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Litho laser system and its fiber optic delivery system are in surgical procedures using open, laparoscopic and endoscopic incision, excision, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectorny, Gynaecology, ENT and General Surgery.

Urology
Open and endoscopic surgery (incision, excision, 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 urethral, 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, excision, resection, ablation, vaporization, and haemostasis of soft tissue and cartilage) including:

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

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, tumors and lesions
• • Biopsy

Litho family includes surgical laser devices that are used by health care professionals in professional healthcare environments. Litho family includes the following models: Litho 60, Litho 100 and Litho 150. They differ only for the maximum power: 60, 105 and 152, respectively.

Litho devices are connected to optical fibers accessories (separately FDA cleared: K131473, K160513, K200234).

The device is equipped with a graphical user interface through which the user can set energy, frequency and pulse duration level. Different pre-sets are available among which the so called "special effects": Virtual Basket and Magneto. Virtual basket and Magneto are optional configurations.

Virtual basket had been introduced with K192600 (for Litho 100) and already included in Litho 150 510K (K201455). While, Magneto is the object of the present 510K.

Virtual basket consists of two sub-pulses separated by a certain delay. The first pulse generates a cavitation bubble and the second one is emitted when the first bubble reaches its maximum expansion. This allows the stone to be "caught" to be fragmentated. The set energy is the sum of the two sub-pulses. While Magneto consists of a pulse with a duration higher than standard one (2000 μs vs 1100 μs). Devices with Magneto configuration installed are characterized by black covers and Magneto logos.

The device can be divided into four main sections:

• . Power electronics: they manage power supplied to all device compartments;
• . Control electronics: they mainly consist of a microcontroller board where device main firmware (FW) is resident and a PC embedded with graphical user interface where device software (SW) runs;
• Cooling system: it cools the laser source pumping chamber;
• . Optical bench.

Here's an analysis of the provided text to extract information about acceptance criteria and the study proving device performance.

It's important to note that the provided text is an FDA 510(k) clearance letter and an accompanying 510(k) summary for a medical laser device. This type of document primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than outlining a detailed clinical or performance study with acceptance criteria in the way one might for a novel AI/ML device.

Therefore, many of the typical questions asked about acceptance criteria and proving device performance for AI/ML devices (e.g., sample size, ground truth establishment, expert adjudication, MRMC studies) are not directly applicable or explicitly detailed in this type of submission.

The "performance" described here is primarily in terms of technical specifications and demonstrating that the device's optical and safety characteristics are similar to or within acceptable limits compared to predicates.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Overview: The submission describes the "Litho 60; Litho 100; Litho 150" laser systems. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to previously cleared predicate devices (Litho 60, Litho 100 (K192600), Litho 150 (K201455)) and a reference device (MultiPulse HoPlus (K161257)). The change addressed in this submission is the introduction of a new "Magneto" configuration, which alters the pulse duration.

The "acceptance criteria" in this context are not performance metrics for an AI/ML algorithm (like sensitivity/specificity), but rather the demonstration that the modified device's technical specifications (e.g., laser wavelength, power, pulse width) and safety profiles remain substantially equivalent to, or are a sub-set of, the predicate/reference devices, and that it continues to meet relevant medical device safety standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• This document does not describe a "test set" in the context of an AI/ML model's performance on patient data.
• The "testing" mentioned refers to non-clinical bench testing to confirm the device's technical specifications and compliance with safety standards (e.g., electrical safety, electromagnetic compatibility, laser safety).
• Data provenance for such bench tests is typically internal laboratory data, not patient data from specific countries or retrospective/prospective studies.

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

• Not applicable. There is no "ground truth" derived from expert review in this type of submission. Performance is measured against engineering specifications and international standards.

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

• Not applicable. No expert adjudication process foreseen for this type of device and submission.

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:

• Not applicable. This is not an AI/ML device, and no MRMC study was performed.

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

• Not applicable. This is a laser surgical instrument, not an algorithm.

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

• Not applicable in the AI/ML sense. The "ground truth" here is the adherence to engineering specifications, validated physical measurements (e.g., laser power, pulse width), and compliance with the requirements of recognized safety and performance standards (e.g., IEC 60601 series).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

In summary, this 510(k) demonstrates substantial equivalence for a medical laser device based on engineering specifications, compliance with international safety standards, and comparison of its performance characteristics (like laser parameters) and indications for use to previously cleared devices. It does not involve AI/ML performance testing or studies with human readers/cases.

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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.

Ask a specific question about this device

LITHO 60 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, Gynaecology, ENT and General Surgery.

Urology
Open and endoscopic surgery (incision, excision, 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 (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 haemostasis) including:

• · Appendectomy
• Polyps
• · Biopsy
• Gall Bladder calculi
• · Biliary/Bile duct calculi
• · Ulcers
• Gastric ulcers
• · Duodenal ulcers
• · Non Bleeding Ulcers
• · Pancreatitas
• Haemorrhoids
• · Cholecvstectomy
• · 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-SI 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, excision, resection, ablation, vaporization and haemostasis of soft tissue and cartilage) including:

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

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 of partial resection of internal organs, tumors and lesions
• Biopsy

This Special 510(k) of the modified device Litho 60 is submitted due to Device Modifications of the already cleared device Cyber Ho (K170331) due to some technical changes. The modified device has the same intended use of the unmodified device. Moreover the the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications. Based on the nature of the changes implemented, the device underwent and successfully passed performance testing and software verifications and validation according to the relevant standards.

The provided text describes a Special 510(k) submission for the Litho 60 laser system, highlighting modifications to an already cleared device, the Cyber Ho (K170331). The submission claims substantial equivalence based on the same intended use and fundamental scientific technology (Holmium laser sources).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "performance testing" and "software verifications and validation." However, it does not specify the sample size for these tests. It also does not provide information on the data provenance in terms of country of origin or whether the tests were retrospective or prospective. These tests are typically conducted in a laboratory or controlled environment rather than with patient data.

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 section is not applicable as the provided document pertains to regulatory compliance and technical performance testing of a laser surgical instrument, not a diagnostic device that requires expert ground truth for interpretation of medical images or data. The "ground truth" here is the adherence to established safety and performance standards.

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

This section is not applicable for the same reason as point 3. Adjudication methods are relevant for cases where human interpretation is involved in establishing a ground truth or evaluating performance, which is not the case for the compliance 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

This section is not applicable. The Litho 60 is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be relevant.

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

This section is not applicable. The Litho 60 is a physical medical device (a laser system) and not an algorithm or software that operates in a standalone capacity for diagnosis or interpretation. Its performance is evaluated based on its physical and electrical characteristics, and its ability to perform its intended surgical functions, not as a standalone algorithm.

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

The "ground truth" for the Litho 60 device's performance is established by its compliance with internationally recognized consensus standards for medical electrical equipment and laser product safety (IEC 60601-2-22 and IEC 60825-1, respectively), as well as successful software verifications and validations. These standards define the expected performance and safety characteristics.

8. The sample size for the training set

This section is not applicable. The Litho 60 is a laser surgical instrument and does not involve machine learning or artificial intelligence, thus it does not have a "training set." Its design and performance are based on engineering principles and regulatory standards.

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

This section is not applicable for the same reason as point 8.

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