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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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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 or the coronary vasculature.

The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guiding sheath and an introducer sheath. 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 braided single-lumen tubing, fitted with a female luer hub at the proximal end 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, 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 sheath is supplied in 4F, 5F and 6F compatible sizes and lengths of 90cm, 70cm, 45cm, 25cm and 10 cm. A vessel dilator which is 0.035" guide wire compatible is provided with each sheath. The 4F and 5F 10cm sheaths will also be offered with a 0.018" guide wire compatible dilator. 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 this coating.

The provided text is a 510(k) Summary for the Halo One Thin-Walled Guiding Sheath, a medical device. It describes the device, its intended use, and comparative testing to a predicate device to demonstrate substantial equivalence.

However, the questions you've asked about acceptance criteria and studies are typically related to Software as a Medical Device (SaMD) or AI/ML-driven devices. Such devices usually involve performance metrics like accuracy, sensitivity, and specificity, and their studies often involve expert readers, ground truth establishment, and statistical analysis like MRMC studies.

The Halo One Thin-Walled Guiding Sheath is a physical medical device (a catheter introducer). The "performance data" in this document refers to a series of in vitro (laboratory) tests to ensure the physical and material properties of the sheath meet design specifications and are safe for use. These are not clinical studies in the typical sense of evaluating diagnostic accuracy or reader improvement with an AI algorithm.

Therefore, many of your questions are not applicable to the information provided in this 510(k) summary for a physical medical device. I will address the applicable parts based on the document's content.

Analysis based on the provided document:

The document describes the Halo One Thin-Walled Guiding Sheath, a physical medical device, and its substantial equivalence to a predicate device. The performance data presented is for non-clinical in vitro testing and biocompatibility assessments, not a study evaluating human-in-the-loop performance or algorithmic accuracy.

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

   The document lists numerous in vitro tests conducted. However, it does not provide a specific table of quantitative acceptance criteria and corresponding performance values for each test. Instead, it states a general conclusion: "The subject device, the Halo One Thin-Walled Guiding Sheath, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

   Here's a list of the types of tests mentioned, which imply associated acceptance criteria:

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

   • Sample Size: The document does not specify exact sample sizes for each in vitro test. For physical device performance testing, sample sizes are typically determined by statistical rationale for verification/validation (e.g., lot sizes, AQLs) but are not explicitly stated here.
   • Data Provenance: The tests were performed "in vitro" (i.e., laboratory testing, not on human subjects or patient data). The testing was conducted as part of the device manufacturing and submission process, managed by ClearStream Technologies Ltd. in Ireland. The document does not specify a country of origin for the data beyond the manufacturer's location. These are non-clinical, prospective tests specifically conducted for this submission.

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

   This question is not applicable as the device is a physical medical device, not an AI/ML-driven diagnostic tool where "ground truth" is established by expert interpretation of medical images or data. The "ground truth" for this device would be its physical and material properties meeting engineering specifications and safety standards, confirmed through validated testing methods.

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

   This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in medical image interpretation studies (e.g., radiology) to resolve discrepancies between readers' assessments. For in vitro physical device testing, results are typically objective measurements or pass/fail determinations based on established protocols.

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:

   This question is not applicable. An MRMC study is designed to evaluate the impact of a diagnostic tool (often AI) on human reader performance. This document pertains to a physical medical device, not a diagnostic AI tool.

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

   This question is not applicable. This device is a physical medical instrument, not an algorithm.

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

   For a physical medical device like this, the "ground truth" is typically defined by:

   • Engineering Specifications: The design parameters the device must meet (e.g., diameter, length, tensile strength).
   • Industry Standards: Compliance with relevant ISO standards (e.g., ISO 10993-1 for biocompatibility).
   • Regulatory Guidance: Conformance to FDA guidance documents for medical devices.
   • Risk Assessment: Demonstration that the device mitigates identified risks.

   The biocompatibility "ground truth" was established based on ISO 10993-1, classifying the device and requiring specific biological tests (cytotoxicity, sensitization, etc.).

8. The sample size for the training set:

   This question is not applicable. There is no "training set" in the context of a physical medical device submission like this. Training sets are relevant for AI/ML algorithms that learn from data.

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

   This question is not applicable for the same reason as #8.

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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 is designed to perform as both a guiding sheath and introducer sheath. The Halo One™ Thin-Walled Guiding Sheath consists of a thin-walled (1F wall thickness) sheath made from braided single-lumen tubing, fitted with a female luer hub at the proximal end and has a formed atraumatic distal tip. A supplied hemostasis valve, employing a crosscut silicone membrane and incorporating a side arm terminating in a 3-way stopcock, may be 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 vessel dilator is compatible with a 0.035" (0.89 mm) guidewire. The longer sheath configurations are provided with a hydrophilic coating over the distal portion of the sheath to provide a lubricious surface to ease insertion. The short sheath configuration is marketed with an appropriately sized guide wire for initial insertion of the device.

This document describes the 510(k) summary for the Halo One™ Thin-Walled Guiding Sheath. However, it does not detail specific acceptance criteria or study results in a format that allows for direct extraction into the requested table. Instead, it lists various in vitro tests performed to demonstrate substantial equivalence to the predicate device.

Here's an analysis based on the provided text, addressing the points you requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists a series of performance tests but does not explicitly state quantitative acceptance criteria or corresponding reported performance values for each. It broadly states that the device "met all predetermined acceptance criteria" and that tests "demonstrate that the technological characteristics and performance criteria... are substantially equivalent."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size for any of the individual tests. It also does not provide details on data provenance (e.g., country of origin, retrospective/prospective). The tests listed are "in vitro tests," suggesting they were conducted in a lab setting, not with patient data.

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

Not applicable. The tests described are primarily physical, chemical, and mechanical performance tests, along with biocompatibility assessments, not clinical evaluations requiring expert ground truth for interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set:

Not applicable, as this refers to adjudication of interpretations or diagnoses, which is not relevant for the types of in vitro tests performed for this device's 510(k) submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document describes a 510(k) submission, which focuses on demonstrating substantial equivalence through non-clinical performance data and biocompatibility, not clinical efficacy or comparative effectiveness against human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Not applicable. This device is a medical instrument (a guiding sheath), not an AI algorithm.

7. Type of Ground Truth Used:

For the in vitro performance tests, the "ground truth" would be established by the specifications of the device, relevant industry standards, and regulatory guidance documents (e.g., ISO, ASTM, FDA guidance). For biocompatibility, the ground truth is adherence to the requirements of ISO 10993-1.

8. Sample Size for the Training Set:

Not applicable, as this device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable for the same reason as above.

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