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The TalWire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. The TalWire is not intended for use in the coronary or cerebral vasculature.

The TalWire is a family of vascular access mandrel guidewires. The TalWire is available in various sizes: between 40 to 80 cm in length and in the 0.018" diameter range. The TalWire is available with Nitinol (NiTi) cores and Stainless Steel coils. The TalWire consist of a solid core shaft with a ground tapered section at the distal end of the guidewire. A microcoil is wound with a lumen that is then placed over the tapered distal end of the coil is secured to the shaft via a weld and the proximal end is bonded to the shaft using adhesive. The TalWire includes an articulatable tip at the distal end of the guidewire. The finished guidewire is placed in a protective polymer dispenser hoop in a labeled Tyvek pouch. The TalWire is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process.

The provided text describes a 510(k) premarket notification for a medical device called TalWire, a catheter guidewire. It compares the TalWire to a predicate device and includes performance data to support substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All tests passed and met the predefined acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria for each performance test. It only lists the types of performance tests conducted.

Biocompatibility:

• Evaluation in compliance with ISO 10993-1.
• Specific tests conducted: Cytotoxicity, Guinea Pig Maximization Sensitization, Intracutaneous Irritation, Material Mediated Pyrogenicity, Acute Systemic Toxicity, ASTM Hemolysis, SC5b-9 Complement Activation Assay, Standard Thrombogenicity in Canine.
• Reported device performance: "The device was found biocompatible."

Sterilization, Packaging and Shelf Life Testing:

• EtO Sterilization validation (SAL 10^-6).
• Shelf life and packaging testing after environmental conditioning and transportation simulation.
• Reported device performance: "All tests were successfully completed."

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

The document does not specify the sample sizes for any of the performance tests.
The data provenance is not explicitly stated beyond being "performance data." This type of testing is typically done in a lab setting rather than using patient data, so concepts like "country of origin" or "retrospective/prospective" studies are not applicable in the usual sense for this kind of device.

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

This information is not applicable as the tests described are performance tests of the physical properties and functionality of the guidewire, not assessments of diagnostic images or clinical outcomes that would require expert human interpretation as "ground truth." These tests rely on standardized methods and measurement equipment.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Performance tests are typically objectively measured against predefined criteria, not adjudicated by experts.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating the substantial equivalence of the device through performance testing against established standards and comparison to a predicate device, not on assessing human reader performance with or without AI assistance. This device is a physical medical device (guidewire), not an AI-driven diagnostic tool.

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

No, a standalone algorithm performance study was not done. This device is a physical guidewire, not an algorithm.

7. The Type of Ground Truth Used

For the performance and biocompatibility testing, the "ground truth" is established by:

• Standardized test methods: Based on FDA guidance "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Guidance for Industry and Food and Drug Administration Staff" and ISO 10993-1 for biocompatibility.
• Predefined acceptance criteria: While not explicitly listed, these criteria would typically be quantitative thresholds or qualitative observations (e.g., "no visible corrosion," "no fracture").

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI model that requires a "training set."

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

This information is not applicable for the same reasons as point 8.

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The Micropuncture® Introducer Set is intended for the placement of wire guides up to 0.038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired.

The Micropuncture® Introducer Set is intended for the placement of wire guides up to 0.038 inch diameter into the peripheral vascular system when a small 21 gage needle stick is desired. The device is utilized to gain access to the vasculature using the Seldinger technique. These introducer sets are comprised of either 4.0 French outer introducer and 3.0 French inner dilator coaxial pair, a 21 gage percutaneous entry needle, and a 0.018 inch mandrel wire guide with a distal coil tip. The dilator of these sets can come with a stainless steel stiffening cannula embedded in the shaft. These sets are supplied sterile and are intended for one-time use.

Here's a breakdown of the acceptance criteria and study information for the Micropuncture Introducer Set, based on the provided text:

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 the exact sample sizes used for each individual test. It only states that "Testing verified..." and "The predetermined acceptance criteria were met."

The data provenance is from benchtop testing conducted by Cook Incorporated. The country of origin for the data is not explicitly stated, but Cook Incorporated is located in Bloomington, Indiana, USA, suggesting the testing likely occurred in the US or under the company's direct supervision. The studies are retrospective in the sense that they are laboratory tests performed on finalized device designs rather than prospective clinical trials.

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

This information is not provided in the document. The tests described are primarily engineering and material science tests, not clinical evaluations requiring expert interpretation of ground truth in the same way an AI diagnostic device would. The "ground truth" for these tests is based on established engineering standards and specifications.

4. Adjudication Method for the Test Set

This information is not applicable as the tests performed are objective physical and material performance tests, not 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?

No, an MRMC comparative effectiveness study was not done. This document describes the clearance of a physical medical device (introducer set), not an AI diagnostic or assistive technology. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on established engineering standards, material specifications, and regulatory requirements (e.g., ISO standards). For example, for biocompatibility, the ground truth is conformance with ANSI AAMI ISO 10993-1. For leakage, it's conformance with BS EN ISO 11070:2014.

8. The Sample Size for the Training Set

This information is not applicable. This device is not an AI/ML product and does not involve a "training set" in the computational sense. The testing described is verification and validation for a manufactured product.

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

This information is not applicable for the same reason as point 8.

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