical performance against defined criteria.

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

Not Applicable / Not Provided. The document does not describe a clinical test set in the manner typically associated with AI/software performance evaluation. The substantial equivalence argument is based on the device's design, functional features, and intended use being similar to existing (predicate) devices. There is no mention of a "test set" of clinical cases for performance evaluation.

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

Not Applicable / Not Provided. As no test set for clinical performance evaluation is described, there is no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided. No test set or performance study is described that would require an adjudication method.

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

Not Applicable / Not Provided. The document does not describe a MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a laser system, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not Applicable / Not Provided. This device is a physical laser system, not an algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

Not Applicable / Not Provided. No clinical performance ground truth is mentioned. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices to which it claims substantial equivalence.

8. Sample Size for the Training Set

Not Applicable / Not Provided. Given this is a physical laser system, the concept of a "training set" (as in machine learning) does not apply. The device's design and manufacturing rely on engineering principles, established medical device standards, and the precedent set by predicate devices.

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

Not Applicable / Not Provided. As there is no "training set" in the context of this device, this question is not relevant.

Summary of Device and 510(k) Approach:

The K081324 submission for the Candela Q-Switched Alexandrite Laser is a classic example of a 510(k) for a physical medical device. The core argument for clearance is substantial equivalence to previously cleared predicate devices, specifically:

• Candela Q-Switched Alexandrite Laser, K073534
• Candela 3630 Laser System (Alexandrite) K063074
• Cynosure Accolade Elite Laser (Alexandrite) K072868 (and K034030, possibly updated in the summary)

The rationale for equivalence is based on:

• Same Intended Use: Treatment of pigmented lesions and tattoos.
• Similar Functional Features: Power output, spot size, repetition rate, energy, fluence.
• Matches Key Design Aspects: Wavelength (755 nm Alexandrite), light generation medium, power supply, cooling, and controls system.
• Similar Methods of Assembly and Operation.

The document states, "Candela believes that there are no new questions of safety or effectiveness raised and the Candela Q-Switched Alexandrite Laser is substantially equivalent to the current legally marketed Candela Q-Switched Alexandrite Laser... in intended use and technological features and therefore the risks and benefits are comparable to the predicate devices."

Therefore, the "acceptance criteria" for this submission were essentially the FDA determining that the new device did not raise new questions of safety or effectiveness compared to the predicates and that its technological characteristics were sufficiently similar to establish substantial equivalence. No explicit quantitative performance metrics or clinical study data of the type requested were provided or required for this 510(k).

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The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is indicated for the following uses:

Pigmented Lesions
Tattoos

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems consist of an Alexandrite laser head, power supply and deionized water circulator. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems also contains a Q-switching mechanism which when disabled allows the laser system the capability of producing a laser pulse duration of 0.050 - 0.120 millisecond. The laser head contains the cavity mirrors, pockels cell, solid state laser medium (the Alexandrite rod), and two high intensity xenon flashlamps which excite the laser medium. A calibration port with an internal meter is located on the control panel, which is used to verify the transmission of the optical fiber and handpiece, and to calibrate the output of the handpiece at selected fluence levels. The temperature of the laser head is regulated by the circulation of distilled water at a controlled temperature. The laser system is fully air cooled.

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems delivers laser energy at a wavelength of 755 nm and pulse duration between 50 and 120 microseconds. The output of this laser is delivered to the area of treatment by means of a lens coupled user replaceable optical fiber with a treatment handpiece attached to its distal end. A trigger switch is used to control the delivery of pulses.

A microprocessor based system controller is used to monitor and direct all system functions. Users of the laser select parameters such as desired energy density (fluence) level and repetition rate and monitor operation via electronic controls and a display panel. The control panel is also used to enable or disable the triggering of the laser, to initiate the calibration feature and to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems support 2mm, 3mm, and 4mm nominal spot sizes.

This document is a 510(k) summary for the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or performance testing documentation.

Instead, the document focuses on regulatory approval based on substantial equivalence to already legally marketed devices. This means the manufacturer is asserting that their new device is as safe and effective as existing ones, rather than necessarily performing a new study against specific acceptance criteria.

Therefore, most of the information requested in your prompt is not available in this document.

However, I can extract the following:

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

• Not available. The document does not specify acceptance criteria or report performance data against such criteria. The basis for approval is substantial equivalence to predicate devices, not performance against new, explicit criteria.

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

• Not applicable/Not available. No new test set data is presented for performance evaluation against acceptance criteria. The approval is based on substantial equivalence to predicate devices already on the market.

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 available. No new test set requiring expert ground truth is described.

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

• Not applicable/Not available. No new test set requiring adjudication is described.

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

• Not applicable/Not available. This device is a laser system, not an AI or imaging device that would typically involve human readers or MRMC studies.

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

• Not applicable/Not available. This device is a laser system, not an algorithm, so a standalone performance study in this context is not relevant.

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

• Not applicable/Not available. No new ground truth is established for this submission. The rationale for approval is based on substantial equivalence to existing, legally marketed devices for which safety and effectiveness have already been established.

8. The sample size for the training set

• Not applicable/Not available. This document describes a physical medical device (laser system), not a software or AI algorithm that would typically have a "training set."

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

• Not applicable/Not available. As above, no training set is relevant to this device submission.

Summary based on the provided document:

The provided document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence of the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems to existing, legally marketed predicate devices. It explicitly states: "The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems has the same intended use, utilizes similar functional features... and matches key design aspects... as the predicate devices."

The determination of substantial equivalence means that "the risks and benefits are comparable to the predicate devices," and therefore, "there are no new questions of safety or effectiveness raised." As such, this document does not contain information on new acceptance criteria, device performance against such criteria, or new studies with test sets, expert ground truth, or training sets. The regulatory pathway chosen (510(k) for substantial equivalence) means such studies are generally not required if the new device is demonstrably similar to existing ones.

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The Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System is indicated for the following uses: An accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration of the treatment beam through it. Reduction of pain during Laser or Intense Pulse Light System treatment.

The Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System is an accessory for a Laser or Intense Pulse Light System for their legally marketed indications. Its handpiece produces a negative pressure over the skin surface just prior to the administration of the treatment beam through it. The chamber of the handpiece produces the negative pressure over the skin surface for a very short duration just prior to firing an intense treatment light pulse or laser beam. The negative pressure results in the flattening of the skin against a highly thermal conductive transparent sapphire window, thereby ensuring tight mechanical contact with the window. The Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System consists of a control unit and a handpiece connected together by a 10' flexible hose containing flexible tubing. The flexible hose has a connector at the front of the control unit and is removable by pulling a connector while pressing a latch. The handpiece is ergonomically designed for easy use.

The provided document is a 510(k) summary for the Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System. This submission is for an accessory system that works with existing laser or intense pulsed light (IPL) systems for hair removal and pain reduction during treatment.

The document indicates that the submission relies on substantial equivalence to predicate devices (K062589 and K001589) rather than presenting a de novo study with specific performance acceptance criteria for the new device. Therefore, explicit acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical trial with specific endpoints, are not provided for this 510(k) submission.

Instead, the submission states that:

• "Performance clinical data demonstrates that the Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System does not introduce new issues of safety and efficacy and therefore is substantially equivalent to the currently legally marketed Inolase Serenity PSF™ (Pneumatic Skin Flattening) System, K062589 and Candela Dynamic Cooling Device, K001589 predicate devices."
• "Performance clinical data demonstrates that the Candela - Inolase Serenity PSF™ (Pneumatic Skin Flattening) System does not introduce new issues of safety and efficacy."

This suggests that comparison data, likely from clinical observations or existing studies on the predicate devices, was used to support the claim of substantial equivalence. However, the details of these "performance clinical data" are not elaborated in the 510(k) summary.

Given the information provided in the 510(k) summary, it's not possible to populate a table of acceptance criteria and reported device performance directly from a new study, nor can the requested details about sample size, ground truth, expert qualifications, adjudication methods, or MRMC studies be provided. This type of information is typically part of a full clinical study report, which is not included in a 510(k) summary.

In summary, the provided 510(k) document is a declaration of substantial equivalence based on prior predicate devices, not a report of a new clinical study with defined acceptance criteria for the submitted device.

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The Candela Fluorescent Pulsed Light System is indicated for the following uses:

Hair removal in all skin types to the Fitzpatrick scale. Permanent Hair Reduction.

Treatment of Vascular Lesions

Treatment of Inflammatory Acne (acne vulgaris)

Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae.

The Candela Fluorescent Pulsed Light System is designed for selective photothermolysis in aesthetic treatments. The technology is based on a unique combination of patented fluorescent filter technology, selected spectrums of light source emission; pulse forming and sapphire based skin cooling system. It operates through creation of a directed incoherent light beam of spectrally balanced light. The light is spectrally filtered to remove the shorter wavelength portions (UV) most likely to cause harm to the skin. A sapphire crystal light guide is used to transport the resultant longer wavelength light to a laser-dye impregnated polymer filter sheet, which absorbs the part of the lamp light spectrum below it's emission and emits the selected wavelength band (417- 1200 nm) to 615 - 1200 nm, and non fluorescent 650 nm - 1200 nm and 850 - 1200 nm.

A liquid-to-air cooling system, including a fluid pump, fluid reservoir, deionization filter, interlocks and forced convection liquid-to-air heat exchanger and a water to water ThermoElectrical cooler is used to maintain the hand piece components at the proper temperature. The electronic components of the system include multiple safety features to protect both the user and patient, and the pulsed-light system itself.

A microprocessor based system controller is used to monitor and direct all system functions. Users of the Candela Fluorescent Pulsed Light System select parameters such as desired energy density (fluence) level and filter wavelength and monitor operation via electronic controls and a display panel. The control panel is also used to enable or disable the triggering of the Candela Fluorescent Pulsed Light System, and to obtain feedback from the system, such as the number of pulses delivered or spot size selected. The Candela Fluorescent Pulsed Light System supports 40mm x 20mm, 20mm x 20mm, 10mm x 20mm, 7mm x 15mm, 7mm x 7mm.

I am sorry, but based on the provided document, I cannot fulfill your request for detailed information regarding acceptance criteria and a study proving device performance in the way you've outlined. This document is a 510(k) summary for a Candela Fluorescent Pulsed Light System (K063800), which focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting the results of a primary clinical study with specific performance metrics against acceptance criteria.

The document states: "The Candela Fluorescent Pulsed Light System is substantial equivalent to the currently legally marketed Luxsano AB OmniLight Fluorescent Pulsed Light System, K032191 and the Palomar Medical Technologies, Inc. StarLux Pulsed Light System, K041086 predicate devices in intended use and technological features and therefore the risks and benefits are comparable to the predicate devices."

This means the FDA cleared the device based on its similarity to previously cleared devices, not necessarily on a new clinical study.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance: This level of detail about specific performance metrics and acceptance thresholds for a new clinical study is not present.
2. Sample size used for the test set and the data provenance: No new test set is described or analyzed in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of expert review or ground truth establishment for a new study.
4. Adjudication method for the test set: Not applicable as no new test set is presented.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
6. If a standalone performance study was done: The document does not describe a standalone study. Instead, it relies on substantial equivalence.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: No training set for an AI/algorithm is mentioned, as this device is not an AI-based system.
9. How the ground truth for the training set was established: Not applicable.

The document's purpose is to establish substantial equivalence based on functional features, intended use, and technological features compared to existing devices. It does not contain the detailed reporting of a clinical study that would answer your specific questions about acceptance criteria and performance data from a new study.

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