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The CIRCA Scientific CardioCurve™ Steerable Sheath is indicated when introducing various cardiovascular devices to the epicardial or endocardial surfaces of the heart, including the left side of the interatrial septum.

The CardioCurve™ Steerable Sheath from CIRCA Scientific is an 8.5 Fr sterile, single-use catheter introducer used for the introduction, withdrawal, and exchange of guidewires and catheters while minimizing blood loss. It is available in lengths of 40cm, 61cm, 71cm, or 82cm. The introducer is packaged with a custom dilator and a 180 cm, 0.032", super stiff, marketed cleared guidewire (K935170). A side port with a 3-way stopcock allows air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. A handle equipped with two linked rotating dials is used to deflect the tip clockwise and counterclockwise 180°. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, a radiopaque tip marker to improve fluoroscopic visualization, and a lubricious coating on the outer surface.

The CardioCurve™ Steerable Sheath shaft is made from Pebax and Nylon. The shaft includes a radiopaque tip marker for visibility under fluoroscopy and is braided, except for the distal tip, for kink resistance; the handle is made of ABS. The dilator is made of HDPE that is barium loaded for visibility under fluoroscopy.

The CardioCurve™ dilator can be used with a curved transseptal Abbott BRK™ type needle with stylet if indicated on the package label.

This Special 510(k) is submitted to support the changes made to the predicate device: the Tuohy Borst adapter in the CardioCurve Steerable Sheath is replaced with a cap; as a result of this change, the dilator shaft usable length is shortened, and the Instruction for Use (IFU) is updated.

This document describes the premarket notification for the CardioCurve™ Steerable Sheath (K240004), which is a modification of a previously cleared device (K210185). The key changes are the replacement of a Tuohy Borst adapter with a cap and a resulting shortening of the dilator shaft usable length, along with an updated Instruction for Use (IFU).

Based on the provided text, the device in question is a physical medical device (a catheter introducer), not an AI/software-based device. Therefore, the questions related to AI/algorithm performance (e.g., ground truth, training set, MRMC study, standalone performance, experts for ground truth) are not applicable to this submission. The validation for this medical device focuses on physical performance testing to demonstrate that the design changes do not raise new questions of safety or effectiveness.

Here's the information that can be extracted relevant to the physical device's acceptance criteria and study, followed by an explanation of why AI-specific questions are not applicable:

Acceptance Criteria and Device Performance (for a physical medical device):

The document references a "Summary of Performance Testing" which includes a list of tests. It states: "The methods and acceptance criteria were the same or equivalent to the predicate device and are relevant to the changes under review. The testing identified in the list below was based on well-established test methods and requirements."

Since specific numerical acceptance criteria and reported performance values are not explicitly provided in the text for each test, the table reflects the types of tests conducted and infers that the device met the criteria, as it received clearance.

Study Details (for a physical medical device):

1. Sample sizes used for the test set and data provenance:
   The document states "Verification testing has been conducted to support that the subject device meets the design specifications and is substantially equivalent to the predicate device." It also mentions "Design verification tests were performed to demonstrate that the subject device...met predetermined performance specifications."
   However, the exact sample sizes for each test (e.g., number of units tested for fatigue, leak, etc.) and the data provenance (e.g., specific country of origin for test materials or retrospective/prospective nature of the physical tests) are not specified in the provided text. These tests would typically be performed in a lab setting rather than on patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not Applicable. This is a physical medical device. "Ground truth" in the context of physical medical devices typically refers to engineering specifications, material properties, and established test methods, not expert consensus on medical images or clinical outcomes. The testing is based on "well-established test methods and requirements," implying engineering and quality control expertise, but not necessarily a panel of medical experts for "ground truth" establishment in the way it's understood for AI.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not Applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. This device undergoes physical performance testing against engineering specifications, not human interpretation against a medical standard.

4. 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. An MRMC study is relevant to AI-assisted diagnostic devices. This is a physical catheter introducer, not a diagnostic AI tool.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not Applicable. This refers to AI algorithm performance.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   As explained in point 2, "ground truth" for this physical device refers to engineering specifications, design requirements, and established testing standards. The document mentions an FMEA (Failure Modes and Effects Analysis) and that testing "met critical design specifications as well as performance attributes for its intended use."

7. The sample size for the training set:
   Not Applicable. There is no "training set" as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:
   Not Applicable.

Summary of Device, Study, and Why AI-specific Questions are Not Applicable:

The CardioCurve™ Steerable Sheath is a Class II medical device, specifically a catheter introducer. The submission is a Special 510(k) to support changes to a previously cleared predicate device. The changes are physical design modifications (replacement of a Tuohy Borst adapter with a cap and resulting dilator length adjustment).

The "study" described is a series of design verification tests conducted to ensure that these physical changes do not negatively impact the device's safety and effectiveness. This is a standard process for physical medical device modifications.

The questions regarding "ground truth," "training set," "experts," "adjudication," and "MRMC studies" are typically applied to diagnostic AI/machine learning devices where the output is an interpretation of data (e.g., medical images), and human performance or algorithmic performance needs to be evaluated against a clinical standard. Since the CardioCurve™ Steerable Sheath is a physical, interventional device, these AI-centric questions do not apply to its regulatory clearance process as described in this document. The "acceptance criteria" relate to engineering and performance specifications, and the "study" involves physical bench testing.

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