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The COREPASS FLEX/CONTROL microcatheters are indicated for:
· supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature (not intended for neurovasculature).
· exchanging guidewires in the coronary and peripheral vasculature.
· the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.

The COREPASS FLEX/ CONTROL microcatheters are singe lumen catheters, offered in two shaft sizes (2.2F and 2.5F) with working lengths of 135cm or 150cm, designed for use in coronary, peripheral, and abdominal vasculature. The COREPASS FLEX/CONTROL share identical shaft profile 2.5F (0.032'') but different distal profile, including 2.2F (0.028'') for the 2.2F configuration (COREPASS FLEX) and 2.5F (0.032'') for the 2.5F configuration (COREPASS CONTROL). The catheter consists of five sections: hub with a female luer connector, catheter body shaft, proximal section, distal section, and tip. The distal most 60cm of the outer surface is coated with a hydrophilic polymer to increase lubricity and the lumen of catheter is lined with a fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014 inch (0.36mm) guidewire.

The provided text is a summary of a 510(k) premarket notification for a medical device (COREPASS Modular Microcatheter) and does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI-powered diagnostic tool. The document focuses on the regulatory clearance process for a physical medical catheter device.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance (in the context of an AI device)
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

The "Performance Data" section in the document lists various physical and material-related tests conducted on the microcatheter (e.g., Sterilization, Shelf-Life Performance, Particulate Evaluation, Dimension Inspection, Media Flow Rate, Shaft Burst Pressure, Guidewire Compatibility, Coating Integrity, Flexibility and Kinking, Corrosion Resistance, Torque Strength, Tensile Strength, Radiopacity, and a range of Biocompatibility tests). It simply states:

"The test results of COREPASS Modular Microcatheter met all acceptance criteria, which are same or similar to the predicate device and reference device. It ensures that the design and construction of COREPASS Modular Microcatheter are suitable for its intended use."

This confirms that acceptance criteria exist for these physical properties and that the device met them, but the document does not elaborate on what those specific criteria are nor does it describe a study design in the way one would for an AI/software as a medical device (SaMD).

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The Teleport XT microcatheters are indicated for:

• supporting and facilitating the placement of guidewires in the coronary and peripheral vasculature.
• exchanging guidewires in the coronary and peripheral vasculature.
• the delivery of contrast media into the coronary, peripheral, and abdominal vasculature.

Teleport XT Microcatheter is a single lumen OTW catheter offered in one size (2.1F, distal OD) with working lengths of 90cm, 135cm or 150cm, designed for use in the coronary and peripheral vasculature. The shaft profile gradually changes from 2.8F (0.0370") to 2.1F (0.0280"). The catheter consists of five primary sections: hub, body shaft, proximal section, distal section, and a radiopaque tip. The distal most 60cm of the outer surface is coated with hydrophilic polymer to increase lubricity and the lumen of the catheter is lined with fluoropolymer to facilitate movement of the guidewire. The catheter is compatible with a standard 0.014-inch (0.36mm) guidewire.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Teleport XT Microcatheter." This document does not contain information about acceptance criteria and study results for an AI/ML device. Instead, it outlines the regulatory approval process for a physical medical device.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details for an AI/ML device based on the provided text. The document discusses performance data for a microcatheter, which includes physical tests such as:

• Sterilization
• Shelf-Life Performance Testing
• Particulate Evaluation
• Visual Inspection
• Dimension Inspection
• Media Flow Rate
• Simulated Use
• Vacuum Leakage
• Shaft Burst Pressure
• Guidewire Compatibility
• Coating Integrity
• Flexibility and Kinking
• Corrosion Resistance
• Torque Strength
• Tensile
• Radiopacity
• Pouch Integrity
• Pouch Burst
• Seal Strength

The document states: "The Teleport XT microcatheter test results met all acceptance criteria and were similar to the predicate and reference devices." However, it does not detail what those specific acceptance criteria were or provide the reported performance values. It also does not discuss any of the AI/ML specific criteria you requested (sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).

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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 product (FineCross M3) is intended to be percutaneously into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. The product should not be used in cerebral and peripheral vessels.

FineCross M3 is a single use, ethylene oxide sterilized device that is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. FineCross M3 features a three-layer construction, which consists of a stainless steel mesh braid sandwiched between an outer layer of polyester elastomer and an inner layer of polytetrafluoroethylene. The outer surface of the catheter is coated with hydrophilic polymer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the FineCross M3 device, structured to answer your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a list of performance tests conducted on the FineCross M3 device. For each test, it states that "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life." However, it does not provide specific numerical or qualitative values for the acceptance criteria, nor does it detail the specific reported device performance values for each test. Instead, it offers a general statement of compliance.

Biocompatibility Testing:

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

The document does not specify the sample sizes used for each of the performance or biocompatibility tests. It only states that tests were performed on "non-aged and accelerated aged samples" for performance testing (except Radio-detectability and Simulated Use Usability) and on "non-aged, sterile, whole device" and "accelerated-aged (2 years), sterile, whole device" for biocompatibility.

The data provenance is industrial (manufacturer-conducted testing) and likely combines both novel testing for this specific device and potentially established testing protocols based on industry standards. It is not patient or clinical data, so terms like "retrospective" or "prospective" are not applicable in this context. The country of origin for the manufacturing and testing is Japan (Ashitaka Factory of Terumo Corporation).

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

This document describes non-clinical performance and biocompatibility testing of a medical device (a microcatheter). It does not involve diagnostic interpretation or patient data where "ground truth" would typically be established by human experts like radiologists. Therefore, this information is not applicable to the provided document. The ground truth for these tests is based on objective, measurable physical and chemical properties and engineering standards.

4. Adjudication Method for the Test Set

As this document describes non-clinical performance and biocompatibility testing, an "adjudication method" in the context of expert consensus (like 2+1 or 3+1 for clinical interpretations) is not applicable. The results of these tests are determined by adherence to pre-defined scientific and engineering protocols and acceptance criteria.

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

There was no MRMC comparative effectiveness study and no AI component mentioned in this 510(k) submission. This K-submission is for a medical device (microcatheter), not an AI/software-as-a-medical-device.

6. 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 medical instrument (microcatheter), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert concensus, pathology, outcomes data, etc)

For the performance tests, the "ground truth" is defined by engineering specifications, material science principles, and established industry standards. For example, the freedom from leakage is tested against a standard preventing fluid escape, and material biocompatibility is tested against ISO 10993 standards and FDA guidance. This is not a "ground truth" derived from expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

There is no training set in this context. This is a physical medical device, not a machine learning model.

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

This is not applicable as there is no training set mentioned in the document.

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