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The Microferret™ catheter is used for percutaneous access to small vessel, distal anatomy.

The Microferret™ catheter is used for percutaneous access to small vessel, distal anatomy. Its single lumen construction provides graduated stiffness, from proximal being very soft. The material used to construct this device is polyethylene with a graduated transition of flexibility along the shaft. The proximal lub of the catheter is designed to conform with Luer lock standards (ANSI) which are compatibile with commercially available syringes.

The provided text is a 510(k) Premarket Notification for a medical device (Microferret™ Catheter) from 1996. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that the device meets specific performance acceptance criteria through the kind of rigorous clinical study described in the prompt.

Therefore, the requested information (acceptance criteria, specific study details like sample sizes, ground truth establishment, MRMC studies, etc.) is not available in the provided document.

Here's why and what information can be extracted:

Information Not Present in the Document (and why):

• Table of Acceptance Criteria and Reported Device Performance: This document doesn't define quantitative performance metrics and acceptance criteria in the way a modern clinical trial would. Its focus is on demonstrating similar characteristics to predicate devices.
• Sample Size for Test Set and Data Provenance: Not applicable in this type of submission. The "study" mentioned is more about design validation and clinical use history, not a formal test set evaluation.
• Number of Experts and Qualifications: Not applicable. There's no mention of a formal expert panel establishing ground truth for a test set.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not a diagnostic imaging AI device.
• Standalone Performance: Not applicable. This is a physical medical device (catheter), not an algorithm.
• Type of Ground Truth Used: Not explicitly defined in terms of a formal study with ground truth. The "clinical success" relies on observational data and general use history.
• Sample Size for Training Set & How Ground Truth for Training Set Was Established: Not applicable, as this is not an AI/machine learning device.

Information That Can Be Inferred/Extracted from the Document (but does not directly answer the prompt's specific questions):

• Device Name: Microferret™ Catheter
• Submitted By: COOK INCORPORATED
• Date: April 24, 1996
• Device Description:
  • Used for percutaneous access to small vessel, distal anatomy.
  • Single lumen construction, graduated stiffness (proximal being very soft).
  • Material: Polyethylene with graduated transition of flexibility.
  • Proximal hub conforms with Luer lock standards.
  • Materials are widely used and biocompatibility verified.
• Predicate Devices:
  • Other devices for percutaneous vascular use.
  • Specific examples: Trackers (K#853997, K#862117, K#874751) by Target Therapeutics®, Evolution™ Microcatheters (K#953114) by Boston Scientific, Venture™ Infusion Catheters (K#931335) by Scimed Life Systems/Boston Scientific.
• Summary of Clinical Use (closest to "study" information):
  • Marketed in Europe since 1992 by a European manufacturing firm owned by COOK Group Incorporated.
  • "Good clinical success with the device in its worldwide use to date." (This is a qualitative statement, not quantitative performance data against acceptance criteria).
  • Firm identified primary risks applicable to vascular catheters in general and included them in labeling.
  • "No adverse health effects associated with the use of this catheter during its marketing history."
  • Study Type: This refers to design validation studies performed to assure the device performs its intended function when used according to instructions. However, no specifics on these studies (sample size, criteria, results) are provided within this summary for a 510(k). The "clinical success" information is observational history rather than a controlled clinical trial.
• Ground Truth for the "Study": Clinical experience and lack of reported adverse events over its marketing history in Europe. This is an outcome-based observation rather than a prospectively defined ground truth for a specific diagnostic accuracy or performance study.

In summary, the provided document does not contain the detailed study design, acceptance criteria, and performance metrics typically associated with proving a device meets specific, quantitative acceptance criteria through a rigorous clinical trial as implied by the prompt. It's a regulatory document focused on demonstrating equivalence to already approved devices.

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