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The Thinline Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

The Thinline Introducer Sheath is a single-lumen, coil-reinforced catheter. The Thinline Introducer Sheath is available in 11cm and 23cm lengths (French size 9F) and is designed to accept 0.038 inch diameter quide wires. A radiopaque outer laver is included for angiographic visualization. A valved hub with integrated suture ring is attached to the proximal end with extension tubing and a three way stop cock which allows attachments for flushing and aspiration. This catheter is designed for use in providing access and facilitating the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The dimensions for the Thinline Introducer Sheath are indicated on the product label. A dilator and guidewire accessory are included within the packaging. It is supplied sterile, non-pyrogenic, and is intended for single use only.

The provided document is a 510(k) Premarket Notification for a medical device called the "Thinline Sheath Introducer." This document details the device's characteristics, indications for use, and the testing conducted to demonstrate its substantial equivalence to a predicate device.

Crucially, this document is for a physical medical device (a catheter introducer) and contains no information about an AI/ML-driven device or its acceptance criteria related to AI performance metrics (like sensitivity, specificity, AUC).

Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria for an AI/ML device, such as sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, or standalone performance. The performance data presented in the document (Table 6.2) relates to physical and functional tests of the sheath introducer, such as tensile strength, burst pressure, and sterility, not AI algorithm performance.

If you can provide a document that discusses an AI/ML-driven medical device and its validation study, I would be able to answer your questions.

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The 091 Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

The 091 Balloon Guide Catheter is a coaxial-lumen, coil-reinforced, variable stiffness catheter with a compliant balloon at the distal end to provide temporary vascular occlusion during angiographic procedures. A radiopaque marker is included at the distal end of the distal tip of the catheter) for fluoroscopic visualization. A bifurcated luer hub on the proximal end of the catheter allows attachments for flushing, and aspiration. This catheter is designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The dimensions and maximum recommended balloon inflation volume for the 091 Balloon Guide Catheter are indicated on the product label. A Peel-Away Introducer accessory is included within the packaging. It is supplied sterile, non-pyrogenic, and is intended for single use only.

This document describes the validation of the 091 Balloon Guide Catheter. Since the provided text focuses on the device's substantial equivalence to a predicate device for regulatory approval, the "acceptance criteria" and "device performance" primarily refer to engineering performance specifications and bench testing results, rather than clinical efficacy metrics for an AI/ML device. There is no mention of an AI/ML component in this premarket notification.

Therefore, the requested information specifically related to AI/ML device validation (e.g., sample sizes for training/test sets, expert ground truth adjudication, MRMC studies, standalone algorithm performance) is not applicable to this document. The document details the testing performed to ensure the device meets safety and performance standards for a medical device.

Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the "Pass" result for each test. The reported device performance is that it met all predetermined acceptance criteria for each test.

Details of the Study:

• 1. A table of acceptance criteria and the reported device performance: Provided above. All tests "Passed," indicating the device met all predetermined acceptance criteria.

• 2. Sample size used for the test set and the data provenance: The document states that "Some of the tests were also conducted on the predicate device to help establish substantial equivalence." However, specific sample sizes for each test are not explicitly detailed in this summary. The data provenance is from bench testing and simulated use, conducted to support a regulatory submission in the United States. It is not patient data, so "retrospective or prospective" is not applicable.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the context of an AI/ML device. For the "In-vitro Simulated Use Study – Benchtop," it states "A simulated interventional procedure was performed by physicians." For "Usability Testing," it mentions "Evaluators representative of the intended user population shall review... then attempt to use the catheters and accessories along with the expected compatible products in a simulated use environment, using worst-case neurovascular models." The specific number or qualifications of these physicians/evaluators are not detailed.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML device with image interpretation or complex diagnostic outputs requiring expert adjudication. Performance was assessed against pre-defined engineering and functional 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: Not applicable. This is a physical medical device (catheter), not an AI/ML diagnostic or assistive tool.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (catheter), not an AI/ML algorithm.

• 7. The type of ground truth used:

  • Engineering/Performance Specifications: For most tests (e.g., Tensile Strength, Torque Strength, Burst, Leak tests, Dimensional Verification), the "ground truth" is defined by established engineering and materials standards (e.g., ISO 10555-1, USP <788>, ASTM F-1929, ISO 594-1:1986).
  • Simulated Use/Usability: For these tests, the "ground truth" is the successful and safe performance of the device by intended users in a simulated clinical environment, meeting pre-defined operational criteria.
  • Biocompatibility: The "ground truth" is compliance with ISO 10993-1 and specific biological test methodologies (e.g., MEM elution, Magnusson-Kligman Method, ASTM Method for Hemolysis) to ensure the device is not harmful to biological systems.

• 8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML device trained on data.

• 9. How the ground truth for the training set was established: Not applicable.

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The Zenith Flex System, including the Zetheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

The InNeuroCo 074 Zenith Flex Catheter is a variable stiffness catheter that has a catheter shaft reinforced with Stainless-Steel and Nitinol to provide support. The Stainless-Steel is wound as a double coil in the proximal section and the Nitinol is a single coil in the distal section. It has a radiopaque Platinum/lridium marker band on the distal 25 cm of the 074 Zenith Flex Catheter has a hydrophilic coating. The 074 Zenith Flex Catheter is available with an internal diameter of 0.074 inches. The outer diameter is of 0.089 inches along its proximal shaft, and 0.083 inches along its distal shaft. The 074 Zenith Flex Catheter is available in three workinq lengths: 115 cm, 125 cm, and 132 cm. The 074 Zenith Flex Catheter has a PTFE lined lumen. Accessories included with the device are a Tuohy-Borst Hemostasis Valve, two peel-away Introducers, and a Scout introducer. The Scout may be used to introduce the 074 Zenith Flex Catheter into distal vasculature, thereby helping the device reach the target anatomy.

The provided text describes the Zenith Flex System (074 Zenith Flex Catheter) and its non-clinical data for demonstrating substantial equivalence. It does not describe a study involving an AI/Machine Learning device or algorithm. Therefore, I cannot provide details regarding acceptance criteria, sample size, ground truth, or adjudication methods in the context of an AI study.

However, I can extract the acceptance criteria and observed performance described for the non-clinical (bench and animal) testing of the Zenith Flex Catheter.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each benchtop or animal test. It refers to "test samples" for bench testing and does not provide numerical counts.

For animal testing: "Clot was used to create occlusions within several arteries of swine. One side of each swine was treated with the subject Zenith Flex system and the contralateral side was treated with the reference device." The exact number of swine used is not provided.

Data provenance: The non-clinical data is generated from laboratory (bench) and animal (swine) studies. The country of origin for the studies is not specified.

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

Not applicable in this context. The non-clinical studies rely on objective measurements and observations in laboratory and animal settings, not on expert ground truth for interpretation of images or clinical outcomes. For 'Simulated Use - Bench' and 'Simulated Use Testing - Usability', a physician's assessment was used, but details on the number or qualifications of these physicians are not provided.

4. Adjudication Method for the Test Set

Not applicable, as the tests involve objective measurements and direct observation rather than subjective interpretations requiring adjudication.

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

Not applicable. This is a medical device (catheter), not an AI/ML device for diagnostic interpretation. There was no MRMC study involving human readers and AI assistance.

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

Not applicable. This is a medical device (catheter), not an AI/ML device.

7. The Type of Ground Truth Used

For bench testing, the ground truth is based on physical and chemical properties measured against established specifications (e.g., ISO, ASTM standards).
For animal testing, the ground truth for effectiveness was "angiographic assessment of revascularization," and for safety, "angiographic assessment and histopathological assessment."

8. The Sample Size for the Training Set

Not applicable. This is a medical device (catheter); there is no "training set" in the context of an AI/ML algorithm.

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

Not applicable.

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