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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 Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 532 and 1064 Nd: Y AG Handpiece Accessories are indicated for the following uses:

Tattoo Removal Treatment of Vascular Lesions Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 532 Nd:YAG Handpiece Accessory consists of a cylindrical housing connecting to the distal end of the optical fiber which plugs into the standard Candela Family of Q-Switched Alexandrite Laser (AlexLaze) systems. The fiber carries the 755nm light from the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems to the handpiece at the distal end where the wavelength conversion from 755mm to 532nm occurs. The principle of operation is outlined here. The 755nm light is focused by focusing lenses to a 2mm beam waist within an Nd: YAG rod situated in the heart of the converter module. It is known that Nd: Y AG can be pumped at 755nm and made to lase at 1064nm with high efficiency. The Nd: YAG rod has two appropriately coated mirrors, one on either side, to form a laser resonator. Within the laser resonator is a Brewster Plate which ensures that the output 1064nm beam is polarized (in another variation of the same scheme, the Nd:YAG will be replaced by Nd:YVO4 or similar gain medium which provides a naturally polarized output, eliminating the need for a Brewster Plate). The output of the Nd: YAG laser has the same pulse duration as the original 755nm laser, but the wavelength is now 1064mm. The 1064nm beam is then incident on a KTP crystal that is aligned for optimum phase matching for second harmonic generation at 1064mm. The KTP crystal converts 1064mm to 532nm efficiently. A dichroic beam-splitter separates the 532nm beam from the residual unconverted 1064m. The 532nm beam is appropriately shaped and sized using lenses and is incident on the skin during treatment. The unconverted 1064nm that is rejected by the beam-splitter is safely absorbed in a beam dump within the module.

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 1064 Nd: YAG Handpiece Accessory is very similar to the 532nm handpiece except that there is no KTP crystal for the 1064nm to 532nm conversion. The beam is extracted immediately after the Nd: Y AG laser resonator.

This is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through clinical studies in the same way a PMA submission would. Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this type of submission.

However, I can extract the information that is present in the document to address the spirit of your request regarding the device's characteristics and the basis for its market entry.

Here's an analysis based on the provided text:

Device Name: Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 532 and 1064 Nd: YAG Handpiece Accessories

Manufacturer: Candela Corporation

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

Since this is a 510(k) submission, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to predicate devices. The "reported device performance" is framed in terms of shared characteristics and intended use with these predicates. The document doesn't present a table of quantitative performance metrics against specific acceptance thresholds in the way a clinical trial might. Instead, it highlights the similarity in functional features and design aspects to establish equivalence.

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 (N/A) / Not provided.
  • 510(k) submissions for devices like this typically rely on engineering testing, performance comparisons with predicate devices, and sometimes bench testing, rather than large-scale human clinical "test sets" in the manner of a drug or novel high-risk device. The document does not describe patient-based testing or clinical study data.

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

• N/A / Not provided.
  • As noted above, this submission focuses on substantial equivalence based on technical specifications and intended use, not clinical "ground truth" derived from expert consensus on patient data.

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

• N/A / Not provided.
  • No clinical "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

• N/A / Not provided.
  • This device is a laser system, not an AI-assisted diagnostic or therapeutic tool for human readers. MRMC studies are not relevant here.

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

• N/A / Not provided.
  • This is a hardware medical device (laser handpiece accessories), not a standalone algorithm.

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

• N/A / Not provided (in the context of clinical ground truth).
  • The "ground truth" in this submission relates to engineering specifications and performance characteristics, verified through internal testing and comparison to established predicate device specifications, rather than clinical outcomes or pathology data.

8. The sample size for the training set

• N/A / Not provided.
  • This type of device does not involve a "training set" in the machine learning sense.

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

• N/A / Not provided.
  • As above, no training set or associated ground truth establishment is applicable to this submission.

Summary of the 510(k) Submission's Approach:

The provided document describes a 510(k) Premarket Notification for the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems: 532 and 1064 Nd: YAG Handpiece Accessories. The primary method for proving the device meets "acceptance criteria" (in this context, regulatory acceptance for market entry) is by demonstrating Substantial Equivalence to already legally marketed predicate devices.

The study presented here is an equivalence comparison, not a clinical trial establishing efficacy or safety against a specific endpoint with patient data. It argues that the new device shares:

• Same intended use: Tattoo Removal, Treatment of Vascular Lesions, Treatment of Pigmented Lesions, Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology.
• Similar functional features: Power output, spot size, repetition rate, energy, and fluence.
• Similar key design aspects: Wavelength (after conversion), light generation medium, power supply, cooling, and controls system.
• Similar methods of assembly and operation.

Therefore, the conclusion is that because of these similarities, the device's risks and benefits are comparable to the predicate devices, and no new questions of safety or effectiveness are raised. This allows the device to be marketed without requiring a more extensive PMA (Premarket Approval) process that would involve comprehensive clinical trials and detailed performance data against pre-defined acceptance criteria.

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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 consists of an Alexandrite laser head, a Q-switching mechanism, a power supply and a deionized water circulator. 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 Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems is fully air cooled.

The Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems delivers laser energy at a wavelength of 755 nm with a nominal pulse width of 50 nanoseconds. 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 supports 2mm, 3mm, and 4mm nominal spot sizes.

The provided text is a 510(k) summary for a medical device called the "Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems." This document does not describe a study to prove the device meets acceptance criteria, but rather asserts substantial equivalence to predicate devices based on similarities in intended use, functional features, and design aspects.

Therefore, many of the requested details, such as a table of acceptance criteria and reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone performance, are not applicable or not provided in this type of regulatory submission.

The document primarily focuses on establishing that the new device is as safe and effective as existing, legally marketed predicate devices, and thus does not require new clinical studies to demonstrate efficacy against specific acceptance criteria.

However, I can extract the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable / Not provided. The document states that the new device "has the same intended use, utilizes similar functional features (including power output, spot size, repetition rate, energy, and fluence) and matches key design aspects (including wavelength, light generation medium, power supply, cooling and controls system)" as the predicate devices. It relies on the predicate devices' established safety and effectiveness rather than presenting new performance data against specific acceptance criteria.

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

• Not applicable / Not provided. This 510(k) summary does not describe a test set or clinical study to establish performance for the new device. It relies on substantial equivalence to predicate devices.

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

• Not applicable / Not provided. Ground truth establishment for a test set is not described as no new clinical study data is presented.

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

• Not applicable / Not provided. Adjudication methods are not discussed as no new clinical study data is presented.

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

• Not applicable. This device is a laser system, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a laser system, not an algorithm.

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

• Not applicable / Not provided. Ground truth refers to the verified condition against which a diagnostic device's performance is measured. Since this document establishes substantial equivalence of a treatment device rather than presenting new diagnostic performance data, a new "ground truth" for the device's efficacy is not established in this submission. Its effectiveness is inferred from the predicate devices' established efficacy.

8. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/ML device that requires a training set.

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

• Not applicable / Not provided. This is not an AI/ML device that requires a training set.

Summary of what the document does state regarding acceptance criteria and "proving" it:

The document asserts that the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems meets its intended purpose by demonstrating substantial equivalence to existing, legally marketed predicate devices.

• Acceptance Criteria (Implicit via Substantial Equivalence): The device is "accepted" if it is determined to be substantially equivalent to predicate devices in:

  • Intended Use: "Pigmented Lesions" and "Tattoos".
  • Technological Features: Similar functional features (power output, spot size, repetition rate, energy, fluence) and key design aspects (wavelength, light generation medium, power supply, cooling, controls system).
  • Safety and Effectiveness: Risks and benefits are comparable to predicate devices, raising no new questions of safety or effectiveness.

• Study Proving Acceptance:

  • Type of "Study": This is a premarket notification (510(k)) submission based on the principle of substantial equivalence, not a clinical trial or performance study against pre-defined acceptance criteria.
  • Method of Proof: The submission describes the new device and compares it to the predicate devices, highlighting their similarities. The "proof" is based on the argument that because the new device is so similar to legally marketed and safe/effective predicate devices, it is also safe and effective.
  • Conclusion: "Based on the similarities in indications for use, design features, and functional features the Candela Family of Q-Switched Alexandrite Laser (AlexLAZR) systems has been shown to be substantially equivalent to the current legally marketed predicate devices."

Predicate Devices Used for Comparison:

• Candela Q-Switched Alexandrite Laser (AlexLAZR), K955662
• Candela Q-Switched Alexandrite Laser (AlexLAZR), K950831

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