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The Asurys™ Fluid Management System is intended for use in conjunction with an endoscope to provide irrigation and distention within endourological procedures.

The Asurys Fluid Management System (FMS) is a multi-functional system for use in a healthcare facility. This device is used during endourological procedures to manage fluid delivery to the patient. This system is comprised of an electromechanical console (capital unit) and a single-use sterile cassette and scope line (also known as Single-Use Device or SUD). The cassette works with the capital unit to apply pressure to the irrigation fluid being used in endourological procedures. Irrigation fluid from a standard source is pumped through a disposable inflow tubing set. The fluid is then delivered through a separate urological endoscope and into the patient's urinary tract. The subject device is compatible with the following fluids: Saline (0.9%), Sterile water, Glycine (1.5%), Mannitol (5%), Sorbitol (3%), Mannitol/Sorbitol (0.54%/2.7%), Glucose (5%). The Asurys FMS supports irrigation across a range of urological procedures, including Ureteroscopy (URS), Percutaneous Nephrolithotomy (PCNL), cystoscopy, and Benign Prostatic Hyperplasia (BPH) procedures. For each procedure type, the physician can utilize the system in Standalone mode, compatible with various urological endoscopes. In this mode, the physician sets a desired pump pressure which is maintained by the Asurys FMS through its software-controlled peristaltic pump. When used with a LithoVue Elite Single-Use Digital Flexible Ureteroscope, the physician can use the Asurys FMS in LithoVue Elite (LVE) mode for URS and PCNL procedures. In this mode, the LithoVue Elite's StoneSmart Connect console is connected to the Asurys FMS console, allowing the physician to use the LithoVue Elite scope buttons to control the irrigation settings and also to initiate an on-demand fluid flush (low, medium, and high flush options are available). When used with a LithoVue Elite device which has intraluminal pressure (ILP) monitoring, the physician can also regulate fluid flow based on ILP in addition to the pump pressure setting. The physician sets ILP flow limiter and flush limiter settings so that the Asurys FMS limits fluid flow to reduce the occurrence of higher-than-desired ILP. In addition, ClariSee (software feature) automated flow compensation is supported, which enables consistent fluid flow to be maintained while the working channel of the scope is occupied by instrumentation. Automated flow compensation generates additional pressure (setpoint +150mmHg pump pressure) to maintain the fluid flow when there is more resistance to fluid flow due to the working channel being occupied with surgical tools. This feature is only possible in LVE Mode. If pressure monitoring data is not available from LithoVue Elite device, then Asurys FMS can operate in LVE Lite mode, which allows use of the LithoVue Elite scope buttons to control the irrigation settings and also to initiate an on-demand fluid flush (low and medium flush options available) but without the ILP flow/flush limiters or ClariSee automated flow compensation.

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The TheraSphere 360™ Y-90 Management Platform includes Treatment Planning and Activity Calculation functionalities as optional interactive tools intended for calculating the activity of TheraSphere Microspheres required at treatment time based upon the desired dose, lung shunt fraction, anticipated residual waste, and liver mass.

The Treatment Planning and Activity Calculation functionalities include features to aid in TheraSphere Microspheres dose vial selection.

Additionally, the TheraSphere 360 Platform includes optional post-treatment analysis functionalities to be used following treatment with TheraSphere Microspheres. For post-TheraSphere Microspheres treatment, the TheraSphere 360 Platform should only be used for the retrospective determination of dose and should not be used to prospectively calculate dose or for pre-treatment planning when there is a need for retreatment using TheraSphere Microspheres.

The TheraSphere 360 Y-90 Management Platform is an end-to-end, browser-based platform that will host a wide range of resources (e.g. radioembolization activity calculations, ordering, tracking, and education) that support Authorized Users of TheraSphere Microspheres.

The TheraSphere 360 Platform includes treatment planning functionality, activity calculation functionality, vial selection and ordering, and post-treatment analysis functionality. The treatment planning functionality and the activity calculation functionality include an interactive tool intended for calculating the activity of TheraSphere Microspheres required at the treatment time based upon the desired dose, lung shunt fraction, anticipated residual waste, and liver mass.

The Vial Selector function allows users to select and order TheraSphere Microspheres dose vials from inventory that match desired results.

The post-treatment analysis functionality is intended as an optional tool for post-treatment evaluation following TheraSphere Microspheres treatment.

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SpaceOAR Vue System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR Vue System to reduce the radiation dose delivered to the anterior rectum.

The SpaceOAR Vue System is composed of biodegradable material and maintains space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.

The SpaceOAR Vue System consists of components for the preparation of an absorbable hydrogel spacer and a delivery mechanism packaged in a single use system. Upon injection, between the anterior rectal wall and prostate, the precursor (trilysine buffer solution with PEG-SG-TIB) and accelerator (a buffered solution) mix in the device Y-connector where the formation of SpaceOAR Vue hydrogel is initiated. The SpaceOAR Vue hydrogel is formed through cross-linking of the polyethylene glycol with succinimidyl glutarate and triiodobenzoate (PEG-SG-TIB) and Trilysine. This reaction gives off no measurable heat. The hydrogel temporarily positions the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR Vue System to reduce the radiation dose delivered to the anterior rectum. The hydrogel is biodegradable and maintains space for the entire course of prostate radiotherapy treatment. The hydrogel degrades via hydrolysis and is excreted via renal filtration.

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The OBSIDIO™ Conformable Embolic is indicated for use in the embolization of:

• Hypervascular tumors
• Blood vessels to occlude blood flow for controlling bleeding/hemostasis in the peripheral vasculature

The OBSIDIO™ Conformable Embolic is a premixed embolic agent consisting of pre-hydrated gelatin and layered silicate, and tantalum powder (to provide for visualization under fluoroscopy). Obsidio Embolic is delivered directly through a microcatheter into the blood vessel to block blood flow to target tissue without relying on precipitation or polymerization. The material conforms to the shape of the vessel. Obsidio Embolic is packaged in a 1 mL (1 cc) syringe. The device is supplied as a sterile, single use product.

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The Moses fibers are intended for use with compatible laser systems in surgical procedures involving endoscopic ablation, vaporization, excision, incision, coagulation of soft tissue, and lithotripsy of calculi in the medical specialty of urology.

The Moses D/F/L Laser Fibers are single-use, straight-firing delivery devices that transfer laser energy from the laser console to the treatment site. The laser energy travels within the fiber's silica glass core and exits through the distal end of the fiber. The Moses 200 D/F/L Fiber consists of a Ball Tip which aids in the passability of the small core fiber through a deflected flexible endoscope. Moses 365 D/F/L and Moses 550 D/F/L Fibers have a flat distal tip. The Moses Fibers also include an embedded RFID Chip, allowing the Laser Console to recognize fibers and limits the fibers to a single use. The Moses fibers are available in a single, box-one configurations. The Moses fibers are compatible with the (Lumenis) Pulse 120 Laser System, used for the energy delivery of the Holmium Laser Energy (Ho:YAG) from the Console. All Moses fibers have a 3-year shelf life and are provided EtO Sterilized.

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The TheraSphere 360™ Y-90 Management Platform includes Treatment Planning and Activity Calculation functionalities as optional interactive tools intended for calculating the activity of TheraSphere Microspheres required at treatment time based upon the desired dose, lung shunt fraction, anticipated residual waste, and liver mass.

The Treatment Planning and Activity Calculation functionalities include features to aid in TheraSphere Microspheres dose vial selection.

Additionally, the TheraSphere 360 Platform includes optional post-treatment analysis functionalities to be used following treatment with TheraSphere Microspheres. For post-TheraSphere Microspheres treatment, the TheraSphere 360 Platform should only be used for the retrospective determination of dose and should not be used to prospectively calculate dose or for pre-treatment planning when there is a need for retreatment using TheraSphere Microspheres.

The TheraSphere 360 Y-90 Management Platform is an end-to-end, browser-based platform that will host a wide range of resources (e.g. radioembolization activity calculations, ordering, tracking, and education) that support Authorized Users of TheraSphere Microspheres.

The TheraSphere 360 Platform includes treatment planning functionality, activity calculation functionality, vial selection and ordering, and post-treatment analysis functionality. The treatment planning functionality and the activity calculation functionality include an interactive tool intended for calculating the activity of TheraSphere Microspheres required at the treatment time based upon the desired dose, lung shunt fraction, anticipated residual waste, and liver mass.

The Vial Selector function allows users to select and order TheraSphere Microspheres dose vials from inventory that match desired results.

The post-treatment analysis functionality is intended as an optional tool for post-treatment evaluation following TheraSphere Microspheres treatment.

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These single-use biopsy forceps are specifically designed to collect tissue endoscopically for histologic examination. These forceps should not be used for any purpose other than their intended function.

The Radial Jaw™ 4 Pulmonary Biopsy Forceps (RJ4 Pulmonary) is a sterile, single-use device. The RJ4 Pulmonary Biopsy Forceps are available in two jaw sizes: RJ4 Pulmonary Large Capacity is compatible with a 2.8 mm or larger working channel endoscope and the RJ4 Pulmonary Standard Capacity is compatible with a 2.0 mm or larger working channel endoscope. The RJ4 Pulmonary Large Capacity is only available without a needle. The RJ4 Pulmonary Standard Capacity is available with or without a needle. Both the RJ4 Pulmonary Large Capacity and Standard Capacity devices have a 100cm working length, and are offered in Box 5 and Box 20 packaging configurations.

To operate the device, the user slides the spool back and forth over the handle body to open and close the jaws. The spool simultaneously actuates the dual pull wires, each of which run the length of the device and terminate with a connection to the jaw. The dual pull wire design allows the jaws to pivot, thus enabling tissue acquisition with a tangential approach if desired. Using RJ4 Pulmonary Biopsy Forceps the user can obtain a tissue sample by opening the jaws, pressing the jaws against the biopsy site, closing the jaws, and pulling the jaws away from the biopsy site.

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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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The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous electrocardiogram (S-ECG). The recorded S-ECG is used for the clinical evaluation and diagnosis of cardiac arrhythmias. The LUX-Dx is indicated for use in patients that have a known heart condition and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia, such as dizziness, palpitations, syncope, chest pain, and/or shortness of breath. The LUX-Dx ICM is indicated for atrial fibrillation monitoring in patients that have been previously diagnosed or treated for atrial fibrillation.

The LUX-Dx II and LUX-Dx II+ ICM devices evaluate S-ECG waveform data for indications of cardiac arrhythmias and "marks" the S-ECG signal for clinical presentation and evaluation when the algorithm criteria are met. The ICM device is inserted into the subcutaneous layer of the fourth intercostal space of the left chest wall. The ICM device is powered by an integrated battery. The LUX-Dx system includes the following main components:

• ICM device - a subcutaneously-implanted cardiac monitor device for cardiac arrhythmia event data collection and transmission. In addition, symptom events are collected and transmitted from the device.
• Mobile Monitor (MM) - mobile applications (myLUX™ Patient app and LUX-Dx™ Clinic Assistant app) running on an OTS mobile device that communicates with the ICM device (using Bluetooth Low Energy (BLE)) and the LATITUDE Clarity™ server (using cellular/Wi-Fi) for collection and transmission of event, patient, and device data.
• LATITUDE Clarity™ server - a server that communicates with the Mobile Monitor for bidirectional data transmission and provides web access for clinicians to perform remote monitoring activities and manage general patient and system parameters and workflow activities.
• System Accessories - for insertion of the ICM device, an insertion tool and incision tool are provided. In addition, a magnet is provided to initiate ICM/MM app communication.

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Flexiva Pulse and Flexiva Pulse TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse and Flexiva Pulse TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use.

Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use

Flexiva Pulse, Flexiva Pulse TracTip, Flexiva Pulse ID and Flexiva Pulse ID TracTip Single Use Laser Fibers are fiber optic laser energy delivery devices consisting of a SMA connector (Black Hole design), and an ETFE jacketed silica core fiber. Flexiva Pulse and Flexiva Pulse ID fibers are equipped with a polished, flat output tip (242µm, 365µm, 550µm and 910µm size) and the Flexiva Pulse TracTip and Flexiva Pulse ID TracTip fibers are equipped with a polished and reinforced ball-shaped output tip (242µm size).

These fibers may be used in a variety of laser-based surgical cases. For Flexiva Pulse ID laser fibers, an RFID (Radio-frequency identification) tag enables read/write data storage for compatible RFID-equipped laser systems (closed systems).

The provided FDA 510(k) clearance letter and summary for the Flexiva Pulse Laser Fibers does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and study particulars for a medical device. This document is a premarket notification for laser fibers, which are physical components and not typically subject to the same kind of performance studies as, for example, an AI diagnostic algorithm.

Specifically, it lacks information about:

• Acceptance Criteria for a diagnostic output: As the device is a laser fiber for surgical use, its "performance" is about its physical properties and ability to transmit laser energy, not diagnostic accuracy.
• Study proving device meets acceptance criteria in the context of diagnostic accuracy.
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for test and training sets, and training set sample size and ground truth establishment for AI-based devices. These are all concepts related to clinical performance evaluation, particularly for AI/Machine Learning devices, which is not the nature of the Flexiva Pulse Laser Fibers.

The document does describe performance testing related to the physical and functional attributes of the laser fiber. I will present the information contained in the document that most closely aligns with the spirit of your request, interpreting "acceptance criteria" and "reported device performance" in the context of a physical medical device.

Overview of Device Performance and Testing (Flexiva Pulse Laser Fibers)

The document describes a Special 510(k) submission for the Flexiva Pulse Laser Fibers, indicating that it is a modification to a previously cleared device (predicate device K210925). The core of the submission is to demonstrate substantial equivalence to the predicate device, primarily due to a "secondary coating resin material change." Therefore, the "study" described is focused on validating that this material change does not negatively impact the critical performance characteristics of the laser fiber.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (laser fiber), the "acceptance criteria" and "reported device performance" are related to its functional integrity and safety. These are not performance metrics like sensitivity, specificity, or accuracy, which would be relevant for a diagnostic AI device.

2. Sample Size for the Test Set and Data Provenance

The document does not specify the exact sample sizes (e.g., number of fibers tested) for the performance tests (Bent Transmission, Fiber Durability, etc.). It generally states that a "Design Verification was executed." The data provenance is internal testing performed by Boston Scientific Corporation. The studies are by nature prospective in the sense that they are performed on newly manufactured devices with the changed coating resin material to verify their performance. There is no mention of country of origin for test data, but it would typically be conducted at the manufacturer's R&D facilities.

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

Not applicable. This is not a diagnostic device where expert ground truth is established for clinical outcomes or interpretations. The "ground truth" for the performance tests mentioned above would be engineering and physical measurement standards.

4. Adjudication Method

Not applicable. This is not a diagnostic device requiring adjudication of clinical interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is for evaluating human performance (e.g., diagnostic accuracy) with and without AI assistance, which is irrelevant for a laser fiber.

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

No. This refers to the performance of a diagnostic algorithm without human intervention, which is not applicable to a laser fiber.

7. The Type of Ground Truth Used

For the physical performance tests:

• Engineering Specifications/Standards: The "ground truth" is adherence to predefined engineering specifications for power transmission, temperature limits, durability, etc. These would be established based on industry standards, the predicate device's performance, and safety requirements.
• Biocompatibility Standards: For biocompatibility, the ground truth is compliance with recognized biological evaluation standards (e.g., ISO 10993 series), ensuring the materials are safe for human contact.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/Machine Learning algorithm, so there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth establishment for it.

Summary of what the document indicates about the "study":

The study was a "Design Verification" executed by Boston Scientific Corporation to support the "safe and effective use" of the proposed laser fibers after a "secondary coating resin material change." The purpose was to demonstrate that the modified device remains "substantially equivalent" to its predicate device (K210925). The tests involved evaluating the fiber's ability to transmit laser energy (Bent Transmission), its resilience during use (Fiber Durability while Firing), and safety (Fiber Connector Temperature, Laser System Output Accuracy, Biocompatibility). The document implies that all these tests were successfully completed, confirming that the material change did not compromise the device's performance or safety.

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