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The SENDERO MAX Delivery Catheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.

The SENDERO MAX Delivery Catheter is a single lumen, variable stiffness catheter with a radiopaque marker on the shaped distal end and a Luer-lock hub on the proximal end. A hydrophilic coating on the catheter shaft reduces friction during navigation through the vasculature. The device is delivered to the target location using standard interventional techniques (e.g. use of guide wire, etc.) under fluoroscopic guidance. Once at the target location, the lumen of the device allows for the introduction of diagnostic and therapeutic agents into the peripheral vasculature.

This document is a 510(k) summary for the SENDERO MAX Delivery Catheter, a medical device. It describes the device's indications for use, technological characteristics, and performance testing conducted to demonstrate its substantial equivalence to a predicate device. This type of document is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the information required to answer your specific questions about acceptance criteria for an AI/CADe device or a study proving its performance.

The questions you've asked (about acceptance criteria, sample sizes, ground truth, experts, MRMC studies, standalone performance, and training sets) are typically relevant for AI/CADe devices or clinical studies used to prove the performance and safety of a device.

This document pertains to a physical medical device, specifically a catheter, not an AI or software device. The "performance testing" described (dimensional, coating, burst pressure, tensile strength, etc.) are standard engineering and material tests for physical medical devices to ensure they meet design specifications and regulatory requirements.

Therefore, it is not possible to answer your questions using the provided document because the device described is a physical catheter, not an AI/CADe device, and the document is a regulatory summary, not a clinical study report.

The document states: "No clinical studies were required." This further confirms that this submission does not contain the kind of study data you are asking about for AI/CADe performance.

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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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MICRUSFRAME, DELTAFILL, and DELTAXSFT Microcoil Delivery Systems are 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 GALAXY G3 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.

The GALAXY G3 XSFT Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT Microcoil Delivery Systems consist of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. As shown in Figure 1, the Microcoil System consists of a microcoil attached to a Device Positioning Unit (DPU). The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the microcatheter catheter. The microcoil is the implantable segment of the device, and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable). The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which may contain either a polypropylene suture (SR) or an absorbable polymer suture and then formed into a secondary shape. The secondary shape may be spherical, complex, or helical. The DPU is a variable stiffness wire and has a radiopaque marker band located three (3) cm from its distal end. The Device Positioning Unit includes five (5) fluoro saver markers on the proximal section of the shaft. The markers are intended to indicate when the tip of the microcoil is approaching the tip of the microcatheter. When the distal-most marker reaches the proximal end of the Rotating Hemostatic Valve (RHV) on the microcatheter, the tip of the coil is approaching the tip of the microcatheter and fluoroscopy should be used to guide further coil insertion. The introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool. The EnPOWER Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU. The connecting cable delivers the energy necessary to detach the embolic coil from the Microcoil System's detachment zone. The connecting cable is connected between the Microcoil System's hub connector on the DPU and the output connector on the DCB. The connecting cables may be one of two types: one with a remote detach button (the EnPower Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00. The EnPower Detachment Control Box works with the EnPower Control Cable and with the standard connecting cable. The device in this submission includes design changes only to the Device Positioning Unit (DPU) element of the microcoil system. There are no modifications to the microcoil components or to the EnPOWER Detachment Control system.

This document describes the premarket notification (510(k)) for the MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, and GALAXY G3 XSFT Microcoil Delivery Systems. The submission focuses on design changes to the Device Positioning Unit (DPU) element of the microcoil system, emphasizing that there are no modifications to the microcoil components or the detachment control system.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established as "PASS," indicating that the samples met the predetermined criteria for each test. Specific quantitative criteria are not explicitly detailed in this summary.

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

The document states that testing was conducted using "statistical sampling methods as required by the Codman & Shurtleff, Inc. Design Control procedures." However, specific numerical sample sizes for each test are not provided.

The data provenance is not explicitly stated as retrospective or prospective, nor is a country of origin mentioned. However, being a premarket notification to the U.S. FDA, it can be inferred that the testing was conducted to meet U.S. regulatory standards, likely in a controlled laboratory environment. The testing is bench testing and biocompatibility testing, not human clinical data.

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

This information is not applicable as the studies described are bench tests and biocompatibility tests, not clinical studies involving human patients or expert interpretation of diagnostic images/data. The "ground truth" for these tests is defined by the technical specifications and performance requirements of the device, assessed through quantitative measurements and established protocols.

4. Adjudication Method for the Test Set

This information is not applicable for the bench and biocompatibility tests described. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "A clinical study was not required as appropriate verification and validation of the modified Device Positioning Unit (DPU) was achieved based on the similarities of the proposed device to the predicate device, and from results of bench testing." Therefore, there is no effect size for human reader improvement with or without AI assistance.

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

This question is not applicable. The device described is a physical medical device (microcoil delivery system), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the performance verification testing, the ground truth is established by engineering specifications, direct physical measurements, and adherence to established industry standards and regulatory guidance documents (e.g., ISO, FDA Guidance Document: "Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices").
For biocompatibility testing, the ground truth is defined by established international standards (ISO 10993 series) and USP (United States Pharmacopeia) guidelines for biological response within acceptable limits.

8. The Sample Size for the Training Set

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

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

This information is not applicable for the same reason as above; there is no training set for a physical device.

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