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The 6F Wallaby Long Sheath is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The 6F Wallaby Long Sheath is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter. The device has an inner diameter (ID) of 0.088 inch and outer diameter (OD) of 0.105 inch designed with three different working lengths (80 cm, 90 cm, and 100 cm) and two different tip configurations (straight and multipurpose curve). The distal tip of the 6F Wallaby Long Sheath is visible under fluoroscopy and the distal shaft of the catheter is designed with an external hydrophilic coating to reduce friction during use. The proximal end of the catheter incorporates a strain relief and a standard Luer adapter to facilitate the attachment of accessories. The 6F Wallaby Long Sheath has a semi-rigid proximal shaft which transitions into a flexible distal shaft to facilitate the advancement of the catheter in tortuous anatomy.

The 6F Wallaby Long Sheath is a non-active, surgically invasive device intended for short term use within the vasculature.

The provided text describes the non-clinical testing performed on the "6F Wallaby Long Sheath" to demonstrate substantial equivalence to a predicate device, the "Neuron MAX System." This document does not describe the evaluation of an AI/ML powered medical device. Therefore, the information requested in the prompt related to AI/ML device evaluations (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable or available in this document.

However, I can extract the acceptance criteria and reported device performance from the Design Verification Testing - Bench and Biocompatibility sections as they relate to a medical device in general.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document often states that the device "met all pre-defined acceptance criteria" or "demonstrated similar results to the predicate," rather than providing specific numerical acceptance thresholds. Where quantitative results are provided, they are included.

For the following points, the information is not applicable to this document as it details the clearance of a non-active, surgically invasive device (a vascular catheter), not an AI/ML powered device.

2. Sample size used for the test set and the data provenance: Not applicable. Data provenance is not relevant for bench and biological testing of this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Physician Validation" involved physicians but their exact number or role in "ground truth" establishment (which is an AI/ML concept) is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
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): Not applicable. Ground truth as typically defined for AI/ML evaluations is not relevant here. The ground truth for device performance is based on established engineering principles, ISO standards, and comparison to a legally marketed predicate device.
8. The sample size for the training set: Not applicable. There is no AI/ML training set.
9. How the ground truth for the training set was established: Not applicable. There is no AI/ML training set.

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The Wallaby Avenir Coil System is intended for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Wallaby Avenir Coil System is also intended for arterial and venous embolization in the peripheral vasculature.

The Wallaby Avenir Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are mechanically detached from the delivery pusher in serial manner until the aneurysm is occluded.

The provided text describes a medical device, the Wallaby Avenir Coil System, and its substantial equivalence to a predicate device. It includes a table of technical characteristics and a summary of performance data from various tests. However, it does not include the specific information requested about acceptance criteria for device performance, particularly related to AI/algorithm performance. It is a submission for a neurovascular embolization device, which is a physical medical device, not an AI/algorithm-driven one.

Therefore, most of the requested information regarding AI/algorithm performance, such as:

• Acceptance criteria related to AI/algorithm performance.
• Study proving device meets acceptance criteria specifically for AI/algorithm performance.
• Sample size and data provenance for AI test set.
• Number of experts and qualifications for AI ground truth.
• Adjudication method for AI test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm-only) performance.
• Type of ground truth for AI.
• Sample size for AI training set.
• How AI training set ground truth was established.

...is not available in the provided document, as it pertains to a physical medical device.

The document states that "All necessary testing has been performed for the Wallaby Avenir Coil System to assure substantial equivalence to the predicate device and demonstrate the device performs as intended." The "Performance Data" table lists various tests conducted, and for each, it states "All devices performed as intended" or similar positive outcomes. These are the "reported device performance" and the "study that proves the device meets the acceptance criteria" in a general sense for a physical device.

Here's the relevant information that can be extracted, largely focusing on the physical device performance rather than AI:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state quantitative acceptance criteria for each test in a clear table format, except by implying that the device successfully met the "established criteria" or "performed as intended." The "acceptance criteria" are generally derived from relevant standards (e.g., ASTM, ISO, USP) and the intended function of the device to be substantially equivalent to the predicate. The reported performance is consistently positive.

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

• Sample Size: Not explicitly stated for most tests (e.g., "All devices performed as intended"). For the GLP Survival Animal Study, it refers to a "chronic canine model" but doesn't specify the number of animals. For particulate testing, it's implied that a statistically relevant sample was tested per USP 788.
• Data Provenance: The animal study was a "GLP Survival Animal Study," implying a controlled laboratory setting. Other tests were "performed on test units representative of finished devices" in a laboratory environment, likely at the manufacturer's facility or a certified contract lab. Country of origin not specified, but the applicant is Wallaby Medical, Inc. in California, USA. The studies are prospective in the sense that they are specifically designed to test the device before market submission.

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

• Not applicable as this is a physical medical device, not an AI/algorithm.
• For the "Physician Simulated Use Validation," it mentions "physician users" but does not specify the number or their qualifications.

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

• Not applicable for a physical medical device. The tests are typically objective measurements or observations against established standards.

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

• No, this is not an AI-assisted device. Therefore, no MRMC study as described was performed. The "Physician Simulated Use Validation" might be seen as a form of human interaction but not in the context of improving human reading with AI.

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

• No, this is a physical medical device.

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

• For physical performance characteristics, the "ground truth" is defined by engineering specifications, material science standards (ASTM, ISO), biological safety standards (ISO 10993), and regulatory requirements for medical devices. For the animal study, histopathology results likely served as a form of ground truth regarding biological response.

8. The sample size for the training set:

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

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

• Not applicable.

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