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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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