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The Profile 1064 Laser Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.

Dermatology:

Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café 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. Additionally, the lasers are 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.

Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.

The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal protection and reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.

Surgical Applications:

Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.

Profile Laser System is an Nd:YAG laser producing emission at a wavelength of 1064nm. It consists of a laser console, internal computer, control panel and display, an optical delivery system comprised of an articulated arm and a handpiece or scanner with cooling capability, and a footswitch.

The provided text describes a 510(k) submission for the Sciton Profile 1064 Laser System, demonstrating its substantial equivalence to previously marketed predicate devices. This type of submission generally relies on demonstrating equivalence rather than conducting new clinical studies with defined acceptance criteria and performance metrics.

Therefore, this document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 as it is a regulatory submission focused on substantial equivalence rather than a study report detailing specific performance criteria, test sets, or training sets for an AI/ML device.

Here's why the information is not present based on the provided text:

• Acceptance Criteria and Reported Device Performance (1): The submission focuses on substantial equivalence to predicate devices, meaning its performance is considered acceptable if it is similar to those already on the market. There are no explicit acceptance criteria or a quantitative performance table mentioned.
• Sample Size, Data Provenance (2): No new clinical study data with test sets, sample sizes, or data provenance is presented. The argument is based on the similarity of the device's technological characteristics and intended use to existing devices.
• Experts, Qualifications, Adjudication (3, 4): These details are relevant for studies establishing ground truth, which is not the primary mechanism of this 510(k) submission.
• MRMC Study (5): The submission does not mention an MRMC study or any assessment of human reader improvement with AI assistance, as the device is a laser system, not an AI-assisted diagnostic tool.
• Standalone Performance (6): Similar to the above, this concept applies to AI/ML devices, not a laser system.
• Type of Ground Truth (7): Ground truth is not established in this context as new clinical validation is not the basis of the submission.
• Training Set Sample Size/Ground Truth (8, 9): These concepts are applicable to AI/ML model development. This submission is for a physical medical device (laser system), not an AI algorithm.

In summary, the provided 510(k) summary focuses on demonstrating that the "Profile 1064 Laser System" is substantially equivalent to other legally marketed Nd:YAG laser systems based on shared indications for use and technological characteristics. It is not a report of a study designed to establish new performance criteria or to validate an AI/ML algorithm against a ground truth dataset.

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The Candela GentleYAG Laser is intended for use for:

• 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.
• 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.
• Removal of unwanted hair in skin types I to VI
• Photocoagulation and hemostasis of pigmented and vascular lesions
• Coagulation and hemostasis of soft tissue.

The GentleYAG laser consists of the following main components:

• a laser system console (including software and control electronics) .
• . a control and display panel
• a lens-coupled, user replacement optical fiber handpiece .
• a skin cooling device integrated into the handpiece
• . a footswitch or handswitch
• . a remote interlock connector

This is a 510(k) summary for a medical device (Candela GentleYAG Laser System), which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria through a study with performance metrics. Therefore, many of the requested elements for a study describing acceptance criteria and device performance are not present in this document.

Here's an analysis based on the provided text:

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

This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy, or a specific treatment outcome percentage) for the GentleYAG Laser System. Its rationale for clearance is based on substantial equivalence to existing predicate devices, not on meeting new quantitative performance criteria.

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

No new clinical study data or test set information is provided for the GentleYAG Laser System demonstrating its performance against specific acceptance criteria. The submission relies on the established safety and effectiveness of its 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, as no new clinical study data or test set requiring ground truth establishment is presented for the GentleYAG Laser System in this document.

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

Not applicable, as no new clinical study data or test set requiring adjudication is presented for the GentleYAG Laser System in this 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, not an AI software/diagnostic tool, so MRMC studies and AI assistance metrics are irrelevant.

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, as no new clinical study data requiring ground truth is presented for the GentleYAG Laser System in this document. The "ground truth" for its equivalence argument comes from the established safety and effectiveness of its predicate devices through their prior clearances and market use.

8. The sample size for the training set

Not applicable. This document is for a medical device (laser system), not an AI algorithm that requires a training set.

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

Not applicable, as no training set is relevant to this device submission.

Summary based on the provided text:

The core of this 510(k) submission is to demonstrate substantial equivalence to currently legally marketed predicate devices, not to present new clinical study data proving the GentleYAG Laser System meets specific, newly defined quantitative performance acceptance criteria.

The document explicitly states:

• VI. Rationale for Substantial Equivalence: "The Candela GentleYag Laser shares the same indications for use, matches key design aspects, including spot size, similar wavelength and/or the same maximum delivered power as the predicate devices, and therefore are substantially equivalent to the currently marketed Candela Long Pulse Nd: YAG Laser System (K010104) and the Altus Family of Cool Glide Lasers (K014040)."
• VII. Safety and Effectiveness Information: "The new indications for use are based on the indications for use for the predicate laser systems. Technologically, the Candela GentleYAG Laser is identical to the previous predicate Candela Long Pulse Nd: YAG Laser (K010104), therefore the risks and benefits for the GentleYAG Laser are comparable to this predicate device. We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the device."

Therefore, the "study that proves the device meets the acceptance criteria" is implicitly the prior regulatory review and market performance of the predicate devices. The "acceptance criteria" are effectively the established safety and effectiveness profiles and engineering specifications of those predicate devices, which the GentleYAG Laser System is declared to match.

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The GentleYAG Laser is intended for the treatment of Pseudofolliculitis Barbae.

The GentleY AG Laser consists of the following main components:

• . a laser system console (including software and control electronics)
• a control and display panel .
• a lens-coupled, user replacement optical fiber handpiece .
• . a skin cooling device integrated into the handpiece
• a footswitch or handswitch .
• a remote interlock connector .

Please note that the provided document is a 510(k) summary for the Candela GentleYAG Laser System, which focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting detailed acceptance criteria and a deep dive into a standalone study for a novel AI device.

Therefore, many of the requested categories for AI device studies (especially relating to sample sizes, ground truth expert details, MRMC studies, training set details) are not applicable or not provided within this type of regulatory submission. This document describes a laser system, not an AI or software-as-a-medical-device (SaMD) product.

However, I will extract the available information and indicate where information is not present or not relevant to this type of device and submission.

Acceptance Criteria and Study Information (Based on Provided Document)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document states that "A clinical study produced results that indicate the GentleY AG is safe and effective for the treatment of Psuedofolliculitis Barbae." However, the sample size for this clinical study is NOT provided in the 510(k) summary.
• Data Provenance: Not specified in this 510(k) summary (e.g., country of origin, retrospective/prospective). This level of detail is typically in the full submission, not the summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable/Not provided. For a laser device, "ground truth" as conceived for AI diagnostic devices (e.g., expert consensus on images) is not directly relevant. The clinical study would involve patient outcomes assessed by clinicians, but the number or specific qualifications of experts establishing "ground truth" in the AI sense are not discussed.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. Adjudication methods (like 2+1) are typically for resolving discrepancies in expert interpretations, common in AI diagnostic tool evaluation. This is not mentioned for this laser device.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic AI systems where human readers interpret cases with and without AI assistance. The Candela GentleYAG is a therapeutic laser device.
• Effect Size: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• No. This is a laser system, not an algorithm. Therefore, a standalone (algorithm only) performance study as understood for AI software is not relevant or applicable. The reported performance refers to the full device.

7. Type of Ground Truth Used

• For the effectiveness claim, the "ground truth" would implicitly be clinical outcomes observed in patients treated for Pseudofolliculitis Barbae during the clinical study. The specifics of how these outcomes were measured or confirmed (e.g., physician assessment, patient self-report, objective measurements) are not detailed in this summary.

8. Sample Size for the Training Set

• Not applicable. This is a hardware medical device, not an AI algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

• Not applicable. No training set for an AI algorithm is involved.

Summary of Limitations due to Document Type:

This 510(k) summary focuses on demonstrating that a new medical device (a laser system) is "substantially equivalent" to existing legally marketed devices. It is not designed to present a detailed AI performance study. Consequently, most questions related to AI-specific study methodologies (like sample sizes for test/training sets, expert qualifications for ground truth, adjudication, MRMC studies) are not addressed or are not applicable within this document. The core argument for safety and effectiveness for this device relies on its technological similarity to approved predicate devices and the results of a generic "clinical study" without detailing its methodology in this summary.

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