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The intended use of the product(s) is to communicate the laser beam of a CO, surgical laser to the target site for the incision, excision, ablation, or photocoagualtion of soft tissue. Representative examples of clinical applications include:

Gynecology--excision and vaporization of cervical, vulvar, and perineal condyloma: ablation of vaginal and vulvar intraepithelial neoplasia; herpes 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 carcinomoa removal; blepharoplasty, xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; 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--hemorthoid 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

Laparoscopic Surgery--vaporization, incision, excision, ablation, or photo-coagulation of soft tissue such as endometriosis ablation, excision of adhesions, salpingotomy

Otorhinolaryngology--lymphangioma removal; turbinectomy, subglottic stenosis vaporization, tonsilectomy, removal of vocal cord papillomas, nodules, and polyps

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

Orthopedic -- menisectorny, chondromalacia abalation, partial synovectomy, lateral release, PMMA removal

No new indications for use are sought beyond those associated with the predicate devices.

This is a family of detachable devices that comprise the distal portion of a beam delivery system to be used with a CO, surgical laser such as that described in K96075. Specifically, the devices consist of a flexible hollow lightpipe (fiber), handpieces that connect to the fiber, and various tips that connect to the handpieces. The tips are short, rigid hollow alumina lightpipes producing a variety of spot sizes. The user may "mix and match" handpieces and tips to suit the clinical task at hand.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it is a 510(k) summary for the Aesculight family of fibers, handpieces, and tips for CO2 surgical lasers. It aims to demonstrate substantial equivalence to a predicate device, not to establish performance against specific acceptance criteria through a clinical study.

Therefore, I cannot provide the requested information in the table format or answer the questions related to studies, sample sizes, experts, ground truth, or MRMC studies, as this information is not present in the provided text.

The document discusses:

• Product Description: Detachable devices for CO2 surgical lasers (flexible hollow lightpipe, handpieces, and tips).
• Intended Use: To communicate the laser beam for incision, excision, ablation, or photocoagulation of soft tissue in various medical fields.
• Technological Characterization: Compares the Aesculight products with the predicate device (Modified LX-20 Laser System) focusing on construction differences (e.g., fiber material, tip construction) and asserting that these differences do not introduce new safety or performance concerns. It states that the Aesculight fiber exhibits "somewhat better transmission efficiency" and the tips "have power-handling capabilities that equal or exceed those of the predicate tips."
• Conclusion: Claims the Aesculight products are substantially equivalent to the predicate products, with "very similar physical and optical characteristics," and that "a user could not distinguish a difference between the predicate products and the Aesculight products, nor do the Aesculight products raise any new safety issues."
• FDA Clearance Letter: Confirms substantial equivalence to legally marketed predicate devices.

The information provided is geared towards proving substantial equivalence for FDA 510(k) clearance, which typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than meeting quantitative acceptance criteria through a specific performance study as might be seen for novel devices or in clinical trials.

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