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The LithoBlast Single-Use Holmium Laser Fiber is indicated for use in surgical specialties in which a compatible Ho:YAG laser system has received regulatory clearance. LithoBlast surgical fiber optic laser delivery devices are intended for use with any open source cleared surgical laser with an SMA 905 connector.

The LithoBlast Single-Use Holmium Laser Fibers are single use surgical fiberoptic laser delivery devices that transmit laser energy in a forward direction. The devices include a SMA 905 connector at the proximal end. The laser fibers are compatible with Ho:YAG laser systems. There are four (4) fiber core diameters: 272 Series (272 µm), 365 Series (365 µm), 550 Series (550 µm), and 940 Series (940 µm).

The laser fibers in the LithoBlast family are 300cm long. All have a 10 mm straight cut flat cleaved distal end. All include a stress booth and an ABS over nut extension sleeve (type A=straight and narrow; type B=indented with finger grips; type C=finger grips protrude) to enable the operator's firm grip. The SMA-905 connector attaches at the proximal end of the device.

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The LithoVue Elite Digital Flexible Ureteroscope System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The LithoVue Elite Digital Flexible Ureteroscope System is a software-controlled digital flexible ureteroscope system that consists of the StoneSmart™ Connect Console (cleared under K233645 on 12-DEC-2023) and the LithoVue™ Elite Single-Use Digital Flexible Ureteroscope (with and without pressure monitoring) (cleared under K241598 on 01-JUL-2024). The LithoVue Elite Digital Flexible Ureteroscope System is designed to allow the physician to access, visualize and perform procedures in the urinary tract.

The proposed device within the scope of this Special 510(k) premarket notification is LithoVue Elite Single-Use Digital Flexible Ureteroscope with Pressure Monitoring (referred hereafter as "ureteroscope" for brevity).

The proposed design changes to the ureteroscope include an updated pressure sensor assembly, along with modifications to the other device components such as the distal tip and PCBA to ensure compatibility with the new sensor assembly. The new pressure sensor is functionally equivalent to the currently used sensor assembly; however, its integration results in changes to patient-contacting materials.

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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.

Ask a specific question about this device

The LithoVue Elite Digital Flexible Ureteroscope System is intended to by used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The LithoVue Elite Digital Flexible Ureteroscope System (cleared under K221515 on 02-FEB-2023 and K233645 on 12-DEC-2023) consists of the StoneSmart Connect Console, LithoVue Elite Single-Use Digital Flexible Ureteroscope with pressure monitoring, and LithoVue Elite Single-Use Digital Flexible Ureteroscope (without pressure monitoring). The proposed devices within the scope of this Special 510(k) premarket notification are the LithoVue Elite Single-Use Digital Flexible Ureteroscope with pressure monitoring and LithoVue Elite Single-Use Digital Flexible Ureteroscope (without pressure monitoring).

The proposed ureteroscope with pressure monitoring contains a redesigned distal tip to improve its durability during a ureteroscopy procedure. To maintain congruence between the two marketed configurations of the ureteroscope, the distal tip of the ureteroscope (without pressure monitoring) is also modified to match the one used in the ureteroscope with pressure monitoring, with the exception that it does not contain the specific modifications intended for pressure monitoring. Furthermore, test methods are also modified to be more representative of "challenging" working conditions as well as for better alignment with the intent of the specifications.

This document is a 510(k) summary for the LithoVue Elite Single-Use Digital Flexible Ureteroscope. It details the device, its intended use, and a comparison to predicate devices, focusing on the substantial equivalence argument for regulatory clearance. Since this is a submission for the clearance of a device (a ureteroscope), and not for an AI/ML algorithm or a diagnostic test, the typical acceptance criteria and study designs that would apply to software are not present. The document focuses on the physical and functional aspects of the hardware.

Therefore, many of the questions regarding AI/ML-specific details, such as data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and training/test set ground truth, are not applicable to this document. The "device" in question is a physical endoscope.

However, I can extract the relevant performance testing information provided:

1. Table of acceptance criteria and the reported device performance:

The document implicitly defines acceptance criteria by stating that the proposed devices have the "Same" or "Identical" performance to the predicate devices across various characteristics. The specific numerical criteria mentioned are for "Pressure Measurement Accuracy" which applies to the ureteroscope with pressure monitoring.

Description of the Study:

The study performed was a "subset of the mechanical performance and durability testing (including pressure sensor durability testing) along with the 'Image Rotation Offset' testing." The purpose was to evaluate the "design changes" to the ureteroscopes, specifically a redesigned distal tip to improve durability. The document asserts that the proposed devices maintained the same performance characteristics as the predicate devices.

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

The document does not explicitly state the sample size for the mechanical performance and durability testing. It indicates that testing was performed on the "proposed ureteroscopes" to evaluate the design changes. The data provenance is not specified, but given it's for a medical device cleared in the US, it would generally be expected to be internal laboratory testing. It is a prospective evaluation of the new design.

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 and therefore not provided. The testing relates to the physical and functional performance of the device, not the interpretation of medical images or diagnoses.

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

This information is not applicable. Adjudication methods are typically used in clinical or image-based studies where expert consensus is needed. The testing described is physical performance testing against engineering specifications.

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 information is not applicable. The device is a ureteroscope (hardware), not an AI-powered diagnostic tool for human readers.

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

This information is not applicable. The device is a physical ureteroscope, not a standalone AI algorithm. It's a tool used by a human clinician.

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

The "ground truth" for this device would be its adherence to established engineering specifications and performance benchmarks for mechanical durability, optical clarity, and pressure measurement accuracy. This is based on objective measurements rather than expert consensus or pathology in a clinical sense.

8. The sample size for the training set:

This information is not applicable. The device is hardware; there is no AI/ML training set.

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

This information is not applicable. There is no AI/ML training set.

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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 document is a 510(k) premarket notification for a medical device called "Litho 150, Cyber Ho 150" (Multicavity Holmium laser). It describes device modifications and asserts substantial equivalence to a predicate device (Litho 100/60, K192600).

However, this document does not contain the detailed information necessary to complete the requested table and answer questions 2-9.

Here's why and what information is missing:

• Acceptance Criteria and Reported Performance: The document states that the device "underwent and successfully passed electrical safety, EMC and performance testing" according to specific standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and "Software Verification and Validation Testing". However, it does not provide specific numerical acceptance criteria (e.g., "power output must be within +/- 5%") or the actual numerical performance results of these tests (e.g., "power output was 150W +/- 2W"). It only confirms successful passing of these tests.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These questions are typically relevant for studies evaluating the clinical effectiveness or diagnostic accuracy of a device, especially those involving AI/ML models, image analysis, or outcomes assessment. This 510(k) is for a surgical laser, and the "performance testing" mentioned refers to engineering and safety standards, not a clinical study to establish diagnostic or treatment efficacy performance metrics in terms of sensitivity, specificity, accuracy, or similar measures against a clinical ground truth.

Therefore, I cannot populate the table or answer questions 2-9 based on the provided text.

However, I can extract the available information regarding the device's technical specifications and the standards it met:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other questions (2-9):

The document provides no information on these points because the submission is a "Special 510(k)" for device modifications based on hardware changes (increased power and frequency) to an already cleared device (K192600). The basis for this type of submission relies on demonstrating that the modified device remains substantially equivalent to the predicate through engineering and safety testing, not typically through new clinical studies involving human subjects or extensive ground truth establishment in the manner described by these questions. Such detailed clinical study methodology would be expected for novel devices or significant changes impacting clinical performance but is not provided for this specific submission type.

Ask a specific question about this device

The Litho EVO 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, Discectory, 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 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
· 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-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, 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

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
Biopsv

Litho Evo is based on Holmium laser cavity emitting at 2100nm. Laser emission is triggered by mean of a footswitch and is delivered to the tissue through fiber optics. The main parts (subsystems) of the subject device are the Holmium laser source, the optical delivery system, the power electronics, the control electronics and the cooling system. Moreover, a specific software controls the device functions and allows the user selections through the touchscreen display.

The provided text describes a 510(k) premarket notification for a medical device called Litho Evo, a Holmium laser system. This submission is a "Special 510(k)" due to modifications of an already cleared device, Olympus Empower H35 (K180426). The document states that performance testing and software verification and validation were conducted according to relevant standards. However, it does not provide a detailed study that proves the device meets specific acceptance criteria in terms of clinical performance or effectiveness.

Here's a breakdown of the requested information based only on the provided text:

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

The document does not explicitly state acceptance criteria for device performance in a clinical or measurable outcomes sense, nor does it report specific performance metrics (e.g., success rates, fragmentation efficiency, treatment times) for the Litho Evo device. Instead, it focuses on compliance with general safety and performance standards for medical electrical equipment and laser products.

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

The document does not describe any specific human-subject or clinical "test set" for evaluating the performance of the Litho Evo device against acceptance criteria. The performance testing mentioned refers to technical compliance with engineering and safety standards, not clinical 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)

Not applicable. The performance testing described is related to engineering and safety standards, not medical interpretation or clinical ground truth.

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

Not applicable. There is no mention of a test set requiring adjudication in the context of clinical performance.

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. The Litho Evo is a laser surgical instrument, not an AI-assisted diagnostic or interpretive device. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.

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

Not applicable. This device is a laser surgical instrument requiring human operation, not an autonomous algorithm.

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

Not applicable. The "ground truth" for the performance testing mentioned appears to be defined by the technical specifications and requirements outlined in the cited IEC and FDA standards for safety, electromagnetic compatibility, and laser product safety.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI that would require a "training set" in the conventional sense. Software verification and validation were conducted, but this doesn't equate to an AI training set.

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

Not applicable. (See #8)

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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The Shockwave Medical Lithoplasty System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.

The Shockwave Medical Lithoplasty System has three components: a proprietary balloon catheter, a generator, and a connector cable. The balloon catheter has integrated lithotripsy emitters and is designed to enhance percutaneous transluminal angioplasty by enabling delivery of the calcium disrupting capability of lithotripsy prior to full balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) prior to low-pressure balloon dilation of the stenosis and facilitates the passage of blood.

The Lithoplasty Catheter is delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat lesion. The balloon is partially inflated and the lithotripsy emitters are energized thereby generating pulsatile mechanical energy within the balloon at the target treatment site and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The Shockwave Medical Lithoplasty Generator delivers energy through the Connector Cable to the pulse emitters located inside the balloon in the Lithoplasty Catheter. The Lithoplasty Catheter is a single-use device supplied sterile to the customer. The Generator and Connector Cable are non-sterile reusable devices.

This document describes a 510(k) premarket notification for the "Shockwave Medical Lithoplasty System" (K163306), which is a medical device for lithotripsy-enhanced balloon dilation in peripheral arteries. This submission is for a modified version of a previously cleared device (K161384).

Here's an analysis of the provided information about acceptance criteria and studies:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance data in a structured format. Instead, it broadly states that:

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 "Component level testing" for the tri-port hub, and "hardware, electrical performance, electromagnetic compatibility, and software verification and validation tests." However, it does not specify the sample sizes used for these tests.

The data provenance is not mentioned. Given the nature of these tests (design verification and validation), they are typically conducted in a laboratory setting by the manufacturer. They are not clinical studies with patient data from a specific country or with retrospective/prospective data collection.

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 to the information provided. The document describes engineering and performance testing of a medical device, not a diagnostic algorithm or image analysis system that requires expert ground truth assessment. The "ground truth" here refers to the device's adherence to engineering specifications and performance standards.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies involving human assessment (e.g., image interpretation) to resolve discrepancies among experts. The tests described are engineering verification and validation, where performance is measured against objective standards.

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 device described is a physical interventional medical device (lithotripsy-enhanced balloon dilatation system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers with and without 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 device is not an algorithm, but a physical medical system. The performance testing described is for the device itself.

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

For the engineering and performance tests described, the "ground truth" implicitly refers to:

• Established engineering specifications and design input requirements: The device's performance was compared against these predefined physical and functional parameters.
• International and national standards: Compliance with standards like ISO 594-1/2, ANSI/AAMI ES60601-1, and IEC 60601-1-2 serves as the ground truth for safety and compatibility.

8. The sample size for the training set

This section is not applicable. The device is not an AI algorithm that requires a training set. The tests performed are for hardware and software verification and validation related to the device's design and manufacturing changes.

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

This section is not applicable as there is no training set for this type of medical device.

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The Litho laser system 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, Discectonly, 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 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, 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
• 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-SI lumbar discs, including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy
  • Percutaneous Thoracic Disc Decompression/Discectorny

Gynaecology
Open and laparoscopic gynaecological surgery (incision, resection, 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

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 is submitted due to Device Modifications of the already cleared device (K141101) due to the broadening of the range of some laser emission parameters such as power, energy and frequency. 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. The modified and unmodified devices are exactly the same except for the available range of emission parameters. A change to the software determined the differences between the modified and unmodified versions.

The provided text describes a 510(k) premarket notification for a medical device called "Litho," which is a laser system for various surgical procedures. The submission is for modifications to an already cleared device, primarily broadening the range of some laser emission parameters.

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria from an AI/algorithm performance perspective. The performance testing mentioned (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) pertains to electrical safety, electromagnetic compatibility, and general performance of the laser equipment, not to the efficacy or analytical performance of an AI or algorithm.

Therefore, I cannot extract the requested information regarding AI/algorithm acceptance criteria and performance study details from the provided text. The document is about a hardware modification (broadening laser parameters) to an existing laser surgical instrument, and its compliance with safety and electrical performance standards.

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The Shockwave Medical Lithoplasty System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.

The Shockwave Medical Lithoplasty System has three components: a proprietary balloon catheter, a generator, and a connector cable. The balloon catheter has integrated lithotripsy emitters and is designed to enhance percutaneous transluminal angioplasty by enabling delivery of the calcium disrupting capability of lithotripsy prior to full balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) prior to low-pressure balloon dilation of the stenosis and facilitates the passage of blood.

The Lithoplasty Catheter is delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat lesion. The balloon is partially inflated and the lithotripsy emitters are energized thereby generating pulsatile mechanical energy within the balloon at the target treatment site and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The Shockwave Medical Lithoplasty Generator delivers energy through the Connector Cable to the pulse emitters located inside the balloon in the Lithoplasty Catheter. The Lithoplasty Catheter is a single-use device supplied sterile to the customer. The Generator and Connector Cable are non-sterile reusable devices.

This document describes the Shockwave Medical Lithoplasty System, a device for treating peripheral arterial disease. The provided information is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone clinical study report. Therefore, some of the requested information cannot be fully extracted in the format requested, particularly for a comparative effectiveness study (MRMC) or a standalone AI algorithm study. However, I can provide the available information regarding the clinical study and its endpoints, which serve as acceptance criteria for safety and effectiveness.

Here's the summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The clinical study (DISRUPT PAD program) established primary and secondary endpoints for safety and effectiveness. These endpoints effectively serve as the acceptance criteria for the device's clinical performance.

2. Sample Size and Data Provenance for the Test Set (Clinical Study)

• Sample Size: 95 subjects were enrolled in the clinical study (DISRUPT PAD Program). 94 of these subjects received treatment with the Lithoplasty System.
• Data Provenance: Prospective, multi-center study conducted at seven sites in Austria, New Zealand, and Germany.

3. Number of Experts for Ground Truth and Their Qualifications

The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with X years of experience) used to establish ground truth for the clinical study endpoints. However, it does mention that "Core Lab" was involved in assessing calcium burden severity.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method used for the clinical study endpoints.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or described in this document. This document pertains to a medical device (Shockwave Medical Lithoplasty System) and its clinical performance, not an AI-powered diagnostic or assistive tool.

6. Standalone Performance Study (Algorithm Only)

No, a standalone (i.e., algorithm only without human-in-the-loop performance) study was not done, as this document is about a physical medical device.

7. Type of Ground Truth Used (Clinical Study)

The ground truth for the clinical study was established through clinical outcomes and measurements, including:

• Procedural success: Defined by a reduction in stenosis measured angiographically.
• Major Adverse Events (MAE): Defined clinically.
• Target lesion patency: Assessed by duplex ultrasound.
• Target lesion revascularization (TLR): Clinically observed and recorded events.
• Functional outcomes: Measured using Ankle-Brachial Index (ABI), Rutherford Category, and walking impairment assessments.
• Calcium burden: Assessed by a Core Lab.

8. Sample Size for the Training Set

This question is not applicable. The document describes a medical device study, not an AI algorithm, so there is no "training set" in the context of machine learning. The clinical study involved 95 patients; this is the test set for evaluating the device's performance.

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

This question is not applicable, as there is no training set for an AI algorithm.

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