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CO2 Laser System is used for human tissue vaporization, coagulation in dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

CO2 Laser System is a laser beam generated by electrically excited carbon dioxide gas molecules, which has a very small divergence angle and high energy density. After focusing, it can reach a power of several kilowatts per square centimeter for vaporization. The unfocused original light beam irradiates the lesion tissue, which can cause coagulation of biological tissue. The CO2 laser penetrates the tissue deeper, and after irradiation, it can heat and treat the deep tissue.

This 510(k) clearance letter is for a CO2 Laser System (CO2 Laser SST-L23), a physical medical device, not an AI/ML-driven software device. The provided text outlines the substantial equivalence claims based on technical specifications and safety standards, rather than performance metrics from a clinical study involving AI. Therefore, most of the requested information regarding acceptance criteria for AI performance, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not applicable to this device and its clearance process.

The clearance relies on demonstrating that the device is substantially equivalent to a predicate device (K200042) in terms of its intended use, design, performance characteristics (e.g., maximum power, wavelength), and safety standards.

Here's a breakdown of the relevant information provided in the document:

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

For a physical device like a CO2 Laser, acceptance criteria are typically compliance with industry standards, performance specifications matching or being equivalent to a predicate device, and safety. The reported device performance is presented as a direct comparison to the predicate.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is described as Non-Clinical Testing.

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

• Sample Size: Not applicable in the context of an AI/ML test set. The evaluation is based on engineering specifications and compliance with standards.
• Data Provenance: Not applicable for a non-AI hardware device that relies on engineering testing and comparison to predicate specifications.

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

• Not applicable as this is a physical laser device, not an AI system requiring ground truth from experts for diagnostic or similar performance. The "ground truth" here is compliance with engineering standards and performance specifications.

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

• Not applicable.

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 a diagnostic AI tool that would assist human readers.

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

• Not applicable. This is not an algorithm, but a physical device. Its performance is evaluated intrinsically against its specifications and safety standards.

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

• Not applicable in the context of AI. The "ground truth" for this device's performance relies on engineering measurements, material properties, electrical safety tests, laser safety tests, and biological compatibility tests, all benchmarked against established international standards (e.g., IEC, ISO). The comparison to the predicate device serves as the primary "ground truth" for substantial equivalence.

8. The sample size for the training set

• Not applicable. This device does not use a training set as it is not an AI/ML system.

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

• Not applicable.

Summary of the Evaluation and "Study":

The "study" proving the device meets acceptance criteria is a series of non-clinical tests (engineering tests) and a comparison study to a legally marketed predicate device (K200042).

• Non-Clinical Tests Conducted:
  • Electrical Safety: Compliance with IEC 60601-1 (Edition 3.2 2020-08)
  • Laser Safety: Compliance with IEC 60825-1:2014 and IEC 60601-2-22:2012
  • Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 (Edition 4.1 2020-09)
  • Biocompatibility (if applicable to contact parts): Compliance with ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation), and ISO 10993-5 (in vitro cytotoxicity).
• Predicate Comparison: The performance and safety characteristics of the proposed device are directly compared feature-by-feature to the cleared predicate device. Differences (e.g., cooling system, dimensions, weight) are analyzed to ensure they do not negatively affect safety or effectiveness.

In conclusion, the clearance of the CO2 Laser System (CO2 Laser SST-L23) through K250183 is based on demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards for physical medical devices, not on data science criteria applicable to AI/ML systems.

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CO2 Laser System is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiaty, otolaryngology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The CO2 Laser System is a computer controlled radiofrequency (RF) excited carbon dioxide (CO2) laser system that delivers CO2 energy to the target treatment area at 10,600 nm. The CO2 Laser System is comprised of multiple components, including the control unit and handpieces. Laser is transmitted to the tissue via a series of lenses integrated into the articulated arm. The CO2 laser energy is absorbed by water in tissue to achieve its intended treatment effects.

The provided document is a 510(k) summary for a CO2 Laser System (Models: PureLase and VanLase). It describes the device, its indications for use, and a comparison to a predicate device to demonstrate substantial equivalence.

However, the document does not contain any information about acceptance criteria, device performance metrics (e.g., accuracy, sensitivity, specificity), sample sizes for testing or training, data provenance, expert ground truth establishment, or any kind of statistical study (like MRMC or standalone performance). It primarily lists the non-clinical tests performed to ensure the device meets design specifications and relevant safety/performance standards (e.g., IEC 60601 series, ISO 10993).

Therefore, I cannot provide the requested table and study details. The information about the study that proves the device meets the acceptance criteria is not present in this 510(k) summary. The document focuses on showing substantial equivalence based on technical specifications and adherence to safety/performance standards, not on clinical performance metrics typically associated with AI/software-as-a-medical-device (SaMD) clearances that often require clinical performance studies.

Here's what I can extract based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided. The document lists non-clinical tests (IEC standards, biocompatibility, software V&V, bench testing) but does not present specific quantitative acceptance criteria (e.g., accuracy > X%, sensitivity > Y%) or the results of such performance against a test set. This type of information is typically found in clearance documents for devices relying on diagnostic performance (like AI algorithms).

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

• Not provided. No information about a "test set" or "training set" of data (e.g., images, patient records) is mentioned. The tests conducted are primarily engineering and safety compliance tests, not clinical performance studies involving patient data.

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

• Not applicable/Not provided. Since there's no mention of a test set based on clinical data, there's no information about experts establishing ground truth for such data.

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

• Not applicable/Not provided.

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 provided. No MRMC study is mentioned. This device is a laser system, not an AI software intended to assist human readers in interpretation.

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

• Not applicable/Not provided. This is a hardware device, not a standalone algorithm.

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

• Not applicable/Not provided.

8. The sample size for the training set:

• Not provided.

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

• Not applicable/Not provided.

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The Modified ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) is indicated for use in surgical or aesthetic applications requiring:

ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including; dermatology and plastic surgery (aesthetic), podiatry, gyneoology, general and thoracic surgery, 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

Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of:

• · vulvar and vaginal intraepithelial neoplasia (VIN, VAIN)
• · Condyloma acuminata, including 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
• Benign and malignant tumors
• · Hemangiomas

General Surgery

• 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 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 Lumenis Be modified ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories when used in conjunction with FemTouch and FemX, is indicated for the vaporization, ablation and coagulation of body soft tissue in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, gynecology, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about the acceptance criteria, reported device performance, sample sizes, ground truth establishment, or any studies conducted to prove the device meets acceptance criteria. The document primarily focuses on the regulatory clearance process and the device's indications for use. Therefore, I cannot fulfill your request based on the given input.

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The CO2 Laser System is used for body soft tissue ablation, vaporization and coagulation in dermatology, plastic surgery and general surgery.

CO2 Laser System is a carbon dioxide surgical laser device intended for prescription use and is comprised mainly of three components: console, articulated arm and footswitch. CO2 Laser System contains a radio-frequency excited CO2 laser tube which generates laser sources at nominal wavelength of 10,600 nm. As CO2 laser radiation is invisible; therefore, a low-power, visible aiming laser source (650 mm) is required to position the treatment laser beam. The output of laser beam is delivered through articulated arm to a fractional handpiece or normal handpiece. The control panel is in the form of an LCD touch screen in front of device and displays for operating and monitoring the laser. The physician activates laser emission by means of a footswitch. The fractional handpiece is suited mainly for general surgical application.

This document is a 510(k) premarket notification for a CO2 Laser System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on clinical performance metrics. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission.

The "performance data" section primarily discusses non-clinical testing related to electrical safety, electromagnetic compatibility, laser safety standards, and software verification and validation. It does not provide clinical performance data or acceptance criteria in terms of accuracy, sensitivity, specificity, or similar metrics typically associated with AI/diagnostic device studies.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This submission describes non-clinical engineering and software testing of a physical laser device, not a study involving human subjects or data sets for performance evaluation of an AI or diagnostic algorithm.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No ground truth based on expert review of clinical data is mentioned. The "ground truth" here is compliance with engineering and safety standards.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudicated test set in the context of clinical or AI performance. The device's compliance is based on direct measurement and verification against established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not describe any MRMC comparative effectiveness study, as it's for a surgical laser device and not an AI or diagnostic tool where reader performance is typically evaluated.

6. If a Standalone Performance Study was done

Yes, in a sense, a standalone engineering performance assessment was done. The device's electrical safety, laser safety, electromagnetic compatibility, and software were independently tested against specified standards. However, this is not a "standalone (i.e., algorithm only without human-in-the-loop performance)" in the context of AI or diagnostic algorithms.

7. The Type of Ground Truth Used

The "ground truth" in this context is adherence to established international and national engineering standards for medical electrical equipment, laser safety, and electromagnetic compatibility. For software, the ground truth is adherence to FDA's guidance for software verification and validation. There is no clinical "ground truth" (e.g., pathology, outcomes data) mentioned in this regulatory submission.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set of data.

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

Not applicable.

Ask a specific question about this device

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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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.

Ask a specific question about this device

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 CO2 Laser System is used for human tissue vaporization, coagulation in dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

The device emits CO2 laser at the wavelength of 10.6um, which is the spectral line in the far infrared range. The device is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

This FDA 510(k) summary describes a CO2 Laser System by Beijing Superlaser Technology Co., Ltd. and seeks to demonstrate its substantial equivalence to a predicate device (K192528).

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

The document doesn't explicitly state "acceptance criteria" as a separate section with specific thresholds. Instead, the substantial equivalence is based on a comparison to a predicate device, showing that the proposed device performs "the same" or "similarly" across various specifications and complies with relevant safety standards.

Here's a table based on the "Performance Comparison" and "Safety Comparison" sections, with "Reported Device Performance" being the specifications of the Proposed Device and "Acceptance Criteria" being implicitly met if it's "SAME" or "SIMILAR" to the Predicate Device, or complies with established standards.

The study (non-clinical testing) states that "The test results demonstrated that the proposed device complies with the following standards" for safety and that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." This implicitly means the device meets the acceptance criteria of conforming to the predicate device's performance characteristics and a set of recognized electrical, EMC, and laser safety standards.

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

• Sample size for the test set: Not applicable. The document describes non-clinical bench testing and software validation, not a study with a "test set" of patient data or images.
• Data provenance: Not applicable, as there isn't patient data/images involved in this type of submission. The tests are bench tests performed in a laboratory setting by the manufacturer. The company is based in Beijing, China.

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 CO2 Laser System that performs surgical functions, not an AI/imaging device requiring expert consensus for ground truth on diagnostic interpretations. The "ground truth" for this device would be its physical performance specifications and adherence to safety standards, verified through engineering tests.

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

Not applicable, as there is no "test set" in the context of clinical or image-based studies requiring adjudication.

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, an MRMC comparative effectiveness study was not done. The device is a physical CO2 laser system, not an AI diagnostic tool that assists human readers.

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

Not applicable. This is not an AI algorithm. The device performance is assessed through its physical operation and compliance with engineering standards.

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

The "ground truth" for this device's performance and safety is established through:

• Engineering specifications and measurements: Comparing output power, wavelength, spot size, etc., against the predicate device's documented specifications.
• Compliance with recognized international standards: IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2 for electrical, EMC, and laser safety.
• Bench Performance Tests: These would involve direct measurements of the device's output and function.
• Software Validation & Verification Test: Ensuring the control system software operates correctly according to its design specifications.

8. The sample size for the training set:

Not applicable. There is no training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set.

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The equipment is used for human tissue vaporization in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing.

The subject device, CO2 Laser System (Model: GP900F) mainly consist of console, articulated arm and a foot switch. CO2 laser wavelength is 10600nm, which is used to gasify the skin tissue based on the principle of the theory selective photothermolysis. The water in skin absorbs laser energy and evaporates. By setting up the suitable energy and other parameters on skin tissue, the device can be used for human tissue vaporization and coagulation as well as for the treatment of wrinkles and skin resurfacing.

This document describes the CO2 Laser System (Model: GP900F) and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria, device performance metrics (e.g., accuracy, sensitivity, specificity), or a study designed to prove the device meets such criteria in terms of clinical effectiveness.

The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through comparisons of technological characteristics, safety standards, and non-clinical testing. This type of submission (510(k)) generally does not require clinical effectiveness studies in the same way a PMA (Premarket Approval) would.

Therefore, many of the requested details cannot be extracted from the provided text. I will answer the questions based on the information that is available.

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

Based on the provided text, specific acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity) and corresponding device performance metrics are not detailed. The acceptance criteria are implicit in the demonstration of substantial equivalence to predicate devices and compliance with safety and performance standards.

The "performance" described relates to adherence to safety standards and the ability to deliver set laser energy parameters within specifications, not clinical outcomes or diagnostic accuracy.

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