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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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