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

• IPL with a spectrum of 400-1200nm (with different filters) is indicated for:

  • Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles).
  • 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 and spider 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).

• Multi-Spot Nd:YAG Laser, with a wavelength of 1064 nm is indicated for:

  • The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg.
  • The non-ablative treatment of facial wrinkles.
  • 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 1565nm ResurFX module, with a wavelength of 1565 nm, is indicated for:

  • Use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

• Q-Switched Nd:YAG Laser, with a wavelength of 1064 nm, is indicated for:

  • Treatment of pigmented lesions.
  • Removal of dark tattoos.

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

The Lumenis Stellar M22 System is multi-application, multi-technology system intended for use in aesthetic dermatologic procedures.

The Stellar M22 System operates with four (4) treatment handpieces options (for connection capability), within serial operational mode:

• Intense Pulsed Light (IPL) handpiece;
• Multi-Spot Nd:YAG Laser handpiece;
• ResurFX Laser module and 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 530650& 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 are available in four (4) different sizes of: 2, 2.5, 3.5, and 5 mm, while the metal treatment tips are available in seven (7) different sizes of: 2, 2.5, 3.5, 4, 5, 6 and 8 mm.

This FDA 510(k) clearance letter for the Stellar M22 device does not contain any information about acceptance criteria or a study proving the device meets said criteria for an AI/algorithm-driven component.

The document explicitly states:

• "No new clinical validation was required to support the Stellar M22 as the clinical validation of the Lumenis predicate device also applies to the subject device." This indicates that no new clinical study was performed for this specific submission to demonstrate performance.
• The modifications described are "mainly due to the addition of new Hardware to serve marketing, business and serviced purposes," and "to maintain Lumenis' high-level service capabilities to the professional end-users and their patients, through establishment of a secure transmission of technical information to the cloud for further analysis and rapid problem-solving." This strongly suggests the changes are related to connectivity and serviceability, not a new AI/algorithm feature requiring performance validation.

Therefore, I cannot provide the requested information from the provided text. The document describes a device modification for an existing system (Stellar M22) and asserts substantial equivalence to its predicate based on the fact that the changes are primarily hardware upgrades for service and marketing, and the clinical validation of the predicate device is considered applicable.

There is no mention of any AI component, performance criteria for such a component, or a study validating its performance in this submission.

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The FoLix System, with wavelength of 1565 mm. is indicated for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV who are seeking treatment for hair loss.

The FoLix™ is a laser system intended to be used for improving the appearance of scalp hair in adult males and females with Fitzpatrick skin type I to IV seeking treatment for hair loss, as well as, for the identical set of functions as the predicate device. The FoLix™ laser system with a wavelength of 1565 nm and consists of the following:

• The laser console includes a power supply unit, a Laser module (+ aiming beam), a control ● unit and a PC module. The laser beam is transferred to the handpiece via fiber optics.
• The handpiece includes a scanner module built of two mirrors that are controlled by two ● motors directing the Laser beam to desired target tissue.
• The handpiece uses a tip to align the Laser beam focus with the target tissue, enabling a . treatment shape size and a thermo-electric cooler (TEC).
  The FoLix™ is intended for professional use only.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for the FoLix System, which is a laser system intended for improving the appearance of scalp hair.

The 510(k) summary primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (F65 Laser System, K222790). This means the manufacturer is asserting that the new device is as safe and effective as the predicate device, not necessarily that it meets specific, independently established performance criteria through a new clinical study.

Here's what the document does state regarding validation:

• Summary of Bench Verification: This includes risk analysis (ISO 14971), electrical, laser, and electromagnetic compatibility safety testing (IEC 60601-1 and IEC 60601-1-2), software verification and validation (IEC 62304 and FDA Guidance "Principles of Software Validation"), system testing, and usability assessment (FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices", IEC 62366-1 and IEC 60601-1-6). These are standard engineering and safety tests, not clinical performance acceptance criteria.
• Summary of Clinical Validation: It explicitly states, "No new clinical validation was required to support the FoLix as the clinical validation of the Lumenis predicate device also applies to the subject device." This indicates that any clinical performance claims are based on the predicate device's data, not a new study for the FoLix system with specific acceptance criteria.

Therefore, I cannot provide the requested table or details about a study proving the device meets acceptance criteria because:

1. No Acceptance Criteria are Quantitatively Defined: The document does not list specific, measurable acceptance criteria for device performance (e.g., a certain percentage improvement in hair appearance, specific accuracy/sensitivity/specificity metrics).
2. No New Performance Study Presented: The document explicitly states that no new clinical validation was required. It relies on the clinical validation of its predicate device, of which no details are provided in this text.

To answer your request, information regarding the predicate device's clinical validation, including its acceptance criteria and study details, would be necessary. This document focuses on demonstrating that the FoLix system is substantially equivalent to that predicate, given its modifications (removal of handpieces, minor hardware/software changes).

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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 subject F65 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:

• o Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles)
• o Cutaneous lesions, including warts, scars and striae
• o Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
• o Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
• o 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:

• o The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg
• o The removal of unwanted hair and to effect table long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles
• o The non-ablative treatment of facial wrinkles

The F65 module and handpiece, with wavelength of 1565 nm, are indicated for:

• o Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue
• o Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV who are seeking treatment for hair loss.

The Q-Switched Nd:YAG Laser Handpiece with a wavelength of 1064 nm is indicated for:
o Removal of dark tattoos
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 Lumenis Be F65 Laser System is intended to be used for the new indication for Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV seeking treatment for hair loss, as well as, for the identical set of functions as the predicate device. The description here is limited to the system module required to support the new indication which is the subject of this 510(k):

• The laser console includes a power supply unit, a Laser module (+ aiming beam), a control unit and a PC module. The laser beam is transferred to the handpiece via fiber optics.
• . The handpiece includes a scanner module – built of two mirrors that are controlled by two motors directing the Laser beam to desired target tissue.
• . The handpiece uses a tip (user may choose from two types) to align the Laser beam focus with the target tissue, enabling a treatment shape size and a tip thermo-electric cooler (TEC).

The F65 is intended for professional use only.

The provided FDA 510(k) summary only describes the clinical studies for the F65 module and handpiece with 1565 nm wavelength, specifically for the new indication of "Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV who are seeking treatment for hair loss." It does not provide detailed acceptance criteria and performance data for all the device's indications, nor does it present the information in a clear table format for acceptance criteria vs. device performance.

Based on the information provided for the 1565nm module and its new indication:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new indication ("Improving the appearance of scalp hair in adult males with Fitzpatrick skin type I to IV who are seeking treatment for hair loss") are implicitly derived from the study results presented in the document. The document states a primary efficacy endpoint of "demonstrating improvement in more than 70% of subjects" for the retrospective study.

2. Sample Sizes and Data Provenance

• Preclinical Study (Animal Testing): Sample size for the preclinical study is not specified, only that it "was conducted to evaluate the Lumenis F65 subject module for hair follicle regeneration capabilities using both Low Level Laser Therapy (LLLT) and untreated controls."
• Clinical Studies:
  • Prospective, Single Arm Study:
    • Sample Size: 32 subjects enrolled, 25 completed.
    • Diagnosis Breakdown: 18 with Androgenic Alopecia, 7 with other diagnoses (evaluated separately).
    • Hair Count Data: 5 male subjects with androgenic alopecia, 18 female subjects with androgenic alopecia.
    • Data Provenance: Not explicitly stated, but clinical studies are generally prospective. No country of origin is mentioned.
  • Retrospective, Single Arm Study:
    • Sample Size: 98 subjects evaluated for performance.
    • Diagnosis Breakdown: 44 with confirmed Androgenic Alopecia, 54 with no documented diagnosis (presumably hair loss but not specifically diagnosed as androgenic alopecia).
    • Data Provenance: Retrospective. No country of origin is mentioned.

3. Number of Experts and Qualifications for Ground Truth

• Retrospective Study: "a group of 3 blinded reviewers" were used for the assessment of improvement in scalp hair appearance.
• Qualifications of Experts: The specific qualifications (e.g., dermatologist, years of experience) of these 3 blinded reviewers are not specified in the provided document. They are only referred to as "reviewers."

4. Adjudication Method for the Test Set

• For the retrospective study, where 3 blinded reviewers assessed improvement, the adjudication method is not explicitly stated. It's mentioned they "yielded a correct identification" in a certain percentage of cases. This implies either:
  • All 3 reviewers had to agree (unlikely for such high percentages given typical inter-reader variability without prior agreement).
  • A majority vote (2 out of 3) was used.
  • One expert's assessment was deemed primary, or they collectively discussed and reached a consensus.
    The document does not detail the process.

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

• No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done comparing human readers with AI assistance vs. without AI assistance.
• The studies described are for the device's direct effect on hair growth, not for evaluating human reader performance with or without an AI. The "blinded reviewers" in the retrospective study were assessing the clinical outcome (improvement in scalp hair appearance), not the performance of an AI algorithm.

6. Standalone (Algorithm Only) Performance

• This document describes a medical device (laser system) that directly treats patients, not an AI algorithm. Therefore, there was no standalone (algorithm only) performance study as it's not an AI device. The "performance" refers to the clinical outcome achieved by the laser system.

7. Type of Ground Truth Used

• For the clinical studies, particularly the retrospective study, the "ground truth" for showing improvement in scalp hair appearance was established by expert consensus/review (3 blinded reviewers).
• For the prospective study, quantifiable metrics like mean increase in hair count per cm² from baseline were reported, which can be considered objective outcomes data.

8. Sample Size for the Training Set

• This document describes physical medical device studies (laser system) for a 510(k) submission, not an AI model requiring a training set. Therefore, there is no concept of a "training set" in the context of this submission. The "training" here refers to the device's design and manufacturing through engineering principles and prior knowledge, not machine learning.

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

• As there is no AI model or "training set" in the context of this device submission, this question is not applicable.

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· Selecta Duet LED or Digital Duet: Photodisruption of ocular tissue using light energy emitted by a Nd: Y AG laser, including discission of the posterior capsule of the eye (posterior capsulotomy) iridectorny, and selective laser trabeculoplasty.

· Selecta LED Trio or Digital Trio: Photodisruption of ocular tissue using light energy emitted by a Nd: Y AG laser, including discission of the posterior capsule of the eye (posterior capsulotomy) iridectorny, selective laser trabeculoplasty, and retinal photocoagulation.

The Selecta Duet LED and Digital Duet subject devices are each a fully integrated, highperformance diagnostic slit lamp and therapeutic laser delivery system. The diagnostic slit lamp is for examining the anterior segment of the eye, from the corneal epithelium to the posterior capsule. The integrated Nd:YAG Q-Switch laser module provides short pulses at the wavelength corresponding with the selected operating mode. Two modes are available: PD (YAG) mode: 1064 nm for photodisruption (PD) of ocular tissues in procedures such as posterior capsulotomy, iridotomy, and iridectomy, and SLT mode: 532 nm for Selective Laser Trabeculoplasty (SLT). The Selecta LED Trio and Digital Trio subject devices are each created by connecting the Selecta LED Duet and Digital Duet, respectively, to a compatible, FDA-cleared, Lumenis continuous 532 nm wavelength photocoagulator laser, via the LaserLink S. When the user connects the Duet to the LaserLink S, the Duet-part acts only as a Slit Lamp since the integrated Duet-laser is disabled and the laser in the external photocoagulator takes over. This combination adds the ability to perform retinal photocoagulation, as well as other indications cleared for the continuous 532 nm wavelength photocoagulator laser. The user disconnects the Duet from the LaserLink S for the system to perform as a Duet.

The provided text is an FDA 510(k) summary for the Lumenis Selecta Duet LED, Digital Duet, Selecta LED Trio, and Digital Trio Laser Systems. It describes the device, its intended use, and a comparison to a predicate device, concluding with performance testing.

However, the document does not contain the kind of detailed information about acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), or training set information that would be typically found in a clinical study report for an AI/ML-based medical device.

The "Performance Testing" section primarily refers to compliance with standards for medical electrical equipment and laser safety, and software verification. It states:

• "Evaluating the implemented changes using the same recognized standards that were used for the cleared devices" (listed standards like ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 15004-2, ISO 14971).
• "Software/Bench Testing" stating that "Lumenis developed and verified the software in accordance with a major level of concern described in the FDA 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' and also per the IEC 62304:2006 and A1:2015 Medical Device Software - Software Life Cycle Processes standard." and "The software/bench tests conducted on the modifications confirmed that they met their requirements."

This document describes a device that is essentially a hardware update and software refresh of a previously cleared laser system, not a novel AI/ML diagnostic or assistive algorithm for which the requested detailed study information would be relevant. The changes are described as "primarily to be responsive to user feedback, upgrade to the latest user interface, or reflect a need to change a supplier or manufacturing contractor."

Therefore, I cannot extract the requested information from this document because it does not appear to describe a study proving an AI/ML device meets acceptance criteria through clinical performance metrics. The phrase "device meets the acceptance criteria" in this context refers to meeting engineering/safety/performance standards for a laser system, not the kind of AI/ML performance metrics typically seen for diagnostic algorithms.

In summary, based on the provided text, the requested information (performance study details for an AI/ML device) is not available. The document focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized technical standards and software verification, rather than clinical performance trials of a new diagnostic AI/ML algorithm.

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The YandR System, handpiece and accessories are intended for dermatological procedures requiring the coagulation of soft tissue as follows:

1410 nm Indications for Use:

• Fractional skin resurfacing procedures
  1927 nm Indications for Use
• Fractional skin resurfacing procedures
  LPTT (Polytherapy) application of 1410 nm and 1927 nm simultaneously
• Fractional skin resurfacing procedures

The Lumenis YandR Laser System consists of:

• System console (contains the laser diodes, the system software, power supply, and various other electronic and mechanical parts)
• Operator control panel with touch-screen technology (GUI)
• NAFR handpiece and single-use removable tips
• Footswitch and other laser safety accessories

The non-ablative fractional NAFR handpiece emits two wavelengths - 1410nm and 1927nm. The 1410nm and 1927nm laser diode modules are located in the console and are coupled into the single handpiece via fiber optics. Through the GUI screen on the system console, the user can select either fractional wavelength, or a combination of both.

The Lumenis Y&R Laser System is intended for fractional skin resurfacing procedures using 1410 nm, 1927 nm, or a combination of both wavelengths (LPTT mode).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity) that a diagnostic or AI device would typically have. Instead, the "acceptance criteria" are implied through the successful demonstration of:

• Safety and effectiveness comparable to predicate devices.
• Expected wound healing responses.
• Compliance with relevant standards and regulatory requirements.

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

• Sample Size: Three (3) female Yorkshire Cross crossbred swine were used for the histology study.
• Data Provenance: The study was conducted by Lumenis Inc. (the manufacturer), and the results were provided to the FDA. The country of origin for the data is not explicitly stated, but as Lumenis Inc. is based in Salt Lake City, UT, USA, and the submission is to the FDA, it is likely the study was conducted in the USA or under protocols recognized by a US-based manufacturer. The study was prospective in the sense that animals were treated and then observed over time.

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

The document does not explicitly state the number or qualifications of experts used for establishing "ground truth" for the histology study. The histopathology analysis was performed, but who specifically read the slides or confirmed the findings (e.g., a board-certified veterinary pathologist) is not detailed.

4. Adjudication method for the test set

The document does not describe an adjudication method for the histopathology findings in the context of multiple readers. The analysis seems to be presented as a single set of conclusions from the study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The study conducted was a histology study on porcine animals to assess wound healing and tissue response, not a human reader performance study.

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

This device is a laser system for medical procedures, not an AI/algorithm-only diagnostic or analytical tool. Therefore, the concept of a "standalone" algorithm performance study (without human-in-the-loop) is not applicable here.

7. The type of ground truth used

The ground truth for the study was based on histopathology analysis of skin tissue samples from the treated porcine animals, examined at different time points post-treatment (0, 1, 7, and 14 days). This involved examining the microscopic structure of the tissue, including re-epithelization, and confirming the non-ablative nature of the device.

8. The sample size for the training set

This device is not an AI/machine learning algorithm requiring a separate training set. The study describes device validation, not algorithm training. Therefore, there is no "training set sample size" in this context.

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

As there is no training set for an AI algorithm, this question is not applicable.

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The UltraPulse Alpha CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) are 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 , gynecology, general and oral surgery, dental and oral surgery and genitourinary surgery as follows:

The UltraPulse SurgiTouch and UltraPulse Encore CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) are indicated for use in surgical or aesthetic applications requiring: ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including: 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:

The Lumenis Be Family of UltraPulse CO2 Surgical and Aesthetic Laser Systems, Delivery Devices and Accessories (subject devices) consist of the following devices:

Laser Systems

• o UltraPulse Alpha (also written as UltraPulse α)
• UltraPulse Encore o
• UltraPulse SurgiTouch o

Delivery Devices and Accessories

• o DeepFX Microscanner and disposable tips
• UltraScan CPG Microscanner o
• o TrueSpot 2.0 mm Collimated Handpiece
• o 0.2 mm and 1.0 mm Focused Incisional Handpieces (also called Standard Handpieces)

Each UltraPulse laser system is an advanced computer-controlled device with RF - modulated CO2 laser tube technology that emits laser beams at a wavelength of 10,600 or 11,100 nm. Each has an additional diode laser in the red visible spectrum emitting along the same optical path as the CO2 to serve as an aiming beam.

Attached to each laser system are the delivery devices and accessories that direct the laser beams to the intended treatment site in the format as selected by the user.

This document is a 510(k) premarket notification decision letter from the FDA regarding a CO2 Laser System for surgical and aesthetic applications. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.

The document states:

• "For the labeling changes described in the 510(k), no testing was required." (Page 12)
• The entire submission is focused on "labeling changes" and a new manufacturer name, not performance evaluation of a new or modified device functionality that would require clinical or technical studies demonstrating performance metrics.
• The device being cleared is a traditional medical laser system, not an AI or algorithm-based device. Therefore, the concepts of "ground truth," "expert consensus," "training set," "test set," "MRMC study," and "human readers improve with AI assistance" are not applicable to this document.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size, expert information, adjudication methods, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) from the provided text. The document pertains to a regulatory clearance based on substantial equivalence for a non-AI device with labeling changes, not a performance study for an AI-enabled device.

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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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