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The Millipede 088 Access Catheter is indicated for use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovasculature.

The Millipede 088 Access Catheter consists of the catheter, a rotating hemostasis valve (RHV) and a valve crossing tool. The catheter, RHV and valve crossing tool are provided sterile. They are sterilized by ethylene oxide (EO).

The Millipede 088 Access Catheter is a single lumen, coil-reinforced, variable stiffness catheter. The distal segment has a hydrophilic coating for navigation through the vasculature. The catheter has a radiopaque marker located at its distal end for visualization under fluoroscopy. The valve crossing tool is used to open the valve of the access sheath and to facilitate insertion of the Millipede 088 Access Catheter through the access sheath without damage. The RHV is assembled onto the hub of the Millipede 088 Access Catheter and is used to maintain hemostasis during infusion of saline and contrast agent and insertion of other devices through the Millipede 088 Access Catheter.

The provided document is a 510(k) summary for the Millipede 088 Access Catheter. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a standalone clinical study to prove the device meets those criteria.

Therefore, the document does not contain the information requested in points 2, 3, 4, 5, 8, and 9, and only partially addresses points 1, 6, and 7.

Here's a breakdown of what can be extracted:

1. Acceptance Criteria and Reported Device Performance

The document lists various performance tests and their conclusions, indicating that the device met "established specifications" or was "suitable for its intended use." However, the specific quantitative acceptance criteria for each test are not provided. The reported device performance is qualitative rather than quantitative in most cases.

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

The document does not specify the sample sizes for the individual performance tests beyond implicitly suggesting multiple samples were tested (e.g., "test specimens," "test articles"). For the Animal Testing, it states "two studies in a porcine model."

The data provenance for the in vitro and animal studies isn't explicitly stated beyond "Good Laboratory Practices" for the animal studies, which is a standard of conduct rather than a geographic origin. No human data is presented.

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 provided as the submission relies on objective performance testing, biocompatibility studies, and animal studies rather than expert-derived ground truth from human data for this type of device.

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

Not applicable. The evaluation methods described are objective performance tests and animal studies, not human data requiring expert adjudication.

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 an access catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

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

Yes, the performance testing described (mechanical, dimensional, coating integrity, etc.) and the animal studies represent "standalone" evaluations of the device's physical and functional properties without human interpretation of data in a clinical context.

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

For the performance and biocompatibility tests, the "ground truth" is defined by the established specifications, relevant ISO standards, and comparison to control devices or predicate devices. For example:

• "The device met established specifications."
• "The test article is non-cytotoxic."
• "The particulate size and count were similar to control devices."
• "The radiopacity of the Millipede 088 Access Catheter was similar to a control device."
• For animal testing, "Usability, radiopacity, thromboresistance, and vessel injury were assessed," and "The results for the subject device were comparable to a control device."

8. The sample size for the training set

Not applicable. This device is a medical catheter and does not involve a "training set" in the context of machine learning or AI. Its performance is evaluated through engineering and biological testing.

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

Not applicable (as above).

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The Minjie Catheter System is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

The Minjie Catheter System consists of the Minjie Catheter, Introducer Peel Away Tool and packaging hoop with Elbow Flush Luer. The Minjie Catheter is a single lumen. flexible, variable stiffness composite catheter with a Nitinol structure. A radiopaque marker band on the distal tip of the catheter is used for visualization under fluoroscopy. The distal section of the catheter is coated with a hydrophilic coating, to reduce friction during intravascular use. The Minjie Catheter System dimensions are included in the individual device label. The devices are supplied sterile and are intended for single use only.

The provided FDA 510(k) summary for the Minjie Catheter System does not contain acceptance criteria or reported device performance in the format requested for AI/algorithm-based devices. This document describes a medical device (a catheter system) and its performance through non-clinical (bench and animal) testing to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI algorithm.

Therefore, many of the requested fields related to AI algorithm evaluation (sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to the information provided in this document.

However, I can extract information related to the device's non-clinical testing and its conclusions, which serve as the "proof" that the device meets some form of acceptance criteria for medical devices of this type.

Here's a summary based on the provided document, adapting the requested structure where possible for a non-AI device:

Acceptance Criteria and Study for the Minjie Catheter System

The Minjie Catheter System is a physical medical device (catheter) and its performance is evaluated against engineering specifications, biocompatibility standards, and functional capabilities rather than AI algorithm metrics. The studies performed are non-clinical, including bench testing and an animal study, to demonstrate substantial equivalence and safety/effectiveness for its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All devices met acceptance criteria" for each bench test, but it does not explicitly define the numeric acceptance criteria themselves. The reported performance is therefore a qualitative statement of compliance.

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

• Bench Testing: The document does not specify the exact sample size for each bench test (e.g., "All devices met acceptance criteria" implies multiple devices were tested). There is no explicit mention of data provenance (e.g., country of origin). This is non-clinical, prospective testing.
• Biocompatibility Testing: Not specified for individual tests.
• Sterilization and Shelf-Life: Not specified, but validation studies would involve multiple units.
• Animal Testing: The document states "An animal study was performed," but does not specify the number of animals used. Data provenance is not specified.

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 is not applicable as this is a physical device and not an AI algorithm requiring expert ground truth for image interpretation or diagnosis. Bench testing results are typically objective measurements against engineering specifications. Animal study evaluations would be performed by qualified veterinary and pathology staff, but specific numbers and qualifications are not provided.

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

Not applicable for physical device 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 is not an AI-assisted diagnostic or therapeutic device.

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

Not applicable.

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

For this physical device:

• Bench Testing: Engineering specifications, industry standards (e.g., ISO), and defined performance parameters serve as the "ground truth" or acceptance criteria.
• Biocompatibility Testing: Established biological response parameters outlined in ISO 10993 series and FDA guidance.
• Animal Testing: Angiographic and histological evaluations, which are considered objective medical findings.

8. The sample size for the training set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. This is not an AI algorithm.

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The SOFIA® EX Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA® EX Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA® EX Catheter is not intended for use in coronary arteries.

The SOFIA® EX Catheter is a single-lumen, flexible catheter equipped with the coil and the braid reinforcement. The distal segment is designed to facilitate vessel selection with 55-65cm of distal shaft hydrophilic coating for navigation through the vasculatures. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. The device is provided sterile and for single use. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (polyethylene) that is provided in a sterile barrier tyvek pouch and placed in a carton box.

The provided document is a 510(k) premarket notification for the SOFIA® EX Intracranial Support Catheter. It describes the device, its intended use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and the study proving the device meets them, as extracted from the document:

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

The document presents the performance data in a table format under section "VII. Performance Data" (pages 7-8). Each "Test" listed implicitly defines an acceptance criterion (e.g., "Device met acceptance criteria"). Because the document is a 510(k) summary, the specific quantitative acceptance criteria values are not explicitly stated, but the results confirm that the "Device met acceptance criteria" for each test.

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The Reverse™M Micro Catheter is intended for use in neuro, peripheral, and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

The Reverse™ Micro Catheter is a single lumen catheter designed to be introduced over a steerable guide wire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate vessel navigation. The micro catheter incorporates a PTFE liner to facilitate movement or introduction of devices passed through its lumen. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter body also employs a hydrophilic coating to enhance lubricity and promote deliverability. The Reverse™ Micro Catheter incorporates a standard luer fitting to facilitate the attachment of ancillary devices. The catheter and included accessories (steam shaping mandrel and peel away introducer sheath) are provided sterile, nonpyrogenic, and are intended for single use only. To accommodate physician preference and anatomical variations, the Reverse™ Micro Catheter is available in two models, Reverse 021, with a 0.021" inner diameter (ID) and, Reverse 027, with a 0.027" ID.

The document you provided describes a medical device, the Reverse™ Micro Catheter, and its non-clinical performance evaluation for substantial equivalence to a predicate device. It does not describe a study involving an AI model or a specific algorithm. Therefore, I cannot provide information about acceptance criteria, device performance, sample sizes, ground truth, expert involvement, or comparative effectiveness studies in the context of AI.

The document focuses on demonstrating that the modified Reverse™ Micro Catheter is substantially equivalent to a previously cleared device (Reverse™ Medical Microcatheter, K130858) based on non-clinical performance data.

Here's a breakdown of what the document does provide, structured to address the spirit of your request where possible, but re-contextualized for a medical device rather than an AI study:

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

The document states that "All testing passed the acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria for each test. The performance results are reported as successful completion of tests without new safety or effectiveness issues.

• Dimensional requirements
• Lubricity/friction
• Particulates
• Coating characterization
• Simulated use device compatibility
• Simulated use navigation and delivery
• Shelf-life verification (1 year accelerated aging) | "All testing passed the acceptance criteria."
  "Comprehensive verification and validation activities were successfully completed; raising no new issues of safety or effectiveness." | Implicitly, meeting specifications and predicate equivalence. |
  | Biological Safety | - MEM Elution Cytotoxicity
• Guinea Pig Maximization Sensitization
• Intracutaneous Reactivity
• Acute System Injection
• Materials Mediated Rabbit Pyrogen
• Hemolysis Direct Contact
• Hemolysis Indirect Extract Method
• Complement Activation
• In vivo Thrombogenicity
• Genotoxicity (Ames Assay, in vitro Mouse Lymphoma, in vivo Mouse Micronucleus)
• USP Physicochemical | "Testing demonstrated that the Reverse™ Micro Catheter finished device, accessories, and packaging materials have no residual risk of biological hazards; and are therefore considered biocompatible for their intended use." | Compliance with ISO 10993-1 and related standards. |
  | Microbial Assessments | - Bioburden
• Endotoxin
• Sterility assurance | "Sterilization has been validated and is controlled... to provide a minimum SAL of 10-6." | Minimum SAL of 10-6; compliance with ISO 11135-1. |
  | Packaging Validation | - Visual Inspection
• Bubble Leak
• Seal Strength | "To evaluate integrity of the packaging configuration." (Implied successful evaluation) | Implicitly, maintaining package integrity after sterilization, environmental conditioning, and simulated shipping. |

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

The document does not specify sample sizes for individual bench tests, biological safety tests, or packaging validation. It refers broadly to "comprehensive verification and validation activities." The data provenance is internal testing by the manufacturer, Medtronic Neurovascular, for a new medical device. This is prospective testing of the device being submitted for clearance.

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

This concept is not applicable to this type of device submission. There isn't "ground truth" established by experts in the context of an AI algorithm's performance. Instead, the "truth" is determined by established engineering specifications, biocompatibility standards, and functional performance requirements for a physical medical device.

4. Adjudication method for the test set

Not applicable. There's no human-in-the-loop performance or diagnostic adjudication involved for this physical device's non-clinical 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, as this is not an AI device.

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

Not applicable, as this is not an AI device. The testing described is "standalone" in the sense that it's the device itself being tested, not an algorithm.

7. The type of ground truth used

For this medical device, the "ground truth" for the non-clinical tests would be:

• Engineering Specifications: Conformance to pre-defined dimensional, material, and performance requirements (e.g., inner diameter, lubricity, navigation).
• International Standards: Adherence to established standards for biocompatibility (ISO 10993-1), sterilization (ISO 11135-1), and packaging integrity.
• Predicate Device Performance: Demonstrating that the subject device performs "at least as safe and effective as the predicate device."

8. The sample size for the training set

Not applicable, as this is not an AI device.

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

Not applicable, as this is not an AI device.

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