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The Guide extension family catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices. The Guide extension family catheters are contraindicated in vessels less than 2.5mm in diameter, vessels in the neurovasculature, and the venous system.

The FlowGuide and GuidionShort are single lumen rapid exchange catheters being compatible with 6F and larger guide catheters and may be placed over either an exchange length or 180cm guide wire. The 150cm long device has a stainless-steel shaft section. The stainless-steel shaft is followed distally by a 15 cm lumen section.

The catheters have a radiopaque distal end which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm and 105cm from the distal tip, respectively.

The catheters are delivered through a guiding catheter resulting in an inner diameter that is approximately 1 French smaller than the guide catheter. The catheters have a proximal hub which indicates guide catheter compatibility.

The FlowGuide has 9 perfusion holes in the distal shaft intended to reduce pressure dampening.

This FDA 510(k) clearance letter pertains to a new medical device, the FlowGuide and GuidionShort catheters. As such, the information provided focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/ML powered device meets certain performance criteria. The document describes the physical and functional characteristics of the catheters and the tests performed to ensure their safety and performance. However, there is no mention of an "AI/ML device" or any study related to its performance, human reader improvement, or ground truth establishment.

Therefore, I cannot fulfill the request as it is based on the premise of an AI/ML powered medical device, which is not what this FDA clearance letter is about.

To clarify, the document describes the device as a "percutaneous catheter" (Page 1) and its function as being "intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices" (Page 4). The "Device Description" (Page 5) further explains that it is a "single lumen rapid exchange catheter." These descriptions all point to a hardware medical device, not a software or AI/ML-powered device.

The "Summary of Studies" section (Page 7) lists a series of performance and biocompatibility tests. These are standard engineering and biological tests for physical medical devices (e.g., kink resistance, radiopacity, bond strength, cytotoxicity, hemocompatibility), not tests typically associated with AI/ML software performance (like sensitivity, specificity, AUC, or reader studies).

In conclusion, this document does not contain information about an AI/ML device, its acceptance criteria, or performance studies in the context of AI/ML. As a result, I cannot provide the requested table or details about reader studies, ground truth, or training sets for an AI/ML model based on the provided text.

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The ShapelT catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature.

The device is contraindicated for use in the neurovasculature.

The ShapelT is a guide wire support catheter intended to be used in the coronary and/ or peripheral vasculature for patients suffering from coronary or peripheral artery disease. The target lesion can be reached by using the femoral or brachial approach. The ShapelT is a single lumen 0.014" rapid exchange catheter. The 135 cm long device has a stainless-steel shaft section. The stainless-steel shaft is followed distally by a 15 cm lumen section. The ShapeIT distal end is preshaped to support guidewire redirection in bifurcations.

The ShapelT catheter has a radiopaque distal tip which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm and 105cm from the distal tip, respectively. Furthermore, two distal shaft exit markers are located at 110 cm and 120 cm to indicate the distal shaft exit.

I'm sorry, but the provided text does not contain information about acceptance criteria and a study that proves the device meets the acceptance criteria in the context of an Artificial Intelligence (AI) enabled medical device.

The document is a 510(k) Premarket Notification from the FDA for a medical device called "ShapeIT," which is a percutaneous catheter. The purpose of this document is to declare the device substantially equivalent to legally marketed predicate devices, not to present a study proving performance against AI-related acceptance criteria.

The information provided details:

• Device Name: ShapeIT
• Regulation Name: Percutaneous Catheter
• Product Code: DQY
• Intended Use: To support a guide wire during access of coronary and/or peripheral vasculature.
• Technological Characteristics: Comparison to a predicate device (Micro Rx Guidewire support catheter), highlighting similarities and differences (e.g., angulated tip and shapeable distal section).
• Performance Tests: A list of performance tests conducted on the ShapeIT catheter (e.g., Kink resistance, Tensile strength, Coating integrity) to demonstrate its design verification and substantial equivalence to the predicate device.
• Biocompatibility Tests: A list of biocompatibility tests performed in accordance with ISO 10993-1.

There is no mention of:

• AI or an algorithm
• A test set or data provenance for AI
• Experts establishing ground truth for AI
• Adjudication methods for AI
• MRMC studies for AI
• Standalone performance for an AI algorithm
• Types of ground truth for AI
• Training set size or how ground truth was established for a training set in an AI context.

Therefore, I cannot fulfill your request for the specific details about AI acceptance criteria and a study proving those criteria were met based on the provided text.

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The Micro Rx catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature. The device is contraindicated for use in the neurovasculature.

The Micro Rx is a guide wire support catheter intended to be used in the coronary and/ or peripheral vasculature for patients suffering from coronary or peripheral artery disease. The target lesion can be reached by using the femoral or brachial approach. The Micro Rx is a single lumen 0.014" rapid exchange catheter. The 135 cm long device has a stainless-steel shaft section. The stainless-steel shaft is followed distally by a 15 cm lumen section. The Micro Rx catheter has a radiopaque distal tip which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm from the distal tip, respectively. Furthermore, two distal shaft exit markers are located at 110 cm and 120 cm to indicate the distal shaft exit.

The provided document is an FDA 510(k) clearance letter for a medical device called "Micro Rx," a guidewire support catheter. It details the device's characteristics, intended use, and comparison to a predicate device, as well as the summary of studies conducted to demonstrate substantial equivalence.

However, the document does not contain the kind of information typically found in studies for AI/ML-based medical devices or devices where performance is measured against a ground truth using expert readers. The provided text is for a mechanical medical device (a catheter), and the "studies" mentioned are performance and biocompatibility tests for that physical device, not studies involving image analysis or expert adjudication.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set details) are not applicable to this type of device and the information provided in this 510(k) document.

I will populate the table and answer the questions based on the information that is available in the provided text, and explicitly state when information is not present or applicable.

Acceptance Criteria and Device Performance for Micro Rx Catheter

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

The document lists "verification tests" that were performed and states that "The results of the verification tests met the specified acceptance criteria." However, it does not provide the specific numerical acceptance criteria or the numerical results for each test. It simply states that they passed.

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: The document does not specify the sample sizes (number of units tested) for each of the performance or biocompatibility tests.
• Data Provenance: Not specified. These are laboratory/bench tests, not clinical studies involving patient data from specific countries. The manufacturing company, IMDS Operations B.V., is located in Roden, Drenthe, Netherlands.

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. This device is a mechanical catheter. The "ground truth" for its performance is established by engineering specifications, physical measurements, and adherence to ISO standards (e.g., ISO 10993-1 for biocompatibility), not by expert human interpretation or consensus.

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

• Not Applicable. No human adjudication of results in the traditional sense (e.g., for image interpretation) is mentioned or relevant for these types of engineering and biocompatibility tests. The tests yield objective, measurable data.

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. This is a mechanical device, not an AI/ML-driven diagnostic or image analysis tool. Therefore, an MRMC study and AI assistance are not relevant.

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

• Not Applicable. This is a mechanical device, not an algorithm.

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

• The "ground truth" for this device's performance is based on engineering specifications, direct physical measurements, and adherence to established international standards (e.g., ISO 10993-1 for biocompatibility). There is no "expert consensus" or "pathology" in the context of diagnostic accuracy.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

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The ReCross Dual Lumen guide wire support catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature and allows for exchange of guide wires and provides a conduit for the delivery of diagnostic contrast agents. The catheter is not intended for use in the neurovasculature.

The ReCross is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The ReCross is a 0.014" Over The Wire (OTW) guide wire support catheter. The ReCross has two over the wire OTW lumens that runs the length of the catheter. The ReCross has two depth markings located at 95 cm and 105 cm from the distal tip. The ReCross has a radiopaque marker identifying the distal end of the catheter, a second radiopaque marker in the stylet lumen located 8 mm from the distal tip identifies the distal end of the OTW lumen and a third radiopaque marker in the tip lumen located at 12 mm from the distal tip indentifying the side port. To reduce friction in the guide catheter and vasculature, the distal shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the lumens of the ReCross are coated with MDX (silicone) coating. To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet is placed in the stylet lumen

The provided text is a 510(k) summary for the ReCross Dual Lumen guide wire support catheter. It discusses the device's technical characteristics and studies performed to demonstrate its substantial equivalence to a predicate device. However, it does not contain information about an AI/ML-based device, nor does it detail acceptance criteria related to algorithmic performance metrics (like accuracy, sensitivity, specificity, etc.) or clinical study designs involving human readers or standalone AI performance.

Therefore, many of the requested details, such as the number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information, are not present in this document. This document focuses on the mechanical and material performance of a medical device (a catheter), not a diagnostic algorithm.

Based on the provided text, here's what can be extracted regarding acceptance criteria and performance:

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

The document lists various performance tests and states that "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." However, the specific numerical acceptance criteria for each test are not explicitly provided in this summary, nor are the numerical results for each test. Instead, it indicates that the device passed these tests.

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

• Sample Size: Not specified in the summary. The tests performed are engineering and material verification tests, which typically involve a specified number of samples for each test (e.g., n=3, n=5, n=10 per batch), but this detail isn't included here.
• Data Provenance: Not applicable in the context of clinical data for an AI/ML device. These are laboratory verification tests on the physical catheter device, likely performed at the manufacturer's facility (IMDS Operations B.V., Roden, The Netherlands) or by a qualified testing lab. The data would be prospective in the sense that the tests were conducted specifically for this submission.

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

This is not applicable to this document. The "ground truth" here is meeting engineering specifications and biocompatibility standards, not clinical diagnostic labels established by medical experts for image interpretation or similar tasks.

4. Adjudication method for the test set:

This is not applicable. There's no clinical imaging data or human interpretation involved that would require an adjudication method. The verification tests have objective pass/fail criteria.

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 is not applicable. This document describes a physical medical device (catheter), not an AI/ML diagnostic or assistive tool.

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

This is not applicable. There is no algorithm being evaluated here.

7. The type of ground truth used:

The "ground truth" for these tests are established engineering specifications, material standards (like ISO 10993-1 for biocompatibility), and internal quality control criteria for the device's physical and functional properties.

8. The sample size for the training set:

This is not applicable. This is a physical device, not an AI/ML model that requires training data.

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

This is not applicable.

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Guidion catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guide wires and other interventional devices.

The Guidion catheter is a single lumen rapid exchange catheter offered in sizes being compatible with 5F; 6F; 7F and 8F guide catheters and may be placed over an guide wire. The 150cm long device has a stainless steel shaft section. The stainless steel shaft is followed distally by a 25cm lumen section.

The Guidion catheter has a radiopaque distal end which enables visibility while using standard fluoroscopic methods. The device has two positioning marks located at 95cm and 105cm from the distal tip, respectively.

The Guidion catheter is delivered through a guiding catheter resulting in an inner diameter that is approximately 1 French smaller than the guide catheter. The Guidion catheter has a proximal hub which indicates guide catheter compatibility.

The provided document is a 510(k) summary for the Guidion Catheter, a medical device. It does not describe an AI/ML powered device, nor does it detail a study involving AI for diagnostic assistance. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and a study proving an AI device meets those criteria.

The document discusses the substantial equivalence of the Guidion Catheter to a predicate device based on performance and biocompatibility tests. It lists the types of tests performed (e.g., kink resistance, radiopacity, bond strength, biocompatibility), but it does not provide specific acceptance criteria or detailed results of these tests. It simply states that "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues."

Therefore, I cannot provide information for the following points as they are not present in the given text:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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The NHancer Rx Dual Lumen Rapid Exchange catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature and allows for exchange of guide wires and provides a conduit for the delivery of diagnostic contrast agents. The catheter is not intended for use in the neurovasculature.

The NHancer™Rx is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The NHancer™Rx is a 0.014" Rapid Exchange (Rx) guide wire support catheter. The NHancer™Rx has an over the wire (OTW) lumen that runs the length of the catheter and a rapid exchange (RX) delivery lumen on the distal end. The NHancer™Rx has an effective length of 135 cm and is compatible with 0.014"/0.36mm or smaller guide wires. The NHancer™Rx has two depth markings located at 95 cm and 105 cm from the distal tip. The NHancer™Rx has a radiopaque marker identifying the distal end of the catheter and a second radiopaque marker located 8 mm from the distal tip identifies the distal end of the OTW lumen.

To reduce friction in the guide catheter and vasculature, the distal 15 cm of the shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the entire lumens of the NHancer Rx are coated with MDX (silicone) coating.

To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet (9) is placed in the OTW lumen

The provided document is a 510(k) premarket notification for a medical device (NHancer Rx Dual Lumen Rapid Exchange catheter). It details the device's characteristics, intended use, and a comparison to a predicate device, along with a summary of performed studies.

However, this document does not contain information about an AI/ML-based medical device study. Therefore, I am unable to provide a response that directly addresses the specific requirements of your prompt regarding acceptance criteria and a study proving device performance for an AI/ML system.

The "studies" mentioned in the document are performance and biocompatibility tests for a physical medical catheter, not a software algorithm. These tests verify physical properties like flexibility, tensile strength, and material biocompatibility, which are fundamentally different from the performance metrics (e.g., sensitivity, specificity, AUC) and study designs (e.g., MRMC, standalone) associated with demonstrating the effectiveness of an AI/ML device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance for an AI/ML system.
• Sample sizes, data provenance, or ground truth details for an AI/ML test set.
• Information on experts, adjudication methods, or MRMC studies for AI/ML.
• Details on training set size or ground truth establishment for an AI/ML model.

Therefore, paraphrasing or extracting information from the given text to fit your prompt's structure for an AI/ML device would be misrepresentative.

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The TrapIT Trapping Balloon Catheter is indicated to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. TrapIT Trapping Balloon Catheter is not intended for use outside of the guide catheter.

The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen which is used for inflation of the balloon with contrast medium. As aid in positioning the balloon in a guide catheter a tactile feedback stop is integrated in the shaft of the 100 cm compatible TrapIt has a shaft depth marking that aid in gauging balloon catheter position relative to the guiding catheter tip when used in 90 cm guide catheters.

The TrapIt Trapping Balloon Catheter is intended to facilitate interventional device exchange while maintaining wire position in patients undergoing PCI procedures. It is not intended for use outside of the guide catheter.

The device's substantial equivalence was established through performance and biocompatibility tests.

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

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

The document does not specify the sample size for individual tests. The tests were likely conducted on a representative sample of devices according to established engineering and quality control protocols. The provenance of this data is internal to the manufacturer (IMDS Operations B.V.). The tests are performed as part of the device verification process to demonstrate safety and performance.

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

Not applicable. The tests performed are engineering performance and biocompatibility evaluations, not clinical studies requiring expert ground truth establishment.

4. Adjudication method for the test set

Not applicable, as this was not a clinical study involving human readers or interpretation of medical images. The acceptance of test results would be based on predefined criteria and successful completion of the tests.

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 device is a medical catheter, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed.

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

Not applicable. The TrapIt Trapping Balloon Catheter is a physical medical device, not an algorithm.

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

The "ground truth" for the performance tests is established by the specifications and acceptance criteria for each test, based on engineering principles, material science, and relevant international standards (e.g., ISO 10993-1 for biocompatibility). For example, the ground truth for "Balloon rated burst" would be the pressure at which the balloon should not burst according to design specifications.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable, as there is no training set for this device.

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The IMDS NHancer™ Guide Wire Support Catheter with Hydrophilic Coating is a guidewire exchange and infusion device designed for use in the vascular system. The IMDS NHancer™ guidewire support catheter is intended to support a guidewire during access of vasculature and allows for exchange of guidewires and provides a conduit for the delivery of diagnostic contrast agents.

The purpose of the NHancer™ guidewire support catheter is to facilitate the placement of a guide wire through an occluded vessel during Percutane Transluminal Coronary Intervention procedures. The NHancer™ is a single use device, consisting of a shaft, a distal tip and a female luer (hub) on the proximal end. On the shaft are two depth markings applied to indicate the length of the device that is in the body. On the distal tip of the device a radiopaque marker band is applied. The distal part of the shaft is fitted with a hydrophilic coating. On the shaft a torquer is placed. With this component the catheter can be locked on to the guide wire that is in the device. The torquer is initially placed on a strain relief which is located on the proximal end of the shaft, near the female luer (hub).

The provided text describes the 510(k) submission for the NHancer™ guidewire support catheter. The device is a traditional guidewire support catheter, not an AI/ML device, and therefore the acceptance criteria and study information typically associated with AI/ML device submissions are not directly applicable.

However, I can extract the performance criteria and the study approach used to demonstrate substantial equivalence to a predicate device, which is the regulatory pathway for this type of medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the NHancer™ guidewire support catheter met all acceptance criteria. Specific quantitative acceptance criteria are not detailed in the provided text. Instead, the document focuses on demonstrating that the NHancer™ performed similarly or was substantially equivalent to the predicate device, the Spectranetics QuickCross® Support Catheter, for a range of performance characteristics.

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

The document details performance testing for both the NHancer™ and a predicate device. However, it does not specify the sample sizes used for the in-vitro and in-vivo tests. It only states that "Comparison testing was performed on the IMDS NHancer™ guidewire support catheter and the Spectranetics QuickCross Support Catheter" and that various "bench tests were performed on NHancer™ guidewire support catheter."

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, these tests would typically be laboratory-based (in-vitro) and animal studies (in-vivo) conducted prospectively for the purpose of demonstrating regulatory compliance.

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

This information is not applicable to this type of device and submission. "Ground truth" established by experts is typically a concept used in the evaluation of AI/ML diagnostic or prognostic devices, where human expert labels are used to train and validate AI algorithms. For a guidewire support catheter, the "ground truth" is determined by objective performance measurements against engineering specifications and predicate device performance, not expert consensus on interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in AI/ML studies to resolve disagreements among human labelers for establishing ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Improvement with/without AI Assistance:

This information is not applicable as the NHancer™ is a physical medical device, not an AI/ML diagnostic or prognostic tool. Therefore, there are no "human readers" interpreting data with or without AI assistance, and no MRMC study would be conducted.

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

This information is not applicable as the NHancer™ is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

For the NHancer, the "ground truth" is based on:

• Engineering specifications: For various dimensions, material properties, and functional tests (e.g., usable length, outer diameter, pull strength, burst strength, flow rate).
• Performance relative to a predicate device: For clinical performance characteristics like crossability, guidewire friction, torqueability, marker visibility, guidewire exchangeability, and contrast administration. The predicate device's established performance serves as the benchmark.
• International Standards: For biocompatibility (ISO 10993), sterility (ISO 11137, ISO 11737), and non-pyrogenicity (Ph. Eur. Chapter 2.6.14 Method C, USP).

8. The Sample Size for the Training Set:

This information is not applicable. The concept of a "training set" refers to data used to train an AI/ML algorithm. The NHancer™ is a physical device and does not involve AI/ML.

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

This information is not applicable for the same reasons as point 8.

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