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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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1. Temporary hair reduction.
2. Stable long-term, or permanent hair 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.
3. On all skin types (Fitzpatrick I-VI) including tanned skin.

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, which 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 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:

• High voltage power supply and modulator system
• Optical laser head
• Circulator system
• Optical delivery system
• Software control system
• 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.

This submission (K024260) for the Candela GentleLASE Family of Laser Systems does not contain a study with acceptance criteria and reported device performance in the typical sense of a clinical trial demonstrating efficacy against specific metrics.

Instead, this 510(k) submission is a "Substantial Equivalence" submission. This means Candela is asserting that their new device is substantially equivalent to a previously legally marketed predicate device (Candela GentleLASE GL K994260). The "acceptance criteria" here are not performance metrics of the device against a disease condition, but rather the regulatory criteria for demonstrating substantial equivalence.

Here's how the provided information relates to your request, interpreted in the context of a 510(k) submission for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not applicable in the context of this 510(k) submission. This is not a clinical study involving a "test set" of patients or data to evaluate performance for efficacy. The "test set" here would refer to the tests conducted to prove compliance with safety and performance standards for the device itself, not for clinical outcomes. The document doesn't specify the sample sizes for these engineering/safety tests (e.g., how many devices were tested for electrical safety).
• Data provenance: Not applicable for clinical performance data. The data presented is related to technical specifications and regulatory compliance of the device itself.

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

• Not applicable. There is no "ground truth" establishment for clinical outcomes in this submission as it's not a clinical performance study. The "ground truth" for regulatory compliance is established by engineering standards and internal testing by Candela.

4. Adjudication method for the test set

• Not applicable. There is 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

• Not applicable. This is a laser device for hair reduction, not an AI-assisted diagnostic tool involving human readers.

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

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

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

• For the purpose of this 510(k), the "ground truth" is compliance with established safety and performance standards (e.g., 21 CFR 1040, UL 2601, EN 60601-1-2) and demonstrating that the device meets the technical specifications (wavelength, fluence, spot size) of the predicate device. This is based on engineering measurements and documented internal testing.

8. The sample size for the training set

• Not applicable. There is no "training set" as this device does not involve machine learning or AI algorithms requiring data for training.

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

• Not applicable for the reasons stated above.

In summary:

This 510(k) submission is focused on demonstrating substantial equivalence to an existing device rather than proving clinical efficacy through a novel study. The "acceptance criteria" discussed are regulatory and technical requirements for clearance, not clinical performance metrics from a trial. Documents like this typically do not include detailed clinical study data with specific acceptance criteria as you would find for PMA submissions or de novo applications where novel claims or technologies are being evaluated for efficacy.

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The GentleLASE Family of lasers is indicated for use for the treatment of wrinkles.

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, which 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 a circular beam 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:

• High voltage power supply and modulator system
• Optical laser head
• Circulator system
• Optical delivery system
• Software control system
• 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 describes the Candela GentleLASE Family of Laser Systems, its intended use for the treatment of wrinkles, and its substantial equivalence to a predicate device. However, it does not include detailed information about specific acceptance criteria for device performance or a study demonstrating that the device meets those criteria, particularly in the context of clinical effectiveness for wrinkle treatment.

Here's an breakdown based on the information provided and what is missing:

The submission mainly focuses on regulatory compliance (Laser Performance Standard 21 CFR 1040, UL 2601, EN 60601-1-2) and establishing substantial equivalence to a predicate device (Candela GentleLASE GL, K994260). Substantial equivalence means it has the same intended use, similar operating principles, and matches key design aspects (spot size, wavelength, maximum delivered fluence) as a previously cleared device.

The claim for the treatment of wrinkles is stated to be "based on a controlled clinical study using a device that has been cleared for use in the market." This implies the predicate device (Candela GentleLASE GL) was proven effective for wrinkle treatment, and because the new device is substantially equivalent, it also claims this indication.

Missing Information:

The document explicitly states that the indications for use for wrinkle treatment are based on a controlled clinical study using a device that has been cleared for use in the market. This implies the predicate device (Candela GentleLASE GL, K994260) had such a study, and the new device is inheriting that claim due to substantial equivalence.

Therefore, the detailed information requested in the prompt's points 1-9 regarding the new device's performance acceptance criteria and a study proving it meets them is largely not present in the provided text. The submission focuses on substantial equivalence rather than a new standalone clinical efficacy study.

However, based on the information available and making inferences where necessary for the context of a 510(k) submission based on substantial equivalence:

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

Please note: These "acceptance criteria" and "reported device performance" are inferred based on the claims of substantial equivalence and safety/regulatory compliance. The document does not provide specific numerical performance metrics for wrinkle reduction, nor does it define specific clinical acceptance criteria for effectiveness (e.g., "X% reduction in wrinkle severity in Y% of patients"). The effectiveness for wrinkle treatment is, by extension, claimed from the predicate device.

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

Not explicitly provided for the new device. The document states: "The indications for use for the treatment of wrinkles is based on a controlled clinical study using a device that has been cleared for use in the market." This refers to the predicate device (Candela GentleLASE GL, K994260). The details of that study are not included in this 510(k) summary.

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 explicitly provided for the new device or the underlying predicate device study.

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

Not explicitly provided for the new device or the underlying predicate device study.

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

Not applicable. This device is a laser system for medical treatment, not an AI-assisted diagnostic or interpretative system that would involve "human readers" in the context of MRMC studies for AI.

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

Not applicable. This pertains to an algorithm's performance, while the device is a physical laser system. The "standalone" performance here would refer to the laser's physical parameters (wavelength, fluence, spot size), which are mentioned as consistent with the predicate device. The clinical effectiveness for wrinkle treatment is derived from the predicate device's study.

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

Not explicitly provided. Given the indication of wrinkle treatment, the ground truth for effectiveness in the predicate device's study would likely involve clinical outcomes data (e.g., blinded physician assessment of wrinkles severity, patient satisfaction, photographic analysis).

8. The sample size for the training set

Not applicable. This refers to machine learning models, not a physical medical device submission based on substantial equivalence.

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

Not applicable. This refers to machine learning models.

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