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A percutaneous introducer is used to facilitate placing a catheter through the skin into a vein or artery. Percutaneous introducers are recommended for initial percutaneous introduction or the exchange of intravascular devices.

The Medtronic Vascular Input® PS Introducer is comprised of a sheath, a locking dilator, a Needle and a guide wire. This set may also contain an introducer obturator which must be left in dwelling post PTCA. Individual components within the Input® PS Introducer set are described below:

1. Input PS Dilator: The function of a dilator is to dilate the artery or vein to provide a less traumatic entry of the introducer sheath to a vasculature. The dilator is usually placed inside the lumen of the introducer sheath during sheath insertion.
2. GuideWire: The guidewire is inserted through the needle into the vessel and provides a platform over which the dilator and introducer sheath can be advanced. The guidewire is available with a maximum outer diameter of 0.038" Double Distal "J" guidewire approximately 15cm in length.
3. Input PS Introducer Sheath: The Input PS Introducer sheath allows for placement of various devices into the vasculature. The sheath shaft is coated with hydrophilic coating to improve ease of insertion. The Input Introducer sheath is available in two different lengths: 11cm sheath and 23cm sheath. The l 1 cm sheath is available in five different diameters measured in French size (5F, 6F, 7F, 8F and 9F). The 23cm sheath is available in four different diameters measured in French size (6F, 7F, 8F and 9F).
4. Needle: The needle provided with the Percutaneous Catheter Introducer Set is a standard puncture needle. The needle is used to puncture the vessel to provide route into the vessel for the guidewire.
5. Obturator: The Medtronic Input Introducer Obturator is inserted into an introducer sheath to provide support and help maintain sheath patency when placement of an intravascular catheter is delayed or removed.

Here's a summary of the acceptance criteria and study information based on the provided text for the Medtronic Input® PS Introducer:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes material modifications to the Input® PS Introducer sheath and performance qualification testing to demonstrate substantial equivalence to the predicate device. The acceptance criteria are implicitly that the modified device's performance is similar to the predicate and meets relevant FDA guidance.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "Bench testing was performed specific to the material modification to the Input PS Introducer sheath." It does not provide specific sample quantities for the various tests (e.g., number of sheaths tested for lubricity).
• Data Provenance: The studies are described as "Bench testing" and "Biocompatibility Testing" performed by Medtronic Vascular. This indicates the testing was conducted internally or by contracted labs for the manufacturer. The country of origin for the data is not specified beyond Medtronic Vascular's address in Danvers, MA, USA, which is where the contact person is located. The tests are prospective in nature, as they are performed on the modified device to demonstrate its performance.

3. Number and Qualifications of Experts for Ground Truth

• Not applicable. This device is a medical introducer, and the "testing" involves physical and chemical property evaluations rather than subjective expert assessment of images or data to establish a "ground truth" in the diagnostic sense. The evaluations are against engineering specifications and industry standards.

4. Adjudication Method

• Not applicable. As noted above, the testing involves objective measurements against predefined criteria and standards, not a process requiring expert adjudication.

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

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical investigation has been performed on the modified device." The evaluation relies on bench testing and biocompatibility.

6. Standalone Performance (Algorithm Only)

• Not applicable. This device is a physical medical instrument (catheter introducer), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used

• The "ground truth" for the performance qualification and biocompatibility testing is based on:
  • Engineering Specifications: Meeting predefined performance requirements for physical properties (coating length, lubricity, durability, insertability, particulate).
  • Regulatory Standards: Compliance with relevant FDA guidance and international standards like ISO 10993-1:2009 for biocompatibility.
  • Predicate Device Performance: The modified device's performance is compared to that of the predicate device to demonstrate "substantial equivalence."

8. Sample Size for the Training Set

• Not applicable. As this is a physical medical device, there is no "training set" in the context of an AI/ML algorithm.

9. How Ground Truth for the Training Set Was Established

• Not applicable for the same reasons as above.

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