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The intended use of the Xanova tips is to comprise the distal end element of a surgical CO2 laser beam delivery system for the incision, excision, ablation, or photocoagulation of soft tissue.

Representative examples of indications for use in various specialties are listed below.

Gynecology-excision and vaporization of cervical, vulvar, and perineal condyloma; ablation. of vaginal and vulvar intraepithelial neoplasia; he pes vaporization of urethral caruncle; I&D Bartholin's and nubothian cysts.

Dermatology-port wine hemangioma removal, rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas, hemangiomas, nevi, and tricoeptiheliomas; dermabrasion for lentigos, keratoses, actinic keratosis and actinic chleilitis.

Dentistry/Oral Surgery-gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors.

General Surgery-hemorrhoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of decubitus ulcers and stasis ulcers; mastectomy; breast biopsy; reduction mammoplasty; cytoreduction for metastatic disease; many dermatological procedures.

Otorhinolaryngology- - lymphangioma removal; turbinectomy.

Podiatry-plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neuroma removal; ingrown toenail treatment.

The Xanova Novatips constitute the disposable end element of the hollow fiber deliverv system of a CO2 surgical laser.

I'm sorry, but based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) summary for laser handpiece tips and focuses on establishing substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.

The document explicitly states: "No new indications were sought in the premarket notification and no clinical data were presented." This indicates that a study with formal acceptance criteria and proof of their fulfillment was not part of this 510(k) submission.

Therefore, I cannot populate the requested table and provide the other study-related details.

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