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The Micrus Ascent Occlusion Balloon Catheters are intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent Occlusion Balloon Catheters are also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.

The Micrus Ascent Occlusion Balloon Catheters are coaxial dual lumen balloon catheters comprised of an inner guidewire lumen and a separate outer lumen to inflate and deflate the balloon. The balloon catheter is designed for use over any .014" or smaller guidewire. The balloon can be inflated and deflated independently of guidewire position. The balloon is equipped with a vent hole for easy preparation and removal of air from the balloon, and with two radiopaque markers for balloon positioning. Certain balloon catheter sizes may have a third radiopaque marker band 3 cm proximal to the tip to facilitate fluoroscopic visualization.

This document describes the acceptance criteria and study that proves the Micrus Ascent Occlusion Balloon Catheter meets these criteria, supporting its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• In-vitro tests: The exact sample size for each in-vitro test is not specified in the summary, but multiple tests were conducted across various performance aspects.
• In-vivo study: The test set for the in-vivo study consisted of 7 devices in a porcine model.
• Data Provenance: The data provenance is from in-vitro laboratory testing and an in-vivo animal study (porcine model). This is prospective data generated specifically for the 510(k) submission. No country of origin is explicitly stated, but it can be inferred the testing was conducted by or for Micrus Endovascular Corporation, based in San Jose, CA, USA.

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

For the in-vivo study, the summary states that "the trackability of the device met physicians' acceptance" and "the device deployed effectively and as expected." This implies subjective assessment by medical professionals.

• Number of experts: Not explicitly stated, but the phrasing "physicians' acceptance" suggests more than one, or at least a general consensus attributed to medical professionals involved in the study.
• Qualifications of those experts: Not explicitly stated, but it can be inferred they were veterinarians or medical researchers with expertise in animal models and catheter deployment.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "physicians' acceptance" in the in-vivo study seems to refer to a qualitative observation and concurrence, rather than a structured adjudication process for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This was a substantial equivalence submission for a modified device, focusing on demonstrating performance against established benchmarks and the predicate device's performance, not comparative effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a physical medical device (balloon catheter), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm or "human-in-the-loop performance" is not applicable. The studies assessed the physical device's performance characteristics.

7. The Type of Ground Truth Used

• In-vitro tests: The ground truth for in-vitro tests was based on engineering specifications, design parameters, and established industry standards for catheter performance (e.g., balloon burst pressure, cycling durability, coating integrity).
• In-vivo study: The ground truth for the in-vivo study was based on direct observation, successful deployment, stability, and "physicians' acceptance" within the porcine model, indicating successful functionality in a biological system.

8. The Sample Size for the Training Set

This device did not involve machine learning or AI algorithms requiring a training set. The term "training set" is not applicable in this context.

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

As there was no training set (see point 8), this question is not applicable.

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Micrus Courier Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.

Micrus Courier Microcatheters are variable stiffness, single lumen catheters designed to aid the physician in accessing small, tortuous vasculature when used with a guiding catheter and steerable guide wire. Multiple levels of stiffness ranging from a highly flexible tip to a semi-rigid proximal section along the length of the catheter are designed to aid the physician in tracking over guide wires without displacement of the wire. The microcatheters have an outer hydrophilic coating that reduces friction during manipulation in the vessel. The lubricious PTFE-coated inner lumen is designed to facilitate movement of guide wires and other devices. A shaft marker, located 90 cm from the distal tip, is provided to expedite microcatheter insertion to the depth of standard guide catheters (90 cm long). Two marker bands, one at the catheter tip and another 3 cm proximal to the tip, are radiopaque to facilitate fluoroscopic visualization. A luer fitting located on the end of the catheter hub can be used to attach accessories. All microcatheters are packaged with a steam shaping mandrel accessory.

The provided text is a 510(k) Summary for the Micrus Courier 270 Microcatheter. This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It does not contain information about specific "acceptance criteria" based on device performance metrics (e.g., sensitivity, specificity, accuracy) or a study proving that the device meets such criteria in terms of clinical or diagnostic effectiveness.

Medical devices like microcatheters are typically evaluated for performance in terms of mechanical properties, biocompatibility, and functional aspects (e.g.,
delivery of agents, trackability). The document states that the "Micrus Courier 270 Microcatheter is substantially equivalent to other Micrus Courier Microcatheters in terms of intended use, design, specifications, and materials," and that "The Micrus Courier 270 Microcatheter uses the same methods and materials in construction, packaging, and sterilization as its predicate." This implies that the 'acceptance criteria' for this 510(k) submission are met by demonstrating equivalence to a legally marketed predicate device, rather than through a de novo clinical trial demonstrating specific performance metrics against a predefined threshold.

Therefore, most of the requested information cannot be extracted from the provided text, as it pertains to clinical performance study details (e.g., sample size, ground truth, expert adjudication, MRMC studies, standalone performance) typically found in documents for AI/ML-driven devices or devices requiring clinical performance data beyond substantial equivalence.

Information that can be inferred or is directly stated:

• Intended Use/Indications for Use: Micrus Courier Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.

Here's a breakdown of the requested information based on the provided text:

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

Note: The document does not provide specific quantitative performance metrics (e.g., in a clinical setting) against which acceptance criteria would typically be set for AI/ML or novel diagnostic devices. The acceptance criteria here are implicitly met by demonstrating substantial equivalence to a predicate device, as required for 510(k) clearance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
No information available. This type of study data is not typically part of a 510(k) summary for a substantial equivalence claim for a microcatheter.

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)
No information available. Ground truth establishment with experts is not detailed as there isn't a performance study described in this document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No information available. Adjudication methods are not applicable to the type of information presented in this 510(k) summary.

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 information available. This is not an AI/ML device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No information available. This is not an AI/ML device, and no standalone algorithm performance study is mentioned.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
No information available. Ground truth for performance metrics is not discussed, as the document focuses on substantial equivalence of design and function. The 'ground truth' for the regulatory submission is essentially the predicate device's established safety and effectiveness.

8. The sample size for the training set
No information available. This is not an AI/ML device, and no training set is relevant.

9. How the ground truth for the training set was established
No information available. Not applicable.

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The Micrus Ascent and Summit Occlusion Balloon Catheters are intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent and Summit Occlusion Balloon Catheters are also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.

The Micrus Ascent and Summit Occlusion Balloon Catheters are coaxial dual lumen balloon catheters comprised of an inner guidewire lumen and a separate outer lumen to inflate and deflate the balloon. The balloon catheter is designed for use over any .014" or smaller guidewire. The balloon can be inflated and deflated independently of guidewire position. The balloon is equipped with a vent hole for easy preparation and removal of air from the balloon, and with two radiopaque markers for balloon positioning.

The provided text is a 510(k) Premarket Notification for medical devices (Micrus Occlusion Balloon Catheters). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting clinical study data to prove the device meets specific acceptance criteria related to efficacy or performance in a clinical setting.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this 510(k) summary.

Here's a breakdown of what can be inferred and what is explicitly unobtainable from the provided text:

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

• UNOBTAINABLE from this document. This 510(k) focuses on demonstrating "substantial equivalence" based on design, specifications, materials, and intended use, not on specific performance metrics or clinical acceptance criteria. There are no performance criteria or corresponding results reported.

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

• UNOBTAINABLE from this document. There is no mention of a "test set" or clinical study data in the traditional sense. The submission likely relies on non-clinical (bench) testing and comparisons to the predicate device to demonstrate equivalence.

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)

• UNOBTAINABLE from this document. As no specific clinical test set is described, there's no mention of experts establishing ground truth.

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

• UNOBTAINABLE from this document. No clinical test set means no adjudication method.

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

• UNOBTAINABLE from this document. This document describes a medical device (balloon catheter), not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related effectiveness is irrelevant and not mentioned.

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

• UNOBTAINABLE from this document. This is not an algorithm or AI device.

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

• UNOBTAINABLE from this document. No clinical ground truth is established or discussed. The "ground truth" for a 510(k) submission like this is primarily the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• UNOBTAINABLE from this document. This is not an AI device, so there's no concept of a "training set."

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

• UNOBTAINABLE from this document. Not applicable.

Summary of Device and 510(k) Approach (based on the provided text):

The Micrus Ascent and Summit Occlusion Balloon Catheters are being submitted for 510(k) clearance by claiming substantial equivalence to an existing predicate device: K080861, Micrus Ascent Occlusion Balloon Catheter.

Key points from the document regarding the "study" (which is primarily a comparison for substantial equivalence):

• Rationale for Equivalence: The submission asserts that the new devices are substantially equivalent to the predicate in terms of intended use, design, specifications, methods and materials in construction, packaging, and sterilization and materials. The modification to the device (new sizes or slight variations) has not altered the fundamental technology of the predicate devices.
• Intended Use: The devices are intended for temporary occlusion in peripheral and neuro vasculature, to stop/control blood flow, and to assist in the delivery of diagnostic/therapeutic agents.
• Device Description: Coaxial dual lumen balloon catheters with an inner guidewire lumen and an outer inflation/deflation lumen. Designed for use over 0.014" or smaller guidewires, with a vent hole and two radiopaque markers.
• Predicate Device: Micrus Ascent Occlusion Balloon Catheter (4x7mm) cleared under K080861.

In essence, the "study" here is the compilation of documentation and analysis demonstrating that the new devices are so similar to an already cleared device that they do not raise new questions of safety or effectiveness, and therefore do not require extensive clinical trials or performance studies as would be seen for novel devices.

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Micrus Courier Flex Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.

Micrus Courier Flex Microcatheters are variable stiffness, single lumen catheters designed to aid the physician in accessing small, tortuous vasculature when used with a guiding catheter and steerable guide wire. Multiple levels of stiffness ranging from a highly flexible tip to a semi-rigid proximal section along the length of the catheter are designed to aid the physician in tracking over guide wires without displacement of the wire. The microcatheters have an outer hydrophilic coating that reduces friction during manipulation in the vessel. The lubricious PTFE-coated inner lumen is designed to facilitate movement of guide wires and other devices. A shaft marker, located 90 cm from the distal tip, is provided to expedite microcatheter insertion to the depth of standard guide catheters (90 cm long). Two marker bands, one at the catheter tip and another 3 cm proximal to the tip, are radiopaque to facilitate fluoroscopic visualization. A luer fitting located on the end of the catheter hub can be used to attach accessories. All microcatheters are packaged with a steam shaping mandrel accessory.

The provided 510(k) summary for the Micrus Courier Flex Microcatheter does not contain any information regarding acceptance criteria, device performance studies, or data related to AI/algorithm performance.

This document describes a medical device (a microcatheter) and is primarily focused on demonstrating substantial equivalence to a previously approved predicate device. It defines the intended use, describes the device's physical characteristics, and confirms that it uses similar materials and manufacturing processes as its predicate.

Therefore, I cannot provide the requested information. The concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth for training set" are typically associated with performance studies for diagnostic or AI-driven devices, which are not detailed in this document.

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The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.

The Micrus Microcoil System consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single use, sterile)

The provided text is a 510(k) premarket notification for the Micrus Microcoil System DELTAPLUSH. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with acceptance criteria for a new device's performance.

Therefore, the document does not report acceptance criteria or a study designed to prove the device meets acceptance criteria in the way you've outlined for a typical diagnostic or AI-driven medical device.

Instead, the submission for the Micrus Microcoil System DELTAPLUSH makes the following claims:

• Comparison to Predicate Devices: "The Microcoil System, DELTAPLUSH, has shown substantial equivalence to the Micrus Microcoil System, Deltapaq, in terms of intended use, design, material of construction, implant dimensions including wire dimensions, coil dimensions, coil pitch, and coil stiffness. The DELTAPLUSH microcoils use the same method and material of construction, packaging, and sterilization method as its predicate. The modification has not altered the fundamental technology of the sponsor's predicate device."
• Conclusion: "Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Micrus Endovascular Corporation, it is concluded that the DELTAPLUSH Microcoil System is substantially equivalent to the predicate device in safety and effectiveness."

In summary, the information requested in your prompt (Table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or available in the provided 510(k) document for this specific device.

The 510(k) process for this device relies on demonstrating that the new device ("DELTAPLUSH") is as safe and effective as a previously cleared device ("Deltapaq") through non-clinical testing and comparison of attributes, rather than a prospective clinical study with defined performance metrics and acceptance thresholds.

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The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.

The Micrus Microcoil System consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit ("DPU")

This document, K082739, is a 510(k) premarket notification for a medical device called the "Micrus Microcoil Delivery System." It aims to demonstrate substantial equivalence to previously cleared devices rather than prove the device meets specific acceptance criteria through a formal study with statistical endpoints. As such, the provided text does not contain the information required to populate most sections of your request.

Here's a breakdown based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not present in the provided document. The 510(k) submission focuses on demonstrating substantial equivalence through design, material, function, and intended use comparison, along with non-clinical testing. It does not detail specific performance metrics and acceptance criteria for patient outcomes or diagnostic accuracy that would be found in a clinical study for a new device.

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

This information is not applicable/not present. No "test set" in the context of a clinical study for performance evaluation is described. The submission relies on "non-clinical testing" which typically refers to bench testing, engineering tests, and biocompatibility, not patient data for performance evaluation in the way you're asking.

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

This information is not applicable/not present. As there is no clinical test set described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set:

This information is not applicable/not present. No clinical test set or adjudication process is described.

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

This information is not applicable/not present. The document does not describe any MRMC study. The comparison is to predicate devices through design and function, not through a clinical performance comparison with human readers.

6. Standalone (Algorithm Only) Performance Study:

This information is not applicable/not present. This device is a physical medical device (microcoil delivery system), not an algorithm or AI-based diagnostic tool.

7. Type of Ground Truth Used:

This information is not applicable/not present in the context of a clinical performance study. For the substantial equivalence claim, the "ground truth" or basis of comparison is the safety and effectiveness of the predicate devices as established by their prior FDA clearance. The assessment is then whether the new device is "substantially equivalent" to these already cleared devices, meaning its design, materials, function, and intended use are similar enough that it raises no new questions of safety or effectiveness.

8. Sample Size for the Training Set:

This information is not applicable/not present. This is not a study involving a "training set" for an algorithm or a clinical trial with patient enrollment numbers.

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

This information is not applicable/not present.

Summary of what the document does state regarding acceptance criteria and "proof":

The document states that the Micrus Microcoil Delivery System with a new "Device Positioning Unit" has shown substantial equivalence to FDA-cleared and marketed Micrus Microcoil Systems.

The "proof" for this substantial equivalence is based on:

• Comparison of intended use, design, material, method of construction, and dimensions to predicate devices.
• The assertion that "The modification has not altered the fundamental technology of the predicate devices."
• Non-clinical testing performed by Micrus Endovascular Corporation. (The specifics of this testing, its acceptance criteria, and results are not detailed in this summary document.)

Conclusion:

This 510(k) summary is designed to demonstrate that the modified device is substantially equivalent to existing, cleared devices. It does not contain the kind of detailed study information (acceptance criteria, sample sizes, expert ground truth, etc.) that would be found for a novel device undergoing a performance study or a clinical trial with predefined endpoints. The "acceptance criteria" here implicitly align with the FDA's requirements for substantial equivalence for a Class II device.

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The Micrus Ascent Occlusion Balloon Catheter is intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent Occlusion Balloon Catheter is also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.

The Micrus® Ascent™ Occlusion Balloon Catheter is a coaxial dual lumen balloon catheter comprised of an inner guidewire lumen and a separate outer lumen to inflate and deflate the balloon. The balloon catheter is designed for use over any .014" or smaller guidewire. The balloon can be inflated and deflated independently of guidewire position. The balloon is equipped with a vent hole for easy preparation and removal of air from the balloon, and with two radiopaque markers for balloon positioning.

The provided text is a 510(k) Premarket Notification for the Micrus Ascent Occlusion Balloon Catheter. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing new clinical study data with specific acceptance criteria as would be found in a PMA (Premarket Approval) application for novel devices often involving AI/ML.

Therefore, the document does not contain the information requested regarding acceptance criteria for device performance, details of a study proving such criteria, sample sizes for test/training sets, expert qualifications, or details about comparative effectiveness studies with AI assistance.

The document states that the Micrus Ascent Occlusion Balloon Catheter is considered substantially equivalent to predicate devices based on:

• Intended use
• Design
• Specifications
• Materials
• Methods and materials in construction, packaging, and sterilization

The "study" in this context refers to the comparison made to predicate devices to establish substantial equivalence, not a performance study against specific acceptance criteria.

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The Micrus Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and are also intended for arterial and venous embolizations in the peripheral vasculature.

The Micrus Deltapaq 10 Stretch-Resistant Microcoil Systems consists of an embolic coil ("Microcoil") attached to a Device Positioning Unit (DPU) (single use, sterile)

The provided document is a 510(k) summary for the Micrus Deltapaq 10 Stretch-Resistant Microcoil System, a neurovascular embolization device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial with specific acceptance criteria and detailed performance studies against a defined ground truth.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance against those criteria, details of a study with a test set, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to an AI/ML device.

Instead, the document emphasizes the following:

1. Comparison to Predicate Device:

The submission states: "The Micrus Deltapaq 10 Stretch-Resistant Microcoil System has shown substantial equivalence to the Micrus Stretch-Resistant Microcoil System in terms of intended use, design, material of construction, implant dimensions including wire dimensions, coil dimensions, coil pitch, and coil stiffness. The Deltapaq 10 Stretch-Resistant microcoils use the same method and material of construction, packaging, and sterilization method as its predicate. The modification has not altered the fundamental technology of the sponsor's predicate device."

2. Conclusion:

"Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Micrus Endovascular Corporation, it is concluded that the Micrus Deltapaq 10 Stretch-Resistant Microcoil System is substantially equivalent to the predicate device in safety and effectiveness."

In summary, as this is a 510(k) submission for a non-AI/ML medical device, the detailed information about acceptance criteria, performance studies with test sets, expert ground truth, and training data as typically required for AI/ML device evaluations is not present in this document. The "study" here refers to non-clinical testing demonstrating equivalence to a predicate device, rather than a performance study against specific diagnostic or prognostic metrics.

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