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The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and the Delivery Accessories that are used with them to deliver light energy are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology; plastic surgery; podiatry; neurosurgery; gynecology; otorhinolaryngology (ENT); arthroscopy (knee surgery); and open and endoscopic general surgery.

The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers are safe and effective when indicated for use in specific surgical applications including:

Dermatology & Plastic Surgery

• Ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery (using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces) in the performance of laser skin resurfacing and laser derm-abrasion (using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces), and laser burn debridement.
• Laser skin resurfacing (ablation and/or vaporization) in dermatology and plastic surgery using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces for the treatment of wrinkles, rhytids, and furrows.
• Laser skin resurfacing (ablation and/or vaporization) of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, solar/actinic elastosis, actinic cheilitis, lentinges, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous cell carcinoma, epidermal nevi, xanthelasma palpebrarum, syringoma, and verrucae vulgares (warts).

Dermatology, Plastic Surgery and General Surgery

• Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery for the performance of blepharoplasty.
• Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery for the creation of recipient sites for hair transplantation.

Podiatry

• Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares (warts)
• Laser ablation, vaporization, and/or excision in podiatry for matrixectomy.

Otorhinolarıngology (ENT)

• Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia of larynx, nasal obstruction, adult and juvenile papillomatosis polyps, rhinophyma, and verrucae vulgares (warts).

Gynecology

• Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies), and vulvar and vaginal intraepithelial neoplasia

Neurosurgery

• Laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors.

The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (and its delivery accessories) are intended to be used to deliver carbon dioxide light energy for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in a variety of medical specialties.

Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers are comprised of the following main components:

• a laser console and tower;
• a counterbalanced articulated arm and delivery system;
• control and display panels;
• footswitch and handswitch delivery controls;
• a remote control unit;
• a filtered air pump purge system; and
• a variety of delivery device accessories (handpieces, scanners, waveguides, micromanipulators, optical couplers and laparoscopic adapters, and insufflation and purge gas systems).

This document describes the 510(k) Summary Statement for the Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers, and as such, it focuses on demonstrating substantial equivalence to existing predicate devices rather than providing a detailed study proving performance against specific acceptance criteria for a novel device.

Therefore, many of the requested categories for a study proving device meets acceptance criteria will not be directly applicable or fully available in this type of submission. This is typical for 510(k) premarket notifications.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a specified threshold for a new device's performance (e.g., "sensitivity must be > 90%"). Instead, its primary goal is to demonstrate that the ULTRAPULSE CO2 laser is substantially equivalent to predicate devices. The "performance" is implicitly deemed acceptable if it's comparable to these already cleared devices, and if clinical studies support its safety and effectiveness for various specific applications.

Therefore, a table of explicit acceptance criteria and corresponding performance metrics, as one might see for a novel diagnostic algorithm, cannot be fully constructed from this text. However, we can infer the "performance" through the stated benefits and comparisons to predicate devices in the clinical studies cited.

Inferred "Acceptance Criteria" and Reported "Performance"

Study Details for Demonstrating Safety and Effectiveness (Implied "Test Set" Data)

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

   • The document refers to "Clinical study" (singular) for skin resurfacing and "Clinical studies" (plural) for blepharoplasty and hair transplantation.
   • Specific sample sizes are not provided in this summary.
   • Data Provenance: The studies are published in medical journals (e.g., J Dermatol Surg Oncol, Ophthalmology, Dermatol Surg). The country of origin is not explicitly stated in this summary, but the journals and authors suggest primarily North American (US) origins. These would be considered prospective or retrospective clinical studies, depending on the design of the individual cited papers.

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

   • This information is not provided in the 510(k) summary. These details would typically be found within the individual clinical study publications. The studies are authored by physicians (e.g., dermatologists, plastic surgeons, ophthalmologists), who would be the "experts" performing the procedures and evaluating outcomes, but the number and specific qualifications (years of experience) are not summarized here.

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

   • This information is not provided in the 510(k) summary. Given the nature of surgical outcomes measured (e.g., hemostasis, edema, cosmetic results, hair density), adjudication methods for a "test set" in the context of image interpretation are not directly applicable. Evaluations would have been clinical assessments by the treating physicians and potentially objective measures (e.g., microscopy for collagen, photographic assessment for cosmetic outcome).

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 surgical laser, not an AI-assisted diagnostic tool. The comparisons are between the device (CO2 laser) and traditional surgical methods (cold steel), not between human readers with and without AI.

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

   • Not applicable. This is a surgical device, not an algorithm. Performance is inherently tied to human use by a surgeon.

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

   • The "ground truth" or primary endpoints for these studies are based on clinical outcomes data and expert assessment.
     • For skin resurfacing: Evidence of "increased sub-epidermal collagen" would likely come from histological analysis (pathology).
     • For blepharoplasty and hair transplantation: "Cosmetic results," "hemostasis," "ecchymosis," "edema," "bruising," "operative times," "bleeding," "compression of sites," and "hair density" are all direct clinical observations and/or quantitative measurements (e.g., time) from actual patient treatment. These outcomes are assessed by the treating surgeons or independent evaluators.

7. The sample size for the training set:

   • Not applicable. This is a hardware surgical device, not a machine learning algorithm that requires a "training set." The concept of a training set is irrelevant here.

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

   • Not applicable, as there is no training set for this type of device.

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The Coherent VersaPulse Aesthetic Surgical Lasers and the Delivery Accessories that are used with them to deliver 532 nm, 1064 nm and 755 nm laser energy that are indicated for use in surgical applications requiring photothermolysis of soft tissue, and 2940 nm laser energy that is indicted for use in surgical applications requiring excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.

The Coherent VersaPulse Aesthetic Surgical Lasers (and its delivery accessories) are intended to be used to deliver: frequency doubled, Q-switched frequency doubled, and Q-switched Nd:YAG; Q-switched Alexandrite:YAG laser energy for use in surgical applications requiring the photothermolysis (photocoagulation) of soft tissue; and Er: Y AG laser energy for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.

Coherent VersaPulse Aesthetic Surgical Lasers are comprised of the following main components:

• · a laser console and tower;
• · a counterbalanced articulated arm and delivery systems;
• · a fiber port and delivery systems;
• · control and display panels;
• · footswitch and handswitch delivery controls;
• · a remote control unit; and
• · a variety of delivery device accessories (articulated arm and fiber handpieces, scanners, and epidermal cooling devices).

This submission is a 510(k) Summary Statement for a medical device (Coherent VersaPulse Aesthetic Surgical Lasers) and does not contain the detailed study information typically found in a clinical trial report or a comprehensive regulatory submission. The document explicitly states it's a "Rationale for Substantial Equivalence," meaning the primary argument for approval is that the device is similar enough to already marketed devices. Therefore, a formal study with acceptance criteria, sample sizes, ground truth establishment, expert adjudication, or MRMC studies is not described in the provided text.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This approach to regulatory clearance (510(k)) often relies on comparing device features and performance to existing, legally marketed devices, rather than conducting new, elaborate clinical trials to establish de novo safety and effectiveness with specific performance metrics and acceptance criteria.

However, based on the information provided, here's what can be extracted and inferred, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, accuracy percentages) are provided in the document, nor are specific performance metrics like "sensitivity" or "specificity" reported. The acceptance criteria essentially revolve around demonstrating equivalence in design, function, and intended use to predicate devices, and demonstrating acceptable physical test results and biocompatibility.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not specified. The document mentions "In-vivo testing" and "Testing is performed to establish biocompatibility," but it does not provide any details on the number of subjects, animals, or test cases involved in these tests.
• Data Provenance: Not specified. It's highly likely this was internal company testing, but no country of origin is mentioned. The description "In-vivo testing" suggests prospective testing, but without further detail, it's impossible to confirm.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided. Given the nature of a 510(k) for a laser device, "ground truth" as it would be understood in an AI/diagnostic study (e.g., expert consensus on image interpretation) is not directly applicable. The "ground truth" here would likely relate to objective measurements of laser output and observed tissue effects, or standard biocompatibility assessments, rather than expert judgment on complex cases.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. There's no indication of any expert adjudication process for the "in-vivo testing" or biocompatibility assessments mentioned. These typically involve objective measurements and established scientific protocols rather than subjective consensus.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human interpretation (e.g., AI for radiology). This device is a surgical laser, and its primary function is to deliver energy for therapeutic purposes, not to provide diagnostic information or assist human "readers." Therefore, the concept of "human readers improving with AI assistance" is not relevant to this device's regulatory submission as described.

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

• Not applicable/Not provided. This device is a physical surgical laser, not a software algorithm. Its "performance" is inherent in its physical output and functional capabilities (e.g., laser power, wavelength, tissue effects). Its operation requires a human operator, so an "algorithm-only" or "standalone without human-in-the-loop" performance is not a relevant concept for this type of device.

7. The Type of Ground Truth Used

• For "in-vivo testing" to demonstrate laser energy equivalence, the ground truth would likely be objective measurements of laser parameters (e.g., power output, energy density, pulse duration) and possibly observed tissue effects (e.g., depth of photocoagulation, ablation rates) against established benchmarks or the performance of predicate devices.
• For "biocompatibility testing," the ground truth would be established through standardized testing protocols (e.g., ISO standards for cytotoxicity, irritation, sensitization) which involve specific assays and observational criteria to determine if a material is biologically compatible.
• The document does not explicitly state these, but these are the standard "ground truths" for such tests.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This device is a hardware surgical laser, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of AI development. The device's design and engineering are based on established physics and medical knowledge, rather than being "trained" on data.

9. How the Ground Truth for the Training Set was Established

• Not applicable/Not provided for the same reasons as point 8. There is no training set for this type of device.

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