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The modified LX-20 Laser System Family is a general surgical instrument used to vaporize, incise, excise, ablate, or photo coagulate soft tissue in surgical procedures in the listed surgical specialties.

The system may be effectively utilized for those applications recognized as within the accepted indications for use of C0, laser devices performed within the listed specialties and which require power densities as calculated by power and spot size referenced in the power density charts in the operator's manual.

Indications for Use - Gynecology
Representative examples: Condyloma, excision and vaporization, cervical, vulvar, & perineal; vaginal intraepithelial neoplasia ablation (VAIN); vulvar intraepithelial neoplasia ablation (VIN); herpes vaporization; urethral caruncle vaporization; I&D Bartholin's & nubothian cysts.

Indications for Use - Laparoscopic Surgery
Vaporization, incision, excision, ablation, or photo coagulation of soft tissue in endoscopic and laparoscopic surgery including GYN laparoscopy where delivery of energy by the hollow fiber may be more convenient than delivery of energy by a handpiece. Representative examples: endometriosis ablation; excision of adhesions; salpingotomy; metroplasty,

Indications for Use - Dermatology
Representative examples: Tattoo removal; port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; keloid reduction; wart removal; basal & squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas, hemangiomas, nevi, and tricoepitheliomas; dermabrasion such as for lentigos, keratoses, actinic keratosis & cheilitis.

Indications for Use - Dental/Oral Surgery
Representative examples: Gingivectomy; frenum release; removal of soft tissue, cysts, and tumors.

Indications for Use - Orthopedic
Representative examples: Menisectomy; chondromalacia ablation; partial synovectomy; lateral release; PMMA removal.

Indications for Use - General Surgery
Representative examples: Hemorthoid removal; skin tag vaporization; pilodidal cyst removal and repair: debridement of decubitus ulcers and statis ulcers; mastectomy, breast biopsy, reduction mammoplasty; cytoreduction for metastatic disease; many dermatological procedures.

Indications for Use - Otorhinolaryngology (ENT)
Representative examples: Subglottic stenosis vaporization; tonsillectomy; removal of vocal cord papillomas, nodules, and polyps; lymphangioma removal; pulmonary bronchial and tracheal lesion removal: turbinectomy; removal of leukoplakia of larynx; ablation of choanal atresia. Myringotomy/tympanostomy; Laser Assisted Uvulopalatoplasty (LAUP).

Indications for Use - Podiatry
Representative examples: Plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neruoma removal; ingrown nail treatment.

The Luxar modified LX-20 Surgical Laser System produces laser (infrared) energy at a wavelength of 10.6 microns which is directed to soft tissue through a knuckled beam delivery assembly, articulated arm or articulated arm plus hollow fiber waveguide, handpieces, and sterile delivery tips.

The provided text describes a 510(k) summary for the Luxar modified LX-20 C0, Surgical Laser System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting new clinical study data to prove the device meets acceptance criteria.

Key takeaway: The submission states, "There are no new indications for use beyond those cleared for the predicate devices, and no clinical data were presented." This directly indicates that a study proving the device meets acceptance criteria, as typically understood for new performance claims, was not conducted or presented in this 510(k) submission. Therefore, I cannot provide information on acceptance criteria or a study proving they were met.

However, I can extract information related to the device's intended use and the basis for its clearance:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission based on predicate devices, not a de novo clearance requiring new performance data. The "acceptance criteria" effectively are that the device performs equivalently to the predicate devices for the stated uses.
• Reported Device Performance: The document states that "Basic system operation and performance are unchanged from the cleared LX-20 Laser System Family." The modified LX-20 shares the same RF excited lasing tube, main chassis, power supply, safety systems, microprocessor controller, and much of the same electronics. The primary modification is the addition of a Sharplan articulated arm, which the submitter believes "do not raise any new issues of safety and effectiveness."

The following information cannot be provided as no new clinical data was presented or a study described in this 510(k) submission:

• 2. Sample sized used for the test set and the data provenance
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• 4. Adjudication method for the test set
• 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
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• 7. The type of ground truth used
• 8. The sample size for the training set
• 9. How the ground truth for the training set was established

Summary of Device Information Presented:

• Device Name: Luxar modified LX-20 C0, Surgical Laser System
• Intended Use: Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in various surgical specialties (Gynecology, Laparoscopic Surgery, Dermatology, Dental and Oral surgery, Orthopedic, General Surgery, Otorhinolaryngology, Podiatry).
• Basis for Clearance: Substantial equivalence to the Luxar LX-20 C0, Surgical Laser System Family (K960475) and Sharplan 20C C02 Laser (K963229 and K935563).
• Key Modification: Addition of the Sharplan articulated arm.
• Performance Claim: "Basic system operation and performance are unchanged from the cleared LX-20 Laser System Family." No new clinical data was presented to support new performance claims or new indications for use.

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