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The Modified Lumenis Family of UltraPulse SurgiTouch CO2 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, incision, 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 Modified Lumenis Family of UltraPulse 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 and/or vaporization) for treatment of: wrinkles, rhytids, and furrows (including fine lines and texture irregularities). Clinical study demonstrated that skin resurfacing of wrinkles, rhytids, and furrows with the UltraPulse CO2 laser increases the amount of sub-epidermal collagen. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: keratoses, including actinic and seborrheic 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 telagiectaticum); 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: 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 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/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 fendoscopic laser-assisted esophagodiverticulostomy (ELAED)]; stenosis, including subglottic stenosis; tonsillectomy (including tonsillar cryptolysis, 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); stapedotomy/stapedectomy; 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 paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea; myringotomy/tympanostomy (tympanic membrane fenestration); uvulopalatoplasty (LAUP, laser UPPP); turbinectomy and turbinate reduction/ablation); septal spur ablation/reduction and septoplasty; partial glossectomy; tumor resection on oral, subfacial and neck tissues; rhinophyma; verrucae vulgares (warts); gingivoplasty/gingivectomy.

Gynecology (GYN): Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology (GYN) for treatment of: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions; leukoplakia (vulvar dystrophies); incision and drainage (I&D) of Bartholin's and nubuthian 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; oophorectomy/ovariectomy; 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, menigiomas (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: menisectomy; chondromalacia: chondroplasty; ligament release (lateral and other); excision of plica; partial synovectomy. General: debridement of traumatic wounds; debridement of dualifatio woulds; debridement of decubitus and diabetic ulcers; and New; 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; cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips; 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: 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.

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

The modified Lumenis family of UltraPulse SurgiTouch CO2 Laser Systems are comprised of the following main components: A laser console. 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 delivery device accessories. Operating software. A variety of delivery device accessories or handpieces, including a pattern generator.

The provided text is a 510(k) summary for the Lumenis Family of UltraPulse SurgiTouch CO2 Laser Systems, which describes the device's indications for use and asserts its substantial equivalence to predicate devices. It does not contain information about specific acceptance criteria or a study proving the device meets particular performance metrics with numerical results.

The document states that "Medical and clinical study information was provided to demonstrate that the modified Lumenis family of UltraPulse SurgiTouch Carbon Dioxide Surgical Lasers are safe and effective," but it does not detail the methodology, results, or acceptance criteria of such studies. It primarily focuses on defining the general surgical applications for which the device is indicated and asserting its equivalence to previously cleared devices.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported performance, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text. The document acts as a regulatory filing summary, emphasizing the device's intended use and its similarity to predicate devices, rather than a detailed performance study report.

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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 Kaplan PenduLaser 115 Surgical Laser with OptoScan II Scanner accessory is indicated for surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: Dermatology, Plastic Surgery, Podiatry, Neurosurgery, Gynecology, Otorhinolaryngology, Arthroscopy (knee), Open & Endoscopic General Surgery.

The Kaplan PenduLaser 115 Surgical Laser with OptoScan II Scanner accessory is safe and effective when indicated for use in specific surgical applications including:

• Ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of laser skin resurfacing, laser derm-abrasion, and laser burn debridement.
• Laser skin resurfacing (ablation and/or vaporization) in dermatology and plastic surgery 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).
• Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery for the performance of blepharoplasty.

The Kaplan PenduLaser 115 CO, Surgical Laser with OptoScan II Scanner Accessory consists of the laser, the Scanner Controller Box, a Footswitch Adapter box, the Sahar SofTouch Scanner, and the handpiece. The Controller houses the electronics and power supply and interfaces to the Pendulaser for communication through the Footswitch Adaptor Box.

The provided document is a 510(k) summary for a medical device (Kaplan PenduLaser 115 CO2 Surgical Laser with OptoScan II Scanner Accessory). It indicates that the device is substantially equivalent to previously cleared predicate devices.

However, a 510(k) summary does not include detailed studies with acceptance criteria, sample sizes, ground truth establishment, or specific performance metrics like those for AI/ML devices or new clinical effectiveness studies. Instead, it focuses on demonstrating equivalence to existing devices.

Therefore, many of the requested items cannot be found in this document:

1. Table of acceptance criteria and reported device performance: Not present. The document asserts substantial equivalence without providing specific performance metrics or acceptance criteria for the new device.
2. Sample size used for the test set and the data provenance: Not applicable. There is no mention of a specific test set or a study quantifying performance against acceptance criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No such study is described.
4. Adjudication method: Not applicable. No such study is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study demonstrates improved human performance with AI and is not relevant to a 510(k) submission based on substantial equivalence to a non-AI surgical laser.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. This device is a surgical laser, not an AI algorithm.
7. Type of ground truth used: Not applicable. No specific performance study requiring ground truth is described.
8. Sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of what can be extracted from the document related to "acceptance" (which, in this context, is substantial equivalence):

The "acceptance criteria" for this device, as per the 510(k) process, is "Substantial Equivalence" to legally marketed predicate devices.

• Predicate Devices:

  • Coherent UltraPulse 5000 system (K963339)
  • Sharplan SilkTouch/Sharplan 1020 Laser (K860087, K960521, K961935)
  • Kaplan PenduLaser 115 (laser component - K950313)
  • OptoScan II Scanner (scanner component - K964684)

• Basis for Substantial Equivalence (the "study" in this context):

  • Same Indications for Use: The KAPLAN PenduLaser 115 Surgical Laser with OptoScan II Scanner Accessory has the same indications for use and target population as the legally marketed predicate devices.
  • Same Technological Characteristics: The technological characteristics of the combined new device are unchanged from those of the component devices (the laser and the scanner) and are the same as those of the predicate devices. The submission asserts these characteristics are "sufficiently precise to ensure equivalence."

Therefore, the "proof" the device meets the "acceptance criteria" (substantial equivalence) is the detailed comparison of its indications for use and technological characteristics to the predicate devices, as presented in the 510(k) submission. No new clinical performance data or studies (of the type requested) are provided or implicitly required for this type of submission.

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Coherent ULTRAPULSE S Series 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, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy (knee), and open and endoscopic general surgery.

Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers are indicated for use in the performance of specific surgical applications in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), and open and endoscopic general 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 and/or vaporization) in dermatology and plastic surgery for the treatment of wrinkles, rhytids and furrows.
  Clinical study demonstrated that skin resurfacing of wrinkles, rhytids, and furrows with the ULTRAPULSE CO2 surgical laser increases the amount of sub-epidermal collagen.
• 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
• lentigines
• uneven pigmentation/dyschromia
• acne scars
• surgical scars
• keloids
• hemangiomas (including buccal hemangiomas)
• tattoos
• telangiectasia
• squamous cell carcinoma
• epidermal nevi
• xanthelasma palpebrarum
• syringoma
• verrucae vulgares (warts).

Dermatology, Plastic Surgery & 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 dermatologf, 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.

Otorhinolaryngology (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
• 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)
• vulvar and vaginal intraepithelial neoplasia

Neurosurgery

• Laser incision, excision, ablation and/or vaporization of soft tissue ja neurosurgery for the treatment of:
• basal tumor-meningioma
• posterior fossa tumors
• peripheral neurectomy
• lipomas/large tumors

The Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers (and their 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 S Series Carbon Dioxide Surgical Lasers are comprised of the following main components:

• a laser console
• a console articulated arm mount
• a counterbalanced articulated arm
• control and display panels
• system microprocessor control electronics and operating software
• a covered footswitch or handswitch for specific delivery device accessories
• a filtered air pump purge system with an insufflator filter for purge of delivery device accessories
• a variety of delivery device accessories or handpieces.

I am sorry, but based on the provided text, there is no information about "acceptance criteria" and "device performance" in the context of a scientific study or clinical trial with specific metrics like sensitivity, specificity, accuracy, or any statistical analysis.

The document is a 510(k) summary statement for the Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving performance against specific acceptance criteria through a newly conducted study as one would expect for a novel device.

Here's what the document does provide:

• Device Description and Indications for Use: It describes the device and lists the surgical applications and medical specialties for which it is intended.
• Predicate Devices: It identifies previously cleared devices to which the new device is compared for demonstrating substantial equivalence.
• Rationale for Substantial Equivalence: It states that the new device shares "the same indications for use, similar design features, and functional features" with the predicate devices.
• Safety and Effectiveness Information: It generally states that "Safety and effectiveness information was provided to demonstrate that the Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers are safe and effective, when indicated for use..." However, it does not detail what that information entailed (e.g., specific study results, performance metrics).
• Conclusion: It concludes that the device was found to be "substantially equivalent" to currently marketed and predicate surgical laser devices.

Therefore, I cannot fill in the requested table or provide the details about sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies because this information is not present in the provided 510(k) summary. The document is a regulatory filing focused on substantial equivalence rather than a performance study report.

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