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Turnpike catheters: The Turnpike catheters are intended to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and to subselectively infuse/ deliver diagnostic and therapeutic agents, and to assist in crossing de novo coronary chronic total occlusions (CTO).

GuideLiner V3 catheter: GuideLiner catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature. to facilitate placement of interventional devices, and to assist in crossing de novo coronary chronic total occlusions (CTO).

TrapLiner catheter: The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature, and to assist in crossing de novo coronary chronic total occlusions (CTO).

Turnpike catheters: The Turnpike catheters are single lumen catheters designed for use in the coronary and peripheral vasculature. The catheter shaft is constructed of two polymer layers that encapsulate a braid and a duallayer coil. The distal 60 cm of the Turnpike catheters are hydrophilic coated, and all models are compatible with 0.014" guidewires and 5F guide catheters. The turnpike catheters are available in four configurations: Turnpike, Turnpike Spiral, Turnpike Gold, and Turnpike LP.

GuideLiner V3 catheters: The GuideLiner V3 catheter is a rapid-exchange guide extension catheter designed for use in the coronary and peripheral vasculature. It is available in five sizes - 5F, 5.5F, 6F, 7F, and 8F. All sizes of the GuideLiner V3 catheter have a 150 cm working length, consisting of a 125 cm long stainless steel pushwire shaft followed distally by a 25 cm long full-round, silicone-wiped guide extension segment. The distal 17 cm of the 125 cm pushwire shaft is covered with a semicircular shaped polymer that meets the proximal end of the full-round guide extension segment.

TrapLiner catheters: The TrapLiner catheter is a rapid-exchange guide extension catheter with a trapping balloon on the distal end of the pushrod. The stainless steel hypotube pushrod is covered on the distal end by a semi-circular polymer ('half-pipe') and transitions to a hydrophilic coated full-round polymer guide extension section. There are two radiopaque marker bands on the guide extension segment, one on the distal tip and one on the collar. The Nylon trapping balloon (3.1 mm diameter) is located proximal to the half-pipe and has a single radiopaque gold marker under the proximal end of the balloon is reflowed, and an adhesive is applied on each end. The TrapLiner catheter has an over-molded Nylon hub on the proximal end to facilitate balloon inflation.

The provided text does not contain information about acceptance criteria or a study designed to prove a device meets acceptance criteria in the context of an AI/ML device. The document is an FDA 510(k) premarket notification for various catheters (Turnpike, GuideLiner V3, TrapLiner) and details their indications for use, technological characteristics, and a clinical study conducted to evaluate their safety and effectiveness for assisting in crossing de novo coronary chronic total occlusions (CTO).

The clinical study described is a prospective, multi-center, single-arm study of 150 subjects. It evaluates the safety and effectiveness of the catheters and specialized guidewires in patients undergoing CTO-PCI, not an AI device. The primary endpoint was "procedure success through discharge or 24 hours post-procedure, whichever came first," with specific components for angiographic visualization of guidewire placement and absence of in-hospital MACE.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details about sample size for a test set, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth type, or training set information as requested, because this information is not present in the provided text for an AI/ML device.

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The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and to subselectively infusedeliver diagnostic and therapeutic agents.

The Turnpike catheters are single lumen catheters designed for use in the coronary and peripheral vasculature. The catheter's shaft is constructed of two polymer layers that encapsulate a braid and a dual-layer coil. The Turnpike catheters have a radiopaque tip (polymer or gold-plated) and are available in various tip and shaft configurations. The distal 60cm of each catheter has a hydrophilic coating. The Turnpike catheters are available in 135 cm or 150 cm working lengths and are compatible with 0.014" guidewires and 5F guide catheters.

The provided document is a 510(k) summary for the Turnpike Catheter, which is a medical device used to access vascular regions, facilitate guidewire placement, and deliver diagnostic and therapeutic agents. The document describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information based on your request:

Acceptance Criteria and Reported Device Performance

Additional Information

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

   • The document does not specify the exact sample sizes (number of devices or tests performed) for the performance and biocompatibility tests.
   • The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that these are laboratory compliance tests for a medical device prior to market, they are typically conducted prospectively in a controlled laboratory setting.

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

   • This question is not applicable to this type of device and study. The testing described involves engineering performance and biocompatibility, which are measured objectively against defined standards (e.g., ISO standards) and internal specifications. There is no "ground truth" derived from expert interpretation of medical images or clinical outcomes in the way this question implies. Instead, the "ground truth" (or acceptance criteria) is established by regulatory standards (e.g., ISO 10555-1, ISO 10993-1) and internal design specifications.

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

   • This question is not applicable for the same reasons as above. The tests performed are objective and yield pass/fail results based on predefined criteria, not subjective interpretations requiring adjudication.

4. 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 is not applicable. The device (Turnpike Catheter) is a physical medical device (catheter) used for vascular access and delivery of agents, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related effect sizes are not relevant to this submission.

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

   • This is not applicable as the device is a physical catheter, not an algorithm.

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

   • For the performance tests (e.g., deliverability, tensile strength), the "ground truth" is defined by engineering specifications and ISO standards (e.g., ISO 10555-1, ISO 594).
   • For the biocompatibility tests, the "ground truth" is defined by biological safety standards as outlined in ISO 10993-1.
   • There is no "expert consensus," "pathology," or "outcomes data" in the typical clinical sense used to establish ground truth for this type of device validation.

7. The sample size for the training set:

   • This is not applicable. The Turnpike Catheter is a physical device, and the testing described is not related to training an algorithm or AI model.

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

   • This is not applicable for the same reason as above.

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The Turnpike catheters are intended to access discrete regions of the coronary and/or peripheral vasculature. They may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.

The Turnpike catheters are single lumen catheters designed for use in the coronary and/or peripheral vasculature. The shaft is constructed of two polymer layers that encapsulate a braid and a dual-layer coil. The Turnpike catheters have a radiopaque tip (polymer or gold-plated) and are available in various tip and shaft configurations and one of two working lengths. The Turnpike catheters are hydrophilic coated and are compatible with 0.014" guidewires and 5F guide catheters.

This document is a 510(k) premarket notification for the Turnpike Catheter and does not contain information about the acceptance criteria or a study proving that a device meets such criteria. This document is related to a labeling change for the device and states that no tests were necessary to demonstrate substantial equivalence because there was no indication or technology change.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device

Turnpike catheter is intended to be used to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.

The Turnpike catheter is a single lumen catheter designed for use in the coronary and/or peripheral vasculature. The shaft is constructed of two polymer layers that encapsulate a braid and a dual-layer coil. Turnpike has a radiopaque tip (polymer or gold-plated) and is available in various tip and shaft configurations and one of three working lengths. Turnpike catheter is hydrophilic coated and is compatible with 0.014" guidewires and 5F guide catheters.

The provided document is a 510(k) premarket notification for a medical device (Turnpike Catheter). It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence.

However, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in an AI/software as a medical device (SaMD) context.

The document describes mechanical and biocompatibility tests performed for the Turnpike Catheter to demonstrate its safety and effectiveness compared to predicate devices. These are standard tests for physical medical devices, not for AI/SaMD.

Therefore, I cannot populate the requested table and answer the questions related to AI/SaMD performance. The document does not describe:

• A table of acceptance criteria and reported device performance for an AI/SaMD.
• Sample sizes, data provenance, or ground truth establishment for a test set in the context of AI/SaMD.
• Number/qualifications of experts or adjudication methods for AI/SaMD ground truth.
• MRMC or standalone studies for AI/SaMD.
• Training set details for an AI model.

The document states that "Verification and validation test results met the specified acceptance criteria and did not raise new questions of safety or effectiveness issues." However, it does not list those acceptance criteria or the specific results in a format relevant to AI/SaMD. It broadly mentions mechanical tests (e.g., working length, radiopacity, torque) and biocompatibility tests (e.g., cytotoxicity, hemolysis), which are entirely different from the performance metrics expected for AI algorithms (e.g., sensitivity, specificity, AUC).

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