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The Hyper Photonics's HYPHO (Ho:YAG) Surgical Laser and Delivery Devices and Accessories (Hyper Photonics optical fibers) is 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 HYPHO Laser System and its delivery system (Hyper Photonics optical fibers) are indicated for use in the performance of specific surgical 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 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: = bladder; ■ superficial and invasive bladder, urethral and ureteral tumors; ▪ condylomas: · lesions of external genitalia; · ureteral and penile hemangioma; · ureteral strictures; ■ 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 guide wires cannot be passed. Arthroscopy o Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including: meniscectomy; plica removal; ligament and tendon release; contouring and sculpting of articular surfaces; debridemnent of inflamed synovial tissue (synovectomy); loose body debridement; chondromalacia and tears; lateral retinecular release: capsulectomy in the knee; chondroplasty in the knee; chondrornalacia ablation. o Discectomy including: percutaneous vaporization of the L4-5 and L5-SI lumbar discs of the vertebral spine; open and arthroscopic spine procedures; foraminotomy. General Surgery o Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including: cholecystectomy: lysis of adhesions; appendectomy; biopsy. pylorostenotomy, and removal of polyps of the sigmoid colon; skin incision: tissue dissection; excision of external tumors and lesions; complete or partial resection of internal organs, tumors and lesions; mastectomy; hepatectomy: pancreatectomy; splenectomy; thyroidectomy; parathyroidectomy; hemniorrhaphy: tonsillectomy; lymphadenectomy; partial nephrectomy; pilonidal cystectomy; resection of lipoma: debridement of decubitus ulcer; hemorrhoids: debridenment of statis ulcer; biopsy. ENT Surgery o Endoscopic endonasal/ sinus surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including: partial turbinectomy; ethmoidectorny; polypectomy: maxillary antrostomy; frontal sinusotomy; sphenoidotomy; dacryocystorhinostomy (DCR); functional endoscopic sinus surgery (FESS). Gynecological Surgery o Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue). Gastroenterology Surgery o Open and endoscopic gastroenterology surgery (ablation, vaporization, incision, excision, resection, coagulation and hemostasis, including: gall bladder calculi: biliary /bile duct calculi; benign and malignant neoplasm; polyps: colitis; ulcers: angiodysplasia; hemorrhoids: varices: esophagitis: esophageal ulcer; Mallory-Weiss tear; gastric ulcer; duodenal ulcer; non-bleeding ulcer; gastric erosions: colorectal cancer; gastritis: bleeding tumnors; pancreatitis: vascular malformations: telangiectasis; telangiectasias of the Osler-Weber-Renu disease. Pulmonary Surgery o 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: scars; tattoo removal: vascular lesions: port wine stains; hemangioma; telangiectasia of the face and leg; rosacea: corns: papillomas: basal cell carcinomas; lesions of skin and subcutaneous tissue; plantar warts: periungual and subungual warts; debridement of decubitus ulcer; skin tag vaporization.

The device includes a Ho:Yag laser source with 35W max output power at 2100 nm wavelength. The optical delivery system is an optical fiber. The HYPHO Laser System is designed with six major sub-systems, including: (1) Power Supply: a high voltage power supply, which converts and rectifies the AC mains current to provide regulated power for the flash lamp simmer current and main triggering pulse; (2) Cooling System: a cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger; (3) Laser System: a Ho:YAG laser rod, capable of generating laser pulses at 2100 nm wavelength and a frequency up to 30 Hz; (4) Delivery System: an optical delivery system, interfacing the energy from the laser to the patient via an optical fiber and surgical hand piece. A RFID recognition system is included to read the fiber diameter and the number of reuses directly from the fiber equipped with the suitable transponder; (5) PC embedded with 7" display and Control Electronics which regulates the functions of the laser and allows parameter selection by the user, (6) Optical fibers (Hyper optical fibers) equipped with the transponder for recognition of core diameter and for the management of number of reuses. In addition to the six subsystems, the HYPHO Laser System incorporates several safety features, including a remote interlock, an emergency red push button, a footswitch and a key switch. Moreover, the system features two laser emission indicators: a Led stripe located on the top of the frontal panel and a buzzer. The led stripe is green in READY mode and blue in EMISSION mode. The buzzer sounds during laser emission. The HYPHO Laser System is operated via proprietary FW and SW. The SW communicates with embedded FW in the main processor and manages Graphical User Interface (GUI) running on the PC embedded.

This looks like a 510(k) summary for a medical device called the "HYPHO Laser System" from Hyper Photonics S.r.l. This type of document focuses on establishing substantial equivalence to a predicate device, rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way a clinical trial or AI algorithm validation study would.

Therefore, the request for a table of acceptance criteria and reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies is not directly applicable to the information provided in this 510(k) summary. These summaries typically describe the type of testing performed to demonstrate safety and effectiveness for a laser surgical instrument, without going into specific numerical performance data or clinical study designs.

However, I can extract what is provided about the validation.

Here's an attempt to answer your questions based on the provided text, highlighting where the information is not present in a typical 510(k) context:

This document does not pertain to an AI/ML powered device, nor does it present a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only study. This is a 510(k) premarket notification for a laser surgical instrument, primarily demonstrating substantial equivalence to predicate devices through technical performance and safety testing.

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

A table of specific quantitative acceptance criteria (e.g., in terms of accuracy, precision, sensitivity, specificity) and corresponding reported performance is not provided in this 510(k) summary. The document states that "Test results indicated that the subject HYPHO Laser system performs in accordance with its requirements and specifications, in similarity with its predicate devices." This is a qualitative statement of successful testing rather than specific numerical performance data.

2. Sample sized 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/not provided in this type of submission. The "test set" in this context refers to the device itself undergoing engineering and bench tests, not a dataset of patient cases.

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)

This information is not applicable/not provided. Ground truth in the context of this device would relate to the clinical outcome of surgical procedures, which is not the focus of this 510(k) submission for substantial equivalence. The "tests" mentioned are primarily engineering and safety tests.

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

This information is not applicable/not provided. Adjudication methods are typically used in clinical studies or AI algorithm validation to resolve discrepancies in expert interpretations, which is not the type of testing described here.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a laser surgical instrument, not an AI diagnostic or assistance tool, so MRMC studies and "human readers improve with AI" metrics are not relevant to this submission.

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

No, a standalone algorithm-only performance study was not done. This is a physical surgical laser device, not a software algorithm.

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

This information is not applicable/not provided in the context of the described performance activities. The performance activities listed are:

• Risk analysis
• Electrical and laser safety and electromagnetic compatibility testing
• Software verification and validation
• System testing (e.g., footswitch, emission indicator, emergency button, ON/OFF button)

For these tests, "ground truth" would be defined by engineering specifications, safety standards, and functional requirements, not clinical outcomes or expert consensus on a dataset.

8. The sample size for the training set

This information is not applicable/not provided. This device does not use a "training set" in the context of machine learning.

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

This information is not applicable/not provided, as there is no training set for this type of device.

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