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Laser Device:

The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use 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, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery,

Urology

Open and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors Ablation of Benign Prostatic Hypertrophy (BHP) 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, excision, resection, ablation, vaporization, coagulation and hemostasis ) including: Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitis Hemorrhoids Cholecystectomy Benign and Malignant Neoplasma 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 / Orthopedic surgery (excision, ablation 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 Chondreoplasty in the knee Debridement of inflamed synovial tissue Chondromalacia Ablation Chondromalacia and tears Plica Removal Meniscectomy Loose Body Debridement Lateral retineacular 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 Forminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy

Pulmonary

Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue)

Gynecology

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

ENT

Endoscopic endonasal surgery (incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including: Endonasal / sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal sinustomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery

Dermatology and Plastic Surgery

Incision, excision, resection, ablation, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas

Lesions of skin and subcutaneous tissue

Skin tags Plantar warts Lesions of skin and subcutaneous tissue Port Wine Stains Papillomas

General Surgery Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete or partial resection of internal organs, tumors and lesions Biopsy

Morcellator:

The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surgical procedures in urology.

Laser Device:

The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use 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, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery,

Urology

Open and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors Ablation of Benign Prostatic Hypertrophy (BHP) 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, excision, resection, ablation, vaporization, coagulation and hemostasis ) including: Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitis Hemorrhoids Cholecystectomy Benign and Malignant Neoplasma 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 / Orthopedic surgery (excision, ablation 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 Chondreoplasty in the knee Debridement of inflamed synovial tissue Chondromalacia Ablation Chondromalacia and tears Plica Removal Meniscectomy Loose Body Debridement Lateral retineacular 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 Forminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy

Pulmonary

Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue)

Gynecology

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

ENT

Endoscopic endonasal surgery (incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including: Endonasal / sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal sinustomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery

Dermatology and Plastic Surgery

Incision, excision, resection, ablation, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas

Lesions of skin and subcutaneous tissue

Skin tags Plantar warts Lesions of skin and subcutaneous tissue Port Wine Stains Papillomas

General Surgery Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete or partial resection of internal organs, tumors and lesions Biopsy

Morcellator:

The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surgical procedures in urology.

This document is an FDA 510(k) clearance letter for the MultiPulse HoPLUS Laser system and MultiCut Solo Morcellator. It outlines the regulatory approval and intended uses of the device.

Based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance beyond its substantial equivalence to predicate devices and adherence to general controls.

The document primarily focuses on:

• Confirming the 510(k) clearance (K231876) for the MultiPulse HoPLUS Laser and MultiCut Solo Morcellator.
• Stating its classification as a Class II device.
• Listing its broad Indications for Use across various medical specialties (Urology, Gastroenterology, Arthroscopy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery).
• Mentioning regulatory requirements and guidance documents.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the provided FDA clearance letter.

The FDA 510(k) pathway for medical devices largely relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to establish new performance metrics or comparison against specific, pre-defined acceptance criteria in the same way a PMA (Premarket Approval) submission might. While the manufacturer would have submitted data to the FDA to support the substantial equivalence claim, the details of those studies and specific acceptance criteria are not typically included in the public-facing clearance letter.

Ask a specific question about this device

The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

The MultiPulse HoPLUS Laser system and its fiber optic delivery system is a laser Class IV, pulsed, solid state Holmium-YAG, which emits laser radiation with a wavelength of approximately 2100 nm with a pulse with between 150-1700 microseconds. The laser power up to 140 Watts is transmitted to the tissue through different optical fibers. The laser system consists of: Laser system including control panel (user interface) Foot switch A variety of application fibers and accessories

The provided text is a 510(k) summary for the Asclepion Laser Technologies GmbH MultiPulse HoPLUS. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

However, the document does not contain information about specific acceptance criteria for performance, a study to prove the device meets those criteria, or details regarding sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

The document states:

• Non-clinical Performance Data: "Verification and Validation activities. These activities comprises the verification and validation of the software, the verification of the device, the verification of the fiber, the verification of the laser, an Investigation Report and the Final Test Report. These investigations lead to the conclusion, that the device is as safe and effective as the predicates and no additional risks occur."
• Clinical Performance Data: "None"

Therefore, based on the provided text, I cannot complete most of the requested information. The device's substantial equivalence is based on non-clinical performance data (verification and validation) and comparison to predicate devices, not on a specific clinical study with defined acceptance criteria and human expert evaluation in the way requested.

Ask a specific question about this device

The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and use in medical specialties including: Urology, Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

The MultiPulse HoPLUS Laser system and its fiber optic delivery system is a laser Class IV, pulsed, solid state Holmium-YAG, which emits laser radiation with a wavelength of approximately 2100 nm with a pulse with between 150-850 microseconds. The laser power up to 110 Watts is transmitted to the tissue through different optical fibers. The laser system consists of: Laser system including control panel (user interface) Foot switch

This document is a 510(k) summary for the ASCLEPION LASER TECHNOLOGIES GmbH MultiPulse HoPLUS, a laser surgical instrument. It details the device's intended use, comparison to predicate devices, and a list of performance testing standards. However, it does not contain specific acceptance criteria or the results of a study that directly compares the device's performance against numerical acceptance criteria.

The document states that the MultiPulse HoPLUS laser system is tested according to various ISO and DIN EN standards, and that it complies with the European Medical Device Directive. These standards are general safety and performance standards for medical devices and lasers, not specific performance metrics for the device's indicated uses in surgery.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present in the provided text. The document lists the standards the device complies with, but not quantifiable acceptance criteria or performance metrics derived from those standards specific to the device's surgical capabilities (e.g., ablation rate, coagulation depth, precision of incision).
• Sample size used for the test set and the data provenance: Not specified. Performance testing is mentioned generally, but no details on specific studies, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective) are provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. There is no mention of expert-established ground truth for performance testing.
• Adjudication method for the test set: Not specified.
• 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 a surgical laser, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reading improvement with AI is not applicable and not mentioned.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This pertains to AI algorithms, which is not what this device is.
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not specified.
• The sample size for the training set: Not applicable for this type of device (a laser surgical instrument).
• How the ground truth for the training set was established: Not applicable for this type of device.

In summary, the provided text confirms that the MultiPulse HoPLUS laser system has undergone performance testing against general medical device and laser safety standards, and is deemed substantially equivalent to predicate devices based on its intended use and functional features. However, it does not provide detailed information about specific performance acceptance criteria or the results of studies directly demonstrating the device's performance against such criteria for its numerous surgical indications.

Ask a specific question about this device