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The Candela GentleLASE GL Dermatology Laser is indicated for the following uses :

1. The Photocoagulation of Dermatological vascular lesions.
2. Temporary hair reduction.
3. 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. It is also intended for the photocoagulation of dermatological vascular lesions.

The Candela (Modified) GentleLASE GL Laser 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 targeted area via an optical fiber/handpiece delivery system. The Dynamic Cooling Device functions to cool the skin prior to laser treatment, minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela GentleLASE Lasers 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 Lasers 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 GL Laser System. It focuses on demonstrating substantial equivalence to predicate devices and describes the device's technical specifications and intended uses.

Crucially, the document explicitly states: "A clinical trial demonstrated that the GentleLASE Laser System removes unwanted hair without raising any unexpected safety issues." However, beyond this high-level statement, the document does NOT provide detailed information about the acceptance criteria, specific performance metrics, or the study design requested in the prompt.

Therefore, I cannot extract the specific information about acceptance criteria and the study that proves the device meets them from the provided text. The document is a regulatory submission for substantial equivalence, not a detailed clinical study report.

Based on the provided text, I can only state the following:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document only states, "A clinical trial demonstrated that the GentleLASE Laser System removes unwanted hair without raising any unexpected safety issues." No specific acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, hair count reduction percentages, etc.) are listed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided in the document.
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 provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided in the document.
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 dermatology, not an AI-assisted diagnostic tool that would involve "human readers."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not have an "algorithm only" component in the sense of AI diagnostics. Its performance is directly tied to the physical application of laser energy by a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but it would presumably be clinical outcomes data related to hair reduction and safety observations.
8. The sample size for the training set: Not applicable and not provided. The device is a physical laser system, not a machine learning algorithm.
9. How the ground truth for the training set was established: Not applicable and not provided. The device is a physical laser system, not a machine learning algorithm.

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The Candela GentleLase GL Dermatology Laser is indicated for the following uses:

1. the Photocoagulation of Dermatological vascular lesions.
2. the removal of hair.

The Candela (Modified) GentleLase GL Laser 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 targeted area via an optical fiber/handpiece delivery system. The Dynamic Cooling Device functions to cool the skin prior to laser treatment, minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela GentleLase Lasers 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 Lasers 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.

Here's an analysis of the provided text regarding the Candela GentleLase GL Laser System's acceptance criteria and supporting study information:

It's important to note that the provided document is a 510(k) summary for premarket notification, not a full clinical study report. Therefore, specific details about acceptance criteria, detailed performance metrics, and in-depth study methodology are often summarized or not present in the same way they would be in a peer-reviewed publication or a comprehensive clinical report.

Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly list quantitative acceptance criteria in a table format with corresponding reported performance metrics. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to predicate devices. The primary 'performance' described is the ability to achieve the intended uses without unexpected safety issues, aligning with the predicate device's performance.

Study Details

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

   • Sample Size: Not specified in the provided text. The document simply states "A clinical trial demonstrated that the GentleLase Laser System removes unwanted hair..." without providing the number of participants or treatments.
   • Data Provenance: Not specified.
   • Retrospective/Prospective: Not specified, but likely prospective given it's a "clinical trial" to demonstrate safety and effectiveness for marketing approval.

2. 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 specified. The document does not describe how the success or failure of hair removal or lesion photocoagulation was explicitly measured or by whom.

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

   • Not specified.

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:

   • No, an MRMC study was not done. This device is a laser system for dermatological treatment and hair removal, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

   • Yes, in essence. The clinical trial likely evaluated the performance of the device itself (the laser system) in standalone operation, applied by a human operator, to achieve its intended effect (hair removal, lesion photocoagulation). There is no "algorithm" in the sense of a standalone AI system being evaluated here without human involvement. The device is the therapeutic and cosmetic tool.

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

   • The document does not explicitly state the "ground truth" method. For hair removal, ground truth would typically involve assessing the reduction in hair count or density over time, often through visual inspection, photography, or specific measurement techniques. For photocoagulation of vascular lesions, ground truth would relate to the reduction or clearance of the lesion, assessed clinically. It would fall under outcomes data or clinical assessment.

7. The sample size for the training set:

   • Not applicable. This device is a physical laser system, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.

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

   • Not applicable. As above, there is no "training set" for this type of device.

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The Candela Gentlelase GL Dermatology Laser is indicated for the following uses: 1. the photocoagulation of dermatological vascular lesions. The Candela GentleLase GL Dermatology Laser includes an integrated Dynamic Cooling Device, which is indicated for: 1. the reduction of pain. 2. cooling of skin prior to laser treatment.

The Candela (Modified) Gentlelase GL Laser utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed area via an optical fiber/handpiece delivery system. The Candela Gentlelase Lasers are designed with five major components: - High voltage power supply and modulator system 1. - Optical laser head 2. - Circulator system 3. - 4. Optical delivery system - Software control system 5. The Candela Gentlelase Lasers 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 intended use of the laser system is for the photocoagulation of dermatological vascular lesions. The Candela (Modified) Gentlelase GL Laser also includes the Candela Dynamic Cooling Device integrated into the laser system. The DCD consists of 1) a source of skin refrigerant fluid, 2) an electronically controlled solenoid delivery valve, and 3) electronic timing circuitry. The Dynamic Cooling Device is connected in line with the laser's triggerswitch system so that activation of the triggerswitch controls the delivery of a pulsed spray of refrigerant, just prior to the delivery of the laser pulse. The pulsed spray of skin refrigerant cools the skin as it evaporates. The intended use of the Dynamic Cooling Device is to cool the skin prior to laser treatment, to minimize thermal damage to skin during laser treatment and to reduce pain associated with laser treatment.

The provided text describes the regulatory clearance of the Candela (Modified) GentleLase GL Laser System, which includes the Candela Dynamic Cooling Device (DCD). However, it does not contain a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for an AI/medical device. Instead, the document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not applicable to the information provided in this 510(k) summary.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document establishes "substantial equivalence" as the primary acceptance criterion, rather than specific performance metrics (like sensitivity, specificity, or reader improvement). The reported performance is implicitly that the device is "substantially equivalent" to its predicate devices concerning its intended use, operating principles, and key design aspects.

Given the nature of this document (a 510(k) summary for a laser system, not an AI/diagnostic device), quantitative performance metrics in the traditional sense are not explicitly stated, nor are acceptance criteria for such metrics. The "performance" is demonstrated by similarity to an already approved device.

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

• Not Applicable. This is a 510(k) summary for a laser surgical instrument, not an AI/diagnostic device. The "testing" mentioned refers to component and functional testing of the hardware, not a clinical study with a test set of patient data.

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

• Not Applicable. See point 2.

4. Adjudication method for the test set:

• Not Applicable. See point 2.

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 photocoagulation, not an AI-powered diagnostic tool that assists human readers.

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

• Not Applicable. See point 5.

7. The type of ground truth used:

• For a traditional medical device like this laser, "ground truth" typically relates to engineering specifications, safety standards, and functional performance, verified through "component testing and functional testing." It's not about diagnostic accuracy against pathology or outcomes data in the way an AI diagnostic device would be evaluated. The core "truth" being established here is that it functions as intended and is safe, similar to its predicate.

8. The sample size for the training set:

• Not Applicable. This is a hardware device; there is no "training set" in the context of machine learning.

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

• Not Applicable. See point 8.

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