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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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The Multicavity Holmium 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: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.

The devices belonging to Multicavity 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. A specific software controls the device functions and allows the user selections. Laser emission is triggered by a footswitch.

The provided text describes a 510(k) premarket notification for a medical device (Quanta System Spa's Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60) which involves a modification to existing cleared devices. The modification is the addition of a new emission mode called "Virtual Basket" based on pulse modulation.

Critically, this document does not contain acceptance criteria or study data that proves the device meets specific performance metrics.

The submission is a Special 510(k) for device modifications, which means it evaluates whether the modified device remains substantially equivalent to its predicate devices, rather than establishing new performance benchmarks through de novo studies. Due to this, the level of detailed performance study data, acceptance criteria, and clinical trial information typically associated with complex AI/ML device submissions is not present.

Here's what can be extracted, and what information is explicitly not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states, "Based on the nature of the changes implemented, the device underwent and successfully passed software verifications and validation according to the relevant standards." This implies the "acceptance criteria" were successful completion of these tests. However, no specific numerical or qualitative performance criteria are listed for the "Virtual Basket" mode.

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

• Sample Size: Not applicable in the context of a clinical test set with patients/data. The testing involved bench testing (presumably on materials relevant to laser-tissue interaction or stone fragmentation) and software verification and validation. No patient-specific test set is described.
• Data Provenance: Not applicable. The tests are technical/engineering in nature (bench testing, software V&V) rather than clinical studies using patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. There is no mention of human experts establishing a "ground truth" for a test set, as this submission is not about an AI/ML diagnostic or prognostic device requiring expert annotation. It's about a laser surgical instrument and a new emission mode.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set requiring adjudication by experts is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC study was not done. The device is a surgical laser, not an imaging analysis or diagnostic AI/ML device that assists readers. The document only mentions "Bench testing comparing the Virtual Basket emission mode to the standard emission mode of the original device".

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable in the typical sense of AI/ML. The "Virtual Basket" mode is an emission mode of a laser; it's always used by a human surgeon. The "software verification and validation testing" would assess the software's standalone functionality.

7. The Type of Ground Truth Used:

• For Bench Testing: Likely physical measurements, observations, and objective assessment against engineering specifications related to laser power, pulse characteristics, and effects on target materials (e.g., stone fragmentation efficiency, tissue ablation depth).
• For Software Verification and Validation: Software requirements specifications, design specifications, and coding standards. The "ground truth" would be whether the software performs as designed and intended, free of critical defects.

8. The Sample Size for the Training Set:

• Not applicable. This submission doesn't describe an AI/ML model that requires a training set of data. The "Virtual Basket" mode is a predefined pulse modulation algorithm, not a machine learning model trained on data.

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

• Not applicable. (See point 8.)

Summary of what the document does tell us about the device and its assessment:

• Device: Holmium laser surgical system (Cyber Ho 60/100, Litho 60/100).
• Modification: Addition of a "Virtual Basket" emission mode via software update.
• Basis for Submission: Device modifications (Special 510(k)).
• Predicate Devices: Litho 60 (K172025) and Litho 100 (K180922).
• Testing Performed:
  • Bench testing comparing the new "Virtual Basket" mode to the standard emission mode.
  • Software Verification and Validation testing (according to FDA guidance).
• Tests Not Repeated (as there was no hardware or architecture change that could affect them): Electromagnetic compatibility, electrical safety, and general performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
• Conclusion: The device is considered substantially equivalent to its predicate devices, indicating the modifications (including the new Virtual Basket mode) do not raise new questions of safety or effectiveness.

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