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This Product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.

The CROSSLEAD Peripheral Guide Wire (hereafter "CROSSLEAD") is a steerable guide wire with a maximum diameter of 0.035 inches (0.89mm) and available in 200cm and 300cm length. The guide wire is constructed from a Ni-Ti alloy core wire with a stainless steel coil. The coil is soldered to the core wire with Ag-Sn solder. The coil has radiopacity to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion The basic structure, construction, and coating of the CROSSLEAD are unchanged from that previously described in the predicate Radifocus Glidewire Advantage (K063372) and reference ASAHI Silverway (K183062) and ASAHI Regalia XS 1.0 (K083146)

The provided text describes the regulatory submission for a medical device called "CROSSLEAD Peripheral Guide Wire". This document does not contain information about an AI/ML powered device, and therefore the acceptance criteria and study details related to AI/ML device performance are not present.

The document discusses the substantial equivalence of the CROSSLEAD device to previously cleared predicate devices through non-clinical testing and biocompatibility assessments.

Here's a breakdown of the information that is provided, as it relates to the non-AI device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the CROSSLEAD met "all acceptance criteria" but does not provide specific quantitative acceptance criteria or the numerical performance results for each test. Instead, it offers a list of tests performed.

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

• Sample Size: Not specified for the non-clinical or biocompatibility tests.
• Data Provenance: Not specified. The tests were performed in a lab setting ("bench testing") and are likely internal to the manufacturer or conducted by contract research organizations.

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

This concept is not applicable to the non-clinical and biocompatibility testing described. These tests involve laboratory measurements against established standards, not expert interpretation of data.

4. Adjudication Method for the Test Set:

Not applicable, as this refers to expert review in clinical or diagnostic assessments.

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

No. This type of study is not relevant for the evaluation of a physical guide wire.

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

No. This device is not an algorithm.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" would be the established engineering specifications and performance benchmarks derived from relevant FDA guidance documents (e.g., "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling, 15JUN2018"). For biocompatibility, the ground truth is defined by the ISO 10993 standards and the expected biological responses.

8. The Sample Size for the Training Set:

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

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

Not applicable.

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This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The VASSALLO® GT Peripheral Guide Wires in this submission are steerable guide wires with a maximum diameter of 0.014 inches (0.36mm) and available in 190cm and 300cm lengths. These devices have a solid core with a hydrophilic coil-type distal end. When wet, the hydrophilic coating increases the lubricity of the quidewire surface. Some models also include silicone coating on the distal tip. The coil is partly or entirely radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the quide wire with a length of less than 300 cm. A Torque device is included in the same package.

This document is a 510(k) summary for the VASSALLO® GT Guide Wire. It details the device's characteristics, intended use, and substantial equivalence to predicate devices, based on non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The in vitro bench tests demonstrated that the VASSALLO GT met all acceptance criteria". However, it does not provide a specific table of acceptance criteria with corresponding performance values. It only lists the types of tests performed.

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

The document does not specify the sample size used for each non-clinical test.
The data provenance is from non-clinical laboratory testing performed on the VASSALLO® GT. The country of origin for the manufacturing company (Filmecc Co., Ltd.) is Japan. The type of study is bench testing (in vitro), not human subject testing (prospective or retrospective).

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

This question is not applicable as the study described is non-clinical bench testing, not a clinical study involving expert interpretation of data or images. Ground truth for non-clinical tests is established by adhering to testing standards and specifications.

4. Adjudication Method for the Test Set

This question is not applicable as the study described is non-clinical bench testing. Adjudication methods are typically relevant for clinical studies where human interpretation or consensus is required.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document focuses on non-clinical bench testing of a guide wire, not an AI-assisted diagnostic device. Therefore, there is no discussion of human readers, AI assistance, or effect sizes in that context.

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

This question is not applicable. The device is a medical guide wire, not an algorithm or software requiring standalone performance evaluation.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" or reference for evaluating performance would be predefined engineering specifications, international standards, and performance characteristics of predicate devices. The document states that the device "met all acceptance criteria" and "performed similarly to the predicate and reference devices," implying comparison against these types of benchmarks.

8. The Sample Size for the Training Set

This question is not applicable. There is no mention of a "training set" as this is a physical medical device undergoing bench testing, not an AI/machine learning model.

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

This question is not applicable as there is no training set for a guide wire.

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