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The Lumenis modified AcuPulse CO2 Laser System. Delivery Devices and Accessories, is indicated for the vaporization. incision, excision, ablation or photocoagulation 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 Lumenis modified AcuPulse CO2 Laser System, Devices and Accessories, 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 Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, 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:
• Keratosis, including actinic and sebortheic keratosis, sebortheic wart and verruca sebortheice.
• 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 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 or coagulation of:
• Benign/malignant vascular/avascular skin lesions
• Moh's surgery
• Lipectomy
• Verrucae and seborrhoecae vulgares, including paronvchial, periungal and subungual warts
• · Laser incision and/or excision of soft tissue for the performance of upper evelid bleoharoplasty
• · Laser incision and/or excision of soft tissue for the creation of recipient sites for hair transplantation

Podiatry
The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated 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) matrixectorny

Otolaryngology (ENT)
The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for laser incision, excision, 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, larvox, pharvnx and traches, including the uyula, 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
• Tonsillectorny (including tonsillar cryptolysis and neoplasma) and tonsil ablation/tonsillotomy
• Pulmonary bronchial and tracheal lesion removal
• Benign and malignant nodules, tumors and fibromas (larynx, 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 nodularis chronica helices/Winkler's disease
• Telangiectasia/hemangioma of larynx, pharynx and traches (includes uvula, palatal, or upper lateral pharyngeal tissue)
• Cordectorny, 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 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 Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated 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
  · Varorization, 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 adhesions
• Salpingostomy
• Oophorectomy
• Fimbrioplasty
• Metroplasty
• Microsurgery (tubal)
• Uterine myomas and fibroids
• Ovarian fibromas and follicle cysts
• Uterosacral ligament ablation
• Hysterectomy

Neurosurgery Indications
The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for 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, for example, gliomas (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 Indication
The Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for incision, excision, excision, excision, excision, excision, excision, excis 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 Lumenis modified AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for the 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 Lumenis modified AcuPulse CO2 Laser System. Delivery Devices and Accessories, is indicated for the 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 Lumenis modified AcuPulse Laser System. Delivery Devices and Accessories when used in conjunction with FemTouch and FemX, is indicated for the vaporization, incision, ablation and coagulation of body soft tissue in medical specialties including aesthetic (dermatology and plastic surgery), podiaty, otolaryngology, neurosurgery, orthopedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The Lumenis AcuPulse CO2 Laser System is an advanced computer-controlled Carbon Dioxide (CO2) laser system, based on a DC-excited sealed-off CO2 laser tube, that can provide up to 30 or 40 Watts (depending on the configuration) on tissue. The AcuPulse CO2 Laser system consists of the following main functional components:

• o a Laser Console with a Free Beam Port, to which an articulated arm is attached
• a Footswitch to activate the laser treatment beam and allow the selected lase energy to o be transmitted via the delivery device to the target location
• 0 a variety of Free Beam Delivery Devices and accessories.

The Free Beam Delivery Devices and accessories include: Endoscopes/Laparoscopy accessories, Handpieces/Tips, Micromanipulators, and Scanners with accessories and adaptors and the FemTouch handpieces.

The modified AcuPulse system, similarly to its predicates, the previously cleared AcuPulse System (member of the cleared AcuPulse Family of CO2 Laser Systems, cleared under K180597) and the Previously cleared AcuPulse W system (K201663 and K202428), is operated and controlled via proprietary software embedded in the Main controller, Peripheral controller units and PC.

The modified AcuPulse System, with the incorporation of the FemTouch and FemX handpieces, shares the same underlying technology and functionality as its predicates.

This document does not describe an AI/ML medical device. Instead, it is a 510(k) premarket notification for a medical device called the "AcuPulse CO2 Laser System, Delivery Devices and Accessories" by Lumenis, Ltd.

The document discusses the device's indications for use, its technical specifications, and the performance data submitted to demonstrate substantial equivalence to previously cleared predicate devices (other AcuPulse systems). The performance data cited focuses on electrical and laser safety, electromagnetic compatibility, biocompatibility, cleaning/disinfection/sterilization validations, and software verification/validation, all typical for traditional hardware-based medical devices.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device, as this document pertains to a laser surgical instrument, not an AI/ML product.

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Universal IPL with a spectrum of 400-1200nm (with different filters) is indicated for: Improvement of signs of Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD), also known as evaporative dry eve or lipid deficiency dry eve, in patients 22 years of age and older with moderate to severe signs and symptoms of DED due to MGD and with Fitzpatrick skin types I-IV. IPL is to be applied only to skin on the malar region of the face, from tragus to tragus including the nose (eyes should be fully covered by protective eyewear). IPL is intended to be applied as an adjunct to other modalities, such as meibomian gland expression, artificial tear lubricants and warm compresses.

The Lumenis Stellar M22 System incorporates a touch-screen control panel, power supply modules, cooling unit, switching module and service panel, monitored and controlled by its control software. Selected parameter treatment options and corresponding relevant user information are displayed on the monitor screen. The subject device (ophthalmic use) uses the spectrum range of 400-1200 nm. The cut-off filters used in the Lumenis presets for Universal IPL pigmented lesions treatment with the Stellar M22 system are the 515, 560, 590, 615, 640 or 695nm filters. Each filter cuts off all light with a wavelength shorter than the number indicated on the filter. The filter is inserted inside the handpiece and is exchangeable.

Universal IPL skin treatments with the Stellar M22 may use one of the three lightguides, 8x15, 15x35 mm rectangles and 6 mm round, which are supplied as accessories. Lightguides are made of sapphire and couple the optical energy from the module to the treatment site.

The provided text describes the regulatory acceptance of the Lumenis Stellar M22 for use in dry eye disease management, focusing on the clinical study that supports its effectiveness and safety. However, the document does NOT contain information about acceptance criteria for a device that uses AI/algorithm or any MRMC (Multi-Reader Multi-Case) comparative effectiveness study. Similarly, there's no mention of standalone algorithm performance or the sample size and ground truth establishment for a training set if an AI component were present.

The information primarily revolves around the performance of the IPL device itself, in conjunction with Meibomian Gland Expression (MGX), and is evaluated through clinical endpoints in human subjects.

Therefore, for aspects related to AI/algorithm performance, ground truth, and MRMC studies, the provided text does not contain the necessary details. I will answer the questions based on the information available in the text, and clearly state when information is not present.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance (Based on Clinical Study Outcomes)

The device's acceptance is primarily based on its clinical performance in improving a specific sign of Dry Eye Disease (DED) and its safety profile.

• IPL+MGX arm: Change in TBUT from baseline (BL) to follow-up (FU) was 1.99 ± 0.36 sec.
• Control (Sham+MGX) arm: Change in TBUT from BL to FU was 0.75 ± 0.34 sec.
• Between-group mean difference in TBUT: 1.24 ± 0.50 sec.
  Support for "meaningful clinical benefit" based on exploratory and post-hoc analyses (e.g., proportion of patients improving by two or more TBUT severity categories, proportion improving to non-MGD TBUT). |
  | Secondary Effectiveness Endpoints: Improvement in self-reported DED symptoms (OSDI questionnaire, Eye Dryness Score (EDS) VAS). | Not Met: The study did not demonstrate significantly greater benefit for the IPL device group with regard to self-reported dry eye symptoms (similar overall mean improvement in both groups, no statistically significant difference between groups).
• OSDI p=(b)(4), EDS VAS p=(b)(4).
  However, exploratory protocol-planned analysis of "OSDI responders" (OSDI (b)(4) interpreted as improvement to "mild or better") showed clinical benefit for active IPL treatment group ((b)(4)%) vs. control group ((b)(4)%). This outcome supports clinically meaningful benefit for a proportion of the study population. |
  | Supportive Effectiveness Endpoints (Signs of DED): Change in Meibomian Gland Score (MGS). | Clinical Benefit: Exploratory analysis of change in MGS showed clinical benefit for the IPL treatment group.
• Improvement of (b)(4) units in active arm vs. (b)(4) units in control arm.
• Between-group difference of (b)(4) units.
  This outcome supports clinically meaningful benefit for a subset of the study population. |
  | Safety: Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events (UADEs). | Acceptable:
• No Serious Adverse Events (SAEs) or UADEs reported.
• AE incidence: 8.9% in IPL active treatment arm (2 ocular AEs, 2 skin AEs) compared to 20% incidence in the control arm.
• With proper eye protection, no ocular AEs attributed to the IPL system were reported. |
  | Other Non-Clinical Criteria (addressed through testing/declarations for device components):
• Thermal Safety
• Electrical Safety and Electromagnetic Compatibility (EMC)
• Biocompatibility
• Software Verification, Validation, and Hazard Analysis | Met:
• Thermal safety assessed (leveraging previous clearances).
• Complies with IEC 60601-1 and IEC 60601-1-2 (similar to previous K193500 device).
• Handpiece identical in materials and manufacturing to K193500, so previous biocompatibility assessments are applicable. Warnings for coupling gel eye contact included.
• Consistent with FDA guidance for software in medical devices; moderate Software Level of Concern (LOC); risks addressed by labeling and risk management process. |

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • The document mentions "Up to male or female subjects". It does not explicitly state the final enrolled sample size. However, it indicates:
     • Type I error of 0.05 (two-tailed test)
     • Type II error of (b)(4) (power = (b)(4))
     • 1:1 ratio of Treatment to Control
   • Data Provenance:
     • The study was a "multi-center, prospective, randomized, sham-controlled, superiority study."
     • Country of Origin: Not explicitly stated, but Lumenis Ltd. is based in Yokneam, ISR (Israel). Clinical trials are often multi-national, but this is not specified.
     • Retrospective or Prospective: Prospective.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • The clinical study evaluates the device's effect on clinical endpoints directly measured or self-reported by patients (TBUT, OSDI, EDS, MGS). These are objective or subjective measures, not interpretations by experts needing to establish ground truth from, for example, images.
   • Therefore, the concept of "experts used to establish ground truth" in the typical sense (e.g., for image annotations) does not apply to this clinical trial design. Measurements like TBUT and MGS are taken by trained clinical personnel, and OSDI/EDS are patient-reported.

3. Adjudication Method for the Test Set:

   • Not applicable as the study relies on direct clinical measurements and patient self-assessment, not interpretive tasks requiring adjudication like image reads.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC comparative effectiveness study was not done. The study was a clinical trial evaluating a device's effect on physiological and symptomatic endpoints, not a study assessing the performance of human readers with or without AI assistance.
   • Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as no AI assistance was being evaluated for human readers.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • No, this was not done. The product being evaluated is a medical device (IPL system), not an AI algorithm. The performance discussed is the direct effect of the device on patients.

6. The Type of Ground Truth Used:

   • The "ground truth" in this context refers to the clinical endpoints measured in the study:
     • Tear Break-up Time (TBUT): A direct physiological measurement (time from blink to tear film break-up).
     • Meibomian Gland Score (MGS): An objective clinical scoring system for meibomian gland function.
     • OSDI and EDS VAS: Patient-reported outcome measures (subjective symptoms).
   • These are considered the gold standard for evaluating DED and MGD in clinical trials. There is no mention of pathology or other external outcomes data beyond these clinical measures.

7. The Sample Size for the Training Set:

   • Not applicable. The document describes a clinical trial for a medical device, not the training of an AI model. Therefore, there is no "training set" in the context of an algorithm.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. As there is no AI model training described, there is no "ground truth for a training set" to be established.

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The UltraPulse system (UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for use in surgical applications requiring the ablation, vaporization, excision, 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 UltraPulse system (UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (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).
  -Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
• Keratoses, including actinic and sebortheic keratosis, sebortheic wart and verruca sebortheica.
• · 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 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 or coagulation of:
• · Benign and 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
• 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 matrixectomy

Otolaryngology (ENT)
-Laser incision, excision, 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, 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 tonsillar cryptolysis and neoplasma) and tonsil ablation/tonsillotomy
• · Pulmonary bronchial and tracheal lesion removal
• · Benign and malignant nodules, tumors and fibromas (larynx, 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 of 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 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 Bowen's disease (Erythrolasia 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 gynecological laparoscopy, for the treatment of:
• · Endometrial lesions, including ablation of endometriosis
• Excision/lysis adhesions
• · Salpingostomy
• Oophorectomy/ovariectomy
• · Fimbrioplasty
• 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, 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
-Incision/excision and vaporization of soft tissue in orthopedic surgery, including the following applications:

• Arthroscopy
• · Menisectomy
• 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
-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
-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 UltraPulse System, member of the UltraPulse SurgiTouch Family of CO2 Surgical and Aesthetic Laser Systems, Delivery Devices and Accessories (K951812 K912029, K96339 K030147 and K151331), is a carbon dioxide laser system based on a Radio Frequency (RF) modulated CO2 laser tube.

The modified UltraPulse is based on the following hardware components in the Lumenis Family of UltraPulse CO2 Laser System, Delivery Devices and Accessories:

• . A Laser Console with a Free Beam Port to which an articulated arm is attached
• A footswitch to activate the laser treatment beam and allow the selected laser energy to be transmitted via the delivery device to the target location.
• A variety of Free Beam Delivery Device and accessories

The modified UltraPulse, similarly to the recent members of the cleared Lumenis Family of UltraPulse CO2 Surgical and Aesthetic Laser Systems. Delivery Devices and Accessories (UltraPulse and UltraPulse DUO models) has a similar proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC.

The modified UltraPulse CO2 Laser System, is a version of the cleared Lumenis Family of UltraPulse CO2 Laser System, Devices and Accessories (see K030147 and K151331 for the latest clearances) with modifications to meet the marketing requirements for a new system with a subset of the supported aesthetic and surgical scanners and accessories. The modified UltraPulse System now supports the Aesthetic Scanners, UltraScan CPG and DeepFX Microscanner used with the cleared UltraPulse SurgiTouch/Encore Systems but with a modern GUI, PC and Operating System. In addition, other hardware, electronic and Software changes were introduced to replace obsolete components. The proposed system relies on the same fundamental underlying technology of the cleared systems with some modifications as compared to the cleared family members.

In addition, this submission describes several minor post-clearance modifications to the cleared Lumenis Family of Surgical and Aesthetic Laser Systems, Delivery Devices and Accessories that were the subject of contemporary regulatory analyses that determined that changes could not significantly affect safety or effectiveness. Accordingly, these post-clearance modifications were implemented via internal documentation and no pre-marketing submission was filed. The postclearance modifications, include addition of the modified SurgiTouch Scanner (cleared under K951812 and K022060), called the DeepFX Microscanner to the UltraPulse SurgiTouch/Encore system, almost identical to the AcuScan120 Microscanner cleared with the Lumenis AcuPulse CO2 Laser system (K100415). Modernization of electronics and hardware of all systems to replace outdated parts and to meet new contemporary standards (e.g., IEC 60601-1-2 Ed.4, IEC 60601-1 Ed 3.1), improvements in laser calibration and stability and finally minor software modifications to enhance the user workflow and accessories supported (e.g., addition of treatment Preference and Utilities Screens and Training Videos).

This document is a 510(k) premarket notification for a medical device, the UltraPulse Surgical and Aesthetic CO2 Laser System. It is focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving a new medical claim or showing improved clinical effectiveness. Therefore, the typical elements of an AI/ML device study (like sample size for test/training, expert adjudication, MRMC studies, or specific performance metrics like sensitivity/specificity for a diagnostic algorithm) are not applicable here.

This submission is for a physical laser system (hardware and software that controls it), not for an AI/ML diagnostic or prognostic algorithm. The acceptance criteria and supporting studies are centered on compliance with safety standards and functional equivalence to its predicate, rather than clinical performance metrics.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance:

Since this is a submission for a physical laser device and not a diagnostic AI/ML algorithm, the acceptance criteria are not typically presented in terms of clinical performance metrics like sensitivity, specificity, or AUC, as would be common for AI/ML. Instead, they are related to safety, functionality, and equivalence to the predicate device. The document describes the studies performed to verify these, rather than providing a quantitative table of achieved "performance" against acceptance criteria for a new clinical claim.

The document implicitly states that the "acceptance criteria" were met by showing that the modified device:

• Conformed to relevant electrical, laser, and electromagnetic compatibility safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
• Underwent software verification and validation according to IEC 62304 and FDA guidance.
• Passed system testing for basic functionalities (energy measurements, safety controls, emission indicator, scanners, aiming beam).
• Underwent usability assessment per FDA guidance and IEC standards.
• Evaluated changes to accessories, reprocessing, and biocompatibility.

The "reported device performance" is summarized as: "Test results indicated that the modified UltraPulse performs in accordance with its requirements and specifications similarly to its predicate UltraPulse System member of the Lumenis Family of UltraPulse SurgiTouch CO2 Surgical and Aesthetic Laser Systems."

2. Sample size used for the test set and the data provenance:

• Not applicable in the context of AI/ML diagnostic/prognostic models. For a physical device verification, "sample size" doesn't refer to a dataset of patient images/samples. Instead, it refers to the number of units tested, or the scope of testing performed according to engineering and quality assurance protocols. The document does not specify a numerical count of devices or components tested, but implies comprehensive testing of the modified system.
• Data Provenance: The data would be internally generated from engineering and quality assurance testing in Israel (Lumenis Ltd. is based in Yokneam, Israel) during the device development and verification process. It is neither retrospective nor prospective in the common sense of clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This submission is for a physical laser device, not an AI/ML system requiring expert-annotated ground truth for clinical decision support. The "ground truth" for this device's performance would be established by objective measurements and adherence to engineering specifications and safety standards, not by human expert consensus on clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to establish a consensus (ground truth) among multiple human readers for diagnostic tasks. This is irrelevant for a hardware/software system verification for substantial equivalence.

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:

• No. This is a hardware/software laser system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted and is not relevant for this 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a device that performs a physical action (laser ablation/vaporization). Its "performance" is inherent to its functional specifications and safety, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For physical device verification and validation, "ground truth" is established by:
  • Engineering specifications and design requirements: The device must perform as designed.
  • International standards: Adherence to electrical safety (e.g., IEC 60601-1), laser safety (e.g., IEC 60825-1), EMC (e.g., IEC 60601-1-2), and software development standards (e.g., IEC 62304).
  • Risk analysis (ISO 14971): Ensuring identified risks are mitigated.
  • Predicate device's established performance: The modified device must perform "similarly" to the cleared predicate.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML algorithm that requires a training set. The software for this device is likely developed using traditional software engineering paradigms, validated through testing, not "trained" on data.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set for an AI/ML model.

In summary, this 510(k) is about demonstrating the safety and effectiveness of a modified CO2 laser system through adherence to engineering standards, risk analysis, and substantial equivalence to a predicate device. It is not an AI/ML product seeking clearance based on diagnostic performance metrics.

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Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The AcuPulse W system (recently cleared under K201663) is a scaled-down version of the cleared Lumenis Family of AcuPulse CO2Laser System. Delivery Devices and Accessories under K180597. The modified AcuPulse W, identically to its predicate (K201663) is comprised of the following main functional components:

• A Laser Console with a Free Beam Port to which an articulated arm is attached .
• . A footswitch to activate the laser treatment beam and allow the selected laser energy to be transmitted via the delivery device to the target location.
• . A variety of Free Beam Delivery Device and accessories
  The modified AcuPulse W and the cleared AcuPulse W (K201663) systems have the same proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC. Importantly, both systems use the same Software version, which was already validated, verified and submitted under K201663. Also, no changes to the Hardware were made to the svstem.
  The AcuPulse W is offered with previously cleared AcuPulse Handpieces/Tips that connect to the articulated arm or/and scanners for controlled delivery of laser energy to the target tissue. Among them, the cleared 90° Side-firing Handpiece (K201663) connects to the AcuScan 120 Microscanner through two adaptors (a Handpiece Adapter and Third Lens Adapter) for delivery of laser energy. The 90° Side-firing Handpiece is comprised of the following components:
• . Handpiece Adapter (cleared under K201663)
• . Tip:
  • Multiuse Standard Focus Tip (cleared under K201663) o
  • Multiuse Fine Focus Tip (cleared under (K201663) о
  • Disposable Standard Focus Tip (subject of this submission) o
  • Disposable Fine Focus Tip ((subject of this submission) o
• . Limiter ring (cleared under K201663)
  In this submission, Lumenis is introducing a disposable configuration of the 90° Side-firing Handpiece Tips in addition to the already cleared multiuse tips to respond to the increased market demand of disposable accessories for reducing the occurrence of treatment acquired infections. These 90° Side-firing Handpiece disposable tips are single use tips, packaged and EO sterilized, similarly to Lumenis devices previously cleared and used with the cleared AcuPulse Family of CO2Lasers (K100384 and K130164).

The provided document describes a 510(k) premarket notification for a medical device, specifically the Lumenis AcuPulse W CO2 Laser System, Delivery Devices, and Accessories. This document is a regulatory submission to the FDA, asserting substantial equivalence to a legally marketed predicate device.

It does not contain information about the performance of an AI/algorithm-driven device, nor does it provide acceptance criteria or study results for such a device. The modifications detailed in this 510(k) are related to the introduction of disposable tips for a laser system, which is a hardware change, not an AI software change.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document discusses design verification processes for the modified laser system and its disposable tips, which include:

• Risk analysis per ISO 14971.
• Electrical safety testing to IEC 60601-1.
• Performance verification and validation to evaluate that the 90° Side-firing Handpiece with the new disposable configuration of Tips performs according to its specifications.
• EO sterilization and Shelf-life validation activities (ISO 11607, ISO 11135-1, ISO 10993).
• Biocompatibility evaluation (ISO 10993).

The key takeaway from the document regarding "performance" is:

"Test results indicated that the AcuPulse W with the 90° Side-firing Handpiece equipped with the new configuration of disposable tips performs in accordance with its requirements and specifications similarly to its predicate device."

This statement confirms that the new disposable tips meet functional and safety requirements comparable to the existing multiuse tips, ensuring substantial equivalence to the predicate device. However, it does not provide specific quantitative acceptance criteria or detailed study results generally associated with AI/ML device performance.

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Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The subject AcuPulse W system is a new scaled-down version of the recently FDA cleared Lumenis AcuPulse CO2 Laser System, Delivery Devices and Accessories under K180597. It is based on the following hardware components in the AcuPulse:

• . A Laser Console with a Free Beam Port to which an articulated arm attached.
  • Identical to the AcuPulse, the Laser Console of the AcuPulse W System houses the laser O tube and optical system, the laser power source, console electronics, laser output ports, cooling system, purge air pump, control components (including touch screen, emergency stop button) and rear connector panel.
• . An articulated arm to guide laser output via a set of folding mirrors to the connected accessory for delivery of laser energy to the tissue.
• . A footswitch to activate the laser treatment beam and allow the selected laser energy to be transmitted via the delivery device to the target location.
• . A variety of Free Beam Delivery Device and accessories.

The AcuPulse and AcuPulse W systems have the same proprietary software, which is embedded in the Main Controller, Peripheral Controller units and PC. The differences between the two are the enabled or disabled software features, through a hardware key (HASP dongle), that reflects the capabilities of each laser system or the particular configuration of a given system. Importantly, both systems use the same Software version, which was already validated, verified and submitted under K180597.

The AcuPulse W is offered with a subset of the previously cleared AcuPulse Handpieces/Tips that connect to the articulated arm or/and scanners for controlled delivery of laser energy to the target tissue. In addition, Lumenis is adding a Titanium (Ti-6Al-4V) 90° Side-firing Handpiece design. Like the cleared handpieces, it has multiple uses. The 90° Side-firing handpiece connects to the cleared AcuScan 120 Microscanner through two adaptors (a Handpiece Adapter and Third Lens Adapter) for delivery of laser energy. The 90° Side-firing handpiece is comprised of the following components:

• Handpiece Adapter
• Tip (Standard or Fine)
• . Limiter ring (Standard or Fine)

This handpiece is based on the same technology and principles of operation of the cleared CO2 delivery devices and its introduction does not raise any new questions of safety and/or efficacy.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Lumenis AcuPulse W CO2 Laser System, Delivery Devices and Accessories:

Observation: The provided text is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific, novel acceptance criteria through a primary clinical study. It details changes from a previous version and outlines various verification and validation activities conducted. Therefore, it does not contain information about a traditional "study that proves the device meets acceptance criteria" in the sense of a standalone clinical trial with pre-defined performance endpoints. Instead, it indicates that the device was evaluated against existing standards and specifications to ensure it performs comparably to the predicate.

Given this context, I will extract relevant information to address your points, acknowledging that some fields might not be directly applicable as they pertain to clinical performance studies, which are not detailed here.

Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily established by the successful demonstration of substantial equivalence to the predicate device and compliance with relevant industry standards for safety and performance. There isn't a table of specific clinical performance criteria (e.g., sensitivity, specificity for a diagnostic device) and reported device performance from a clinical trial in this document.

The document implicitly states that the device performs in accordance with its requirements and specifications similarly to its predicate device. The "reported device performance" is effectively its compliance with the listed standards and its functional equivalence to the cleared predicate.

• IEC 60601-1
• IEC 60601-1-2
• IEC 60825-1
• IEC 60601-2-22 | Testing performed and results indicated that the new configuration performs in accordance with its requirements and specifications similarly to its predicate device. This implies successful completion and compliance with these standards. |
  | 90° Side-firing Handpiece performance (functional) | Testing demonstrated that the accessory (90° Side-firing Handpiece) together with the AcuPulse W system performs in compliance with their specifications and requirements. This includes functional equivalence to existing cleared CO2 delivery devices based on the same technology and principles. |
  | 90° Side-firing Handpiece Cleaning Validation (AAMI TIR 30) | Validation activities performed. |
  | 90° Side-firing Handpiece Sterilization Validation (ISO 17665-1) | Validation activities performed. |
  | 90° Side-firing Handpiece Biocompatibility (ISO 10993) | Biocompatibility testing performed for materials. |
  | Software Validation | The AcuPulse and AcuPulse W systems use the same proprietary software version, which was already validated, verified, and submitted under K180597. The differences are enabled or disabled features via a hardware key. This implies the software continues to meet its previously established performance criteria as the core software remains unchanged. |
  | Substantial Equivalence to Predicate Device (K180597) | The device is deemed substantially equivalent. Test results indicated that the new configuration performs in accordance with its requirements and specifications, similarly to its predicate device, and does not raise new questions of safety and/or effectiveness. |

Study Details (as inferable from the 510(k) Summary):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: Not applicable in the context of a clinical test set. The document describes engineering verification and validation activities (testing against standards, functional testing of accessories). For these engineering tests, sample sizes are not explicitly stated, but typically involve representative samples of the device and its components.
   • Data Provenance: Not applicable for a clinical test set. The studies are engineering and regulatory compliance tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. This device is not an AI/diagnostic device that requires expert-established ground truth for a test set. The "ground truth" for the engineering tests is compliance with established safety and performance standards and the functional specifications of the device.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This is not a study requiring adjudication of clinical outcomes or diagnostic interpretations.

4. 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:

   • No. This device is a laser surgical instrument, not an AI-based diagnostic or assistive system for human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. This is not an AI algorithm but a physical medical device. Software validation was done, but it pertains to the device's operational control, not a standalone diagnostic algorithm. The software is embedded and controls the laser device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" for the evaluation documented here is primarily compliance with recognized electrical, laser safety, and biocompatibility standards (e.g., IEC 60601-1, IEC 60825-1, ISO 10993, ISO 17665-1, AAMI TIR 30), and the functional specifications set for the device and its accessories, evaluated through engineering tests, rather than clinical outcomes or expert consensus on patient data.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that involves a "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for an AI model.

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The subject Stellar M22 has connection capability with the following available treatment handpieces, for multi-application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:

• The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200 nm (with 9 different filters) is indicated for:
  • Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and o ephelides (freckles)
  • Cutaneous lesions, including warts, scars and striae O
  • Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, O truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
  • Removal of unwanted hair and to effect stable long term, or permanent* hair O reduction in skin types I-V through selective targeting of melanin in hair follicles
  • Mild to moderate inflammatory Acne (Acne vulgaris) o
• The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is ● indicated for:
  • The coagulation and hemostasis of vascular lesions and soft tissue, including the O treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg
  • The removal of unwanted hair and to effect table long term, or permanent* hair O reduction in skin types I-V through selective targeting of melanin in hair follicles
  • The non-ablative treatment of facial wrinkles o
• . ResurFX module and handpiece, with wavelength of 1565 nm, is indicated for:
  • Use in dermatological procedures requiring fractional skin resurfacing and O
    coagulation of soft tissue

The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated ● for:

• Removal of dark tattoos O
• o Treatment of pigmented lesions

*Note

Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.

The subject Stellar M22 for Intense Pulsed Light (IPL) and Laser System is a multi-application, multitechnology platform with four (4) available treatment handpieces:

• Stellar Intense Pulsed Light (IPL) handpiece; ●
• . Multi-Spot Nd:YAG laser handpiece;
• ResurFX non-ablative laser handpiece: ●
• Q-Switched Nd:YAG laser handpiece. ●

The following accessories are provided with and/or may be purchased independently for each of the four (4) available treatment handpieces of the Stellar M22 for Intense Pulsed Light (IPL) and Laser Systems:

• The Stellar IPL handpiece has nine (9) different filters available: Cut-off filters of 515, . 560, 590,615, 640, 695 and 755 nm, Notch Filters of 400-600 & 800-1200 nm and 530-650& 900-1200 nm. Further, the IPL handpiece has three (3) Sapphire Cool LightGuides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6 mm diameter.
• The Multi-Spot Nd:YAG handpiece has three (3) different LightGuides available in sizes . of: 2mm x 4mm, 6 mm, and 9 mm.
• The ResurFX handpiece has two (2) different treatment tips available: SapphireCool and Precision tips
• . The Q-Switched Nd:YAG handpiece has both disposable and gold plated metal treatment tips available. The disposable treatment tips and metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.

The provided text is a 510(k) summary for the Stellar M22 for Intense Pulsed Light (IPL) and Laser system. This document outlines the device's intended use, technological characteristics, and compares it to a predicate device (M22 System, K170060) to establish substantial equivalence.

However, the summary does not include specific acceptance criteria or details of a study that proves the device meets those criteria in a quantitative sense as often seen in clinical performance studies with specific endpoints. Instead, it describes "Performance Data" in the context of design verification, compliance with standards, and software validation to demonstrate that modifications to the device do not raise new questions of safety or effectiveness compared to the predicate device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not detailed in this type of regulatory submission, as it focuses on demonstrating substantial equivalence rather than proving a specific diagnostic accuracy or treatment efficacy de novo.

Below is a summary based on the information provided, with "N/A" for information not present in the document.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a quantitative table format that measures specific performance metrics against a defined threshold. Instead, it focuses on demonstrating that the Stellar M22 device's modifications do not introduce new safety or effectiveness concerns compared to its predicate. The "reported device performance" is framed in terms of functional verification and compliance with standards.

2. Sample size used for the test set and the data provenance

N/A - The document describes general performance data related to engineering verification and validation, and compliance with standards. It does not refer to a clinical "test set" with a specific sample size of patients or images for diagnostic or therapeutic performance evaluation. The data provenance is also not specified in terms of country of origin or retrospective/prospective nature, as this is not a clinical study report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A - No clinical "test set" requiring ground truth established by experts is described in this regulatory submission for substantial equivalence.

4. Adjudication method for the test set

N/A - No clinical "test set" or adjudication method is described.

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

N/A - This document does not describe an MRMC comparative effectiveness study or involve AI assistance for human readers. The device is a laser and IPL system for dermatological procedures, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

N/A - This device is a medical instrument (laser and IPL system), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A - As there is no clinical "test set" for performance evaluation in the context of diagnostic accuracy or treatment efficacy against a reference standard, the concept of ground truth in that sense is not detailed. The performance data focuses on engineering and safety compliance.

8. The sample size for the training set

N/A - The document does not describe a "training set" in the context of machine learning or AI algorithms.

9. How the ground truth for the training set was established

N/A - Not applicable, as there is no mention of an AI training set or related ground truth.

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The Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), is indicated for the vaporization, incision, excision, ablation or photocoagulation 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 Lumenis AcuPulse Family of CO2 Laser Systems, Delivery Devices and Accessories (AcuPulse, AcuPulse 40WG and AcuPulse DUO), 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, Neurosurgery, Orthopedics, General Surgery and Podiatry as follows:

Dermatology
Podiatry
Otolaryngology (ENT)
Gynecology and GYN Laparoscopy Indications
Neurosurgery Indications
Orthopedic Indication
General and Thoracic Surgery
Dental and Oral Surgery

The Lumenis AcuPulse Family of CO2 Laser Systems are advanced computer-controlled Carbon Dioxide (CO2) laser systems based on a DC-excited sealed-off CO2 laser tube, that depending on their configuration, can provide up to 30 or 40-Watts on tissue. The AcuPulse Family of CO2 Lasers includes the following system models:

• The AcuPulse (previously called AcuPulse 30/40ST) system that incorporates a Free Beam Port only.
• The AcuPulse 40WG System that incorporates a Fiber Port only.
• The AcuPulse DUO, a new member of the family, which incorporates both a Free Beam Port and a Fiber Port.

The AcuPulse DUO laser added to the AcuPulse family represents a combination of the previously cleared AcuPulse 30/40ST and AcuPulse 40WG lasers. The minor differences in technological characteristics between the AcuPulse DUO and the predicate systems exist to facilitate this integration (mechanical and software adaptations that enable having two ports in one System) and do not affect any of the device's functionalities or performance specifications. The AcuPulse DUO System, with the incorporation of both the Free Beam and the Fiber port in one console, shares the same underlying technology and fundamental functionality as the previously cleared AcuPulse Family of CO2 Laser Systems. All of these laser systems are comprised of the following main functional components:

• a Laser Console with a port: a Free Beam Port to which an articulated arm is attached (AcuPulse model), a Fiber Port to which a Fiber is attached (AcuPulse 40WG), or both the Free Beam Port and Fiber Port (AcuPulse DUO)
• a Footswitch
• Various Free Beam Delivery Device and accessories (AcuPulse and AcuPulse DUO compatible) or Fiber Delivery Devices and accessories (AcuPulse 40WG and AcuPulse DUO compatible).

The AcuPulse DUO, similarly to the previously cleared AcuPulse and AcuPulse 40WG, is operated and controlled via proprietary software embedded in the Main controller. Peripheral controller units and PC.

The Delivery Devices and accessories, in accordance with their type and compatibility (e.g., Fiber Port or Free Beam port) are shared by all AcuPulse Laser Systems. The Free Beam Deliverv Devices and accessories include: Endoscopes/Laparoscopy accessories, Handpieces/Tips, Micromanipulators, and Scanners with accessories and adaptors. The Fibers that may be used with the Fiber Port are supplied with various handpieces (through which the Fiber may be inserted for more convenient handling during surgical procedures) and additional accessories for Fiber maintenance and handling.

The provided text is a 510(k) summary for the Lumenis AcuPulse Family of CO2 Laser Systems. It describes the device, its intended use, and indicates that performance testing was conducted. However, it does not contain detailed information regarding specific acceptance criteria, reported device performance in those criteria, sample sizes, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone algorithm studies) in the manner typically associated with clinical performance evaluation for AI/ML devices.

The document focuses on demonstrating substantial equivalence to a predicate device (AcuPulse 30/40ST and AcuPulse 40WG CO2 Lasers, K100415) based on:

• Intended use and indications for use: These are stated to be the same as the predicate devices.
• Principles of operation: Stated to be the same.
• Technological characteristics: Stated to be "nearly identical," with "minor differences" related to combining capabilities of previously cleared devices.
• Performance data: General statements about risk analysis, electrical and laser safety, electromagnetic compatibility testing, software verification and validation, and system testing to ensure compliance with specifications.

Given these limitations, I cannot provide a table of acceptance criteria, reported device performance, or details about clinical study specifics such as sample sizes, data provenance, expert ground truth, adjudication methods, or MRMC/standalone study results for AI.

Here's a breakdown of what can be extracted from the document based on your request, and where information is explicitly not present:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative acceptance criteria (e.g., specific thresholds for laser power output, pulse duration accuracy, beam quality, or safety interlock response times) are not detailed, nor are the precise numerical results of the performance tests against such criteria. The document states "performance in compliance with their specifications and requirements" but does not list those specifications.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The performance testing mentions "system testing" but does not refer to a clinical "test set" in the context of diagnostic or predictive performance metrics. The evaluation focuses on device functionality and safety.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. The tests appear to be engineering/technical verification and validation rather than clinical data studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable/Not specified. Ground truth in the context of clinical interpretation, as would be relevant for AI/ML devices, is not mentioned. The testing described relates to the laser system's technical specifications and safety.
• Qualifications of Experts: Not applicable/Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not specified. This information is relevant for studies involving human interpretation or challenging cases, which is not the type of study described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. The document does not mention any clinical comparative effectiveness study involving human readers, with or without AI assistance. The device is a surgical laser system, not an AI diagnostic tool that would typically be evaluated with MRMC studies.
• Effect Size of Human Readers with AI vs. without AI: Not applicable, as no such study was conducted or reported.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No. This device is a physical CO2 laser system, not an AI algorithm intended for standalone performance evaluation against a diagnostic problem. Performance testing was related to the physical and software functionality of the laser itself.

7. Type of Ground Truth Used

• Type of Ground Truth: For the performance tests conducted (risk analysis, electrical/laser safety, EM compatibility, software V&V, system testing), the "ground truth" would be the engineering specifications, regulatory standards (e.g., IEC standards), and the device's design requirements. There is no mention of clinical ground truth (e.g., pathology, outcomes data, or expert consensus) as would be relevant for a diagnostic or prognostic device.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. This concept is relevant for AI/ML models that learn from data. The document describes a traditional medical device (laser system) with embedded proprietary software, but not an AI/ML system with a "training set."

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable/Not specified. As there's no mention of an AI training set, this information is not relevant to the provided document.

In summary: The provided 510(k) summary is for a traditional surgical laser system. The "performance data" section focuses on engineering verification and validation against regulatory standards and internal specifications to demonstrate safety and effectiveness for substantial equivalence, rather than clinical performance evaluation of an AI/ML algorithm against a diagnostic ground truth. Therefore, many of the specific details requested regarding AI/ML study design are not present in this document.

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The LightSheer Family of Pulsed Diode Array Laser Systems (LightSheer Desire, LightSheer Desire Light and LightSheer Infinity) is indicated for use in surgical, aesthetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Family of Pulsed Diode Array Laser Systems is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

Specific indications for each system and handpiece combination are listed in the document and include:

• Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins
• Treatment of pseudofolliculitis barbae (PFB)
• Hair removal, permanent hair reduction*
• Treatment of benign pigmented lesions, including age spots, solar lentigines, cafe-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions
• Treatment of wrinkles

*Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Lumenis LightSheer Family of Pulse Diode Array Laser Systems consists of four laser consoles that can be used with up to four different types of handpieces. The four laser consoles are: LightSheer Duet, LightSheer Infinity, LightSheer Desire, and LightSheer Desire Light. The laser consoles provide (1) a graphical user interface and software for control of the system, (2) the needed electronics to control and power the accessories, (3) handpiece connection port(s), (4) a vacuum pump (most models) and (5) cooling system.

Handpieces can be divided into two categories, depending on the technology applied to the skin during treatment: high speed (HS) Handpieces with vacuum technology (HIT™) or ET, XC and LR Handpieces with cooling technology (ChillTip), available with different sized tips. Some handpieces are universal, supporting different ChillTip sizes within a single handpiece. In addition, these handpieces either deliver pulsed diode laser light with wavelengths ranging from 790 - 950nm (805nm nominal) or 1040-1080nm (1060nm nominal), depending on the diode array type. The same LightSheer Handpieces are compatible with multiple systems (such as the LightSheer Duet, LightSheer Infinity, LightSheer Desire, and LightSheer Desire Light), in which case they differ only in terms of the mechanical connection to the console.

The provided text describes a 510(k) submission for the Lumenis LightSheer Family of Pulsed Diode Array Laser Systems. The purpose of the submission is to add 1060nm handpieces to the LightSheer Desire and LightSheer Desire Light Systems, which were previously cleared for use with other systems in the LightSheer Family. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving those criteria are met for the device's indications for use.

Therefore, the specific information requested in the prompt regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within this document. The document primarily details regulatory compliance and safety testing concerning substantial equivalence.

However, I can extract information related to the performance testing that was conducted to support the substantial equivalence claim, which can be interpreted as demonstrating the device meets general safety and effectiveness requirements.

Acceptance Criteria and Reported Device Performance (General Safety and Effectiveness)

While explicit "acceptance criteria" in the format of specific clinical metrics are not provided, the document states performance testing was conducted to verify that the modifications did not raise "different questions of safety and effectiveness." The reported performance is that the device conforms to relevant safety and performance standards.

Information Not Available in the Document:

1. Sample size used for the test set and the data provenance: The document does not describe a clinical "test set" with patient data or its provenance for demonstrating the device's clinical efficacy against specific acceptance criteria.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed clinical testing with expert-established ground truth is not described.
3. Adjudication method for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser system, not an AI-assisted diagnostic tool for human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: Not explicitly stated beyond conformance to engineering and safety standards. There is no mention of expert consensus, pathology, or outcomes data for a clinical ground truth.
7. The sample size for the training set: Not applicable, as this is a laser and not a machine learning algorithm.
8. How the ground truth for the training set was established: Not applicable.

Summary of Study Described:

The study referenced in the document is a regulatory "performance testing" conducted internally by Lumenis to demonstrate that the modifications (adding 1060nm handpieces) to the LightSheer Desire and LightSheer Desire Light Systems, and other system modifications, do not raise new questions of safety or effectiveness. This testing primarily involved:

• Risk Analysis: Performed according to ISO 14971.
• Electrical and Laser Safety and Electromagnetic Compatibility (EMC) Testing: Conformance to international standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22).
• Software Verification and Validation: Ensured the software functions as intended and meets requirements.

The document asserts that based on these activities, the device is "substantially equivalent" to its legally marketed predicates. This type of submission relies on demonstrating that the new device or modification is as safe and effective as a predicate device, rather than proving a set of specific clinical performance claims with clinical trials against acceptance criteria.

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The subject Lumenis M22 System has connection capability with the following available treatment handpieces, for multiapplication treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows:
The Intense Pulsed Light (IPL) handpiece with a spectrum of 400-1200nm (with 10 different filters) is indicated for:

• Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos
• Cutaneous lesions, including warts, scars and striae
• Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, poikiloderma of Civatte, leg veins and venous malformations
• Removal of unwanted hair from all skin types, and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
• Mild to moderate inflammatory Acne (Acne vulgaris)
  The Nd:YAG Laser handpiece with a wavelength of 1064 nm (Multi-Spot Nd:YAG) is indicated for:
• The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias) and reticular veins (0.1 - 4.0 mm. diameter) of the leg
• The removal of unwanted hair from all skin types, and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
• The non-ablative treatment of facial wrinkles
  ResurFX module and handpiece. with wavelength of 1565 nm. is indicated for:
• Use in dermatological procedures requiring fractional skin resurfacing and coaqulation of soft tissue
  The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064nm is indicated for:
• Removal of dark tattoos
• Treatment of pigmented lesions
  *Note Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
  The ResurFX System with wavelength of 1565 nm. is indicated for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

The subject Lumenis M22 System is a multi-application, multi-technology platform with four (4) available treatment handpieces:

• Universal Intense Pulsed Light (IPL) handpiece:
• Multi-Spot Nd:YAG laser handpiece;
• ResurFX non-ablative laser handpiece;
• Q-Switched Nd:YAG laser handpiece.
  The following accessories are provided with and/or may be purchased independently for each of the four (4) available treatment handpieces of the M22 System:
• The Universal IPL handpiece has ten (10) different filters available: Cut-off filters of 515, 560, 590,615, 640, 695 and 755 nm, Notch Filters of 400-600 & 800-1200 nm and 530-650 & 900-1200 nm, and a Narrow band filter of 525-585 nm. Further, the IPL handpiece has three (3) sapphire cool light guides available with sizes of: 15mm x 35mm, 8mm x 15 mm, 6mm diameter.
• The Multi-Spot Nd:YAG handpiece has four (4) different light guides/tips available in sizes of: 2mm x 4mm, 6 mm, 9 mm and 1.5 mm.
• The ResurFX handpiece has two (2) different treatment tips available: SapphireCool and Precision tips.
• The Q-Switched Nd: YAG handpiece has both disposable and gold plated metal treatment tips available. The disposable treatment tips are available in four (4) different sizes of: 2, 2.5, 3.5, and 5 mm. The metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.

The ResurFX System is an advanced computer-controlled laser emission system operating at a wavelength of 1565 nm, and is intended for Fractional Non-Ablative Skin Resurfacing application when using a dedicated handpiece.
The following accessories are provided with and/or may be purchased independently for the ResurFX System:

• Two (2) different treatment tips: SapphireCool and Precision tips.
• Footswitch.

The provided document is a 510(k) summary for the Lumenis M22 and ResurFX Systems, which are laser surgical instruments. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria through studies involving human-in-the-loop or standalone algorithm performance.

Therefore, many of the requested details about acceptance criteria, study types, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory document. This document details engineering and performance bench testing to ensure the modified device functions as intended and safely, similar to its predicate.

Here's an analysis of the information that can be extracted from the document:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present a table of specific clinical acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy for a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implied by the performance bench testing ensuring the device meets safety and operational standards and functions as intended, similar to the predicate devices. The "reported device performance" is essentially that it passed these engineering and safety tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) for a device modification, focusing on engineering verification and validation (V&V) and safety testing. There is no "test set" in the context of clinical data for an AI algorithm. The V&V activities involve testing the physical device and its components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No "ground truth" was established by clinical experts for a test set, as this is not a study of an AI or diagnostic device's clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication was used.

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

Not applicable. This document is not about an AI-assisted diagnostic device, but rather a laser surgical instrument. Therefore, no MRMC study was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not have a standalone algorithm in the sense of a diagnostic or image interpretation AI. Its "standalone" characteristic refers to the ResurFX system being made available as a separate unit rather than just a module of the M22. This is a hardware device for treatment, not an algorithm for analysis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The ground truth for this device's performance is its physical and electrical specifications, and its ability to function safely and effectively within those parameters as demonstrated by engineering bench testing and compliance with recognized standards.

8. The 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.

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The Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories (VersaPulse PowerSuite, Lumenis Pulse 30H, Lumenis Pulse 50H, Lumenis Pulse 60H, Lumenis Pulse 100H and Lumenis Pulse 120H) are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery.

The Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories are indicated for use in the performance of specific surqical applications as follows:

Urology
. Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser enucleation of the prostate (HoLEP), holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH)
. Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of:
o bladder;
O superficial and invasive bladder, urethral and ureteral tumors;
O condvlomas:
O lesions of external genitalia;
O ureteral and penile hemangioma;
O ureteral strictures;
O bladder neck obstructions
● Urinary Lithotripsy including:
o endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones;
o treatment of distal impacted fragments of steinstrasse when quide wires cannot be passed.

Arthroscopy
. Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including:
o meniscectomy:
o plica removal;
O ligament and tendon release;
O contouring and sculpting of articular surfaces;
O debridement of inflamed synovial tissue (synovectomy);
O loose body debridement;
O chondromalacia and tears;
O lateral retinecular release;
O capsulectomy in the knee;
O chondroplasty in the knee;
O chondrornalacia ablation.
. Discectorny including:
o percutaneous vaporization of the L4-5 and LS-SI lumbar discs of the vertebral spine; open and arthroscopic spine procedures; foraminotomy.

General Surgery
● Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including:
o cholecystectomy;
o lysis of adhesions;
O appendectomy;
O biopsy, pylorostenotomy, and removal of polyps of the sigmoid colon;
O skin incision:
O tissue dissection;
O excision of external tumors and lesions;
O complete or partial resection of internal organs, tumors and lesions;
O mastectomy;
O hepatectomy;
O pancreatectomy;
O splenectomy;
O thyroidectomy;
O parathyroidectomy;
O herniorrhaphy;
O tonsillectomy;
O lymphadenectomy;
O partial nephrectomy;
O epilonidal cystectomy;
O resection of lipoma;
O debridement of decubitus ulcer;
O hemorrhoids;
O debridement of statis ulcer;
o biopsy.

ENT Surgery
● Endoscopic endonasal/ sinus surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including:
o partial turbinectomy;
o ethmoidectomy;
o polypectomy;
o maxillary antrostomy;
o frontal sinusotomy;
o sphenoidotomy;
O dacryocystorhinostomy (DCR);
O functional endoscopic sinus surgery (FESS).

Gynecological Surgery
● Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue).

Gastroenterology Surgery
● Open and endoscopic gastroenterology surgery (ablation, vaporization, incision, excision, resection, coagulation and hemostasis, including:
o gall bladder calculi;
o Biliary /bile duct calculi;
o benign and malignant neoplasm;
o polyps;
o colitis;
O ulcers;
O angiodysplasia;
O hemorrhoids;
O varices;
o esophaqitis:
O esophageal ulcer;
O Mallory-Weiss tear;
O gastric ulcer;
O duodenal ulcer;
o non-bleeding ulcer;
O gastric erosions;
O colorectal cancer;
O gastritis;
O bleeding tumors;
O pancreatitis;
o vascular malformations;
O telangiectasia;
O telangiectasia of the Osler-Weber-Renu disease.

Pulmonary Surgery
● Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and coagulation of soft tissue.

Dermatology and plastic surgery
. Incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft, mucosal, fatty and cartilaginous tissues, in therapeutic plastic, dermatologic and aesthetic surgical procedures, including:
o scars;
O tattoo removal;
O vascular lesions;
O port wine stains;
O hemangioma;
O telangiectasia of the face and leg;
O rosacea;
O corns;
O papilloma;
O basal cell carcinomas;
O lesions of skin and subcutaneous tissue;
O plantar warts:
O periungual and subungual warts;
O debridement of decubitus ulcer;
O skin tag vaporization.

The Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories (also referred to as 'Lumenis Family of Holmium Surgical Lasers'), subject of this submission, is a family of single wavelength holmium (Ho:YAG) lasers manufactured by Lumenis Ltd. The family is composed of two main series; the VersaPulse PowerSuite series (VPPS) which includes the VersaPulse PowerSuite 20W, VersaPulse PowerSuite 30W, VersaPulse PowerSuite 45W, VersaPulse PowerSuite 60W, VersaPulse PowerSuite 80W and VersaPulse PowerSuite 100W, cleared under K011703, together with the VersaPulse P20 cleared under K100228, and the modern Lumenis Pulse series which includes the recently cleared Lumenis Pulse 120H system (K140388) and further expanded with the addition of the Lumenis Pulse 30H, Lumenis Pulse 50H, Lumenis Pulse 60H and Lumenis Pulse 100H, subjects of this submission.

The modifications to the subject Lumenis Family of Holmium Surgical Lasers include addition of modernized family members as well as updates to existing systems.

Mainly, the subject additional devices are basically similar to the previously cleared Lumenis Pulse 120H (LP120H, recently cleared under K140388). The modified Lumenis Pulse 30H, Lumenis Pulse 50H, Lumenis Pulse 60H and Lumenis Pulse 100H systems rely on the same fundamental underlying technology of the cited predicate systems with the laser power outputs similar to the previously cleared configurations of the VersaPulse PowerSuite series cleared under K011703. The subject device modifications involve both hardware (HW) and software (SW) elements, whereas the functional capabilities of the laser systems remain unaltered in both the modified and cleared systems. The Lumenis Lumenis Pulse 60H and 120H are provided with the Moses Mode, based on the wellknown Moses Effect, which limits the attenuation of holmium laser energy in the liquid environment, thus reducing dependency of the fiber positioning (i.e. distance) in respect to the target tissue. All other characteristics of the laser emission are maintained identical as in the cleared Regular Mode.

All of the modified Lumenis Family of Holmium Surgical Lasers are solid state Single Wavelength (Holmium) surgical laser, comprised of the following functional components:

• Laser Console
• Dual or single pedal Footswitch
• Variety of Fiber Optic Delivery Devices (fibers) and accessories
• An integrated suction pump and accessories (Lumenis Pulse 120H and Lumenis Pulse 60H)

The systems are operated and controlled via proprietary SW. The SW comprises embedded SW in the main and peripheral processors, and Graphical User Interface (GUI) application running on a Personnel Computer (PC).

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics against those criteria. Therefore, much of the requested information regarding acceptance criteria and performance study specifics (like sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, specific ground truth types) is not typically included or required in this type of submission.

However, I can extract the information that is present and explain why some of the requested details are not available in this document.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a formal table of acceptance criteria and reported device performance in the way one might expect from a clinical trial or algorithm validation study for a new device claiming novel functionality. Instead, the submission focuses on demonstrating that the modified device remains as safe and effective as its predicate.

The "acceptance criteria" here are implicitly related to compliance with various medical device standards and the demonstration that the modifications do not raise new questions of safety or efficacy compared to the predicate. The "reported device performance" is largely described qualitatively as performing "in accordance with its requirements and specifications, in similarity to its predicate family."

• Compliance with electrical and laser safety standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1)
• Biocompatibility in compliance with ISO 10993-1:2009/(R)2013
• Sterilization validation in compliance with ISO 11135 2nd ed.: 2014
• Moses Mode: Ex-vivo and in-vivo setups demonstrated comparable tissue response and similar thermally coagulated zones, indicating no new issues of safety as compared to the Regular Mode. |
  | Effectiveness/Performance | - Software verification and validations in compliance with FDA Guidance for Premarket Submissions for Software Contained in Medical Devices (2005) verified performance according to specifications.
• The device performs "in accordance with its requirements and specifications, in similarity to its predicate family."
• The Moses Mode enhancement "does not raise different questions of safety and efficacy, rather facilitates the physician by reducing the dependency of the fiber distance from the target tissue." |
  | Substantial Equivalence | - Intended use and indications for use are identical to the predicate device.
• Same technological characteristics and principles of operation apply.
• Modifications (addition of new family members, updates to existing systems, Moses Mode) do not raise different questions of safety and efficacy. |

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable as this is not a study validating an algorithm against a specific test set. The performance testing refers to engineering tests, safety compliance tests, and a limited ex-vivo/in-vivo comparison to show the Moses Mode does not introduce new risks.

• Test Set Sample Size: Not specified as it's not a study in that context. The "ex-vivo and in-vivo set ups" for the Moses Mode comparison would involve biological samples, but their number is not detailed.
• Data Provenance: Not specified. Standard engineering and biological testing would typically be conducted at the manufacturer's facilities or accredited labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study that uses expert-established ground truth on a test set (e.g., for diagnostic accuracy). The "ground truth" for the performance testing is based on engineering specifications, regulatory standards, and observed tissue responses in scientific experiments.

4. Adjudication Method for the Test Set

Not applicable, as there is no test set that requires expert adjudication in the context of this submission.

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

Not applicable. This device is a surgical laser, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are not relevant here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (surgical laser), not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established scientific and engineering principles, and regulatory standards against which the device's performance and safety are assessed.

• For Safety: Compliance with specific ISO and IEC standards for medical electrical equipment, laser safety, risk management, biocompatibility, and sterilization.
• For Performance (Moses Mode): Comparison of "thermally coagulated zones" and "tissue response" in ex-vivo and in-vivo setups against the predicate device's "Regular Mode," implying a scientific observation and measurement of biological effects.
• For Software: Verification and validation against software specifications and FDA guidance.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. It is a hardware and software system designed to perform specific physical functions.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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