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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 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 Zenith Flex System consists of the Zenith Flex Catheter, the VC-701 Cliq Aspiration Pump and the Aspiration Tubing Set. The InNeuroCo Zenith Flex Catheter is a variable stiffness 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/Iridium marker band on the distal end. The distal 25 cm of the Zenith Flex Catheter has a hydrophilic coating. The Zenith Flex Catheter is available with an internal diameter of 0.0715 inch. The outer diameter is of 0.0850 inch in the proximal section, and tapers to a nominal of 0.082 inch in the distal section. The Zenith Flex Catheter is available in three working lengths: 115 cm, 125 cm, and 132 cm. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and two peel-away Introducers and a Scout introducer. The Scout may be used to introduce the Zenith Flex Catheter into distal vasculature, thereby helping the device reach the target anatomy. The Zenith Flex Catheter is supplied sterile, nonpyrogenic, and intended for single use only. The off-the-shelf aspiration pump is provided non-sterile.

This document is a 510(k) summary for the Zenith Flex System, a medical device for revascularization in acute ischemic stroke. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench and animal) testing rather than clinical study. Thus, it does not describe a study involving an AI component or complex ground truth establishment for diagnostic output.

Here's an analysis based on the provided text, addressing your points where information is available:

1. A table of Acceptance Criteria and Reported Device Performance

The document provides extensive tables summarizing non-clinical testing. Here's a consolidated and simplified version of the information, focusing on the Zenith Flex Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump:

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

• Test Set Sample Size: The document does not explicitly state numerical sample sizes for each non-clinical test (e.g., "N=X catheters were tested"). It refers to "test samples" for bench testing and describes animal testing involving "several arteries of swine." For some tests, it states that results were "leveraged" from a previous submission (K171672 or K152202), implying a previous sample size was deemed sufficient for those components/materials.
• Data Provenance: The data is primarily from non-clinical (bench and animal) testing.
  • Animal Testing: Performed on "swine." There's no indication of country of origin for the animal study, but given the FDA submission, it's presumed to be from a facility following GLP (Good Laboratory Practices). The study was prospective in nature for this device.
  • Bench Testing: Performed in a lab setting. No country of origin is specified, but again, standard practice for FDA submissions implies testing in a controlled environment.
  • Leveraged Data: Some results are leveraged from previous 510(k) submissions (K171672 for Zenith Catheter, and K152202 for Corrosion, for an "Intermediate Catheter"). This suggests the data was generated at an earlier time for similar or identical components/processes.

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

There is no mention of "experts" in the context of establishing ground truth for a test set in the way one would for an AI/diagnostic device. The "ground truth" here is based on:

• Standardized Test Methods: Adherence to ISO, ASTM, and USP standards (e.g., ISO 10993-1, ISO 10555-1, ASTM F1929-12, USP 788, etc.). These methods define the criteria and procedures for measuring various physical, chemical, and biological properties.
• Animal Model Outcomes: In the animal study, effectiveness was assessed via "angiographic assessment of revascularization" and safety via "angiographic assessment and histopathological assessment." These assessments would be performed by qualified veterinary or medical professionals (e.g., veterinarians, pathologists), but their specific number or qualifications are not provided here.
• Physician Feedback: For "Simulated Use - Bench" and "Simulated Use - Usability" tests, it states "simulated use testing by a physician in a benchtop model." The number and specific qualifications of these physicians are not detailed.

4. Adjudication Method for the Test Set

Not applicable in the context of this submission. Adjudication typically applies to human interpretation of diagnostic data, which is not the primary focus here. The assessment of non-clinical tests relies on quantitative measurements against pre-defined acceptance criteria, or expert observation (e.g., pathologist reading histology slides), but not formal adjudication of conflicting expert opinions for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance in diagnostic imaging, which is not relevant for this device. The submission explicitly states: "No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes."

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

This device, the Zenith Flex System (catheter, aspiration tubing, pump), is a physical medical device, not a software algorithm or AI tool. Therefore, "standalone" performance in the sense of an algorithm operating independently is not applicable. Its performance is measured through its physical and functional properties, and its interaction with biological systems (in the animal model).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Quantitative Measurements: Direct measurements of physical properties against engineering specifications (e.g., diameter, length, tensile strength, burst pressure, leak rates).
• Biocompatibility Standards: Adherence to ISO 10993 guidelines, which define acceptable biological responses.
• Angiographic and Histopathological Assessment: For the animal study, the "effectiveness" (revascularization) and "safety" (tissue response, thrombus formation) endpoints were evaluated using these clinical and pathological methods. This is the closest to "outcomes data" or "pathology" in your list.
• Physician Feedback: For simulated use, "predetermined user needs" served as the criteria.

8. The Sample Size for the Training Set

Not applicable. This is a traditional medical device (catheter system), not an AI/machine learning device. Therefore, there is no "training set."

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

Not applicable, as there is no training set for this device.

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The 091 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasulature.

The InNeuroCo, Inc. 091 Long Sheath is a variable stiffness catheter that has a catheter shaft reinforced with a stainless steel double coil. It has a radiopaque Platinum/lridium marker band on the distal end. The distal 10 cm of the 091 Long Sheath Catheter has a hydrophilic coating. The catheter has a nominal outer diameter of 0.109 inches and a nominal inner diameter of 0.091 inches. It is available in three working lengths: 70 cm, and 90 cm. The 091 Long Sheath has a PTFE-lined lumen. The 091 Long Sheath is inserted at a vascular access point to provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and a Vessel Dilator. The 091 Long Sheath is supplied sterile, non-pyrogenic, and intended for single use only.

The provided text is a 510(k) summary for the InNeuroCo 091 Long Sheath peripheral, coronary, and neuro vasculature catheter. It outlines the device's characteristics and its comparison to a predicate device, along with the results of performance testing to demonstrate substantial equivalence.

Based on the provided document, here's a description of the acceptance criteria and the study proving the device meets these criteria:

This document describes the validation of a medical device, the InNeuroCo 091 Long Sheath, for regulatory approval. It is not an AI/ML device, and therefore several of the requested sections (e.g., number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable as they relate to the validation of AI/ML algorithms, not traditional medical devices like catheters.

Acceptance Criteria and Device Performance Study for the InNeuroCo 091 Long Sheath

The InNeuroCo 091 Long Sheath is a percutaneous catheter intended for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The study conducted was a series of non-clinical (bench and animal) tests to demonstrate substantial equivalence to a legally marketed predicate device (Stryker AXS Infinity LS, K152876).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The exact sample sizes for each specific test are not explicitly enumerated in the provided summary table. The statements typically indicate "Test samples" or "All samples," implying that a sufficient number were tested according to the referenced ISO or ASTM standards.
• Data Provenance: The data is a mix of:
  • Direct testing: For many bench tests (e.g., Visual Inspection, Leaks, Particulates, Simulated Use, Catheter Burst, Tensile, Kink Resistance, Torque, PTFE Liner inspection, Hydrophilic Coating Integrity, Labeling Legibility, Barcode, Sterilization, Bacterial Endotoxin, Shelf Life). These tests were conducted on the 091 Long Sheath.
  • Leveraged data: For all biocompatibility tests, Chemical Compatibility, Hub compatibility, and Corrosion, data was leveraged from previously approved InNeuroCo devices (Super Distal Access K161262, Zenith Catheter K171672, and Intermediate Catheter K152202). This leveraging is justified by stating that the materials and manufacturing processes are equivalent.
  • Animal Testing: Product evaluated within a porcine model for angiographic evaluation.
• Retrospective/Prospective: All described testing appears to be prospective (new tests conducted for this device and leveraged results from other devices), not retrospective analysis of existing clinical data.
• Country of Origin: Not specified in the document, but given the FDA 510(k) submission, it would be expected to follow US or internationally recognized standards. The company address is in Florida, USA.

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

• Not Applicable. This is a traditional medical device (catheter) validation, not an AI/ML algorithm. Ground truth for device performance is established through standardized physical, chemical, biological, and animal testing, not human expert interpretation of data.
• For "Simulated Use" testing, it mentions "by a physician," indicating one or more physicians were involved in that specific assessment, but their number and specific qualifications are not detailed beyond "physician."

4. Adjudication Method for the Test Set

• Not Applicable. As this is not an AI/ML study, there is no need for adjudication of conflicting expert opinions on a dataset. Test results are objective measurements against defined acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not relevant for the validation of a physical medical device like a catheter.

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

• Not Applicable. There is no AI algorithm being validated in this submission. The "device" is a physical catheter.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by:
  • Standardized Test Methods: Adherence to established international (ISO, ASTM, USP) and industry standards for material properties, mechanical performance, biocompatibility, and sterility.
  • Physical Measurements: Objective measurements of dimensions, burst pressure, tensile strength, etc.
  • Chemical/Biological Assays: Results from biocompatibility tests (e.g., cytotoxicity, hemolysis, pyrogenicity, sensitization) and bacterial endotoxin tests.
  • Functional Demonstrations: Successful performance in simulated use environments and in an animal model (porcine model for angiographic evaluation, showing no vessel injury).
  • Predetermined Specifications: Comparison against established product specifications and the performance of the predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. As there is no AI/ML training set, this question is not relevant.

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