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RAIN SheathTM Tibial Pedal Introducer is indicated to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee.

The RAIN Sheath™ Tibial Pedal Introducer device (hereafter referred as RAIN Sheath™ Pedal) consists of a sheath introducer, a vessel dilator (0.021" guidewire compatible), a stainless-steel entry needle, and a 0.021" guidewire (either stainless steel or nitinol). The sheath introducer has a lubricious hydrophilic coating, a smooth shoulder transition to the dilator and low-profile outer diameters (OD). To provide an atraumatic transition between the dilator tip and the 0.021" mini guide wire, the RAIN Sheath™ dilator is tapered at the distal end and the inner diameter (ID) of the dilator has been optimized. The hub is overmolded to the dilator and includes a locking mechanism between the hub of the vessel dilator and the hub of the sheath cannula to facilitate insertion of the product while preventing the vessel dilator from backing out of the cannula. The RAIN Sheath™ Pedal device is available in four (4) product configurations which differ based on the French sizes (4F and 5F) and specific wire included in the system. RAIN Sheath™ Pedal is a single-use sterile device, sterilized by ethylene oxide.

The provided text is a 510(k) summary for the RAIN Sheath™ Tibial Pedal Introducer, which is a medical device. This type of document is used to demonstrate substantial equivalence to a predicate device, not necessarily to prove efficacy through rigorous clinical studies. Therefore, it focuses on non-clinical tests and comparisons rather than comprehensive clinical trial data.

Based on the provided text, here's an analysis regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the RAIN Sheath™ Pedal device uses the same fundamental technology and operating principles as the predicate device. Therefore, the acceptance criteria are implicitly tied to demonstrating that the new device meets the established performance characteristics and safety profile of the predicate. The document doesn't explicitly list specific quantitative acceptance criteria in a table format, but rather discusses successful completion of various non-clinical tests.

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

• Non-Clinical Performance (Kinking Resistance): The document does not specify a numerical sample size for the "Design Validation testing" which addressed kinking. It simply states "Design Validation testing was performed."
• Usability: The document states that "devices were tested in the simulated use condition using a clinically relevant bench top model." It does not specify the number of devices or number of users (sample size).
• Biocompatibility: The biocompatibility data was leveraged from the previously cleared RAIN Sheath™ Transradial (K181592). The sample size for these original tests is not provided in this document, nor is the provenance of the biological materials/samples used within those tests.
• Sterilization: The sterilization validation was leveraged from the RAIN Sheath™ Transradial (K181592) and followed ISO 11135. The sample size for the validation and provenance is not detailed here.

Data Provenance: For the RAIN Sheath™ Pedal, the primary "data" for equivalence comes from its identical design, materials, and manufacturing process to the RAIN Sheath™ Transradial (the reference device) and from non-clinical benchtop testing. The origin of the non-clinical testing is implied to be internal (Cordis US Corp). There is no mention of country of origin of data or whether it was retrospective or prospective in the context of clinical data, as no clinical data was used for this submission.

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

• Not applicable / Not explicitly stated for non-clinical tests. For device performance tests like kinking or usability, the "ground truth" is typically objective measurements or observations by test engineers and subject matter experts. The document does not specify the number or qualifications of experts involved in conducting or evaluating these non-clinical tests.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based AI studies where there are subjective interpretations that need consensus. Since the tests described are non-clinical and product-level, such adjudication methods are not relevant.

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

• No. The document explicitly states: "No clinical studies were deemed necessary to support substantial equivalence." Therefore, an MRMC comparative effectiveness study was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done:

• Not applicable. This device is a physical medical device (an introducer sheath), not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant.

7. The Type of Ground Truth Used:

• Non-clinical objective measurements and industry standards. For kinking resistance, the ground truth would be physical observation of kinking under simulated use conditions and evaluation against reasonable force. For usability, the ground truth would be successful completion of critical tasks by users on a benchtop model. For biocompatibility and sterilization, the ground truth is compliance with recognized international standards (ISO 10993-1, ISO 11135) and successful results from the leveraged tests.

8. The Sample Size for the Training Set:

• Not applicable. This submission is for a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context. The "design validation" and "usability testing" can be considered as verification and validation activities rather than training.

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

• Not applicable. As explained above, there is no training set for this type of device.

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