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The Extracorporeal Shock Wave Lithotripter, model: U200, is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

The Extracorporeal Shock Wave Lithotripter, U200, is intended to treat urinary tract stones using ESWL. The Extracorporeal Shock Wave Lithotripter generates high-energy shock waves using a shock wave generator that is focused to produce a highly concentrated stress area at the focal point. These pressure pulses are focused on a specific point in the body where the Urinary calculi are located using assisted movement and manual localization through B-ultrasound. The pressure generated by the shock wave causes the human urinary tract stones to produce physical effects to achieve the therapeutic purpose of crushing stones.

The Extracorporeal Shock Wave Lithotripter, U200, is composed of main unit, control console, patient table, electrical cabinet, power supply unit, and computer.

Control platform is integrated control of electric cabinet, main engine and treatment bed.

Electrical cabinet is used to provide power control of the whole machine, and shock wave source function control.

Main Unit contains the L-shape arm and the support matrix of the impact wave source, and realize the movement of L-shape arm up and down, rotation and oscillation of the impact wave source inside and outside.

Power box is power supply of the whole machine, power supply input voltage 120 V, 60 Hz, 3000VA.

Treatment bed is used for patient support and treatment position, and provides three-dimensional movement to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures.

PC(OptiPlex 7000 Tower) is used for installation of Extracorporeal Shock Wave Lithotripter Computer Control System, and to realize the Movement Control Support Function and the calibration of shock wave target, and image handling.

Principle of operation:

The extracorporeal shock wave lithotripter generates pressure pulses using an electromagnetic shock wave generator, with water serving as the transmission medium. These high energy shock waves with peak acoustic pressure up to 35MPa are focused on a specific point using a lens. In addition, the lithotripter often incorporates an ultrasound-based assisted movement system which locates and aligns the shock wave focus with the urinary tract stone. The shock waves create a stress effect on the stone. After several hundred to around two thousand discharges, the stones are fragmented into smaller pieces which can be excreted from the body.

This document is a 510(k) clearance letter for an Extracorporeal Shock Wave Lithotripter (U200). It describes the device, its intended use, and the studies conducted to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative thresholds for the clinical study's primary effectiveness endpoint. Instead, the clinical study aims to demonstrate that the device has a "safety and effectiveness profile that is similar to the predicate device." The reported device performance is presented as successful outcomes in various subgroups. The key performance metrics are "effective rate" for stone fragmentation.

• FAS (Full Analysis Set): 79.2%
• PPS (Per-Protocol Set): 86.4% |
  | Localization Accuracy: Auxiliary positioning target error, number of auxiliary positioning operations, and total time of auxiliary positioning operations should demonstrate relative speed, accuracy, and convenience. | Localization Performance:
• Auxiliary positioning target error: within 3mm
• Number of auxiliary positioning operations: within 3 times
• Total time of auxiliary positioning operations: within 15min
  (Stated as "relatively fast, accurate, and convenient, and the system ergonomics performance is good.") |
  | Safety: Device should be safe with no device malfunctions reported in the clinical investigations. | Safety: "The incidence of device malfunction does not happen in these clinical investigations." "patients treated by the Extracorporeal Shock Wave Lithotripter (model: U200) are safe." |
  | Subgroup Effectiveness (Inferred, as results are presented): Demonstrate effectiveness across different stone sizes, locations, and densities. | Stone Size:
• Stones 5-10mm (FAS): 92.9% effective rate
• Stones 10-15mm (FAS): 60.0% effective rate
• Stones 5-10mm (PPS): 100% effective rate
• Stones 10-15mm (PPS): 66.7% effective rate |
  | | Stone Location:
• Kidney stones (FAS): 80.0% effective rate (Renal calyx: 75.0%, Renal pelvis: 100%)
• Ureteral stones (FAS): 78.6% effective rate (Upper ureteral: 70.0%, Middle ureteral: 100%, Lower ureteral: 100%)
• Kidney stones (PPS): 80.0% effective rate (Renal calyx: 75.0%, Renal pelvis: 100%)
• Ureteral stones (PPS): 91.7% effective rate (Upper ureteral: 87.5%, Middle ureteral: 100%, Lower ureteral: 100%) |
  | | Stone Density:
• Density 1000HU (FAS): 81.8% effective rate
• Density 1000HU (PPS): 81.8% effective rate |

Study Details from the Provided Text:

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

   • Clinical Test Set Sample Size: 25 subjects enrolled, 22 subjects completed the study. (4 subjects failed screening, 3 dropped out). The study used both a Full Analysis Set (FAS) and a Per-Protocol Set (PPS) for effectiveness calculation, implying some missing data handled by intent-to-treat (FAS) and per-protocol (PPS).
   • Data Provenance: The clinical investigation was a "multicenter, open-label clinical design." The specific countries of origin for the clinical data are not mentioned, but the manufacturer and correspondent are based in China. The retrospective or prospective nature is not explicitly stated, but "clinical investigations" with "subjects screened," "enrolled," and "followed for a period of follow-up" strongly suggest a prospective study design.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

   • The document does not explicitly state the number of experts or their qualifications used to establish "ground truth" for stone fragmentation. The primary effectiveness endpoint, "effective rate," is defined based on the outcome of the ESWL treatment, likely assessed clinically (e.g., successful fragmentation and clearance/passage of stones). This assessment would typically be done by treating physicians (urologists) or through imaging (e.g., ultrasound, X-ray) reviewed by radiologists, but the document does not specify.

3. Adjudication Method for the Test Set:

   • The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for assessing the "effective rate" or other clinical outcomes. It suggests that the clinical outcomes were observed and reported as part of the study.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

   • No. This device is an Extracorporeal Shock Wave Lithotripter, which is a physical medical device for breaking up stones, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable in the AI sense. The device's primary function is a physical therapy. However, the document does mention "PC(OptiPlex 7000 Tower) is used for installation of Extracorporeal Shock Wave Lithotripter Computer Control System, and to realize the Movement Control Support Function and the calibration of shock wave target, and image handling." It also states "Software Verification and Validation was performed, and it was demonstrated that the software performs as intended." This implies a standalone software performance assessment, but not a standalone diagnostic algorithm performance assessment. The device's "localization/stone targeting system" appears to be an integral part of its operation, not a separate diagnostic algorithm.

6. The Type of Ground Truth Used:

   • For the clinical effectiveness endpoint ("effective rate"), the ground truth is based on clinical outcomes (successful stone fragmentation and presumed clearance) observed in patients after receiving ESWL treatment. This would typically be assessed by follow-up imaging and clinical evaluation.
   • For Localization Accuracy, the ground truth was likely established by physical measurements comparing the "target location" to the "shock wave focus."

7. The Sample Size for the Training Set:

   • The document does not mention a separate training set or its sample size for the clinical study. This is a medical device clearance, not an AI model development project where explicit training sets are typically discussed. If any software component used machine learning, details of its training would be relevant, but those are not provided. The clinical study described appears to be a validation/test set for the entire system's clinical performance.

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

   • Since no explicit training set for a machine learning model is mentioned, the method for establishing ground truth for a training set is not applicable based on the provided text.

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The Bolt Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, and infra-popliteal arteries. Not for use in the coronary, carotid, or cerebral vasculature.

The Bolt Intravascular Lithotripsy (Bolt IVL) System is a proprietary balloon catheter and console designed to enhance percutaneous transluminal angioplasty by delivering calcium disrupting lithotripsy prior to balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) allowing low-pressure balloon dilatation of the stenosis.

The Bolt IVL catheter is delivered through the peripheral arterial system of the lower extremities to the lesion site. The balloon is partially inflated and the lithotripsy emitters generate pulsatile mechanical energy within the balloon at the target treatment site allowing subsequent dilatation of a peripheral artery stenosis using low balloon pressure. The Bolt IVL Catheter is a single-use device supplied sterile to the customer.

The Bolt IVL console delivers energy through the integrated catheter cabling to the emitters located inside the catheter balloon. The Bolt IVL Console is a non-sterile, reusable device.

Here's a breakdown of the requested information based on the provided text, focusing on the study that proves the device meets the acceptance criteria. It's important to note that the provided text is an FDA 510(k) summary, which often provides high-level summaries of acceptance criteria and performance rather than detailed tables for every test.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally qualitative for many of the bench tests (e.g., "meets its design specifications"). For the clinical studies, quantitative performance goals are provided.

Bench and Animal Testing Acceptance Criteria & Performance:

Clinical Study (RESTORE ATK & RESTORE BTK) Acceptance Criteria & Performance:

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The Electrohydraulic Lithotriptor is intended to be used with Potent Medical disposable electrohydraulic lithotripsy (EHL) probes for disintegration of concernments in the bile duct.

The EHL is a compact, table-top medical device designed for the fragmentation of biliary calculi. It operates by generating high-voltage electric pulses, which are transmitted through a compatible disposable EHL probe (sold separately) that is inserted into the biliary tract via an endoscope. The device features two operational modes: single pulse and continuous pulse. These electric pulses create hydraulic shock waves in a saline medium, causing fragmentation of biliary stones into smaller pieces that can either be naturally passed or removed endoscopically.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that specifically proves the device meets such criteria.

The document is a 510(k) summary for an Electrohydraulic Lithotriptor (TCS-B3-II) and focuses on demonstrating substantial equivalence to a predicate device (EL27-Compact). It outlines various performance and safety tests conducted but does not provide specific acceptance criteria values or detailed study results in the format requested.

The "Performance Data" section mentions "Stone Fragmentation Test," "Shockwave Pressure Attenuation Test," "Acoustic Characterization Test," "Electrical Safety and Electromagnetic Compatibility (EMC) Testing," and "Software Verification and Validation." However, it only describes what these tests validated or complied with (e.g., "validated the system's ability to generate consistent high-voltage pulses," "tested for compliance with IEC 61846," "tested for compliance with IEC 60601-1"), rather than presenting quantitative acceptance criteria and the device's reported performance against them.

Therefore, I cannot populate the table or answer the specific questions regarding sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details for any specific acceptance criteria from this text.

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The Shockwave Medical IVL System with the Javelin Peripheral IVL Catheter is intended for lithotripsy-enabled modification and crossing of calcified lesions in the peripheral vasculature, including the iliac, femoral, popliteal, and infra-popliteal arteries, prior to final treatment.

Not for use in the coronary, carotid, cerebral, or pulmonary vasculature.

The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves modify calcified plaque in peripheral arteries. Energizing the intravascular lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion and allowing dilation of peripheral artery stenosis.

The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter consists of three main components: the IVL Catheter, the IVL Generator, and the IVL Connector Cable. The Shockwave Javelin IVL Catheter is comprised of a catheter with an integrated emitter located near the distal end to enable the localized delivery of acoustic pressure pulses in the peripheral vasculature. The emitter is racilitate catheter visibility under fluoroscopy and is surrounded by a fluid-filled space (IVL window) that allows for the transmission of acoustic pressure pulses.

The Shockwave Javelin Peripheral IVL Catheter shaft contains a lumen to pressurize and a lumen to de-pressurize the catheter with saline (the medium to create IVL), a guidewire lumen, and a lithotripsy emitter. The emitter is enclosed within a non-expandable polymer fluid-filled space (i.e., IVL window) containing saline that is connected to the proximal shaft, inlet and outlet ports, and is tapered down to the distal tip of the catheter. The IVL window is located near the distal tip of the catheter. The emitter is radiopaque to facilitate catheter visibility under fluoroscopy and is surrounded by the IVL window that allows for the transmission of acoustic pressure pulses. The IVL window is designed to provide a static catheter profile.

The IVL Generator and Connector Cable are used with the Shockwave Javelin Peripheral IVL Catheter to deliver localized, lithotripsy-enabled modification and crossing of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of acoustic pressure pulses. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator.

The Shockwave L Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters are positioned along the length of the balloon working length for delivery of acoustic pressure pulses. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure.

The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.

This document is a 510(k) Summary for the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter. It describes the device, its intended use, and the testing conducted to demonstrate substantial equivalence to a predicate device.

Based on the provided information, the device discussed is primarily a mechanical device (a catheter system that uses lithotripsy) and not an AI/ML powered device. The document does not contain the specific information requested in questions 1 through 9, which are typically associated with the acceptance criteria and study designs for AI/ML-powered medical devices. The performance data section refers to "design verification and validation testing" for mechanical and electrical properties (e.g., guidewire compatibility, balloon diameter, sonic output, pulse rate), not AI/ML model performance metrics.

Therefore, I cannot provide a response filling in the requested table and answering questions 1-9 accurately, as the provided text does not contain information about acceptance criteria, study details, expert involvement, or ground truth for an AI/ML-powered device.

To answer your request, the provided document does not contain the necessary information regarding: AI/ML acceptance criteria, performance metrics, sample sizes for AI/ML test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment relevant to an AI/ML device.

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

The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of acoustic pressure pulses. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator.

The Shockwave E Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The emitters are positioned along the length of the balloon working length for delivery of acoustic pressure pulses. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure.

The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.

The provided text does not contain information about acceptance criteria for device performance in a clinical study, nor does it detail a clinical study that proves the device meets specific performance criteria.

The document is a 510(k) Pre-Market Notification from the FDA for a device called the "Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter". It states that the device is substantially equivalent to a legally marketed predicate device (K191840) and a reference device (K203365).

The "Summary of Performance Data" section (on page 6 of the input) lists various design verification and validation tests that were conducted to ensure the device meets its design specifications and conforms to user needs. These are engineering and performance tests on the device itself, rather than clinical efficacy or safety studies with human subjects.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance (as it pertains to clinical data).
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size with AI assistance.
6. Standalone (algorithm-only) performance results.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document explicitly states: "Results demonstrated that the performance of the IVL System meets its design specifications and demonstrates substantial equivalence for its intended use; therefore, additional clinical data were not required." This indicates that no clinical study was performed or needed for this 510(k) clearance, and thus, no such clinical data is available in the provided text.

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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 is a software-controlled digital flexible ureteroscope system that consists of the StoneSmart Connect Console and the Single-Use Digital Flexible Ureteroscope. 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 devices within the scope of this Special 510(k) premarket notification are the StoneSmart Connect Console and the LithoVue Elite Single-Use Digital Flexible Ureteroscope (without pressure monitoring).

Changes to the StoneSmart Connect Console (cleared under K221515 on 02-FEB-2023) include software changes to introduce a new user control feature (referred to as "Aiming Beam Mode") that is designed to provide the physician with more options to reduce interference from high intensity laser aiming beams within the live image displayed by the LithoVue Elite ureteroscope system and implement software bug fixes and enhancements.

The proposed LithoVue Elite Single-Use Digital Flexible Ureteroscope is the same as the predicate LithoVue Elite Sinqle-Use Digital Flexible Ureteroscope with pressure monitoring (K221515) with respect to its design, performance, intended use, operating principle, and fundamental technology, except that it does not possess the pressure monitoring capability.

This document is a 510(k) summary for the StoneSmart Connect Console and LithoVue Elite Single-Use Digital Flexible Ureteroscope. It details the device's characteristics and its substantial equivalence to a predicate device (K221515).

Based on the provided text, the device is an endoscope system used to visualize the urinary tract and perform diagnostic/therapeutic procedures. The core of the submission revolves around software changes to the console and the removal of the pressure monitoring capability from the ureteroscope.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

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

The document doesn't explicitly present a table of acceptance criteria in the way one might see for an AI/ML device (e.g., predefined sensitivity/specificity thresholds). Instead, it relies on demonstrating substantial equivalence to a predicate device (K221515) by comparing technological and performance characteristics. The acceptance criterion is implicitly that the changes do not negatively impact safety or effectiveness, and the device performs similarly or better than the predicate.

Here's a table based on the "Comparison of Key Technological/Performance Characteristics" section, which serves as the evidence for meeting the implicit acceptance criterion of substantial equivalence:

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

The document states: "Design verification (bench) testing for visualization, mechanical performance, and durability, conducted by utilizing the predicate ureteroscope (K221515), remains valid for the proposed ureteroscope. Changes to the cleared console (K221515) are limited to software changes only. The existing bench testing information/data reviewed by the FDA for the predicate console (reference K221515) remains valid for the proposed console."

This indicates that a new clinical test set was not used for this submission. The "test set" for performance evaluation is effectively the data that supported the previous K221515 clearance. The document focuses on demonstrating that the changes (software update and removal of pressure monitoring) do not invalidate the prior testing.

• Sample size for test set: Not explicitly mentioned for this submission. It relies on the testing performed for K221515.
• Data provenance: Not specified for K221515's data (e.g., country of origin, retrospective/prospective).

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

This information is not provided in the document. Given that this is largely a performance and software change submission for an existing device, and not an AI/ML diagnostic system with new clinical claims requiring interpretation of images by experts, such details are generally not included. The "ground truth" for a ureteroscope is its ability to visualize and manipulate within the urinary tract, which is assessed through bench testing and, for prior clearances, likely clinical use data (though not detailed here).

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

This information is not provided. Not applicable for bench testing or performance verification of an endoscope system.

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. An MRMC study is typically for evaluating the diagnostic performance of software, especially AI, in assisting human readers. This submission is for an endoscope system (hardware and software for visualization and procedure) and not specifically an AI-based diagnostic aid that assists human readers in interpreting images for a specific diagnostic outcome. The "Aiming Beam Mode" is a user control feature for image quality, not an AI interpretation feature.

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

No. This is not an AI/ML algorithm that operates standalone to provide a diagnostic output. The "algorithm" here refers to the software controlling the endoscope system and processing the live video feed. Its performance is intrinsically tied to the human operator using the device for visualization and intervention.

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

For this type of device and submission, the "ground truth" relates to the functional performance of the device:

• Visualization Quality: Resolution, field of view, working distance (bench tested, as shown in the table).
• Mechanical Performance: Deflection, shaft dimensions.
• Safety: Biocompatibility, electrical safety, EMC, sterility (tested or demonstrated as equivalent to previously tested predicate).
• Software Functionality: Verification and validation of software changes (e.g., Aiming Beam Mode) against specifications.

The document states: "Design verification (bench) testing for visualization, mechanical performance, and durability, conducted by utilizing the predicate ureteroscope (K221515), remains valid for the proposed ureteroscope." This implies the ground truth for these aspects comes from bench test standards and measurements.

For software, the "ground truth" is adherence to software requirements and specifications through V&V activities. "Software testing was completed. The software documentation stipulated in FDA guidance document... was included in this premarket submission."

8. The sample size for the training set:

Not applicable. This submission is not for an AI/ML model that would have a "training set" in the traditional sense. The software changes are bug fixes and a new user control feature, which are typically developed and tested using standard software engineering practices (unit testing, integration testing, system testing) rather than a machine learning training dataset.

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

Not applicable. As above, there's no "training set" in the context of machine learning. The "ground truth" for software development would be the documented requirements and design specifications, against which the software's functionality is verified and validated.

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The LithoVue Elite Digital Flexible Ureteroscope System is intended 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 System is a software-controlled digital flexible ureteroscope system that consists of the Workstation (to be marketed as StoneSmart Connect Console) and the Single-Use Digital Flexible Ureteroscope (sterile, single-use disposable).

The LithoVue Elite System is designed to allow the physician to access, visualize and perform procedures in the urinary tract, and to provide real-time intraluminal pressure monitoring in the kidney and ureter during ureteroscopy.

The provided text is a 510(k) summary for the LithoVue Elite Digital Flexible Ureteroscope System. Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of "acceptance criteria" with quantitative targets alongside reported device performance for all aspects. Instead, it discusses performance testing and successful outcomes against design specifications. However, we can infer some criteria and reported performance from the "Comparison of Key Technological/Performance Characteristics" table and the "Performance Testing" section.

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

The document mentions "Bench testing" and a "GLP Animal Study."

• Bench Testing: The sample size for bench testing is not specified. The provenance is internal to the manufacturer (Boston Scientific Corporation). Nature of the data is not applicable (bench tests, not patient data).
• GLP Animal Study: The specific sample size (number of animals) for the GLP Animal Study is not provided. The provenance is internal to the manufacturer, conducted under Good Laboratory Practice (GLP) standards, which implies a controlled, prospective study.

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

Not applicable. The reported performance testing primarily involved objective measurements against design specifications and recognized standards (e.g., electrical safety, biocompatibility) and an animal study for pressure accuracy. There is no indication of human experts establishing ground truth for perception or diagnostic accuracy.

4. Adjudication method for the test set

Not applicable. The testing described does not involve expert adjudication for decision-making or image interpretation.

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 MRMC study was done. The device does not involve AI assistance for human readers; it is a diagnostic/therapeutic tool for visualization and pressure monitoring. Clinical testing was explicitly stated as not required to demonstrate substantial equivalence.

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

A standalone performance evaluation was conducted for the device's components and overall system. This includes bench testing for mechanical, optical, and pressure sensor characteristics, as well as an animal study for in-vivo pressure monitoring accuracy. The device itself (image capture and pressure sensing) operates in a standalone manner, providing data to the human user.

7. The type of ground truth used

• Bench Testing: Engineering specifications, physical measurements, and compliance with industry standards (e.g., for resolution, field of view, electrical safety).
• Biocompatibility: Results of standardized chemical and biological tests defined in ISO 10993-1.
• GLP Animal Study: Direct physiological measurements of intraluminal pressure in an animal model were used as ground truth for the device's pressure monitoring accuracy. The report of this study was included in the submission.

8. The sample size for the training set

Not applicable. This device is a hardware system for visualization and pressure monitoring, not a machine learning or AI-driven diagnostic device that requires a training set in the conventional sense.

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

Not applicable, as there is no training set for an AI model.

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