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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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Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG® Tip Confirmation System (TCS), the Sherlock 3CG® TPS Stylet also provides the placer rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.

Bard Access Systems, Inc.'s Sherlock 3CG® Tip Positioning System (TPS) Stylet is a sterile, single use device 0.49 mm (0.019 in) outer diameter x 78.5 cm, made of specially-formulated materials designed to aid in the placement of specific Bard catheters, as well as any open-ended, non-valved, polyurethane, peripherally inserted central catheters (PICCs) that meet the dimensional specifications of the stylet. The Sherlock 3CG® TPS Stylet is designed to work with catheters containing a minimum lumen diameter of 0.51mm (0.020 in). The stylet provides internal reinforcement to aid in catheter placement. The Sherlock 3CG® TPS Stylet may be used with the Sherlock 3CG® Tip Confirmation System (TCS) to provide catheter tip placement information during the procedure.

The provided document is a 510(k) summary for the Sherlock 3CG® Tip Positioning System (TPS) Stylet. It outlines the intended use, technological characteristics, and safety and performance tests. However, it does not contain the detailed acceptance criteria and study results in the format requested.

The document indicates that "Verification and validation tests have been performed in accordance with Design Controls as per 21 CFR §820.30" and that "The subject devices met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate devices." However, it does not explicitly state what those predetermined acceptance criteria were, nor does it provide specific reported device performance metrics against them.

Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text.

Here's what can be extracted and what cannot:

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

• Cannot be provided. The document states that the devices met predetermined acceptance criteria, but it does not list these criteria or specific performance values. Instead, it lists technical standards and guidance documents (e.g., BS/EN/ISO 10555-1: 1997, ISO 594-2: 1998, AAMI/ANSI/ISO 11135-1:2007) that were used to determine appropriate methods for evaluating performance. It also mentions risk management according to ISO 14971:2012.

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

• Cannot be provided. The document mentions "Verification and validation tests" but provides no details on sample size, data provenance, or whether the study was retrospective or prospective.

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/Cannot be provided. This device is a stylet for a catheter tip positioning system, which uses passive magnets and cardiac electrical signal detection for feedback on catheter tip location. The ground truth for such a device would likely involve direct physical measurement or imaging confirmation (e.g., X-ray) of the catheter tip, not expert review of images for diagnosis. The document does not describe the establishment of a ground truth by experts in this context.

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

• Not applicable/Cannot be provided. As above, the nature of the device and the information provided do not suggest an adjudication method for a test set, which is typically relevant for interpretative tasks often involving human expert readers.

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

• Cannot be provided. The document does not mention an MRMC study. This device is an accessory to a positioning system, which is a tool to aid in placement, not an AI for interpretation that would typically require an MRMC study to evaluate reader improvement.

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

• Cannot be directly answered. The device is described as a "stylet" that "provides the placer rapid feedback." This implies it works with human-in-the-loop (the placer). The document doesn't detail the performance of the "Sherlock 3CG® Tip Confirmation System (TCS)" itself, only the stylet which is an accessory to it. The stylet's function is to provide internal reinforcement and, when used with the TCS, enables the system to provide tip location feedback.

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

• Cannot be determined from the text. The document does not specify how the accuracy of the catheter tip location detected by the Sherlock 3CG® TCS (when used with the stylet) was validated or what "ground truth" method was employed for this validation.

8. The sample size for the training set

• Not applicable/Cannot be provided. As this is not an AI/machine learning device in the context of image interpretation or diagnosis (it's a physical medical device accessory), the concept of a "training set" is not relevant in the sense of data used to train an algorithm.

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

• Not applicable/Cannot be provided. For the same reason as above.

In summary, the provided document is a regulatory submission summary focusing on the equivalence of the device to a predicate based on technological characteristics and general safety/performance testing protocols. It does not contain the detailed study results or acceptance criteria in the requested format.

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