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The PVS 1300 Synchro® 0.014" & 1600 Synchro® 0.010" Neuro Guidewire series of products are intended for general intravascular use, which includes peripheral and neurovascular use. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral & neurovasculature. The device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

products having a 0.014" & 0.010" outside diameter respectively, being sterile, single use/disposable products, with shapeable tip which is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for peripheral, neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Merit Medical Systems (K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire introducer (B. Braun (K760389)) is also supplied and may be used to aid introduction of the guidewire into the catheter hub and/or hemostasis valve and to gently shape the guidewire's distal flexible tip, if desired, according to standard practice. Neither the guidewire introducer or the torque device are intended to enter the body. The products are projected to be provided in a 180cm - 300cm length range, with 200cm being nominal. The Nitinol tip length is projected to be presented in a 25cm - 65cm range, with 35-45cm being nominal. A traditional range of flexibility profiles shall also be provided, ranging from support (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. The marker coil is platinum wire at the distal tip of the device to aid visualization under fluoroscopy. The subject device has the ability to access distal, tortuous vasculature, with steerability and torque transmission properties.

The provided text describes a 510(k) submission for guidewires, which are physical medical devices, not software or AI-powered devices. Therefore, the questions related to AI/algorithm performance metrics, expert reviews, ground truth, and training sets are not applicable to this document. The submission focuses on demonstrating substantial equivalence to predicate guidewires through material properties and performance testing.

Here's the relevant information that can be extracted from the provided text, structured to best fit your request:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study conducted was a series of "Safety and Performance Tests" on the materials comprising the PVS 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" guidewires. These tests were performed in accordance with ISO 11070:1998, Sterile, Single-Use Intravascular Catheter Introducers.

2. Sample Size for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each individual performance test (e.g., how many guidewires were tested for tensile strength or fatigue). It generally states "Subject product testing has yielded acceptable safety & performance outcomes."

The data provenance is from laboratory testing of the manufactured guidewires by Precision Vascular. It is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate the device's performance. The country of origin of the data is not explicitly stated, but the manufacturer is based in West Valley City, UT, USA, suggesting the testing was likely conducted in the USA or by a contracted lab.

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

This question is not applicable. The "ground truth" for a physical medical device like a guidewire is its adherence to predefined engineering specifications and performance standards through physical testing, not expert interpretation of data.

4. Adjudication Method for the Test Set

This question is not applicable, as there was no expert review or "ground truth" establishment in the context of interpretation that would require an adjudication method. The results are from objective physical tests.

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

This question is not applicable. This is a physical medical device, not an AI or imaging device that would involve human readers.

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

This question is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering and material specifications and internationally recognized standards (e.g., ISO 10993-1, ISO 11070:1998). The performance tests directly assess whether the device meets these objective, quantifiable standards.

8. The Sample Size for the Training Set

This question is not applicable. There is no algorithm or AI model being "trained" for this device.

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

This question is not applicable.

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