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The Boomerang™ Wire/PlusWire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Wire/PlusWire System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F or 7F introducer sheaths.

The Boomerang™ Plus Wire System is an extension of the Boomerang Wire System family of devices. The Boomerang Plus Wire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Plus Wire System includes design modifications to enhance ease of device removal and to minimize ooze from the tissue tract. The Boomerang Plus Wire System maintains the same indication for use as the Boomerang Wire System family of devices.

The Boomerang Plus Wire System consists of a sterile disposable Boomerang Plus Wire and a sterile disposable Boomerang Clip. In conjunction with manual compression, the Boomerang PlusWire System provides temporary hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Plus Wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Plus Wire is deployed, which opens the flat, low-profile Boomerang Disc within the lumen of the femoral artery. The Boomerang Disc is then pulled back gently to the distal end of the introducer sheath. The introducer sheath is then removed from the vessel over the Boomerang Plus Wire and the low-profile Boomerang Disc conforms to the contours of the vessel and secures it against the intima, sealing the arteriotomy. As gentle tension is applied to the Boomerang Plus Wire, the sleeve covering the tensioning coil is gently retracted until the distal tip appears at the skin surface to expose the coated tensioning coil to the tissue tract. The applied tension is maintained by the external Boomerang Clip at the surface of the skin at the puncture site. The tension between the Boomerang Disc and the Boomerang Clip creates a site-specific compression of the arteriotomy and tract and establishes temporary hemostasis. This allows natural recoil of the smooth muscle of the vessel wall to occur at the arteriotomy site while the body's natural clotting process begins. Following the procedure, the Boomerang Disc is collapsed and the Boomerang Plus Wire is completely removed from the artery. No part of the device is left behind. Final closure of the arteriotomy occurs by applying gentle manual or mechanical compression after removal of the Boomerang Plus Wire System.

The provided text describes the Cardiva Medical Boomerang™ Plus Wire System. However, it does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes, expert qualifications, or ground truth establishment methods as typically required for medical device clearance based on AI/ML.

Here's an analysis of what is present and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated. The document focuses on demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: No specific quantitative performance metrics (e.g., success rates, complication rates, time to hemostasis) are provided in a table. The document states that "various testing which included bench, biocompatibility, animal and clinical testing was performed... to insure the product and the product materials were adequately tested and evaluated to demonstrate the product meets or exceeds the performance requirements and is safe and effective for its intended use." However, the results of this testing are not detailed.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not provided. While "clinical testing" is mentioned, no details about the size or characteristics of the patient cohort are given.
• Data Provenance: Not provided. There's no information about the country of origin, whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not applicable/Not provided. This device is a mechanical hemostasis system, not an AI/ML diagnostic tool requiring expert ground truth establishment for image or data interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. As above, this is not an AI/ML diagnostic device.

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:

• No. This is not an AI/ML device, and therefore, no MRMC study or AI assistance comparison would be relevant.

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

• No. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not explicitly stated for the "clinical testing." For a device like this, ground truth would likely be based on clinical outcomes relevant to hemostasis (e.g., successful closure, absence of bleeding, time to hemostasis, complication rates) assessed by treating physicians and follow-up. The document does not elaborate on how these outcomes were measured or whether they were adjudicated against a specific "ground truth" standard.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that uses a "training set."

9. How the ground truth for the training set was established:

• Not applicable.

Summary of Device and Approval Process based on the text:

• Device Name: Cardiva Medical Boomerang™ Plus Wire System
• Intended Use: To promote hemostasis at arteriotomy sites as an adjunct to manual compression in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures using 5F, 6F, or 7F introducer sheaths.
• Predicate Device: Cardiva Medical Boomerang™ Wire System (K051817)
• Basis for Clearance: Substantial Equivalence to the predicate device. The document explicitly states: "The Boomerang PlusWire System is substantially equivalent to the predicate device with regard to function, intended use, physical characteristics and performance testing."
• Testing Mentioned: Bench, biocompatibility, animal, and clinical testing were performed to ensure safety and effectiveness and that the product meets performance requirements. However, detailed results or specific acceptance criteria from these tests are not included in this summary.

This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than providing a detailed technical report of all performance testing results and acceptance criteria. For detailed performance data, one would usually refer to the full 510(k) submission or associated clinical trial reports, which are not provided here. The questions posed are highly relevant to AI/ML device submissions, which this is not.

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