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PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA).

The PCI Guide Wires are not intended for use in the neurovasculature.

The MINAMO consists of a hybrid NiTi and stainless-steel core wire and a coil assembly on the distal end of the device. The coil assembly is soldered to the NiTi portion of the core. In addition, coatings are applied on the surface of the MINAMO. The proximal portion is coated with PTFE. The distal section is coated with hydrophilic coating, with the distal tip coated with silicone. The MINAMO is available in both 190cm and 300cm lengths and with different tip shapes.

The MINAMO is a coronary guide wire. The 510(k) summary provides details about non-clinical testing performed to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The in vitro bench tests demonstrated that the MINAMO met all acceptance criteria and performed similarly to the predicate devices." Specific numerical acceptance criteria values and reported device performance values are generally not detailed in 510(k) summaries for non-clinical tests. This is a common practice, as the focus is on demonstrating that the device meets established performance thresholds and is comparable to previously cleared devices.

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

The document does not specify the exact sample sizes used for each individual non-clinical test. It generally refers to "non-clinical laboratory testing." For medical devices, these tests are typically performed in a laboratory setting, and the provenance is the company's internal R&D or a contract testing lab. These are all retrospective tests conducted on manufactured device samples. There is no information regarding country of origin for the data for non-clinical bench testing, but the applicant's headquarters are in Japan.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable to the non-clinical bench testing described. These tests do not involve human interpretation or the establishment of ground truth by clinical experts in the same way an AI diagnostic device would. Performance is measured against physical and chemical specifications.

4. Adjudication Method:

This information is not applicable. Adjudication methods are typically used in clinical studies or studies involving human readers, which is not the nature of the reported performance data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not done. The device is a physical medical instrument (guide wire), not an AI diagnostic tool.

6. Standalone Performance Study:

A standalone performance study was not done in the context of an AI algorithm. The reported tests are for the physical properties and performance of the guide wire itself. The document describes "non-clinical laboratory testing" which inherently is a standalone evaluation of the device against predefined specifications.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical tests is established by:

• Engineering Specifications: Predetermined physical and chemical properties that an equivalent guide wire must possess (e.g., specific tensile strength, flexibility parameters, corrosion resistance).
• International Standards: Adherence to relevant ISO standards (e.g., for biocompatibility, sterility) or equivalent national standards.
• Predicate Device Performance: Demonstrating comparable performance to legally marketed predicate devices through comparative bench testing.

8. Sample Size for the Training Set:

This information is not applicable. The MINAMO is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable, as there is no training set for a physical guide wire.

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The Endura guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.

The Endura guidewire is a straight tip guidewire with a maximum outer diameter of 0.014" available in 190 cm and 300 cm lengths. The Endura guidewire consists of a bi-metal stainless steel and nitinol core wire covered on the distal end by a radiopaque coil at the distal end of the Endura guidewire has a hydrophilic coating (HPC) and the proximal end is coated with polytetrafluoroethylene (PTFE). The 190 cm length model is compatible with a guidewire extension.

The Endura Guidewire is a medical device intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each individual performance test or biocompatibility test. It mentions that "device samples" passed the biocompatibility tests and that the design was "verified through the following tests." The data provenance can be inferred as originating from Vascular Solutions, Inc., USA, the manufacturer of the device, through prospective testing conducted to demonstrate the device's performance and safety.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This section is not applicable as the Endura Guidewire is a physical medical device. The "ground truth" for its performance and safety is established through laboratory and bench testing, as well as biocompatibility assessments, rather than expert interpretation of data or images.

4. Adjudication Method for the Test Set:

This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, which is not the case for the pre-market testing of this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This section is not applicable. An MRMC study is relevant for AI algorithms or diagnostic tools where human reader performance is being evaluated with and without AI assistance. The Endura Guidewire is a physical interventional device, not a diagnostic or AI-powered system.

6. Standalone (Algorithm Only) Performance:

This section is not applicable. The Endura Guidewire is a physical medical device, not an algorithm, so the concept of "standalone algorithm performance" does not apply.

7. Type of Ground Truth Used:

The ground truth for the Endura Guidewire's performance is based on:

• Engineering specifications and test methodologies: Each performance test (e.g., tensile strength, torque response, flexibility, coating adherence) has predefined engineering benchmarks and standards that the device must meet.
• Biocompatibility standards: Compliance with ISO 10993-1 guidelines for biological evaluation of medical devices.
• Sterilization standards: Achieving a Sterility Assurance Level (SAL) of 10-6.

8. Sample Size for the Training Set:

This section is not applicable. The Endura Guidewire is a physical medical device and does not involve AI or machine learning, therefore, there is no "training set."

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

This section is not applicable as there is no training set for this device.

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