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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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The Holmium Medical Laser and its fiber optic delivery system are in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectory, Gynecology, ENT, Pulmonary Surgery and General Surgery.

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

• · Urethral Strictures
• · Bladder Neck Incisions (BNI)
• · Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors,
• · Ablation of Benign Prostatic Hypertrophy (BPH),
• · Transurethral incision of the prostate (TUIP)
• · Holmium Laser Resection of the Prostrate (HoLRP)
• · Holmium Laser Enucleation of the Prostate (HoLEP)
• · Holmium laser Ablation of the Prostate (HoLAP)
• · Condylomas
• · Lesions of external genitalia

Lithotripsy and Percutaneous Urinary Lithotripsy
· Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate,

• monohydrate and calcium oxalate
• · dehydrate stones.
• · Endoscopic fragmentation of kidney 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
• Polyps
• · Biopsy
• · Gall Bladder calculi
• · Biliary/Bile duct calculi
• · Ulcers
• · Gastric ulcers
• · Duodenal ulcers
• · Non Bleeding Ulcers
• · Pancreatitas
• · Haemorrhoids
• · Cholecystectomy
• · Benign and Malignant Neoplasm
• · Angiodysplasia
• · Colorectal cancer
  · Telangiectasias
• · Telangiectasias of the Osler-Weber-Renu disease
• Vascular Malformation
• · Gastritis
• · Esophagitis
• · Esophageal ulcers
• Varices
• · Colitis
• · Mallory-Weiss tear
• · Gastric Erosions

Arthroscopy
Arthroscopy/Orthopaedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:

• · Ligament and tendon Release
• · Contouring and sculpting of articular surfaces
• · Capsulectomy in the Knee
• · Chondreplasty in the Knee
• · Debridement of inflamed synovial tissue
• Chondromalacia Ablation
• · Chondromalacia and tears
• · Plica Removal
• · Meniscectomy
• · Loose Body Debridement
• · Lateral retinecular release

Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including
· Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy
Percutaneous Thoracic Disc Decompression/Discectomy

Gynaecology
Open and laparoscopic gynaecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue

ENT
Endoscopic endonasal surgery (incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and cartilage) including:

• · Endonasal/sinus Surgery
• · Partial turbinectomy
• · Polypectomy
• · Dacryocystorhinostomy
• · Frontal Sinusotomy
• · Ethmoidectomy
• · Maxillary antrostomy
• · Functional endoscopic sinus surgery

Pulmonary Surgery
Open and endoscopic pulmonary surgery (cutting, vaporization, incision and coagulation of soft tissue)

General Surgery
Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:

• · Appendectomy
  · Skin incision
• · Excision of external and internal lesions
• · Complete or partial resection of internal organs, turnors and lesions
• · Biopsy

The devices belonging to Holmium laser family are laser devices based on a Holmium laser source. The main parts (subsystems) of the device are the Holmium laser source, the power electronics, the optical delivery system, the control electronics and the cooling system. Specific software controls the device functions and allows the user selections. Laser emission is triggered by a footswitch.

The provided document is a 510(k) summary for a medical device called "Holmium Medical Laser." It demonstrates substantial equivalence to predicate devices, which means it has similar intended use, technological characteristics, and safety/efficacy profile to devices already legally marketed in the U.S.

However, the document does NOT describe a study that proves the device meets specific acceptance criteria based on metrics like sensitivity, specificity, or reader performance with and without AI assistance. This type of study is typically done for AI/ML-enabled devices that rely on complex algorithms for diagnosis or analysis, often involving image interpretation.

The Holmium Medical Laser is a surgical instrument, a hardware device that emits laser energy for various surgical procedures. The testing described is primarily focused on safety and performance standards for a physical device, not an AI algorithm.

Therefore, many of the requested details from your prompt, such as "multireader multicase study," "effect size of how much human readers improve with AI," "standalone algorithm performance," "type of ground truth (expert consensus, pathology, outcomes data)," and "training set details," are not applicable to the information provided in this 510(k) summary for a "Holmium Medical Laser."

Based on the provided document, here's what can be extracted regarding acceptance criteria and performance, reinterpreted for a physical medical device:

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

For a physical medical device like a laser, "acceptance criteria" and "reported device performance" are typically defined by adherence to recognized electrical, laser safety, and risk management standards. The document states that the device was tested in compliance with these standards.

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

• Sample Size: Not applicable in the context of clinical test sets for AI/ML. The "testing" refers to verification and validation of engineering specifications and compliance with safety standards, not a clinical trial on patient data.
• Data Provenance: Not applicable for device safety and performance testing.

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

• Not applicable. Ground truth as understood in AI/ML (e.g., expert annotations on images) is not relevant for this type of device submission. Safety and performance are established through engineering tests and adherence to established standards.

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

• Not applicable. This refers to consensus methods for expert labeling in AI/ML datasets.

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 surgical laser, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.

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

• Not applicable. The device is a surgical laser, directly operated by a human surgeon. There is no "standalone algorithm" performance to evaluate.

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

• Not applicable in the AI/ML context. The "ground truth" for this device's performance is adherence to established engineering specifications, safety standards, and functional requirements (e.g., laser output measurements, electrical safety checks).

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML model that requires a training set.

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

• Not applicable.

In summary, the provided document is a 510(k) premarket notification for a physical medical device (Holmium Medical Laser) and details its substantial equivalence to predicate devices by demonstrating compliance with established safety and performance standards. It does not contain information related to AI/ML device acceptance criteria or studies involving clinical image interpretation, which is what your detailed prompt questions are geared towards.

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