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The PICA™ Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The PICA Catheter is a variable stiffness catheter with an outer diameter of 0.056in, has a catheter shaft reinforced with a stainless steel coil, and has a radiopaque markerband on the distal end. It is available with an inner diameter of 0.041 in and in various lengths. The PICA Catheter has a PTFE-lined lumen, which is coil re-enforced, flexible, and hydrophilically coated. The PICA Catheter is inserted through a guide catheter or vascular sheath, provides access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. The device is provided sterile and includes a rotating hemostasis valve and tip shaping mandrel. The PICA Catheter will be available in various configurations to allow physician ease of device tracking to the target site

Here's an analysis of the provided text regarding the PICA™ Catheter, focusing on acceptance criteria and the study that proves the device meets those criteria:

Important Note: The provided document is a 510(k) summary for a medical device (PICA™ Catheter) intended for market clearance, not an in-depth clinical study report. Therefore, it does not contain the detailed clinical study results, statistical analyses, or specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) that would typically be found in a performance study for an AI/ML device.

This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not describe a study involving an AI model or human readers.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary for a catheter, the "acceptance criteria" are not framed in terms of AI model performance metrics like sensitivity, specificity, or AUC. Instead, for this type of device, acceptance criteria relate to its physical, mechanical, and biological properties to ensure safety and effectiveness.

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

• Sample Size for Test Set: This document does not describe a "test set" in the context of an AI/ML model where a dataset is used to evaluate algorithmic performance. The testing described is non-clinical performance testing of the device itself (e.g., mechanical, physical, biocompatibility). The sample sizes for these engineering and lab tests are not specified in this summary.
• Data Provenance: Not applicable in the context of clinical data provenance for an AI/ML model. The tests are described as "non-clinical data," conducted in accordance with ISO-10993-1 guidelines and 21 CFR, Part 58 (Good Laboratory Practices). This implies laboratory testing of the device components/assembly, not clinical patient data.

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

• This information is not applicable as the document describes non-clinical laboratory testing of a mechanical device, not the evaluation of an AI algorithm against expert-established ground truth from clinical images/data. Ground truth in this context would be physical measurements and chemical analyses performed by trained technicians/scientists.

4. Adjudication Method for the Test Set

• Not applicable. There is no "adjudication method" in the context of consensus among experts for clinical data, as this document describes non-clinical testing.

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

• No. An MRMC study was not done. This device is a catheter, not an AI diagnostic or assistive tool. The document does not discuss AI assistance or human reader performance.

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

• No. This document describes a physical medical device (catheter), not an algorithm. Therefore, no standalone algorithm performance study was conducted or is relevant.

7. The Type of Ground Truth Used

• For the non-clinical testing: The "ground truth" would be established by validated laboratory methods and engineering specifications. For example, a successful biocompatibility test would mean the materials did not elicit a toxic response based on established biological assays. A mechanical test might verify that burst pressure exceeds a certain threshold. These are objective measurements against predefined engineering and biological standards.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this device is a physical catheter, not an AI/ML model that requires training.

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

• Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

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