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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

7. The Type of Ground Truth Used

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

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

8. The Sample Size for the Training Set

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

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

Not applicable, as there is no training set.

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