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The Halo One Thin-Walled Guiding Sheath is indicated for use in peripheral arterial and venous procedures requiring percutaneous introduction of intravascular devices. The Halo One Thin-Walled Guiding Sheath is NOT indicated for use in the neurovasculature nor the coronary vasculature.

The Halo One Thin-Walled Guiding Sheath consists of a thin-walled (Up to 1F reduction in outer diameter compared to standard sheaths of equivalent French size) sheath made from single-lumen tubing, fitted with a female luer hub at the proximal end and a formed atraumatic distal tip. The thin-wall design reduces the thickness of the sheath wall to help facilitate intravascular access from access sites including but not limited to radial, femoral, popliteal, tibial and pedal. A detachable hemostasis valve, employing a crosscut silicone membrane and incorporating a side arm terminating in a 3-way stopcock, is connected to the sheath luer hub. The sheath is supplied with a compatible vessel dilator that snaps securely into the hemostasis valve hub. The sheath has a strain relief feature located at the luer hub and a radiopaque platinum-iridium marker located close to the distal tip. The Halo One Thin-Walled Guiding sheath is supplied in 4F, 5F and 6F compatible sizes and lengths of 90cm. 70cm. 45cm. 25cm and 10 cm. The Halo One Thin-Walled Guiding Sheath 4F, 5F and 6F 25cm and 10cm sheaths will be offered with a 0.018" and 0.035" guide wire compatible dilator option. The Halo One Thin-Walled Guiding Sheath is also offered as an access kit in 4F,5F and 6F 10cm and 25cm lengths incorporating access needle (21G x 4cm or 19G x 7cm option available) and access guidewire in both 0.018" (0.018" x 80cm or 0.018" x 50cm option available) and 0.035" (0.035" x 80cm or 0.035" x 50cm option available) configurations to the existing predicate device product range. All sheath configurations (lengths) are provided with a hydrophilic coating over the distal portion of the sheath to provide a lubricious surface to ease insertion. The shorter sheath configurations (25cm and 10cm) are also provided without the coating.

This document is a 510(k) Summary for a medical device called the "Halo One Thin-Walled Guiding Sheath." It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

The information provided does not describe an AI/ML powered device, nor does it detail a study that proves the device meets specific acceptance criteria related to AI/ML performance. Instead, it describes a conventional medical device (a catheter introducer) and outlines non-clinical performance testing for its physical and functional characteristics.

Therefore, many of the requested categories for AI/ML device studies cannot be answered from this document.

Here's an attempt to answer the relevant parts based on the provided text, and identify where the information is not applicable (N/A) for an AI/ML context:

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

The document provides a general list of performance criteria that were evaluated for the subject device to demonstrate substantial equivalence to the predicate device. However, it does not present a specific table with detailed quantitative acceptance criteria and their corresponding reported device performance values. It only states that the device "met all predetermined acceptance criteria" and that tests "demonstrate that the technical characteristics and performance criteria... is substantially equivalent to the predicate."

Here's a summary of the characteristics and performance criteria evaluated:

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

The document does not specify sample sizes for any of the performance tests. It also does not discuss "data provenance" in terms of country of origin or retrospective/prospective, as these are typically relevant for clinical studies or AI/ML model training data, which is not the focus here. The testing appears to be non-clinical, in-vitro, or bench testing based on FDA guidance and internal risk assessments.

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

N/A. This is a non-clinical device performance study, not an AI/ML study requiring expert ground truth for interpretation of medical images or data.

4. Adjudication method for the test set

N/A. Not applicable to non-clinical device performance 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

N/A. This is not an AI/ML powered device, and no MRMC study is detailed.

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

N/A. This is not an AI/ML powered device.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" would be established by physical measurements, standardized test methods, and pre-defined specifications derived from engineering requirements, applicable standards (e.g., ISO), and risk assessments. For biocompatibility, it's adherence to international standards like ISO 10993-1.

8. The sample size for the training set

N/A. This is not an AI/ML powered device.

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

N/A. This is not an AI/ML powered device.

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