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The BodyGuardian™ Remote Monitoring System detects and monitors cardiac arrhythmias in ambulatory patients, when prescribed by a physician or other qualified healthcare professional.

The BodyGuardian Remote Monitoring System is intended for use with adult and pediatric patients who are at least 29 days old in clinical and non-clinical settings to collect and transmit electrocardiogram (ECG) and other health parameters to healthcare professionals for monitoring and evaluation. Health parameters, such as heart rate and ECG data, are collected from external devices such as ECG sensors.

The BodyGuardian Remote Monitoring System does not provide any diagnosis.

The BodyGuardian Remote Monitoring System (BGRMS) is a system for recording and analyzing ECG data for cardiac arrhythmias to assist healthcare professionals, including ECG technicians at 24/7 attended analysis centers in evaluating a patient's cardiac health. Reports are generated for clinician review, that provide analysis and summary of the ECG data collected during a patient's monitoring study. Both the predicate and proposed devices, feature a modular design inclusive of outpatient cardiac telemetry (commonly called mobile cardiac telemetry (MCT)), cardiac event monitor and connected/non-connected Holter modalities. Components in the system external to the software include ECG monitors, electrodes, mobile phones and apps.

The BGRMS System includes the following main components:

• ECG monitor – a patient worn device for ECG waveform data collection and transmission, utilized with compatible electrodes
• Mobile App – applications that execute on an off-the-shelf (OTS) smartphone to communicate with the ECG monitor and the PatientCare Server for collection and transmission of data
• PatientCare – server software responsible for receiving, storing, analyzing, and displaying and reporting data gathered from the ECG monitors; includes the ECG analysis algorithm BeatLogic™
• AI-Based Device Software Functionality (AI-DSF) – Automated classification of continuous
  ECG based on the proprietary BeatLogic™ AI algorithm. BeatLogic consists of an ensemble of deep neural networks (DNNs), trained on real-world patient data and post-processing logic that combines the DNN output to produce individual beat, rhythm, and waveform classifications. This output is intended to be reviewed and confirmed by healthcare professionals to assist in diagnosis.

The provided FDA 510(k) clearance letter and summary for the BodyGuardian Remote Monitoring System (BGRMS v3.0) contains information on the device's acceptance criteria and study to prove it.

Acceptance Criteria and Reported Device Performance

The clinical validation results met all predefined acceptance criteria, though the specific criteria are not explicitly detailed in the provided document beyond "substantially equivalent performance for BeatLogic." The performance was assessed by evaluating the Sensitivity and Positive Predictive Value (PPV) for key rhythms. While specific numerical values for the acceptance criteria are not given, the reported device performance is stated as meeting these unspecified criteria.

Details of the Study Proving Device Meets Acceptance Criteria

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

• Sample Size: Not explicitly stated, but described as "real-world, randomly selected ECG records" with a demographic breakdown of 48.6% Female, 39.2% Male, 12.2% unknown gender, 50.1% < 65 years of age, 49.8% ≥ 65 years of age, and 0.1% unknown age.
• Data Provenance: "Real-world patient data" with representation across "US geographic region," indicating data from the United States. The data is retrospective as it was used to train and validate the algorithm, selected to reflect various algorithm outputs, compatible ECG device configurations, accessory types, and demographic factors.

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

This information is not provided in the document. The document states that the BeatLogic™ AI algorithm's "output is intended to be reviewed and confirmed by healthcare professionals to assist in diagnosis," but it does not specify how the ground truth for the test set was established or the number/qualifications of experts involved in this process.

3. Adjudication Method for the Test Set

This information is not provided in the document.

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

• Was it done?: No, an MRMC comparative effectiveness study is not explicitly mentioned. The study focuses on the standalone performance of the AI algorithm (BeatLogic™).
• Effect size of human readers improvement: Not applicable, as an MRMC study was not described.

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

• Was it done?: Yes. The performance measurement of the BeatLogic™ algorithm involved evaluating Sensitivity and PPV, which are metrics typically used for standalone algorithm performance against a ground truth. The document explicitly states, "Performance of the algorithm was assessed by evaluating the Sensitivity and Positive Predictive value (PPV) for key rhythms across different patient subgroups." Furthermore, it mentions that the algorithm's "output is intended to be reviewed and confirmed by healthcare professionals to assist in diagnosis," implying that the performance reported is that of the algorithm prior to human review.

6. The Type of Ground Truth Used

The ground truth annotations were established based on "ground truth annotations on real-world ECG data." The method of establishing these annotations (e.g., expert consensus, pathology, outcomes data) is not explicitly stated. However, the context of cardiac arrhythmia detection strongly suggests ground truth would be established by qualified cardiologists or electrophysiologists.

7. The Sample Size for the Training Set

• Sample Size: Not explicitly stated, but described as "real-world, randomly selected ECG records" that ensured "representation across algorithm outputs, compatible ECG device configurations and accessory types and demographic factors encompassing patient age, gender, geographic location, and indication for monitoring."

8. How the Ground Truth for the Training Set was Established

The document states that the BeatLogic™ AI algorithm consists of "deep neural networks (DNNs), trained on real-world patient data." However, the specific method for establishing the ground truth for this training data is not explicitly provided. It is implied that this involved annotations on "real-world patient data," but the process for generating these annotations (e.g., expert review, automated processes) is not detailed.

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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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The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.

The Orca Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.

Orca Air/Water and Suction Valves are endoscopic channel accessories that attach to the Air/Water and Suction ports on the endoscope handle to control the amount of air/water flow and suction of an endoscope.

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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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The Boston Scientific RFG-X1 (GX1) Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The Boston Scientific GX1 Radiofrequency Generator is used with separately approved Boston Scientific Radiofrequency Probes

The Boston Scientific GX1 Radiofrequency (RF) Generator is a 50W RF lesion generator that supplies electrical power to associated RF Probes. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. The GX1 Generator is a product line extension of the Boston Scientific G4 Radiofrequency Generator which is FDA approved under 510(k) K082051.

The GX1 Generator is a small, portable unit (14.3" W x 10.8" H x 12.5" D, 24lbs) that can accommodate line Voltage between 100 and 240 Volts. The GX1 Generator has advanced functionality and a Graphical User Interface (UI) equivalent to the Boston Scientific RF Generator, its predicate device.

The provided FDA 510(k) clearance letter describes a medical device, the Boston Scientific GX1 Radiofrequency Generator, and its performance testing. However, the document does not contain information related to acceptance criteria, a study proving the device meets those criteria, or details regarding AI/ML components.

The GX1 Radiofrequency Generator is a hardware device used to create radiofrequency lesions, not a software or AI/ML device that would typically have acceptance criteria based on diagnostic performance metrics (like sensitivity, specificity, AUC) and require a clinical study with a test set, ground truth, and expert adjudication.

Therefore, I cannot fulfill most of your request as the information is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing based on the prompt's requirements:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as specific numerical targets for performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly "Pass" for compliance with electrical safety standards, electromagnetic compatibility, and various design verification tests.
• Reported Device Performance:

Missing Information (Not present in the provided document):

2. Sample size used for the test set and the data provenance: Not applicable for this type of hardware device testing. There isn't a "test set" in the context of clinical data for diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for hardware performance is typically established through engineering specifications, calibrated measurements, and adherence to international standards.
4. Adjudication method: Not applicable.
5. 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: Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth used for these technical tests are established engineering specifications, physical measurements, and compliance with recognized industry standards (e.g., IEC standards for electrical safety and EMC, ASTM for packaging).
8. The sample size for the training set: Not applicable, as this is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The Boston Scientific GX1 Radiofrequency Generator underwent a series of non-clinical bench testing to demonstrate its performance, safety, and effectiveness. These tests included:

• Electrical Safety Testing: To ensure compliance with IEC 60601-1 and IEC 60601-2-2.
• Electromagnetic Compatibility (EMC) Testing: To confirm compliance with IEC 60601-1-2.
• Performance Testing: A range of specific tests covering RF power, voltage, current, impedance, temperature measurement/control, stimulation output, contact quality measurement, and lesion size comparison with the predicate device (G4 RF Generator) in "homogenous tissue."
• Packaging Testing: To ensure integrity during shipping.
• Mechanical Testing: Covering various physical durability and environmental factors.
• Software Verification: To confirm user interface, error handling, security, and other software functionalities.

All tests "Passed," indicating that the device met its design input requirements and compliance standards. The study's conclusion was that the GX1 Generator is substantially equivalent to its predicate device (K082051) based on indications for use, technological characteristics, and acceptable results from verification and validation testing.

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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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