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The Wedge Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and to assist in the delivery of interventional devices, such as the SOFIA 6F Catheter, in the neurovasculature.

The Wedge Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The microcatheter has a semi-rigid proximal section with an outer shaft made of Grilamid nylon. The catheter shaft transitions to progressively softer durometers and different lengths of Polyether block amide (Pebax). The distal-most length of the microcatheter, beyond the enlarged segment, consists of a softer, atraumatic polyurethane.

The enlarged segment on the distal end of the Wedge is designed to reduce the gap between the OD of the guidewire and ID of the Sofia 6F. The tapered bulb section, approximately 1 cm length and located approximately 1.5 cm from the distal tip, can be identified on fluoroscopy between the two radiopaque proximal marker bands of the Wedge Microcatheter. The bulb OD (0.068") is sized specifically to work with the lumen ID (0.070") of the Sofia 6F allowing for continuous flush of saline through the Sofia.

Three radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the microcatheter is coated with a hydrophilic polymer coating to reduce friction during navigation in the vasculature. The lubricious inner liner is made from polytetrafluoroethylene (PTFE). A luer fitting on the Microcatheter hub is used for the attachment of accessories. The hub/strain relief provides for the kink resistance at the proximal end. The microcatheter has a straight tip that is designed to be steam shaped by the physicians at the time of the use. A steam shaping mandrel and introducer sheath (accessories) are packaged with the catheter.

The provided document describes the MicroVention, Inc. Wedge Microcatheter and its substantial equivalence to predicate devices, rather than a standalone study with defined acceptance criteria and detailed device performance metrics in the way a clinical trial or a specific performance study for a diagnostic device might.

However, based on the Verification Test Summary and the Biocompatibility Evaluation sections, we can infer the acceptance criteria and reported device performance for various engineering and biological aspects. The "Results" column in these tables implicitly represents the device's performance against an unstated "Pass" acceptance criterion.

Here's an attempt to structure the information as requested, interpreting the "Pass" result as meeting the acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: For the tests marked with an asterisk (), the document states: "Testing was previously conducted on test article that was equivalent in all aspects relevant to the testing performed, therefore it was deemed unnecessary to repeat the testing for the Wedge Microcatheter." This implies these tests were accepted based on prior results on an equivalent device.*

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

The document does not explicitly state the numerical sample sizes for each specific verification test mentioned. The "Verification Test Summary" refers to tests conducted on the "subject device," implying direct testing of the Wedge Microcatheter.

• Animal Testing Summary: While not a "test set" in the sense of human patient data, the animal study compared the Wedge Microcatheter with the predicate Headway 21. It doesn't specify the number of animals used.
• Biocompatibility Evaluation: This section describes various in vitro and in vivo tests (e.g., Guinea pigs for sensitization, mice for systemic injection, rabbits for pyrogenicity). The numerical sample sizes for these animal models are not provided, nor is the country of origin. The data is prospective, generated specifically for this submission.

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

This document does not describe a scenario where "experts" are establishing ground truth for a test set in the context of clinical images or diagnostic outcomes. The tests performed are primarily engineering performance tests and biological reactivity tests. Therefore, this question is not applicable in the traditional sense for this type of device submission. The "ground truth" for these tests is established by standardized testing methods and validated experimental procedures.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of data requiring adjudication. The device performance is assessed through objective measurements and standard laboratory protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device submission for a microcatheter, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is not an algorithm or AI device. The tests performed are standalone in the sense that they evaluate the device itself, but not an algorithm.

7. The Type of Ground Truth Used

• Engineering/Performance Tests: The "ground truth" is based on established engineering standards and specifications for catheter performance (e.g., burst pressure, flow rate, force at break). These are objective, measurable outcomes.
• Biocompatibility Tests: The "ground truth" is based on the results of validated in vitro and in vivo biological assays comparing the device's interaction with biological systems against established thresholds for toxicity, irritation, sensitization, etc., as per ISO 10993-1:2009 and FDA guidelines.
• Animal Testing: The "ground truth" for the animal study (comparative performance and histopathology) was direct observation of the animal's vasculature and subsequent histopathological examination.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device that requires a training set.

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

Not applicable. As this is not an AI or machine learning device, there is no training set or associated ground truth.

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The AZUR Peripheral Coil System is intended to reduce or blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

The AZUR CX Coils consist of implant coil made of platinum alloy with inner hydrogel core. The coils are designed in 3D spherical structure in various loop sizes and lengths. The AZUR CX Coil System (Detachable) consists of an implantable coil attached to a delivery pusher. The coil system is delivered to the treatment site through the microcatheter. The proximal end of the delivery pusher is inserted to the AZUR detachment controller. The detachment controller is activated by the user and this detaches the coil. The AZUR coils are designed for use with the AZUR Detachment Controller (Also known as AZUR Detachment Controller), specifically designed for coil detachment and is sold separately.

This document is a 510(k) premarket notification for a medical device called the AZUR CX Peripheral Coil System - Detachable 35. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document provides a "Verification of Test Summary" and "Biocompatibility Summary" which can be interpreted as the acceptance criteria and the results of tests performed.

Note: The document explicitly states "Passed" for bench tests. For biocompatibility, it lists test methods and standards, and the "Summary of Substantial Equivalence" implies that these tests were passed and support the equivalency claim.

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

The provided document does not specify the sample sizes used for the bench tests or biocompatibility tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature) for these tests. This information would typically be found in the detailed test reports, which are not included in this summary.

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 document describes a medical device, the AZUR CX Peripheral Coil System, which is an implantable coil for embolization. The tests conducted are primarily mechanical/physical bench tests and biocompatibility tests, not studies involving expert interpretation of medical images or clinical outcomes that would require a ground truth established by medical experts for a test set. Therefore, this question is not applicable in the context of the information provided.

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

As the tests are primarily bench and biocompatibility tests, there is no adjudication method described or relevant for establishing a clinical "ground truth" for a test set by human experts. The results are typically objectively measured or observed (e.g., a "pass" or "fail" for a mechanical test, or quantitative results against a standard for biocompatibility).

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

No MrMC comparative effectiveness study was done or is mentioned in this document. This filing is for a physical medical device (embolization coil), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical implant, not an algorithm, so standalone performance in the context of AI is irrelevant.

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

For the bench tests, the "ground truth" is defined by engineering specifications and performance requirements for the device's physical and functional characteristics. For biocompatibility tests, the "ground truth" is established by international standards (ISO 10993 series), which define acceptable biological responses to medical devices. There isn't a "ground truth" in the sense of clinical diagnoses or outcomes used in AI or clinical trials with human subjects.

8. The sample size for the training set:

Not applicable. The device is a physical medical implant, 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 AI model or training set, there is no ground truth to establish for a training set.

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The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

The Headway 27 Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. An introducer sheath and shaping mandrel are also provided.

The provided text describes the MicroVention, Inc. Headway 27 Microcatheter and its substantial equivalence to a predicate device (Headway 27 Microcatheter, K110813). The document primarily focuses on bench testing and biocompatibility testing to demonstrate this equivalence.

Here's an analysis of the acceptance criteria and study data based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes general bench testing and biocompatibility testing. It does not specify the sample sizes (number of units tested) for each individual bench test or the biocompatibility studies.

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. Given the context of a 510(k) submission, this data would typically be generated by the manufacturer (MicroVention, Inc., USA) as part of their device development and validation process, likely in a controlled laboratory environment.

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

This information is not provided in the document. The studies performed are primarily physical and chemical bench tests, and in vitro and in vivo biocompatibility tests, which do not typically involve human expert interpretation for "ground truth" establishment in the way, for example, a diagnostic image review would. For "rated 3 or higher," "passed," etc., these would be based on predefined objective criteria in test protocols, not subjective expert consensus.

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

This information is not applicable and not provided in the document. Adjudication methods are typically used in studies involving human interpretation or decision-making, such as clinical trials or diagnostic accuracy studies, to resolve discrepancies among multiple reviewers. The tests described are objective, physical, chemical, and biological assessments.

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 and not provided. The device in question is a microcatheter, a physical medical device used for intravascular delivery. It is not an AI-powered diagnostic or assistive technology that would involve "human readers" or "AI assistance" in the sense of an MRMC study.

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

This is not applicable and not provided for the same reasons as point 5. The device is a physical tool, not an algorithm.

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

The "ground truth" for the bench tests are the pre-defined engineering specifications and performance criteria for the physical properties of the catheter (e.g., length, diameter, burst pressure, kink resistance, force at break). For the biocompatibility tests, the "ground truth" is established by standardized ISO 10993 biological evaluation test methods which define acceptable biological responses (e.g., non-toxic, non-irritant, non-hemolytic).

8. The sample size for the training set:

There is no mention of a "training set." This concept is relevant to machine learning or AI algorithms. The Headway 27 Microcatheter is a physical medical device, and its development and testing involve traditional engineering and biological validation, not machine learning model training.

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

This is not applicable as there is no training set for this device.

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The SOFIA Distal Access Catheter is intended for general intravascular use, including The GOT IA Dicture al vasculature. It can be used to facilitate the introduction of the nours and therapeutic agents. It is not intended for use in coronary arteries.

The SOFIA Distal Access Catheter is a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steam-shapeable and it has a hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. An introducer sheath and shaping mandrel are also provided.

The provided text describes a medical device, the SOFIA™ Distal Access Catheter, and its verification testing for 510(k) clearance. This submission does not include information about AI/ML models, therefore, many of the requested fields related to AI/ML studies cannot be answered. The information pertains to traditional medical device testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document presents internal acceptance criteria implicitly through the "Results" and "Conclusions" sections of the verification tests. The "Conclusions" often state that the device "met established specifications" or "performs as intended," implying these were the acceptance criteria.

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

The document does not specify exact sample sizes for each test in terms of "N" or "number of unique cases/patients." It refers to "test articles," implying a number of device units were subjected to each test. For some tests, it mentions "two out of two test sites" or "test articles."
Data provenance is not provided in terms of country of origin or retrospective/prospective clinical data, as these are bench and biocompatibility tests, not clinical studies involving patient data.

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

N/A. This is a medical device performance and safety (bench and biocompatibility) study, not an AI/ML diagnostic accuracy study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

N/A. Not applicable for bench and biocompatibility testing. Ground truth for these tests is based on physical measurements, chemical analyses, and biological responses according to established standards.

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

No. This document does not mention any MRMC comparative effectiveness study, nor does it involve human readers or AI assistance.

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

No. This document is for a physical medical device, not an algorithm or AI model.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" is based on:

• Physical measurements: E.g., dimensions (OD, ID, length), force at break, unscrewing torque, flow rates, burst pressures. These are measured objectively against defined specifications.
• Qualitative assessments: E.g., presence/absence of kinks, visibility under fluoroscopy, ease of assembly, presence of stress cracks, evaluation of surface contaminants. These are typically assessed by trained technicians against defined criteria.
• Performance metrics: E.g., successful tracking, minimal resistance, non-overriding threads. These are observed outcomes during simulated use or specific tests.

For biocompatibility testing, the "ground truth" is based on:

• Standardized biological assays: E.g., MEM elution assay for cytotoxicity, Kligman Maximization Test for sensitization, rabbit blood tests for hemocompatibility, rabbit pyrogen test, dog thrombogenicity study. These tests produce quantitative or semi-quantitative results that are interpreted against established acceptance criteria defined in ISO 10993 series of standards.
• Pathology/Histology: For the thrombogenicity study, "minimal thrombosis observed" would be a histological assessment.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML study, so there is no training set.

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

N/A. This is not an AI/ML study, so there is no training set or ground truth for one.

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The AZUR PURE is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

The AZUR PURE Peripheral Coil System, Pushable 35, consists of an implantable all-polymer coil housed in an introducer. A stainless steel stylet is used to deploy the coil from the introducer into a delivery catheter. The coil is delivered to the treatment site through the delivery catheter using a standard guidewire.

The provided document describes a 510(k) submission for a design modification to the AZUR PURE Peripheral Coil System, specifically the addition of an "Overcoil." This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies to prove device performance against specific acceptance criteria.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving device performance, is not applicable or available in this summary. The submission focuses on verifying that the modified device's performance is equivalent to the predicate device through non-clinical testing.

Here's a breakdown of why this information is not provided in the document:

• Nature of 510(k) for design modification: Special 510(k)s for design modifications, like this one, aim to demonstrate that the changes do not raise new questions of safety and effectiveness. This is typically achieved by showing that the modified device performs similarly to a legally marketed predicate device through engineering tests and comparisons, rather than de novo clinical trials.
• Focus on equivalence: The document explicitly states, "The subject of this submission are substantially equivalent to the predicate device with regard to intended use, patient population, device design, materials, processes, and operating principal." This is the core argument of the submission.

Analysis based on the provided text:

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

Explanation: The "acceptance criteria" for the modified device were to "Met same criteria as predicate." The actual quantitative criteria for the predicate device themselves are NOT provided in this document. The "reported device performance" is simply that the modified device met these (unspecified) criteria.

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: Not specified.
• Data provenance: Not specified. This would typically be non-clinical, in-vitro testing rather than human data.

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)

• Number of experts: Not applicable. These are engineering/performance tests, not human-read clinical evaluations.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable. This refers to consensus among human readers for clinical ground truth, which is not relevant here.

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

• MRMC study: No, an MRMC study was not done. This is a non-clinical device modification submission, not an AI efficacy study.
• Effect size: Not applicable.

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

• Standalone study: Not applicable. This device is not an algorithm, but a physical medical device. The "standalone" performance here would refer to the device's physical and mechanical capabilities. The Verification & Validation test summary (Simulated Use, Advancement Force, Tensile Strength, Expansion Characteristics) can be considered "standalone" in this context, demonstrating the device's functional performance.

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

• Type of ground truth: The "ground truth" for these engineering tests would be derived from established engineering specifications, mechanical testing standards, and the validated performance characteristics of the predicate device. For example, a tensile strength test would have a pre-defined pass/fail threshold based on the predicate.

8. The sample size for the training set

• Sample size: Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Ground truth establishment: Not applicable.

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For use in the blood vessels of the peripheral and neurovasculature where temporary occlusion is desired. These catheters offer a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow and for balloon assisted embolization of intracranial aneurysms.

For use in the peripheral vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials.

For neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials, that have been approved or cleared for use in the neurovasculature and are compatible with the inner diameter of the Scepter C/XC Balloon Catheter.

The Scepter C and XC Occlusion Balloon Catheter is a dual coaxial lumen catheter with a nondetachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over a steerable guidewire. The inner lumen can be used for infusion/delivery of diagnostic and therapeutic agents. The outer lumen is used for the inflation and deflation of the balloon independent of guidewire position. Radiopaque marker bands are located at ends of the balloon and distal tip of the catheter to facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories. The catheters are packaged sterile for single use only.

The Scepter C and XC Occlusion Balloon Catheter is intended for temporary occlusion in peripheral and neurovasculature, controlling blood flow for balloon-assisted embolization of intracranial aneurysms, and infusing diagnostic and therapeutic agents in peripheral and neurovascular applications.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes pre-clinical testing performed on the Scepter C and XC Occlusion Balloon Catheter. The acceptance criterion for each test is implicitly "Pass," indicating that the device must meet the specified performance standards for each category.

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

The document does not explicitly state the sample sizes used for each pre-clinical test. The testing is referred to as "Pre-clinical Testing," which typically involves laboratory-based assessments rather than human or animal studies with large sample sizes.

• Sample Size for Test Set: Not explicitly stated.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given it's pre-clinical testing for a 510(k) submission, it's virtually certain to be prospective, laboratory-based testing conducted by the manufacturer, MicroVention, Inc., based in Tustin, California, U.S.A.

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

Not applicable. For pre-clinical engineering and biocompatibility tests, ground truth is established by standardized test methods and criteria, not by expert consensus on clinical images or patient outcomes. The "ground truth" is defined by the physical or chemical properties being measured against established regulatory standards (e.g., ISO standards for biocompatibility).

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or image interpretation studies where there's variability in expert assessment. For pre-clinical engineering tests, results are typically objective measurements against defined pass/fail criteria.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic devices, especially those involving human interpretation of medical images (e.g., radiologists reading scans with and without AI assistance). The Scepter C and XC Occlusion Balloon Catheter is an interventional device, not a diagnostic one.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone (algorithm only) performance study was not done. This type of study is specifically for evaluating the performance of AI algorithms without human intervention. The Scepter C and XC Occlusion Balloon Catheter is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used:

The ground truth used for these pre-clinical tests is based on engineering specifications, standardized test methods, and regulatory requirements (e.g., ISO 10993 for biocompatibility). For example, "Tensile strength Pass" implies the device met a pre-defined tensile strength threshold established by engineering design and industry standards; "Cytotoxicity (ISO 10993-5) Pass" means the device met the criteria outlined in that specific ISO standard for cytotoxicity.

8. Sample Size for the Training Set:

Not applicable. The Scepter C and XC Occlusion Balloon Catheter is a physical medical device, not an AI/ML algorithm 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 AZUR Peripheral Coil System is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

The AZUR Peripheral Coil System - Detachable 18 Coils are designed in the helical structure in various diameter and lengths. The coils are comprised of platinum alloy that are wound around the mandrels to form into the helical shape. The implant segment is then attached to the delivery pusher. The pusher is inserted into detachment controller which when activated detaches the coil from the delivery pusher. The detachment controller utilizes battery power to detach the coils from the delivery pusher. The coils are specified to be delivered through a microcatheter with a minimum inner diameter of 0.021" (0.053 mm).

The sponsor, MicroVention, Inc., submitted an amendment to their 510(k) for the AZUR Peripheral Coil System - Detachable 18. This device is a vascular embolization device intended to reduce or block blood flow in peripheral vasculature. The device has the same indications for use as predicate devices, MicroVention AZUR Detachable 18 HydroCoil (K090168) and AZUR Pushable 35 (K071939). In conclusion, the AZUR Peripheral Coil System - Detachable 18 is substantially equivalent to legally marketed predicate devices.

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

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

Not applicable. The provided text details bench testing, not clinical studies with patients.

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

Not applicable. Ground truth for bench testing is typically based on engineering specifications and measurement standards, not expert clinical interpretation.

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

Not applicable. This information is relevant for clinical studies with subjective assessments, not for bench testing.

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 vascular embolization device, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This device 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 bench testing was based on "established criteria," which likely refers to engineering specifications, design parameters, and established industry standards for dimensional accuracy, device tracking, repositioning/deployment functionality, and detachment effectiveness.

8. The sample size for the training set

Not applicable. This information is not relevant for the type of bench testing described.

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

Not applicable. This information is not relevant for the type of bench testing described.

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The Scepter XC Occlusion Balloon Catheter is intended for use in the peripheral and neurovasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms.

The Scepter XC Occlusion Batheter is a dual coaxial lumen catheter with a nondetachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over a steerable guidewire. Radiopaque marker bands are located at ends of the balloon and distal tip of the catheter to facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories. The catheters are packaged sterile for single use only.

The provided document describes a 510(k) premarket notification for the Scepter XC Occlusion Balloon Catheter, seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than performing de novo clinical trials to establish efficacy and safety from scratch. Therefore, the information typically found in a study proving a device meets acceptance criteria (like specific performance metrics from a clinical study, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies) is not present in this document.

Instead, the submission focuses on non-clinical performance testing to demonstrate that the new device performs comparably to the predicate and meets design specifications.

Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is not applicable or not provided in a 510(k) summary of this nature:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table of "Pre-clinical Testing" with "Pass" as the result for each test. This indicates that the device met the internal acceptance criteria for these engineering and performance tests, which are typically designed to ensure safety and functionality. However, the specific quantitative acceptance criteria for each test (e.g., "Tensile strength must be > X Newtons") are not explicitly stated in this summary, only the outcome "Pass."

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

• Test Set Sample Size: Not applicable in the context of clinical performance testing for this 510(k) submission. The "test set" here refers to physical devices undergoing pre-clinical engineering tests. The sample sizes for these specific tests are not provided in this summary.
• Data Provenance: The device is submitted by MicroVention, Inc., based in Tustin, California, U.S.A. The pre-clinical testing would have been conducted by or for MicroVention.

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 this submission focuses on pre-clinical engineering and performance testing, not a clinical study involving expert interpretation of data or images to establish a diagnostic ground truth.

4. Adjudication Method for the Test Set:

• This information is not applicable for the same reason as point 3. Adjudication methods are relevant for clinical studies where multiple reviewers assess outcomes or diagnoses.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:

• No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. This type of study is typically conducted for diagnostic imaging devices to compare human reader performance with and without AI assistance, which is outside the scope of this device (an occlusion balloon catheter).
• Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable as no MRMC study or AI component is described.

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

• No, this information is not applicable. The Scepter XC Occlusion Balloon Catheter is a physical medical device, not a diagnostic algorithm or AI system. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

• For the pre-clinical tests, the "ground truth" equates to pre-defined engineering specifications and international standards (e.g., ISO 10993-1 for biocompatibility). The device either met these specifications ("Pass") or it did not. This is not clinical ground truth (like pathology or outcomes data).

8. The Sample Size for the Training Set:

• This information is not applicable. There is no "training set" in the context of this device, as it is a physical medical device and not an AI or machine learning system that requires data for training.

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

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

In summary:

This 510(k) submission for the Scepter XC Occlusion Balloon Catheter primarily relies on demonstrating substantial equivalence to a predicate device (Scepter C Occlusion Balloon Catheter, K110741) through pre-clinical engineering and performance testing. The "acceptance criteria" were internal design specifications and relevant international standards for medical devices, which the new device "passed." The submission does not involve clinical studies with human participants, expert ground truth establishment, or AI algorithm performance evaluations, which are typically associated with the other questions.

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The Headway 27 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neurovasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

The Headway 27 Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the Microcatheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the Microcatheter hub is used for the attachment of accessories.

Section 1:

Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The provided document states "Pass" for each test, implying that the device met the pre-defined acceptance criteria for that specific test. The specific numerical or qualitative thresholds for each criterion are not explicitly stated in this summary.

Section 2:

• Sample size used for the test set: Not specified. The document summarizes the results of various bench and biocompatibility tests, but does not provide details on the number of units tested for each criterion.
• Data provenance: Not specified. This document pertains to pre-market notification (510(k)) for a medical device and describes laboratory and in-vitro testing. There is no indication of clinical trial data or data from human subjects in this summary. Therefore, the concepts of "country of origin" and "retrospective or prospective" do not directly apply to the reported tests.

Section 3:

• Number of experts used to establish the ground truth for the test set: Not applicable. The "ground truth" concept is typically associated with clinical studies or diagnostic artificial intelligence, where expert consensus or pathological findings define the true state. The described tests are primarily engineering and biological performance evaluations. These tests rely on established scientific methods and validated measurement techniques rather than expert interpretation of complex clinical cases.
• Qualifications of those experts: Not applicable. (See above explanation).

Section 4:

• Adjudication method: Not applicable. The tests described are objective, quantitative or qualitative industrial and laboratory tests. They do not involve interpretation of ambiguous data requiring adjudication for ground truth establishment.

Section 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 done. This type of study is relevant for evaluating the performance of diagnostic devices or AI algorithms in clinical settings, often in comparison to human readers. The provided document details the pre-market submission for a physical medical device (microcatheter) and focuses on bench testing and biocompatibility, not diagnostic performance or AI effectiveness.
• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable. (See above explanation).

Section 6:

• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm performance study was not done. This document describes the performance of a physical medical device, not an algorithm.

Section 7:

• The type of ground truth used: Not applicable in the traditional sense of clinical diagnostic ground truth (e.g., pathology, outcomes data, expert consensus). For the bench and biocompatibility tests, the "ground truth" or reference standard is derived from:
  • Validated test methods and specifications: Standards like ISO 10993 for biocompatibility provide the framework for evaluating the device's interaction with biological systems.
  • Engineering specifications and design parameters: For bench tests, the device's design requirements define what constitutes a "pass" result (e.g., specific tensile strength thresholds, flow rates, burst pressures).
  • Chemical and material analysis: Compatibility tests (like DMSO compatibility) rely on known material properties and reactions.

Section 8:

• The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI algorithm that would require a training set.

Section 9:

• How the ground truth for the training set was established: Not applicable. (See above explanation).

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