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ExcelsiusXR™, when used in conjunction with ExcelsiusHub™ and/or ExcelsiusGPS®, is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. This system is indicated for the placement of spinal and orthopedic (Sacroiliac, Ulna, and Tibia) bone screws, and interbody fusion devices.

The ExcelsiusXR™ Headset displays 2D stereotactic images and 3D virtual anatomy images, and displays the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. This headset should not be relied upon solely for absolute positional information and should always be used in conjunction with the primary stereotactic display.

ExcelsiusXR™ is a head-mounted navigation device, or headset, that is used in conjunction with ExcelsiusHub, and ExcelsiusGPS if robotic guidance is desired, as an aid for precisely locating anatomical structures in open or percutaneous procedures, and for precisely positioning compatible surgical instruments or implants (screws and interbody devices) during surgery. ExcelsiusXR™ includes hardware and software that enables real-time surgical visualization using radiological patient images (preoperative CT, intraoperative CT, and fluoroscopy), provides tracking and planning capabilities for a series of compatible instruments, and contains hand tracking cameras for manipulation of the head-mounted display by the user. The Headset displays 2D stereotactic images and provides a 3D visual, or virtual image, of the patient anatomy in the lower region. The 2D data and 3D model, along with tracking information, are projected to the surgeon's retina from the transparent near-eye-display Headset, allowing the surgeon to look at the patient and the navigation data at the same time.

The provided FDA 510(k) Clearance Letter for ExcelsiusXR™ describes performance testing in a general manner but does not contain the specific details required to fully address all parts of your request for acceptance criteria and the study that proves the device meets them.

Here's a breakdown of what can be extracted and what information is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table with numerical acceptance criteria and corresponding performance metrics. It generally states that "Verification and validation testing were conducted on ExcelsiusXR™ to confirm that the device meets performance requirements under the indications for use and to ensure safety and efficacy of the system."

It mentions the types of tests performed:

• Non-clinical system, software, and instrument verification and validation – demonstrated compliance with user needs and corresponding design inputs
• Surgical simulations conducted on phantom models
• Qualitative and quantitative validation to confirm intended use and accuracy
• Optical bench testing to evaluate the image quality characteristics of the head mounted display
• Electrical Safety and Electromagnetic Compatibility (compliance with standards)
• Software Verification and Validation Testing (compliance with FDA guidance)

Without specific numeric thresholds or results, a detailed table cannot be created. However, generally, for a navigation system like this, key performance metrics and their associated acceptance criteria would typically include:

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

• Sample Size: The document does not specify the sample size used for any of the performance tests (e.g., number of phantom models, number of tests, number of unique cases).
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. Phantom studies are typically prospective tests under controlled lab conditions.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the number of experts used to establish ground truth or their specific qualifications (e.g., "Radiologist with 10 years of experience").
• Given that "surgical simulations conducted on phantom models" were performed, the "ground truth" would likely be established by the physical measurements taken from the phantom and the known ideal trajectory/placement, often assessed by engineers and potentially verified by clinically experienced personnel.

4. Adjudication Method for the Test Set

• The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating performance. This is generally more relevant for studies involving human interpretation of medical images. For phantom studies, ground truth is typically precisely measured rather than adjudicated in the same way.

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

• The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• There is no information provided on the effect size of how much human readers improve with AI vs. without AI assistance. This type of study would typically be done if the device were primarily an AI-driven diagnostic or interpretative tool, which this navigation system is not. Its primary function is to aid surgical guidance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• The document describes the device as "an aid for precisely locating anatomical structures to be used by surgeons for navigating and/or guiding compatible surgical instruments." It also states "This headset should not be relied upon solely for absolute positional information and should always be used in conjunction with the primary stereotactic display."
• This strongly indicates that the device is intended for human-in-the-loop use, assisting the surgeon.
• While there are "software verification and validation testing" and "surgical simulations on phantom models," these would assess the algorithm's performance within the system context, but the document does not present a standalone, algorithm-only performance metric separate from its intended use as a surgeon's aid. The emphasis is on the system's performance when used by surgeons.

7. Type of Ground Truth Used

• Based on "surgical simulations conducted on phantom models" and "qualitative and quantitative validation," the ground truth was likely established through physical measurements and known anatomical references on the phantom models. This is a form of objective, fabricated ground truth suitable for evaluating a navigation system's precision and accuracy in a controlled environment. It is not expert consensus, pathology, or outcomes data in the traditional sense, though expert surgical opinion would guide the design and interpretation of phantom studies.

8. The Sample Size for the Training Set

• The document does not provide any information regarding the training set size. The FDA 510(k) summary focuses on the "performance testing" (verification and validation), which relates to the test set that demonstrates the device's capabilities post-development. Information about model training (if applicable for any AI components involved in image processing or tracking) is typically not included in such summaries unless it's a primary AI/ML device where the training data directly impacts the cleared function.

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

• Since no information about a training set is provided, there is no information on how its ground truth was established.

In summary, the 510(k) summary provides a high-level overview of the types of performance tests conducted (phantom models, software V&V, electrical safety), but it lacks the detailed quantitative data, sample sizes, and specific methodologies for ground truth establishment that would be found in a full study report. This level of detail is typically contained in the more comprehensive "Basis for Substantial Equivalence" documentation submitted to the FDA, which is not fully replicated in the public 510(k) summary letter.

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VERZA™ High Speed Drills are indicated for drilling, burring, removing, and otherwise manipulating hard tissue, bone, bone cement, prosthesis, implant, and other bone related tissue during spinal and orthopedic procedures.

ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody fusion devices.

VERZA™ High Speed Drills are electrical drill handpieces/attachments powered by a motor with a control unit and foot pedal, and may be navigated using ExcelsiusGPS® or ExcelsiusHub™. The navigated components are provided nonsterile and are reusable. Burs are provided sterile and are single-use.

I am sorry, but the provided text is a 510(k) Premarket Notification from the FDA regarding a medical device called "VERZA™ High Speed Drills". This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. It does not contain the detailed information necessary to answer your specific questions about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/ML-based medical device.

The document mentions that "The navigation and guidance accuracy of VERZA™ High Speed Drills was evaluated using intra-operative imaging and accuracy verification testing. Testing confirmed that accuracy values meet the product requirement specification." However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Details about standalone (algorithm-only) performance.
• The type of ground truth used (beyond "accuracy verification testing" and meeting "product requirement specification").
• Sample size for the training set.
• How ground truth for the training set was established.

This device appears to be a surgical tool (drills) that may be navigated using existing systems (ExcelsiusGPS® or ExcelsiusHub™), rather than a new AI/ML software device that diagnoses or predicts outcomes based on data. Therefore, the types of studies and information you are requesting are not typically found in a 510(k) for this kind of physical medical device.

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CoreLink Robotic Navigation Instruments are indicated to be used during the preparation screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients, where reference to a rigid anatomical structure such as vertebra can be identified. These instruments are designed for use with the Globus ExcelsiusGPS system, which is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

CoreLink Robotic Navigation Instruments are non-sterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical Excelsius GPS® Robotic Navigation Platform to aid in implantation of CoreLink Pedicle Screw System implants (NextGen Pedicle Screw System, CoreLink Midline Fixation System (CentraFix), and Tiger Spine System). The instruments are manufactured from stainless steel.

The provided document is a 510(k) summary for the CoreLink Robotic Navigation Instruments. This type of submission is for medical devices that are substantially equivalent to a predicate device already on the market. As such, the focus of the submission is primarily on demonstrating this substantial equivalence through engineering analysis and comparison to existing cleared devices, rather than on extensive clinical performance data or a standalone performance study as would be seen for novel AI/ML-enabled devices.

Therefore, the document does not contain the information requested regarding acceptance criteria, a specific study proving device performance (beyond engineering analysis for equivalence), sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The document states:

• "The CoreLink Robotic Navigation Instruments have been evaluated through an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance."
• "The results of this engineering analysis show that the subject is substantially equivalent to the cleared predicate."

This means the device's acceptable performance is demonstrated by its similarity to already cleared devices, and it's not being assessed as a novel AI/ML device requiring the robust performance study details typical for such submissions.

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The Micromate™ Navi+ device is a user-controlled electromechanical arm with a needle guide. It is intended to assist the user in the positioning of 8-19 gauge needles in the chest, abdomen and musculoskeletal structures when computed tomography (CT) optical navigation can be used for target trajectory planning and intra-operative tracking. The needle is then manually advanced by the user. Trajectory planning is made with software that is a part of the Micromate™ Navi+ device.

The Micromate™ Navi+ system allows the percutaneous execution of a surgical intervention by providing instrument guidance according to one or more pre-operative plans defined by an internal planning and navigation software (MicroNav). The alignment to the surgical plan is performed through a manual gross-positioning using a Positioning Arm, followed by automatic or joystick-controlled movement with image guidance, such as optical CT navigation (tracked by camera). After alignment, the advancement of surgical instruments and delivery of therapy is performed manually by the user, while the position is retained by the targeting platform of Micromate™ Navi+, relying on the displayed navigation information or real-time images from third party imaging device.

The Micromate Navi+ device is intended for biopsy and percutaneous tumor ablation procedures, in the abdomen, thorax and musculoskeletal tissue.

The Micromate™ Navi+ system comprises the following main components:

• Targeting Platform, a robotic positioning unit that aligns to the surgical plan and holds the surgical instruments through an end-effector acting as a tool-guide adapter,
• Control Unit, device that allows the automatic or manual control of the Targeting Platform movement and can communicate with an internal planning and navigation station,
• Positioning Arm, a multi-functional arm that is used to gross-position the Targeting Platform in such a way the traiectory is reachable.
• Strain Relief Box, which distributes power and data through the Micromate™ system,
• Power and Network Unit, which connects the system to power and allows an optional direct point-to-point connection to an internal planning and navigation station for input of real-time navigation data,
• Connecting Cables.

and following Accessories:

• Sterile Drapes for the Control Unit and Targeting Platform,
• Needle guides for instrument guidance, packaged together with a drape for the sterile covering of the Targeting Platform,
• Sterile Tracker, to which off-the-shelf mounting spheres can be attached, to enable optical tracking for the localization of the Targeting Platform in space,
• A trolley for transport and storage,
• Medical grade PC,
• Camera tracking system,
• Planning and navigation software (MicroNav).

The provided text describes the 510(k) premarket notification for the Micromate™ Navi+ device, which is a user-controlled electromechanical arm with a needle guide intended to assist in positioning 8-19 gauge needles in the chest, abdomen, and musculoskeletal structures under CT optical navigation.

Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numbered or bulleted list with specific numerical thresholds for clinical performance. However, it details the performance achieved which, implicitly, must have met internal or regulatory acceptance thresholds for substantial equivalence. The key performance metrics reported are accuracy measurements.

The document states: "The overall scope of accuracy testing supported, with high statistical confidence, a positive conclusion on the safe and effective use of the device in a clinical setting." This suggests that the reported accuracy values and the low needle readjustment rate were deemed acceptable by the manufacturer and, subsequently, by the FDA for substantial equivalence.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Clinical Guidance Accuracy: 54 interventions (19 abdominal lesions, 19 thoracic lesions, and 16 musculoskeletal lesions). This constitutes the number of procedures in which performance data was collected.
  • Bench Test Accuracy: The sample size for the bench test is not explicitly stated in terms of number of measurements, but it refers to the validation per ASTM F2554-18.
• Data Provenance: The text does not specify the country of origin for the clinical study data or whether it was retrospective or prospective. It only mentions the manufacturer's location as Austria. It states "data gathered in simulated clinical environment" for pre-clinical performance data and then discusses "clinical guidance accuracy," implying a clinical study for that part.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience"). For the clinical guidance accuracy, it would implicitly be the outcome of surgical procedures, likely assessed post-procedure by imaging or surgical confirmation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set. Ground truth appears to be based on the outcome of the interventional procedures as measured by CT imaging after needle placement.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted. The study focuses on the device's accuracy in assisting human users, not on comparing outcomes of human readers with vs. without AI assistance in interpretation. The device is a navigation system for needle placement, not primarily an AI for image interpretation.

6. Standalone (Algorithm Only) Performance

The device is described as a "user-controlled electromechanical arm." Its "planning and navigation software (MicroNav)" is an integral part of the device assisting the user. The study focuses on the device's accuracy in assisting the user in needle placement. Therefore, a standalone (algorithm only without human-in-the-loop) performance study, in the sense of an AI interpreting images, is not applicable or described in this context. The "bench-test accuracy" could be considered a form of standalone performance for the mechanical/software system, independent of a live clinical user's influence beyond initial setup.

7. Type of Ground Truth Used

The ground truth for accuracy validation appears to be based on objective measurement of the actual needle position relative to the planned trajectory using imaging (CT) after the procedure. This is inferred from "lateral deviation" and "angular deviation" measurements in both "simulated use environment" (bench-test) and "clinical guidance accuracy." It is not explicitly stated to be "expert consensus" or "pathology outcomes data" in the traditional sense of diagnostic AI.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set for the planning and navigation software (MicroNav). This information is typically not included in a 510(k) summary relating to substantial equivalence unless significant changes in software algorithms or AI training are explicitly being reviewed.

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

The document does not specify how the ground truth for the training set of the MicroNav software was established. Given the nature of a medical device 510(k) submission, the focus is on verification and validation (V&V) of the final product, rather than the developmental steps like training data ground truth establishment, unless it directly impacts the safety and effectiveness of the device in a novel way. However, software verification and validation testing are mentioned, performed in accordance with FDA Guidance and IEC 62304.

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The ExcelsiusGPS is intended for use as an aid for precisely locating anatomical structures and for spatial positioning and orientation of an instrument holder or guide to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws and interbody spacers, and intracranial devices including biopsy needles, electrodes, and tubes.

The ExcelsiusGPS® Cranial Module includes hardware and software that enables real time surgical navigation using radiological patient images (MRI, CT, and fluoroscopy), using a dynamic reference base and positioning camera. The navigation system determines the registration or mapping between the virtual patient (points on the patient images) and the physical patient (corresponding points on the patient's anatomy). Once this registration is created, the software displays the relative position of a tracked instrument on the patient images. As an aid to visualization, the surgeon can plan trajectories for instrument placement on the patient images prior to surgery. Registration provides the necessary information to provide visual assistance to the surgeon during freehand navigation. During surgery, the system tracks the position of GPS compatible instruments in or on the patient anatomy and continuously updates the instrument position on patient images utilizing optical tracking. System software is responsible for all navigation functions, data storage, network connectivity, user management, case management, and safety functions. ExcelsiusGPS® surgical instruments include non-sterile, re-usable instruments and sterile instruments that are operated manually or with the use of the positioning system.

The ExcelsiusGPS® Cranial Module is designed to assist with stereotactic procedures that include guidance to cranial targets for instrument navigation and device placement. Instruments consist of end effector instruments, registration instruments, navigated instruments, patient positioning instruments, and surgical instruments. End effector instruments include instruments to the Interchangeable Guide End Effector. Registration and navigated instruments incorporate unique array patterns with reflective markers, and are used to track patient anatomy and surgical instruments. Patient positioning instruments aid in patient fixation. Surgical instruments are used to access and prepare the local site and place devices, such as needles, electrodes, and tubes.

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

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The SI-LOK® Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroiliitis.

Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy.

The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

The SI-LOK® Sacroiliac Joint Fixation System (including SI-LOK® Select) consists of cannulated, fully or partially threaded screws that are available with or without slots and optional pre-assembled contouring washers. One, two or three screws may be placed in one sacroiliac joint, depending on the approach.

The screws and washers are manufactured from titanium alloy, as specified in ASTM F136 (Ti6Al4V) and F1295 (Ti6Al7Nb). SI-LOK® screws are available with or without hydroxyapatite (HA) coated, as specified in ASTM F1185.

SI-LOK® Sacroiliac Joint Fixation System include surgical instruments manufactured from stainless steel, as specified in ASTM F899.

SI-LOK® ExcelsiusGPS® Instruments are nonsterile, reusable instruments that can be operated with the ExcelsiusGPS® robotic arm, or may be used for a freehand navigated surgical procedure.

SI-LOK® Navigation Instruments are nonsterile, reusable instruments that can be operated manually or under power using a power drill such as POWEREASE that are intended to be used with the Medtronic StealthStation® System.

This FDA 510(k) K183119 summary does not describe a study involving device performance metrics related to diagnostic accuracy, sensitivity, specificity, or reader studies utilizing AI. Instead, it focuses on the substantial equivalence of the "SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments" to previously cleared predicate devices based on mechanical, biocompatibility, and technological characteristics.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted from the provided text. The device in question is a surgical fixation system and related navigation instruments, not an AI-powered diagnostic or assistive tool in the typical sense for which an MRMC study or standalone algorithm performance metrics would be assessed.

Here's a breakdown of what can be extracted based on the provided document:

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

The document does not specify quantitative acceptance criteria in terms of accuracy metrics for an AI system. Instead, the "acceptance criteria" are implied through the successful completion of specified mechanical and biocompatibility tests, demonstrating substantial equivalence to 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)

• Sample Size for Test Set: Not specified in terms of human subjects or diagnostic cases, as this is primarily a mechanical and material performance evaluation for a surgical device. The "sample size" would refer to the number of devices or components tested in the mechanical evaluations, which is not detailed.
• Data Provenance: Not applicable in the context of diagnostic data. The provenance for the device materials and testing standards is US (ASTM, ANSI/AAMI).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth in the context of device performance in this submission refers to adherence to mechanical and material standards, not expert medical opinion on diagnostic images.

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

Not applicable. There is no adjudication process involving expert readers described.

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 comparative effectiveness study was done or described. This submission is not for an AI-assisted diagnostic device. The ExcelsiusGPS® and Navigation Instruments are tools to assist surgeons in locating anatomical structures and positioning instruments, often used with imaging but not as a primary diagnostic AI.

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

Not applicable. This device is not a standalone algorithm. Its function is to aid a human surgeon.

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

The "ground truth" for the device's substantial equivalence is based on:

• Engineering standards (ASTM F2193, ASTM F543, ANSI/AAMI ST-72:2011) for mechanical and biocompatibility properties.
• Comparison of technological characteristics (design, intended use, material composition, function, range of sizes) to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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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