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The PINNACLE R/O is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.

Pinnacle™ R/O is comprised of an introducer sheath and a dilator. The introducer sheath has a radiopaque marker that is highly visible under fluoroscopy. The marker is a band that is located approximately 5 mm from the sheath's tip. The introducer sheath consists of 2 layers. Both layers are ETFE and the outer laver entirely covers the inner laver.

Pinnacle™ R/O is used to facilitate placement of a catheter through the skin into a vein or artery. A Mini Guide Wire (with Inserter) may be included with Pinnacle™ R/O. The Inserter does not contact blood and is used strictly for quiding the Guide Wire into a cannula or Introducer.

The Mini Guide Wire is inserted through a cannula placed in the patient's blood vessel. The Pinnacle™ R/O (comprised of the Sheath and the Dilator) is then inserted over the Mini Guide Wire and into the blood vessel. The Mini Guide Wire is then withdrawn from the vessel. The Dilator maintains the integrity of the Sheath and dilates the blood vessel while Pinnacle™ R/O is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted. The RADIFOCUS Obturator is an accessory device which creates an occlusion when inserted into the Sheath. The Obturator also provides support to the indwelling Sheath after the catheter is removed.

The Sheath, Dilator and Obturator contain bismuth, making these devices slightly visible under fluoroscopy.

The provided text describes the regulatory filing for the PINNACLE™ R/O or RADIFOCUS® Introducer R/O device, seeking substantial equivalence to a predicate device (RADIFOCUS® Introducer II, K954234). The information provided is for a traditional medical device (introducer sheath), not an AI/ML powered device. As such, many of the typical acceptance criteria and study details for an AI-powered device, such as those related to diagnostic performance metrics, ground truth establishment, or human-in-the-loop studies, are not applicable here.

Therefore, the response will focus on the acceptance criteria and performance data relevant to this type of medical device as presented in the document.

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 sample sizes used for each verification test. The tests (Kink Resistance, Sheath-to-Housing Joint Strength, Sheath Tip Penetration, Sterility Validation, Radiopacity, and Biocompatibility) are typically conducted on a representative sample of manufactured devices or materials.

The data provenance is from internal testing conducted by Terumo Medical Corporation for regulatory submission to the FDA. The tests are focused on the physical and material properties of the device itself, not on patient-specific data or diagnostic images.

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

Not applicable. This device is a traditional medical introducer sheath, and its performance criteria are based on engineering specifications, material properties, and biological compatibility testing, not on interpretation of images or clinical diagnoses requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are primarily objective measurements against specifications, 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

Not applicable. This is not an AI-powered device, so MRMC studies or human reader improvement with AI assistance are irrelevant.

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

Not applicable. This is not an AI-powered device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance acceptance is based on:

• Engineering Specifications: Defined parameters for physical properties like Kink Resistance, Sheath-to-Housing Joint Strength, and Sheath Tip Penetration.
• International Standards: Compliance with ISO-10993 for biocompatibility testing.
• Radiopacity Requirements: Ensuring visibility under fluoroscopy.
• Sterility Standards: Ensuring the device meets sterile conditions.

These are objective standards and measurements, not subjective evaluations or clinical outcomes in the same way an AI diagnostic device would have.

8. The Sample Size for the Training Set

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

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

Not applicable. There is no training set as this is not an AI/ML powered device.

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