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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 Lumenis® Smart532™ Laser System is indicated for use in Ophthalmic Applications; Ear, Nose and Throat Applications; Dentistry; and Dermatologic Applications as follows:

Ophthalmology
Diabetic Retinopathy including Macular Edema or Proliferative Retinopathy Proliferative Diabetic Retinopathy (PDR) Retinal Tear Macular Edema or Proliferative Retinopathy associated with Central Retinal Vein Occlusion (CRVO) or Branch Retinal Vein Occlusion (BRVO) Choroidal Neovascularization (CNV) secondary to Age-related Macular Degeneration (AMD) Central Serous Chorioretinopathy (CSCR) Trabeculoplasty for Primary Open Angle Glaucoma (POAG) Iridotomy / Iridoplasty for Angle-Closure Glaucoma (ACG)

Ear, Nose and Throat (ENT) Stapedectomy Stapedotomy Myringotomies Lysis of Adhesions Control of Bleeding Removal of Acoustic Neuromas Soft Tissue Adhesion in Micro/Macro Otologic procedures

Dermatology Pigmented lesion, including soar lentigine Vascular lesions, including cherry hemangiomas and angiokeratomas Extremeties telangiectases, including facial and leg telangiectases Cutaneous lesions Flat warts Dermatosis Papulosa Nigra

Dentistry Frenectomy Treatment of oral mucous cyst Treatment of benign vascular lesions: Capillary hemangioma Hemorrhagic hereditary telangiectasia Capillary/cavernous hemangiomas Lymphangioma AV malformation of the tongue Hermaniolymphangiomas Photocoagulation of superficial vessels Vaporization of superficial blood or lymph containing vessels Treatment of superficial tongue lesions Tissue management and hemostasis for crown and bridge impressions Incision and drainage for abscess Gingivoplasty/Gingivectomy: Operative procedures Crown and bridge, gingival reduction Crown lengthening Hyperplasia (Drug, irritation, Epulus, ... ) Hemostasis during dental procedures Operculectomy (Operculotomy) Excisional biopsy Free Ginvical Graft (Adjunct): Hemostasis of donor site Hemostasis of graft site Vestibuloplasty Soften Gutta Percha Treatment of canker sores, herpetic lesions, and aphthous ulcers Laser-assisted bleaching/whitening

The subject Lumenis® Smart532™ Laser System product is a dual port, solid state, frequency doubled, green Nd:GdVO4 surgical laser instrument used in the photothermolysis (photocoagulation) of soft tissue at an operating emission wavelength of 532nm, a wavelength that has been used widely and effectively in the market for procedures in the fields of ophthalmology, ENT (ear, nose & throat), dermatology and dentistry.

Compatible delivery devices & accessories for use with the subject Lumenis® Smart532™ Laser System include: Slit lamps, Slit lamp adapters/attachments, Laser Indirect Ophthalmoscopes (LIO), Eye safety filters, Laser links, Array LaserLink, Selecta Trio, Fibers and Endo-ocular and Endo-Oto probes. The device software may be adjusted by Lumenis to fit customer needs within the system overall range of parameters.

This document is a 510(k) summary for the Lumenis® Smart532™ Laser System, seeking clearance from the FDA. It declares substantial equivalence to predicate devices, focusing on technical specifications rather than clinical study results demonstrating diagnostic or treatment accuracy. Therefore, information regarding acceptance criteria, study sample sizes (for test and training sets), expert consensus, ground truth establishment, MRMC studies, or standalone algorithm performance, which are typical for AI/ML device submissions, is not present in this document.

The document discusses performance data in a general sense, referring to engineering performance testing (electrical safety, EMC requirements, functional testing) to ensure the device meets design specifications and is substantially equivalent to predicates. It does not refer to clinical performance in terms of diagnostic effectiveness or AI accuracy metrics.

Here's a breakdown of what can be extracted and what cannot:

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

• Acceptance Criteria (Implicit): The primary acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing that the new device has "equivalent indications for use, safety compliance, similar design features, functional characteristics, fundamental technology features, technical applications, patient population, and general modes of operation."
• Reported Device Performance:
  • The document states that "Appropriate testing for the subject Smart532™ Laser System device, including safety, performance and functional testing, has been performed to determine substantial equivalence..."
  • Specifically, "electrical safety & EMC requirements per governing IEC 60601 3"-Edition Series, and side-by-side comparative performance assessment to the identified primary predicate Lumenis® Novus Spectra™ Laser System (K022327)" were performed.
  • It concludes that "all established testing criteria and product performance specifications have been met."
  • The "Device Comparison Table" on page 7 implicitly serves as a performance comparison, showing that key characteristics (wavelength, aiming beam, laser type, power input/output, operating mode, pulse duration, pulse/exposure interval) are either identical or similar with explanations for differences (e.g., SmartPulse vs. MicroPulse). However, this table does not present "acceptance criteria" in the traditional sense of numerical thresholds for clinical accuracy (e.g., sensitivity, specificity). It's a technical comparison for substantial equivalence.

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

• Not Applicable / Not Provided: This type of information (patient sample sizes for a test set) is typically relevant for studies validating diagnostic or predictive AI/ML algorithms. This submission is for a surgical laser system, and the "performance data" refers to engineering and functional testing, not clinical data from patient populations in the context of an AI test set. There's no mention of a "test set" in this context.

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

• Not Applicable / Not Provided: As in point 2, this is relevant for AI/ML validation. Ground truth for a surgical laser system's performance would relate to its physical outputs (power, pulse duration, wavelength) and safety features, measured by instruments and engineering standards, not expert readers.

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

• Not Applicable / Not Provided: This is a method for resolving discrepancies in expert labeling of ground truth data, relevant for AI/ML studies.

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 / Not Provided: This document does not describe an AI-assisted device. It describes a surgical laser. Therefore, MRMC studies are not relevant to this submission.

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

• Not Applicable / Not Provided: This pertains to AI/ML software. The device is a physical laser system.

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

• Implicit (Engineering Standards): The "ground truth" for this device's performance would be established through engineering measurements against industry standards (e.g., IEC 60601 for electrical safety and EMC) and comparison to the technical specifications of the predicate devices. It's not based on clinical outcomes or expert consensus on medical images.

8. The sample size for the training set:

• Not Applicable / Not Provided: This is for AI/ML models.

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

• Not Applicable / Not Provided: This is for AI/ML models.

In summary, this document is a 510(k) premarket notification for a physical medical device (a surgical laser system), not an AI/ML diagnostic or therapeutic device. The "acceptance criteria" and "study" described are focused on demonstrating technical substantial equivalence to predicate devices and adherence to engineering safety and performance standards, rather than clinical performance metrics typically associated with AI/ML validation studies.

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The Lumenis® Array™ LaserLink™ device is a laser system accessory intended for use in the treatment of ocular pathology.

• For the posterior segment, the Lumenis® Array™ LaserLink™ device is indicated for use in retinal photocoagulation and panretinal photocoagulation of vascular and structural abnormalities of the retina and choroid including:
  • Proliferative and severe and very severe nonproliferative diabetic retinopathy
  • Macular edema associated with proliferative or nonproliferative diabetic retinopathy
  • Choroidal neovascularization
  • Retinal neovascularization associated with retinal occlusive disease (Branch retinal vein occlusion; Central retinal vein occlusion)
  • Macular edema associated with Branch retinal vein occlusion
  • Retinal tears and detachments
• And anterior segments as follows:
  • Iridotomy in closed angle glaucoma
  • Trabeculoplasty in open angle glaucoma

The Lumenis® Array™ LaserLink™ device is a delivery system that adapts an examination slit lamp for use as a therapeutic laser delivery system, utilizing a scanning pattern generator to deliver predefined patterns of treatment. The Lumenis® Array™ LaserLink™ device is comprised of the following components:

• ArrayTM LaserLink™M module .
• . Console
• . Touchscreen display
• Remote touchpad .

The Array™ LaserLink™ module attaches to the slit lamp and delivers the treatment beam to the target tissue.

The console houses the control electronics and power supply, and integrates the Array™ LaserLinkTM module with the laser system.

The touchscreen display is used to adjust laser treatment settings, such as laser mode, energy, and aiming beam intensity. It can be positioned on either side of the slit lamp, and duplicates the functions of the laser's remote control.

The touchpad is used to micromanipulate the position of the aiming and treatment beams, adjust laser power, spot size, the number of spots, and pattern parameters.

The provided 510(k) summary for the Lumenis® Array™ LaserLink™ describes a medical device, not an AI/ML algorithm. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.

Here's the summary of the acceptance criteria and study findings based on the provided text:

Device: Lumenis® Array™ LaserLink™ (an ophthalmic laser delivery system)

Acceptance Criteria and Reported Device Performance

No acceptance criteria or performance metrics related to diagnostic accuracy, sensitivity, specificity, F1 score, AUC, or other typical AI/ML metrics are present, as this is not an AI/ML device.

Study Details (as related to a non-AI/ML medical device)

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

   • This information is not applicable as the document describes a hardware medical device and its performance testing, primarily for electrical safety and functional equivalence, not a study involving patient data or a test set in the context of an AI/ML model. The testing mentioned is "side-by-side comparative performance assessment to competitive products" and "verification & validation to ensure the subject product met all determined design specifications," which refers to engineering and design validation, not a clinical study on a patient test set.

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. "Ground truth" in the context of an AI/ML model's performance on a test set is not relevant for this device. The "ground truth" for the device's design specifications would be defined by engineering standards and regulatory requirements.

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

   • Not applicable. No adjudication method for a test set is described, as this is not an AI/ML diagnostic or prognostic device.

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:

   • Not applicable. This device is a laser delivery system, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant.

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

   • Not applicable. This is a hardware device; there is no standalone algorithm. Its function is to deliver laser treatment through a slit lamp.

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

   • Not applicable in the context of AI/ML evaluation. The "ground truth" for this device's performance is adherence to engineering specifications, safety standards (IEC 60601 Series), and functional requirements validated through engineering tests.

7. The sample size for the training set:

   • Not applicable. There is no training set mentioned or implied for this non-AI/ML device.

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

   • Not applicable. There is no training set mentioned or implied for this non-AI/ML device.

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The Vision One Laser System is intended for use in the treatment of ocular pathology. The Vision One Laser System green, vellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments including:

• . Retinal photocoagulation, panretinal photocoagulation, and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
  • Proliferative and nonproliferative diabetic retinopathy .
  • Choroidal neovascularization .
  • Branch retinal vein occlusion .
  • . Retinal tears and detachments
  • Retinopathy of prematurity .
• Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and . open angle glaucoma

The Vision One Laser System is classified as a Class IV laser by the Center for Devices and Radiological Health of the Food and Drug Administration. The Vision One Laser System is intended for use in the treatment of ocular pathology. The system's green, yellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments. The Vision One Laser System will incorporate the newest laser technology - Optically Pumped Semiconductor Laser (OPSL) in additions to Nd:YAG which are both subsets of DPSS (Diode Pumped Solid State Laser).
The system shall be configurable so that any combination of up to three (3) treatment lasers can be installed and used.
The Vision One Laser System is comprised of the laser console, control and display panel, remote control, an external door interlock plug, & footswitch.

The provided document is a 510(k) summary for the Lumenis Vision One Laser System, an ophthalmic surgical laser. It establishes substantial equivalence to a predicate device and details the device's intended use and technical specifications. However, it does not contain the specific information required to answer your request regarding acceptance criteria for a study proving device performance.

Specifically, the document states under "VII. Performance Data:" that "The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence has been conducted." However, it does not provide the detailed results of these tests, acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and the reported device performance:

• Cannot be answered from the provided text. The document states that performance testing was conducted but does not provide specific acceptance criteria or detailed reported performance metrics.

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

• Cannot be answered from the provided text. The document does not describe a clinical study or a test set, nor does it provide details on sample size or data provenance for any performance testing.

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

• Cannot be answered from the provided text. There is no mention of a test set, ground truth establishment, or experts involved in performance evaluation.

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

• Cannot be answered from the provided text. There is no information about a test set or adjudication methods.

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:

• Cannot be answered from the provided text. This device is a surgical laser, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers improving with AI assistance is not applicable and not mentioned.

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

• Cannot be answered from the provided text. This device is a surgical laser, not an algorithm. Standalone algorithm performance is not applicable.

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

• Cannot be answered from the provided text. There is no information on ground truth establishment for any performance testing.

8. The sample size for the training set:

• Cannot be answered from the provided text. This device is a surgical laser; the concept of a "training set" in the context of machine learning or AI is not applicable here.

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

• Cannot be answered from the provided text. Not applicable for this type of device.

In summary, the provided document focuses on demonstrating substantial equivalence to a predicate device based on intended use, fundamental scientific technology, patient population, principles of operation, and method of energy delivery. It does not provide the detailed performance study information with acceptance criteria, sample sizes, or ground truth establishment that you are requesting.

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The VersaPulse P20 Laser System is intended for use in surgical procedures requiring open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue.

The VersaPulse P20 Ho:YAG (2.1 μm wavelength) is indicated for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: Arthroscopy, Urinary lithotripsy, Gynecological surgery, Gastroenterological surgery, Urology, ENT surgery, General surgery

The VersaPulse P20 Laser System is a desktop 20 Watt surgical Holmium laser and is an improved model configuration of the 20 Watt VersaPulse PowerSuite Holmium Surgical Laser, [510 (k) K011703].

Main functional components :

• A Laser console .
• . Control and display panel
• A fiber port for Laser delivery systems
• . A covered foot switch
• Operating software
• A variety of fiber optic delivery devices with accessories .

The system uses the same type of laser delivery devices as the predicate.

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

No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in the document. The submission focuses on demonstrating substantial equivalence to a predicate device.

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

Not applicable. This device is a laser system; the evaluation focuses on engineering, safety, and functional testing, not on clinical performance metrics derived from patient data.

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

Not applicable. Ground truth as typically understood in medical image analysis (e.g., expert consensus on diagnoses) is not relevant for this type of device.

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. The device is a surgical laser, not an AI-powered diagnostic or assistive tool.

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

Not applicable.

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

Not applicable. The "ground truth" for this device would be its adherence to engineering specifications and safety standards, confirmed through various types of technical and functional testing, rather than clinical ground truth from patient data.

8. The sample size for the training set

Not applicable. The device is a hardware system, not a machine learning model requiring a training set.

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

Not applicable.

Study that proves the device meets the acceptance criteria:

The document states: "The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence of the VersaPulse P20 Laser System has been conducted."

This statement indicates that a series of internal tests were performed by the manufacturer (Lumenis, Inc.) to ensure the VerasPulse P20 Laser System met the necessary safety, performance, and functional requirements. The goal of these tests was to demonstrate "substantial equivalence" to a predicate device (Holmium 20 Watt VersaPulse PowerSuite and Dual Wavelength Surgical Lasers, K011703).

The summary does not provide specific details on the methodologies, sample sizes, or results of these "safety, performance, and functional testing" procedures. Instead, the FDA's decision to clear the device (K100228) signifies their acceptance of the manufacturer's presented data and conclusion of substantial equivalence. This type of submission relies on the manufacturer's internal verification and validation activities rather than external clinical trials with patient data for performance evaluation in the context of diagnostic or AI devices.

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The PolyScope Flexible Endoscope is indicated in flexible endoscopic procedures for diagnostic and therapeutic applications where flexible endoscopes are standard of care including:

• Gastroenterology, including procedure of the Biliary system involving the hepatic and pancreatic ducts.
• Urology, including procedures involving the bladder, ureter, renal pelvis and kidney.

The PolyScope Xenon-Endoscopic light source LS 200 provides white examination light (sunlight spectrum) for all endoscopic applications including:

• During video endoscopy.
• During fiber endoscopy.
• During micro-endoscopy.
• During endoscopy using rigid optics.
• During usage of forehead illumination.

The PolyScope Flexible Endoscope is comprised from two main components: a disposable, flexible, steerable mini-endoscope and a flexible, modular, reusable optical disposable, Holters, etc. to the catheter to allow the visualization of the desired area.

The PolyScope LS 200 XENON-Endoscopic light source provides white examination light (sunlight spectrum) for all endoscopic applications including:

• During video endoscopy.
• During fiber endoscopy.
• During micro-endoscopy.
• During endoscopy using rigid optics.
• During usage of forehead illumination.

The provided text is a 510(k) summary for the PolyScope Flexible Endoscope and PolyScope Xenon Light Source. It focuses on establishing substantial equivalence to predicate devices based on intended use, general design, and fundamental scientific technology. There is no information provided regarding specific acceptance criteria or a study proving the device meets performance metrics in the way a clinical study would for an AI-powered device.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and a study proving the device meets those criteria, as the document doesn't contain that type of information.

The document discusses:

• Device Description and Intended Use: Clearly outlines what the devices are and what they are used for.
• Predicate Devices: Identifies the legally marketed devices to which the PolyScope devices are compared for substantial equivalence.
• Technological Characteristics Summary & Substantial Equivalence Statement: Asserts that the subject devices share the same intended use, general design, and fundamental scientific technology as their predicates.
• Performance Data Summary: States that "appropriate testing including safety, performance and functional testing" was conducted, but does not provide any specific criteria, results, or study details. This typically refers to bench testing, electrical safety, biocompatibility, and sterilization validations, which are not outlined in the provided text.

Specifically, the following information you requested is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance: No test set details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study or test set with ground truth is described.
4. Adjudication method 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: This device is an endoscope and light source, not an AI-powered diagnostic device, so an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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The intended use for the Selecta Family of Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duet, LaserLink S, Selecta Duo, and Selecta Trio) and Accessories are as follows:

• Selecta 1064: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, includinq discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy.
• Selecta SLT: Selective laser trabeculoplasty.
• Selecta Duet: Photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy and selective laser trabeculoplasty.
• LaserLink S: Laser delivery system for use by an ophthalmologist in the treatment of ocular tissue. The laser delivery system is intended for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, General Intended Use section.
• Selecta Duo: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectorny and retinal photocoaqulation.
• Selecta Trio: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy, retinal photocoaqulation and selective laser trabeculoplasty.

The Lumenis Selecta is a fully integrated, high-performance diagnostic slit lamp and therapeutic laser delivery system. Selecta has all of the standard controls and functions of a diagnostic slit lamp and is intended for use in eve examination of the anterior segment, from the cornea epithelium to the posterior capsule.

The Lumenis Selecta is also an ophthalmic surqical laser designed for performing photodisruption of ocular tissue using laser energy emitted by a Nd:YAG laser including discission of the posterior capsule of the eye (posterior capsulotomy), discission of pupillary membranes (pupillary membranectomy), and iridotomy/iridectomy; and selective laser trabeculoplasty.

The Selecta Family of Ophthalmic Lasers is comprised of:

Selecta 1064: A Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nm for use in photodisruption of ocular tissue (posterior capsulotomy, papillary membranectomy, and iridotomy).

Selecta SLT: A Nd:YAG laser providing Q-switched laser pulses at a wavelength of 532 nm for use in selective laser trabeculoplasty.

Selecta Duet: A Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nm for use in photodisruption or Q-switched frequency doubled laser pulses at a wavelength of 532 nm for use in selective laser trabeculoplasty, depending on the mode selected.

LaserLink S: Laser delivery adapter that may be coupled to each of the above Selecta models and connected to a currently cleared Lumenis 532 nm retinal photocoaqulator (Novus Spectra, Novus Varia) to allow use of the slit lamp to deliver 532 nm continuous wave laser energy for retinal photocoagulation.

Selecta Duo: A Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nm for use in photodisruption or Q-switched 532 nm continuous wave laser energy for retinal photocoagulation.

Selecta Trio: A Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nm for use in photodisruption, Q-switched frequency doubled laser pulses at a wavelength of 532 nm for use in selective laser trabeculoplasty, or Q-switched 532 nm continuous wave laser energy for retinal photocoagulation, depending on the mode selected.

The Selecta produces short, individual pulses of focused laser light with wavelengths of either 1064 nm or 532 nm. depending on the selected operational mode. Using a slit lamp microscope and aiming beam, the pulsed light is accurately targeted on a structure within the patient's eye.

When the photodisruptor mode is selected, the treatment wavelength is 1064 nm. A twin-aiming beam targets the area of tissue disruption. The energy contained within a single short pulse is concentrated by focusing to a very small spot size so that plasma formation occurs at the focal point. This creates an acoustic wave which disrupts nearby tissue.

When the SLT mode is selected, the treatment wavelength is 532 nm. A coaxial aiming beam targets the trabecular meshwork via a contact lens. The SLT treatment laser provides a low energy, short pulse of laser light that produces a thermal effect in pigmented cells in the trabecular meshwork.

If the optional LaserLink S adapter is attached to the Selecta system and the compatible Lumenis Spectra 532 nm retinal photocoagulator laser, the Selecta works strictly as a diagnostic slit lamp - all photodisruptor and SLT laser functions are disabled. The Laser delivery adaptor is used for treatments specifically cleared for the compatible laser retinal photocoaqulator.

The provided 510(k) summary for the Lumenis Selecta Family of Ophthalmic Laser Systems (K081704) does not present an acceptance criteria table or a detailed study proving the device meets specific performance criteria with metrics like sensitivity, specificity, or accuracy.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, general design, and fundamental scientific technology. The "Performance Data Summary" section is very brief and states: "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the Selecta Family of Laser Systems has been conducted." It does not provide any specifics about these tests, their results, or how they relate to numerical acceptance criteria.

Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth, and expert evaluation cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or is explicitly missing, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The submission relies on demonstrating substantial equivalence to predicate devices rather than meeting specific quantifiable performance metrics.

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

Not applicable/Not provided. There is no mention of a clinical "test set" in the context of diagnostic performance or AI model evaluation. The "testing" mentioned is likely focused on engineering safety and functional performance for substantial equivalence.

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

Not applicable/Not provided. Ground truth establishment is not described as there's no clinical performance study presented that would require it.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Adjudication methods are relevant for studies involving human interpretation or multi-expert evaluations, which are not detailed here.

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

Not applicable/Not provided. The document describes a medical device (laser system) and does not involve AI or human reader interpretation that would necessitate an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable/Not provided. This device is a physical laser system, not an algorithm, and its performance is inherently human-in-the-loop (operated by an ophthalmologist).

7. Type of Ground Truth Used

Not applicable/Not provided. The concept of "ground truth" as it pertains to diagnostic accuracy (e.g., pathology, outcomes data) is not relevant or described for this type of device submission. The "ground truth" in this context would likely be defined by physical measurements of laser output and functional operation, but these details are not provided in the summary.

8. Sample Size for the Training Set

Not applicable/Not provided. This is a physical laser system, not an AI model, so there is no "training set."

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

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

Summary of the Study (Based on 510(k) Content):

The "study" presented in this 510(k) summary is not a clinical efficacy or performance study in the traditional sense, but rather a substantial equivalence determination. The manufacturer, Lumenis, Inc., states that they have conducted "appropriate testing including safety, performance and functional testing" to demonstrate that the Selecta Family of Ophthalmic Laser Systems is substantially equivalent to previously cleared predicate devices:

• Lumenis Selecta Duet (K021550)
• Coherent Popeye Ophthalmic Laser System (EPIC I and EPIC IV), (K97340)
• LaserLink Z-1000 (Z022181)

The basis for this substantial equivalence is stated as having the "same intended use, general design and fundamental scientific technology" as the predicate devices, and that "There are no new hazards introduced by the Selecta Family of Laser Systems as compared with the predicate devices." No specific data from these "appropriate tests" are included in the provided summary.

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LightSheer® Pulsed Diode Array Laser Systems are indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer® Pulsed Diode Array Laser Systems are intended for use on all skin types (Fitzpatrick skin types I – VI), including tanned skin.

LightSheer® Duet™ Laser Systems with LightSheer® ET™ Laser Handpiece is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The LightSheer® Duet™ Laser System with LightSheer® ET™ Laser Handpiece is also intended for hair removal, permanent hair reduction, and the treatment of benign pigmented lesions and leg veins.

LightSheer® Duet™ Laser Systems with LightSheer® HS™ Laser Handpiece is intended for the treatment of benign vascular and pigmented lesions, hair removal, and permanent hair reduction.

The LightSheer Duet Laser System is a non-invasive aesthetic laser. The system delivers pulsed infrared laser light with a wavelength ranging from 790 - 950 nm (800 nm nominal) and has two unique treatment handpieces. One handpiece is the LightSheer® ET™ handpiece, which delivers laser energy through a 9 x 9 mm tip up to 90 J maximum. The settings for this handpiece are selectable pulse duration from 5 – 400 ms, selectable fluence from 10 - 100 J/cm2 and a pulse repetition rate up to 3 Hz maximum. The second handpiece is the LightSheer® HS™ handpiece, which delivers laser energy from a 22 x 35 mm diode array up to 45 J maximum. The settings for this handpiece are pulse duration from 10 - 30 ms, selectable fluence from 3 - 5.2 J/cm2 and multiple pulsing up to 3 pulses.

The complete system consists of a console and two handpieces connected to the system by umbilical cables. In standard use, the handpiece is pressed against the patient's skin and a pulse of light is delivered. To initiate energy output, the system requires redundant activation of the handpiece enable button and the handpiece trigger button while the system is in the Ready mode. The LightSheer ET handpiece tip is watercooled to provide active skin cooling. The LightSheer HS handpiece tip uses vacuum and lower laser energy densities which reduces skin heating. The physician is able to control the settings of laser energy from the LCD display on the main console.

This section of the 510(k) submission for the Lumenis LightSheer® Duet™ Laser System is focused on establishing substantial equivalence to predicate devices, rather than presenting a study demonstrating new acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.

Here's an analysis of the information that is available, and an indication of what is missing based on your request:

1. Table of acceptance criteria and the reported device performance:

• Not provided. This document does not detail specific performance acceptance criteria for the LightSheer Duet Laser System nor does it provide a table of reported device performance against such criteria. The submission aims to demonstrate "substantial equivalence" to predicate devices, implying that if the new device is sufficiently similar to an already cleared device, it doesn't need to meet new, separate performance criteria in the same way a novel device might.

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

• Not applicable/Not provided. No specific test set or clinical study data is presented in this document to support new performance claims. The submission relies on demonstrating equivalence rather than new clinical proof.

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

• Not applicable/Not provided. As no new clinical study data with ground truth establishment is presented, this information is not available.

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

• Not applicable/Not provided. See above.

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/Not provided. This device is a laser system, not an AI-powered diagnostic tool requiring human reader studies or AI assistance.

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

• Not applicable/Not provided. This device is a treatment system, not a standalone diagnostic algorithm.

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

• Not applicable/Not provided. See above.

8. The sample size for the training set:

• Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Not applicable/Not provided. See above.

Summary of what is provided in the text:

The provided text from the 510(k) submission for the Lumenis LightSheer® Duet™ Laser System focuses on describing the device and establishing its substantial equivalence to predicate devices already cleared by the FDA.

• Device Description: The document details the LightSheer Duet Laser System as a non-invasive aesthetic laser with two handpieces (LightSheer® ET™ and LightSheer® HS™) delivering pulsed infrared laser light. It describes their specifications (wavelength, fluence, pulse duration, spot size) and skin cooling mechanisms.
• Intended Use: The device is indicated for surgical, aesthetic, and cosmetic applications in general and plastic surgery, and dermatology, for all Fitzpatrick skin types (I-VI), including tanned skin. Specific indications for each handpiece include:
  • LightSheer® ET™: Treatment of vascular lesions (angiomas, hemangiomas, telangiectasia, other benign vascular lesions), pseudofolliculitis barbae, hair removal, permanent hair reduction, benign pigmented lesions, and leg veins.
  • LightSheer® HS™: Treatment of benign vascular and pigmented lesions, hair removal, and permanent hair reduction.
• Substantial Equivalence Claim: The core of this submission, as indicated by the "Substantial Equivalence" section, is that the specifications and indications for use of the LightSheer Duet Laser System are "the same or very similar" to those of its claimed predicate devices (Lumenis, Inc. LightSheer® Pulsed Diode Array Laser System and AesThera Corporation AIP™ Intense Pulsed Light System). The FDA's letter confirms that the device is deemed "substantially equivalent" for the stated indications for use.

Conclusion based on the provided text:

This 510(k) summary does not present new acceptance criteria or the results of a primary study to prove new performance claims. Instead, it relies on the FDA's "substantial equivalence" pathway, meaning the device is considered safe and effective because it is comparable to devices already legally marketed. Therefore, the detailed questions about study design, sample sizes, and ground truth establishment for a novel performance study are not addressed in this document.

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photodisruption of ocular tissue using light energy emitted by a Nd: Y AG Selecta 1064: laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy

selective laser trabeculoplasty Selecta SLT:

photodisruption of ocular tissue using light energy emitted by a Nd: Y AG Selecta Duet: laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy; and

selective laser trabeculoplasty

laser delivery system for use by an ophthalmologist in the treatment of LaserLink S: ocular tissue;
laser delivery system indicated for use for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, Indications for Use section.

The Selecta 1064, Selecta SLT and Selecta Duet Ophthalmic Lasers are also intended for use as a diagnostic slit lamp, specifically,

An AC-powered slit lamp biomicroscope intended for use in eye examination of the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior segment.

same indications for use as a Selecta 10648 and LaserLink S slit lamp Selecta Duo: delivery device with a currently cleared Lumenis 532nm photocoagulator

Selecta Trio: same indications for use as a Selecta Duet and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator

The Lumenis Selecta is a fully integrated flash lamp pumped, solid state, Nd:YAG ophthalmic surgical laser system intended for use in the treatment of ocular pathology and for use as a diagnostic slit lamp.

The Selecta Family of Ophthalmic Lasers, Delivery Device and Accessories are comprised of the following configurations:

Selecta 1064 - a Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064nm for use in photodisruption of ocular tissue (posterior capsulotomy, papillary membranectomy, iridotomy). The 1064nm treatment beam delivers a 4 nsec, 0.3-10mJ adjustable and selectable single, double or triple pulse of energy. It is conditioned through beam shaping optics to generate a photodisruption micro pulse of plasma at a precision location relative to the visual focal plane (located at slit lamp center of adjustable rotation) and along the slit lamp objective lens axis. A twin aiming beam is also focused by the slit lamp objective to a converging 20um spot located at the focal point of the lens. The focal point of photodisruption is adjustable 0-350μm in the posterior direction by the physician relative to this convergence of the twin aiming beams.

Selecta SLT® - a Nd:YAG laser providing Q-switched frequency doubled pulses at a wavelength of 532nm for use in selective laser trabeculoplasty. The treatment beam delivers a 4nsec, 0.1-2mJ adjustable single pulse of energy. The aiming and treatment beams are coaxial with each other and focused by the slit lamp objective to a 400um spot at the focal point of the lens.

Selecta Duet® - a Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nanometers for use in photodisruption or Q-switched frequency doubled pulses at a wavelength of 532nm for use in selective laser trabeculoplasty, depending upon the mode selected. The Selecta Duo contains two aiming beam modules that produce a single beam for the 532nm mode and a dual beam for the 1064nm mode, respectively.

LaserLink S - a laser slit lamp delivery adaptor that may be coupled to each of the above Selecta models and connected to a currently cleared Lumenis 532nm photocoagulator to allow the physician to use the Selecta slit lamp to deliver 532nm continuous wave laser energy for photocoagulation.

Selecta Duo - a Selecta 1064® and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator

Selecta Trio - a Selecta Duet and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator

Selecta SLT and LaserLink S with a currently cleared Lumenis 532nm photocoagulator

The provided text is a 510(k) summary statement for the Lumenis Family of Selecta Ophthalmic Laser Systems. It explicitly states that no performance data was submitted because the purpose of the 510(k) was for a name change only, with no changes to the device or its indications for use. The submission claims substantial equivalence to previously cleared predicate devices.

Therefore, the following information directly addresses the points in your request:

1. Table of acceptance criteria and the reported device performance: Not applicable. No performance data or acceptance criteria are reported in this 510(k) summary, as it explicitly states "Performance Data: None."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No performance study was conducted or reported.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. No performance study was conducted or reported.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No performance study was conducted or reported.

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 an ophthalmic laser system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an ophthalmic laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No performance study was conducted or reported.

8. The sample size for the training set: Not applicable. This document pertains to a physical medical device, not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable. This document pertains to a physical medical device, not a machine learning algorithm.

In summary, the provided 510(k) notification explicitly states that no performance data was included or required, as the submission was solely for a name change and claimed substantial equivalence to already cleared predicate devices without any changes to the device itself or its intended use.

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