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The intended use of the AcuPulse series is for the vaporization, incision, excision, ablation, or coagulation of soft tissue in the surgical specialties of: ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics. General Surgery and Podiatry.

The intended use of the AcuPulse series is for the performance of specific surgical applications in the surgical specialties of: ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Orthopedics, General Surgery and Podiatry as follows:

Dermatology
The AcuPulse laser is indicated for use in dermatology and plastic surgery for the following applications.

• Ablation, vaporization, excision, incision, and coagulation of soft tissue in the performance of:
• Laser skin resurfacing
• Laser dermabrasion
• Laser burn debridement
• Laser skin resurfacing (ablation and/or vaporization) for the treatment of:
• Wrinkles, rhytids, and furrows (including fine lines and texture irregularities)
• Laser skin resurfacing (ablation, and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
• Keratoses. including actinic and sebortheic keratosis, seborrhoecae vulgares, seborrheic wart and verruca seborrheica
• Vermillionectomy of the lip
• Cutaneous horns
• Solar/actinic elastosis
• Cheilitis, including actinic cheilitis
• Lentigines, including lentigo maligna or Hutchinson's malignant freckle
• Uneven pigmentation/dyschromia
• Acne scars
• Surgical scars
• Keloids including acne keloidalis nuchae
• Hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telangiectaticum)
• Tattoos
• Telangiectasia
• Removal of small skin tumors, including periungual (Koenen) and subungual fibromas
• Superficial pigmented lesions
• Adenosebaceous hypertrophy or sebaceous hyperplasia
• Rhinophyma reduction
• Cutaneous papilloma (skin tags)
• Milia
• Debridement of eczematous or infected skin
• Basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions
• Nevi, including spider, epidermal and protruding
• Neurofibromas
• Laser de-epithelialization
• Tricoepitheliomas
• Xanthelasma palpebrarum
• Syringoma
• Laser ablation, vaporization, and/or excision for complete and partial nail matrixectomy
• Vaporization/coagulation of:
• Benign/malignant vascular/avascular skin lesions
• Moh's surgery
• Lipectomy
• Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts
• Laser incision and/or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty
• Laser incision and/or excision of soft tissue for the creation of recipient sites for hair transplantation

Podiatry
The AcuPulse laser is indicated for use in podiatry for the following applications:

• Laser ablation, vaporization and/or excision of soft tissue for the reduction, removal, and/or treatment of:
• Verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts
• Fungal nail treatment
• Porokeratoma ablation
• Ingrown nail treatment
• Neuromas/fibromas, including Morton's neuroma
• Debridement of ulcers
• Other soft tissue lesions
• Laser ablation, vaporization, and/or excision for complete and partial (nail) matrixectomy

Otolaryngology (ENT)
The AcuPulse laser is indicated for laser incision, ablation, and/or vaporization of soft tissue in otolaryngology for the treatment of:

• Choanal atresia
• Leukoplakia, including oral, larynx, uvula, palatal, and upper lateral pharyngeal tissue
• Nasal obstruction
• Adult and juvenile papillomatosis polyps
• Polypectomy of nose and nasal passages
• Lymphangioma removal
• Removal of vocal cord/fold nodules, polyps and cysts
• Removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords
• Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue
• Zenker's Diverticulum/ pharyngoesophageal diverticulum [endoscopic laser-assisted esophagodiverticulostomy (ELAED)]
• Stenosis, including subglottic stenosis
• Tonsillectomy (including tonsilar cryptolysis and neoplasma) and tonsil ablation/tonsillotomy
• Pulmonary bronchial and tracheal lesion removal
• Benign and malignant nodules, tumors and fibromas (larynx, pharynx, trachea, tracheobronchial/endobronchial)
• Benign and malignant lesions and fibromas (nose and nasal passages)
• Benign and malignant tumors and fibromas (oral)
• Acoustic neuroma in the ear
• Superficial lesions of the ear, including chondrodermatitis nondularis chronica helices/Winkler's disease
• Telangiectasia/hemangioma of larynx, pharynx, and trachea (includes uvula, palatal, or upper lateral pharyngeal tissue)
• Cordectomy, cordotomy (for the treatment of vocal fold motion impairment), and cordal lesions of larynx, pharynx, and trachea
• Myringotomy/tympanostomy (tympanic membrane fenestration)
• Uvulopalatoplasty (LAUP, laser UPP)
• Turbinectomy and turbinate reduction/ablation
• Septal spur ablation/reduction and septoplasty
• Partial glossectomy
• Tumor resection of oral, subfacial and neck tissues
• Rhinophyma
• Verrucae vulgares (warts)
• Gingivoplasty/gingivectomy

Gynecology and GYN Laparoscopy Indications
The AcuPulse laser is indicated for use in gynecology for the following applications:

• Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of:
• Conization of the cervix, including cervical intraepithelial neoplasia (CIN), and vulvar and vaginal intraepithelial neoplasia (VIN, VAIN)
• Condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowenoid papulosa (BP) lesions
• Leukoplakia (vulvar dystrophies)
• Incision and drainage (I&D) of Bartholin's and nabothian cysts
• Herpes vaporization
• Urethral caruncle vaporization
• Cervical dysplasia
• Benign and malignant tumors
• Hemangiomas
• Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including gynecological laparoscopy, for the treatment of:
• Endometrial lesions, including ablation of endometriosis
• Excision/lysis of adhesions
• Salpingostomy
• Oophorectomy
• Fimbrioplasty
• Metroplasty
• Microsurgery (tubal)
• Uterine myomas and fibroids
• Ovarian fibromas and follicle cysts
• Uterosacral ligament ablation
• Hysterectomy

Neurosurgery Indications
The AcuPulse laser is indicated for laser incision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of:

• Cranial
• Posterior fossa tumors
• Peripheral neurectomy
• Benign and malignant tumors and cysts, for example, gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas, and large tumors
• Arteriovenous malformation
• Pituitary gland tumors (transphenoidal approach)
• Spinal Cord
• Incision/excision and vaporization of benign and malignant tumors and cysts
• Intra- and extradural lesions
• Laminectomy/laminotomy/microdiscectomy

Orthopedic Indications
The AcuPulse laser is indicated for incision, excision, and vaporization of soft tissue in orthopedic surgery, including the following applications:

• Arthroscopy
• Meniscectomy
• Chondromalacia
• Chondroplasty
• Ligament release (lateral and other)
• Excision of plica
• Partial synovectomy
• General
• Debridement of traumatic wounds
• Debridement of decubitus and diabetic ulcers
• Microsurgery
• Artificial joint revision
• PMMA removal

General and Thoracic Surgery
The AcuPulse laser is indicated for incision, excision, and vaporization of soft tissue in general and thoracic surgery, including endoscopic and open procedures. Applications include:

• Debridement of decubitus ulcers, stasis, diabetic, and other ulcers
• Mastectomy
• Debridement of burns
• Rectal and anal hemorrhoidectomy
• Breast biopsy
• Reduction mammoplasty
• Cytoreduction for metastatic disease
• Laparotomy and laparoscopic applications
• Mediastinal and thoracic lesions and abnormalities
• Skin tag vaporization
• Atheroma
• Cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips
• Pilonidal cyst removal and repair
• Abscesses
• Other soft tissue applications

Dental and Oral Surgery
The AcuPulse laser is indicated for incision, excision, and vaporization of soft tissue in dentistry and oral surgery. Applications include:

• Gingivectomy/removal of hyperplasias
• Gingivoplasty
• Incisional and excisional biopsy
• Treatment of ulcerous lesions, including aphthous ulcers
• Incision of infection when used with antibiotic therapy
• Frenectomy (frenum release)
• Excision and ablation of benign and malignant lesions
• Homeostasis
• Operculectomy
• Crown lengthening
• Removal of soft tissue, cysts, and tumors
• Oral cavity tumors and hemangiomas
• Abscesses
• Extraction site hemostasis
• Salivary gland pathologies
• Preprosthetic gum preparation
• Leukoplakia
• Partial glossectomy
• Periodontal gum resection

The AcuPulse 30 and 40 series is the next generation of Lumenis CO2 lasers. The new product will retain the same console, articulated arm, delivery devices and other basic features of the current Compact 20C, 30C & 40C series, while integrating improved versions of the GUI and SurgiTouch scanner currently used with the UltraPulse SurgiTouch.

The AcuPulse 30 and 40 Carbon Dioxide Laser is an advanced computer-controlled, user friendly CO2 laser system based on a sealed-off CO2 laser tube providing up to 30 or 40 Watts (model dependent) on tissue. The system incorporates the CO2 laser tube within the main cabinet, an articulated arm beam delivery system and attachable laser accessories. The system is activated for laser emission by a footswitch.

This system incorporates a DC-excited CO2 laser tube. The CO2 laser wavelength falls in the mid-infrared region of the electromagnetic spectrum. This wavelength is invisible to the human eye. CO2 laser energy is readily absorbed by water in tissue. Since soft tissue is comprised primarily of water, CO2 laser energy can be used effectively for the excision, incision, ablation, vaporization and coagulation of soft tissue

The provided text describes the AcuPulse 30 and 40 Carbon Dioxide Laser System and its intended use, but it does not contain information about acceptance criteria for device performance or any study conducted to prove the device meets specific performance criteria.

Instead, the document is a 510(k) summary for regulatory clearance, primarily focused on demonstrating "substantial equivalence" to predicate devices. This means the manufacturer is asserting their new device is as safe and effective as a device already legally marketed. The core claim is that:

• "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the AcuPulse 30 and 40 Carbon Dioxide Laser System has been conducted." (Page 9)

This statement indicates that internal testing was done, but the details of that testing, including specific acceptance criteria, study methodology, sample sizes, ground truth establishment, or expert involvement, are not provided in this 510(k) summary.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and study details based on the information given. The document focuses on regulatory classification, intended use, and comparison to predicate devices, not on detailed performance study results against predefined acceptance criteria.

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The Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.

The Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers are indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery. orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery as follows:

Dermatology & Plastic Surgery: The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: laser skin resurfacing, laser derm-abrasion, laser burn debridement. Laser skin resurfacing (ablation &/or vaporization) for treatment of: wrinkles, rhytids, and furrows. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, &/or treatment of: keratoses, including actinic keratosis; solar/actinic elastosis; cheilitis, including actinic cheilitis; lentigines; uneven pigmentation/ dyschromia; acne scars; surgical scars: keloids; hemangiomas (including Buccal and port wine); tattoos: telangiectasia; removal of small skin tumors; superficial pigmented lesions; adenosebaceous hypertrophy; rhinophyma reduction; cutaneous papilloma (skin tags); milia: debridement of eczematous or infected skin; basal and squamous cell carcinoma; nevi, including spider and epidermal; neurofibromas; tricoepitheliomas; xanthelasma palpebrarum; syrinqoma. Laser ablation, vaporization and/or excision for complete and partial nail matrixectomy. Vaporization/coagulation of: benign/malignant vascular/avascular skin lesions; Moh's Surgery; lipectomy; verrucae and seborrhoecae vulgares. Laser incision &/or excision of soft tissue for the performance of blepharoplasty. Laser incision &/or excision of soft tissue for the creation of recipient sites for hair transplantation.

Podiatry: Laser ablation, vaporization &/or excision of soft tissue for the reduction, removal. &/or treatment of: verrucae vulgares/plantar (warts); fungal nail treatment; porokeratoma ablation; ingrown nail treatment: neuromas/fibromas, including Morton's neuroma; debridement of ulcers; other soft tissue lesions. Laser ablation, vaporization and/or excision in podiatry for complete and partial matrixectomy.

Otolaryngology (ENT): Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for treatment of: choanal atresia; leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue: nasal obstruction: adult and juvenile papillomatosis polyps; polypectomy of nose and nasal passages; lymphangioma removal; removal of vocal cord nodules and polyps; removal of recurrent papillomas in the oral cavity, nasal cavity, larynx. pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords; laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue; stenosis, including subglottic stenosis; tonsillectomy (including tonsilar cryptolysis and neoplasma); pulmonary bronchial and tracheal lesion removal; benign and malignant nodules and tumors (larynx, pharynx, trachea); benign and malignant lesions (nose and nasal passages): benign and malignant tumors (oral); stapedotomy/stapedectomy: acoustic neuroma in ear; superficial lesions of the ear; telangiectasia/hemangioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue); cordectomy and cordal lesions of larynx, pharynx and trachea: myringotomy/tympanostomy; uvulopalatoplasty (LAUP, laser UPPP); turbinectomy: partial glossectomy; tumor resection on oral, subfacial and neck tissues; rhinophyma; verrucae vulgares (warts); qinqivoplastv/ginqivectomy.

Gynecology: Laser incision, ablation and/or vaporization of soft tissue in GYN for treatment of: conization of the cervix, including cervical intraepithelial neoplasia (CIN), 1 vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); condyloma acuminata, including cervical, genital, vulvar and perineal: leukoplakia (vulvar dystrophies); incision and drainage of Bartholin's and nabothian cysts; herpes vaporization; urethral caruncle vaporization; cervical dysplasia; benign and malignant tumors; hemangiomas.

GYN Laparoscopy: Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery including GYN laparoscopy for treatment of: endometrial lesions, including ablation of endometriosis; excision/lysis of adhesions; salpingostomy; fimbroplasty: metroplasty; microsurgery (tubal); uterine myomas and fibroids; ovarian fibromas and follicle cysts; uterosacral ligament ablation; hysterectomy.

Neurosurgery: Laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of: Cranial: posterior fossa tumors; peripheral neurectomy; benign and malignant tumors and cysts (e.g. gliomas, meningiomas -(including basal tumors), acoustic neuromas, lipomas and large tumors); arteriovenous malformation; pituitary gland tumors (transphenoidal approach). Spinal Cord: incision/excision and vaporization of benign and malignant tumors and cysts; intra- and extradural lesions; laminectomy/ laminotomy/ microdiscectomy.

Orthopedics: Incision/excision and vaporization of soft tissue in orthopedic surgery. Applications include: Arthroscopy: meniscectomy; chondromalacia: chondroplasty; ligament release (lateral and other); excision of plica; partial synovectomy. General: debridement of traumatic wounds; debridement of decubitus and diabetic ulcers; microsurgery; artificial joint revision; PMMA removal.

General/Thoracic Surgery: Incision/excision and vaporization of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include: debridement of decubitus ulcers, stasis, diabetic and other ulcers; mastectomy; debridement of burns: rectal and anal hemorrhoidectomy; breast biopsy: reduction mammoplasty; cytoreduction for metastatic disease; laparotomy and laparoscopic applications; mediastinal and thoracic lesions and abnormalities; skin tag vaporization; atheroma; cvsts: pilonidal cyst removal and repair; abscesses; other soft tissue applications.

Dental/Oral Surgery: Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: qingivectomy- removal of hyperplasias; qingivoplasty: incisional and excisional biopsy; treatment of ulcerous lesions. including aphthous ulcers: incision of infection when used with antibiotic therapy; frenectomy (frenum release); excision and ablation of benign and malignant lesions; homeostasis; operculectomy; crown lengthening; removal of soft tissue, cysts and tumors; oral cavity tumors and hemangiomas; abscesses; extraction site hemostasis; salivary gland pathologies; preprosthetic gum preparation; leukoplakia; partial glossectomy; periodontal gum resection.

Genitourinary: Incision/excision and vaporization of soft tissue in genitourinary procedures. Applications include: benign and malignant lesions of external genitalia; condyloma; phimosis; erythroplasia.

The Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers and Delivery Device 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.

Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers are comprised of the following main components:

• a laser console s
• a laser console tower ・
• a counterbalanced articulated arm and delivery system -
• control and display panel ।
• system microprocessor control electronics -
• a covered footswitch or handswitch for specific delivery device ・ accessories
• an optional air purge pump system with an insufflator filter for purge of ﺘ delivery device accessories
• operating software ﺳ
• a variety of delivery device accessories or handpieces, including a pattern generator

The provided document is a 510(k) Summary Statement for the Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific acceptance criteria in the way a clinical trial might.

Therefore, the document does not contain the following information:

• A table of acceptance criteria and reported device performance (in terms of clinical efficacy or specific quantifiable metrics beyond listing indications for use).
• Sample size used for a test set.
• Data provenance (e.g., country of origin, retrospective or prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Information about a multi-reader, multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Information about standalone (algorithm only) performance studies.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for performance evaluation studies.
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the document focuses on demonstrating substantial equivalence to previously cleared devices. This is a regulatory pathway where the new device is shown to be as safe and effective as another legally marketed device without requiring extensive de novo clinical trials.

The document indicates the following:

1. Predicate Devices:
The Lumenis UltraPulse Encore Carbon Dioxide Surgical Lasers are substantially equivalent to:

• Lumenis, Inc. (formerly Coherent Medical Group) UltraPulse S Series Carbon Dioxide Surgical Lasers (K974789)
• Lumenis, Ltd. (formerly Sharplan Lasers, Inc.) Model 700 and 1000 Series CO2 Surgical Lasers (K935563)
• Lumenis, Ltd. (formerly Sharplan Lasers, Inc.) Model 20c, 30c and 40c CO2 Surgical Lasers (K963229)
• Lumenis, Ltd. (formerly Sharplan Lasers, Inc.) Model 1080 CO2 Surgical Laser System (K933918)
• Lumenis, Ltd. (formerly ESC Medical Systems) Luxar modified LX-20 CO2 Surgical Laser System (K991628)
• Aesculap-Meditec MultiPulse CO2 Laser (K983215)
• MedArt® Corp. Uni-Laser 450-P CO2 Laser System (K991297)

The modified Delivery Device Accessories are substantially equivalent to:

• Focused spot handpieces with reusable and single-use tip accessories (K933918)
• Fiber/Waveguide handpieces (K900076 and K950725)
• Scanner devices (K955621, K960521 and K963339)
• Scanner handpieces (K951204 and K963229)
• Bronchoscopes and accessories (K822136 and K943700)
• Micromanipulators (K933918, K881953 and K951204)

The Lumenis Stand-Alone Air Purge Pump and Related Accessories are substantially equivalent to:

• Lumenis gas purge accessories previously cleared in K951812

2. Indication for Use:
The device is indicated for surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in a wide variety of medical specialties, including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery, and genitourinary surgery. A comprehensive list of specific procedures within these specialties is provided across multiple pages.

Conclusion:
This submission relies on the concept of substantial equivalence to existing, legally marketed devices. The "study" that proves the device meets acceptance criteria is implicitly the demonstration that its technological characteristics, materials, and intended uses are sufficiently similar to predicate devices that have already been deemed safe and effective by the FDA. There is no independent clinical study described in this 510(k) summary with specific acceptance criteria that would typically be evaluated in a clinical trial.

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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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