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Thulium Fiber Laser is intended for incision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue in the following indications: Urology, Lithotripsy, Gastroenterological surgery and Gynecological Surgery.

Urologv

• · Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
• · Laser Resection of the Prostrate (LRP)
• · Laser Enucleation of the Prostate (LEP)
• · Laser Ablation of the Prostate (LAP)
• · Transurethral Incision of the Prostate (TUIP)
• · Condylomas
• · Urethral strictures
• · Lesions of external genitalia
• · Bladder neck incisions (BNI)
• · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
• · Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
• · Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy Indications

• · Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
• · Endoscopic fragmentation of renal calculi
• · Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:

• · Appendectomy
• · Angiodysplasia
• · Polyps
• · Colorectal cancer
• · Biopsy
• · Telangiectasias
• •Gall Bladder calculi
• · Telangiectasias of the Osler-Weber-Renu disease
• · Biliary/Bile duct calculi
• · Vascular Malformation
• · Ulcers
• · Gastritis
• · Gastric ulcers
• · Esophagitis
• · Duodenal ulcers
• · Esophageal ulcers
• Non Bleeding Ulcers
• Varices
• Pancreatitis
• Colitis
• Haemorrhoids
• Mallory-Weiss tear
• Cholecystectomy
• Gastric Erosions
• Benign and Malignant Neoplasm

Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

Thulium Fiber Laser is a laser system that emits a wavelength of 1.94 um with a laser output power up to 60W and 35W respectively. Laser radiation is delivered to the patient via an optical fiber.

The main subsystems of the device are the laser, the power electronics, the optical delivery system, the control electronics, and the cooling system. Software controls the device functions and allows the user select device settings. Laser emission is triggered by a footswitch.

This document details the FDA's 510(k) clearance for the Thulium Fiber Laser (FiberLAZE+, FiberLAZE) manufactured by Allengers Global Healthcare Private Limited. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.

The provided text describes a medical device, specifically a Thulium Fiber Laser system, and its substantial equivalence to a predicate device. The performance testing outlined focuses on electrical, laser, and software safety and usability standards (e.g., ISO, IEC, FDA guidance for software), which are relevant for hardware and software functionality but do not cover AI/ML performance.

Therefore, I cannot extract the requested information about acceptance criteria for AI/ML performance and a study proving its fulfillment because this information is not present in the provided document. The document pertains to a traditional medical device clearance that does not involve AI or machine learning components.

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Medical Thulium Fiber Laser System (UroFiber 60Q) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissuewith or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Medical Thulium Fiber Laser System (UroFiber 60Q) consists of a host (including a power supply, thulium fiber laser, safety conrol module, cooling module), foot switch and optical fiber (disposable use, sterilized by the user before use. Model: RL-150, RL-200, RL-272, RL-365, RL-550, RL-800, RL-1000, specification: 300) composition. Protective glasses not included.

This document pertains to the FDA 510(k) premarket notification for the Medical Thulium Fiber Laser System (UroFiber 60Q) manufactured by Rhein Laser Technologies Co., Ltd. The information provided outlines the device's characteristics and its comparison to predicate and reference devices to demonstrate substantial equivalence, rather than detailing a study that proves the device meets specific acceptance criteria for an AI/software-as-a-medical-device (SaMD) product.

Therefore, the requested information regarding acceptance criteria for AI performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, and how ground truth was established for the training set is not applicable and not present in the provided document.

This document describes a traditional medical device (a laser surgical instrument), and the testing described is primarily for electrical safety, electromagnetic compatibility, and biocompatibility, as well as a comparison of its technical specifications and intended use against legally marketed predicate devices.

Here's a breakdown of what the document does provide, and why it doesn't fit the requested AI/SaMD criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (as implied by FDA 510(k) for a device like this): Substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. This is demonstrated through non-clinical performance data (compliance with general and particular medical device standards) rather than clinical performance metrics or AI algorithm performance metrics.

• Reported Device Performance: The document states that "Performance data supports that the device is as safe and effective as the predicate/reference devices for its intended use." Specific performance aspects tested include:

  • Safety of Laser Products (IEC 60825-1:2014)
  • Medical Electrical Equipment (IEC 60601-1:2005+AMD1:2012+AMD2:2020)
  • Electromagnetic Disturbances (IEC 60601-1-2:2014+AMD1:2020)
  • Particular Requirements for Surgical Laser Equipment (IEC 60601-2-22:2019)
  • Biocompatibility (ISO 10993 series: Parts 10, 23, 5, 11, 4)

  Acceptance Criteria (Implied by Standards & Substantial Equivalence)	Reported Device Performance (Compliance)
  Laser Safety Compliance	Complies with IEC 60825-1:2014
  Electrical Safety & Essential Performance	Complies with IEC 60601-1:2005+AMD1:2012+AMD2:2020
  Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2:2014+AMD1:2020
  Specific Surgical Laser Equipment Safety	Complies with IEC 60601-2-22:2019
  Biocompatibility (Skin Sensitization, Irritation, Cytotoxicity, Systemic Toxicity, Blood Interaction)	Complies with ISO 10993-10, -23, -5, -11, -4; found to be biocompatible

2. Sample Size Used for the Test Set and Data Provenance:
* Not applicable. This isn't an AI/SaMD. The "test set" in this context refers to the physical device being tested against recognized consensus standards for electrical, laser, and biological safety. The "data provenance" specifically for patient data or images (as would be relevant for AI) is not relevant for this type of device submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:
* Not applicable. This is not an AI/SaMD. Ground truth, in the AI context, refers to a definitive correct answer for patient data, often established by experts. For this laser device, "ground truth" is adherence to engineering and safety standards, not a clinical assessment of data by experts in the same way.

4. Adjudication Method:
* Not applicable. No clinical data interpretation by multiple readers is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
* No. This type of study is specifically relevant for assessing the impact of AI on human reader performance, which is not the subject of this 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Not applicable. No algorithm performance is being evaluated.

7. The Type of Ground Truth Used:
* Not applicable. For this laser device, the "ground truth" of its safety and effectiveness is demonstrated by its adherence to established national and international engineering, electrical, laser, and biocompatibility standards, and its substantial equivalence to legally marketed predicate devices with a history of safe use. There is no "pathology," "outcomes data," or "expert consensus" in the sense of clinical interpretations for an algorithm.

8. The Sample Size for the Training Set:
* Not applicable. This device does not involve a training set as it is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established:
* Not applicable. No training set exists for this device.

In summary, the provided document is a standard FDA 510(k) clearance letter and summary for a physical medical device (a laser system), not an AI/SaMD. Therefore, it does not contain the specific information requested regarding acceptance criteria and performance studies for an AI device.

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