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This product is intended to direct a catheter to the desired anatomical vasculature (excluding coronary and cerebral vessels).

The CROSSLOOP is steerable guide wire with a maximum diameter of 0.018 inches (0.46 mm) and available in various lengths of 200 cm, 235 cm and 300 cm. The CROSSLOOP consists of a stainless-steel (SUS) core wire with a Pt-Ni alloy coil, soldered with Au-Sn solder. The distal tip is loop-structured. The coil is radiopaque to achieve visibility and can be made to bend easily to accommodate vessel tortuosity. A silicone and hydrophilic coating are applied to the distal portion of the guide wire. A hydrophobic coating (PTFE) is applied to proximal portion. The purpose of these surface coatings is to provide lubricity when the guide wire is passed through percutaneous catheters.

The provided text describes a 510(k) premarket notification for a medical device called "CROSSLOOP," a catheter guide wire. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval Application).

Therefore, the information you're asking for, such as "acceptance criteria and the study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established," are not directly applicable or available in this document.

This 510(k) summary focuses on non-clinical testing/performance data and biocompatibility to demonstrate that the device is substantially equivalent to existing cleared devices, not that it independently proves clinical efficacy or diagnostic accuracy (as would be the case for an AI-powered diagnostic device, for example).

Here's how to address your points based on the provided text:

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

The document states: "The in vitro bench tests demonstrated the CROSSLOOP met all acceptance criteria and performed similarly to the predicate and reference devices." However, it does not provide a table specifying the precise acceptance criteria or quantitative performance results for each test. It only lists the types of non-clinical tests performed:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: The tests are "in vitro bench tests" and "biocompatibility" tests. The manufacturer is ASAHI INTECC CO., LTD. whose global headquarters and R&D center are in Japan. The specific country where the testing was performed is not explicitly stated, but it's likely linked to the manufacturer's R&D facilities. These are laboratory tests, not clinical data, so terms like "retrospective" or "prospective" don't apply in the common clinical sense.

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

This information is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists for imaging devices) is relevant for AI/ML-powered diagnostic tools or clinical studies, neither of which are described here. The "ground truth" for the non-clinical tests would be the established engineering and materials science standards and specifications.

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

This is not applicable. Adjudication methods are typically used in clinical trials involving human observation or interpretation, especially with imaging reads. For bench testing, results are typically quantitative measurements compared against predefined engineering specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. An MRMC study is designed for AI-assisted diagnostic devices to assess the impact of AI on human reader performance. The "CROSSLOOP" is a physical medical device (catheter guide wire), not an AI/ML software tool.

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

This is not applicable. This question refers to the performance of an AI algorithm in isolation. The CROSSLOOP is a physical medical device.

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

For a physical device like a guide wire, the "ground truth" for non-clinical testing refers to pre-defined engineering specifications, material properties, and performance standards (e.g., tensile strength required to withstand certain forces, flexibility within a specified range, biocompatibility per ISO standards). This is not derived from expert consensus on clinical cases, pathology, or outcomes data, but rather from material science and mechanical engineering principles.

8. The sample size for the training set

This is not applicable. "Training set" refers to data used to train AI/ML models. This device is not an AI/ML product.

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

This is not applicable for the same reason as point 8.

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This product is intended to direct a catheter to the desired anatomical vasculature (excluding coronary and cerebral vessels) during diagnostic or interventional procedures.

The CROSSLEAD 0.018inch is steerable guide wire with a maximum diameter of 0.46mm (0.018inches) and available in various lengths of 100 cm, 200 cm, 235 cm and 300 cm. The quide wire consists of a hybrid nitinol (Ni-Ti) and stainlesssteel (SUS) core wire with a stainless steel inner coil, a stainless steel and Platinum-Nickel (Pt-Ni) outer coil. The coil is radiopaque to achieve visibility and can be made to bend easily to accommodate vessel tortuosity. A hydrophilic and polyurethane coating are applied to the distal portion of the guide wire. A hydrophobic coating (PTFE) is applied to proximal portion. The purpose of these surface coatings is to provide lubricity when the guide wire is passed through percutaneous catheters.

The provided text is a 510(k) Premarket Notification from the FDA regarding the "CROSSLEAD 0.018inch" guide wire. This document primarily focuses on establishing substantial equivalence to predicate devices through non-clinical bench testing and biocompatibility assessments. It does not contain information about a study involving human-in-the-loop performance, expert ground truth establishment for a test set, or a multi-reader multi-case (MRMC) comparative effectiveness study, which are typically associated with the evaluation of artificial intelligence (AI) or software-based medical devices.

Therefore, I cannot fulfill your request for information related to:

• A table of acceptance criteria and reported device performance in the context of an AI/software study. The document lists non-clinical tests and states they met acceptance criteria, but these are for the physical device, not an AI.
• Sample size used for a test set (in the context of an AI study).
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for a test set.
• MRMC comparative effectiveness study or related effect sizes.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document discusses the physical characteristics and performance of a medical guide wire, not a software or AI device that would require such studies. The "non-clinical testing/performance data" section refers to bench tests for the physical guide wire's properties (e.g., tensile strength, torqueability, coating integrity, biocompatibility), not an algorithm's performance on a dataset.

In summary, the provided text does not describe the kind of study you are asking about, which typically pertains to the evaluation of AI/software in medical devices.

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The R2P Radifocus Glidewire Advantage is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), are both operated through a manual process. The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), exhibit some differences in design and construction. Terumo has confirmed that these differences don't introduce any new concerns in safety and performance compared to the predicate device.

The provided text is a 510(k) summary for a medical device (guide wire) and does not contain any information about an AI/ML-driven device or study results related to acceptance criteria for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML-driven device meets those criteria based on this document. The document describes traditional performance and biocompatibility testing for a physical medical device.

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The indications for use of the FMD Peripheral Guide Wires F-14 and F-18 :

The FMD Peripheral Guide Wires are intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The indications for use of the FMD Guide Wire Extension F-14 EXT :

The FMD Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.

The FMD Peripheral Guide Wires F-14 and F-18 are designed to facilitate the placement of interventional peripheral devices such as dilating balloon catheters, stent delivery systems and other peripheral artery diagnostic or therapeutic devices. The guide wires are available in nominal diameters of 0.014 (F-14) and 0.018 (F-18) inches and nominal lengths from 190cm to 300cm. The F-14 and F-18 guide wires with a length of less than 300 cm are compatible exclusively with the FMD Guide Wire Extension F-14 EXT, which can extend the guide wire length allowing for exchange of Over-The-Wire systems. The guide wires are composed of a stainless-steel core wire and a stainless steel and platinum nickel coil assembly on the distal end of the device. The coil assembly is soldered to the core. The Pt-Ni radiopaque coil allows for visualization while using fluoroscopy. The proximal portion is coated with PTFE. The distal section is coated with hydrophilic coating. All wires are available in a straight tip configuration.

The FMD Guide Wire Extension F-14 EXT is composed of a stainless steel core wire coated with PTFE. It has an outer diameter of 0.014" (0.36 mm) and a length of 165cm. Its distal end contains a connecting hypotube that is compatible with guide wires less than 300cm of both the F-14 and F-18 series.

Attachment of the FMD Guide Wire Extension F-14 EXT to FMD's extendable guide wire creates an extended guide wire that can be used to exchange out a percutaneous transluminal angioplasty (PTA) catheter without removing the original guide wire from the artery. When the exchange is complete, the FMD Guide Wire Extension F-14 EXT can be detached, and the original guide wire can be used in a conventional manner.

This document describes the premarket notification for the FMD Peripheral Guide Wires F-14 and F-18, and the FMD Guide Wire Extension F-14 EXT. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis based on your request:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria alongside performance data in a detailed quantitative manner. Instead, it broadly states that "The in vitro bench tests demonstrated that the FMD Peripheral Guide Wires F-14 and F-18 met all acceptance criteria and performed similarly to the predicate and reference devices." and for the biocompatibility tests, it indicates "The following biocompatibility tests were completed".

Here's a summary based on the listed tests:

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

The document does not specify the exact sample sizes used for each non-clinical bench test. The data provenance is from non-clinical laboratory testing performed on the FMD Peripheral Guide Wires F-14 and F-18 and FMD Guide Wire Extension F-14 EXT. The country of origin of the data is not explicitly stated, but the applicant and contact information are for FMD Co., Ltd. located in Japan. All data would be considered prospective as it's generated 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 information is not applicable as the study described is a series of non-clinical bench tests and biocompatibility tests, not a clinical study involving human data or expert review of images for ground truth. The "ground truth" for these tests would be the established scientific and engineering principles and standards for medical device performance.

4. Adjudication method for the test set

This information is not applicable as the described study involves non-clinical bench testing and biocompatibility assessments, not a clinical trial requiring adjudication of patient outcomes or expert consensus. Decisions would be based on quantitative measurements and established pass/fail criteria for each test.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes the premarket notification for physical guide wires and guide wire extensions, which are mechanical devices, not AI-powered software or diagnostic tools that would involve human readers or AI assistance. The document explicitly states "Clinical evaluation was not required for this device."

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

A standalone performance study of an algorithm was not done. This submission is for mechanical medical devices, not an algorithm or AI.

7. The type of ground truth used

The ground truth used for this submission is based on established engineering principles, international and national standards (e.g., ISO, ASTM), and the performance characteristics of legally marketed predicate devices. For biocompatibility, the ground truth is based on the results of validated in vitro and in vivo toxicology tests as per relevant standards (e.g., ISO 10993 series).

8. The sample size for the training set

This information is not applicable. The submission is for physical medical devices and does not involve an AI algorithm or a "training set" in the context of machine learning.

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

This information is not applicable, as there is no "training set" in the context of an AI algorithm described in this submission.

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SoundBite™ Crossing System - Peripheral is indicated to facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions. The SoundBite™ Crossing System -Peripheral is not intended for use in the carotid arteries.

The SoundBite™ Crossing System - Peripheral is a recanalization tool, designed to help physicians place conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions in the peripheral vasculature. The SoundBite™ Crossing System - Peripheral consists of the reusable mobile SoundBite™ Console, the single-use sterile SoundBite™ Active Wire 18, and their accessories.

The SoundBite™ Console generates controlled mechanical pulses (i.e., shock waves) which are transmitted to the SoundBite™ Active Wire 18 and cause the distal tip of the wire to accelerate axially in a reciprocating motion, acting like a micro-jackhammer.

The SoundBite™ Active Wire 18 is similar in construction to other commercially available CTO crossing wires, with friction reducing PTFE coating (except for the distal tip), a radiopaque marker near the tip, and enhanced flexibility at the distal end. It has an outer diameter of 0.46 mm (0.018") and it is 300 cm long, with a working length of 150 cm; the proximal end flares up to a larger diameter for connection to the console. The single-use SoundBite™ Active Wire 18 is supplied sterile with a shelf life of 24 months.

Here's an analysis of the acceptance criteria and study findings for the SoundBite™ Crossing System - Peripheral, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a table format with pre-defined thresholds for performance metrics. However, it reports the primary and secondary endpoints observed in the clinical study, which implicitly serve as the performance measures. The primary endpoint was technical success of the device.

Based on the study summary, here's a representation of the reported performance:

Study Details

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

   • Test Set Sample Size: 52 patients.
   • Data Provenance: The document states it was a "single-arm clinical study involving 52 patients with documented symptomatic infrainguinal chronic total occlusions (CTO)." It does not specify the country of origin, but given the submission is to the US FDA and the company is based in Canada, it's likely a multi-national or North American study. The study is prospective in nature as it involved actively evaluating the device in clinical conditions.

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

   • The document mentions "independent physician adjudication" for adverse events but does not specify the number or qualifications of experts used to establish the ground truth (e.g., initial diagnosis of CTO or assessment of technical success) for the main efficacy endpoints. The "ground truth" for CTO diagnosis was "confirmed angiographically."

3. Adjudication method for the test set:

   • The document explicitly mentions "independent physician adjudication" for adverse events. For the primary and secondary efficacy endpoints, the method details are not provided.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This device is a medical instrument (crossing system for CTOs), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.

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

   • Not applicable. This device is a physical medical instrument requiring human operation, not a standalone algorithm.

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

   • CTO diagnosis: Confirmed angiographically.
   • Technical Success: Defined as the ability to facilitate the treatment of target lesions by allowing additional crossing and/or treatment devices to cross the CTO. This would be based on procedural success documented by the operating physician and confirmed radiographically.
   • Adverse Events: Based on clinical observation and "independent physician adjudication."
   • Secondary Endpoints: Based on procedural and post-procedural clinical/radiographic observation.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI model requiring a training set in the conventional sense. The "training" of the device's design and manufacturing processes comes from extensive bench, animal, and usability testing.

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

   • Not applicable. As the device is not an AI model, a "training set" with ground truth as commonly understood for AI is not relevant. The device development involved design verification and validation testing, risk assessment, and comparison to reference devices through bench and animal testing. These processes validate technical specifications and safety rather than "train" an algorithm.

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The Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

The Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.

The Radifocus Glidewire Advantage Track consists of a Nickel Titanium alloy and stainless steel core wire. The distal portion from the junction is NiTi and the proximal portion is stainless steel. A polyurethane and hydrophilic coating is applied to the distal portion of the wire while a PTFE coating is applied to the proximal portion. The wire distal segment comes in angled configuration. The wire contains a distal radiopaque gold coil. The wire comes packaged in a plastic holder contained within an individual package. A guide wire inserter is contained within the individual package to assist with the insertion of the wire into a needle or catheter.

During an interventional or diagnostic procedure, the physician will follow the standard procedure of placing an access wire and introducer within a vessel. Once the introducer is placed, the physician may choose a wire such as the Radifocus Glidewire Advantage Track to gain access to the target lesion or therapeutic site. It is also used in conjunction with a catheter which is advanced over the wire to the desired anatomical location.

The provided document is a 510(k) Premarket Notification for a medical device, specifically the Radifocus Glidewire Advantage Track. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and biocompatibility testing. It does not describe an AI/ML-driven device or a study involving human readers or expert consensus for ground truth establishment. Therefore, most of the requested information regarding AI acceptance criteria and study methodology (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth types) is not applicable or cannot be extracted from this document.

Here's an analysis based on the information that is present in the document:

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

The document broadly states that "All testing met acceptance criteria" and "The Radifocus Glidewire Advantage Track met the predetermined acceptance criteria" for performance testing. However, the exact acceptance criteria values themselves are not explicitly detailed in a table; rather, it lists the standards against which the tests were conducted (e.g., ISO 11070:2014, FDA Guidance, In-house Standard). For biocompatibility, it states "Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product."

Table of Acceptance Criteria and Reported Device Performance (as inferred):

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

• Sample Size for Test Set: Not specified in the document. This is a non-clinical submission, and specific sample sizes for each mechanical/biocompatibility test are typically found in detailed test reports, not the 510(k) summary itself.
• Data Provenance: The tests are conducted by the manufacturer, Terumo Medical Corporation (Ashitaka Factory in Japan). The data is generated prospectively through laboratory testing.

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

• Not applicable. This device is a physical medical device (guidewire), not an AI/ML diagnostic tool requiring human expert interpretation or ground truth establishment in the diagnostic sense.

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

• Not applicable, as this is not an AI/ML diagnostic device with human interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is not an AI/ML device, and no MRMC study was performed or is relevant to this submission.

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

• Not applicable. This is not an algorithm. Performance tests mentioned are for the physical guidewire itself.

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

• For this device, "ground truth" equates to the established standards and specifications for medical guidewires (e.g., ISO 11070:2014, in-house standards for physical properties, ISO 10993 for biocompatibility). Test results are compared against these predetermined specifications. There is no diagnostic ground truth (like pathology or expert consensus) involved.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."

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

• Not applicable. No training set is involved.

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This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The ASAHI Peripheral Guide Wires in this submission have a coil-type distal end or a plastic covered-type distal end. The coil is partly or entirely radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy.

The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2cm of the distal end can be shaped. ASAHI INTECC detachable extension wire (hereafter "extension wire") (previously cleared as part of K083145 and K101985) is available to connect with the proximal end of the guide wire with a length of less than 300 cm. The total length of the system after the connection with be 300cm to 400cm. Torque device may be included in the same package.

The ASAHI Peripheral Guide Wires in this submission have an overall length range of 200 to 300 cm and a nominal outer diameter range of 0.36 to 0.45 mm.

This document is a 510(k) summary for ASAHI Peripheral Guide Wires, which includes three models: ASAHI Gladius, ASAHI Halberd, and ASAHI Gaia PV. The purpose of this summary is to demonstrate substantial equivalence to legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and study information provided:

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

The document broadly states that "The in vitro bench tests demonstrated that the ASAHI Peripheral Guide Wire met all acceptance criteria and performed similarly to the predicate devices." However, specific numerical acceptance criteria for each test (e.g., minimum tensile strength in Newtons, or maximum torque strength in N/cm) are not explicitly listed in the provided text. The performance is reported qualitatively as "met all acceptance criteria and performed similarly."

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

The document mentions "Non clinical laboratory testing was performed," which implies a test set. However, the sample size used for the test set is not specified. The data provenance is also not specified beyond being "non clinical laboratory testing." It does not mention the country of origin of the data or whether it was retrospective or prospective, as these are typically not applicable to bench testing of this nature.

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

This information is not applicable or provided. For medical devices undergoing bench testing against engineering specifications, ground truth is established by physical measurements and engineering standards, not typically by expert review in the same way it would be for AI model validation in image interpretation, for example.

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

This information is not applicable or provided. Adjudication methods are typically relevant for human review of data, especially in clinical studies or when establishing ground truth for AI model training/testing. For bench testing, the results are typically objectively measured against established engineering specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable or provided. The device in question is a guide wire, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

This information is not applicable or provided. The device is a physical medical device (a guide wire), not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this product.

7. The type of ground truth used:

The ground truth for the bench tests would have been the engineering specifications and performance standards applicable to guide wires. These are based on industry standards, established medical device requirements, and the characteristics of the predicate devices.

8. The sample size for the training set:

This information is not applicable or provided. The document describes a physical medical device undergoing bench testing, not an AI system that requires a "training set."

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

This information is not applicable or provided for the same reason as point 8.

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