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The Abiomed 14Fr Low Profile Introducer Kit is intended to facilitate access to the vascular system for the introduction and removal of the Impella CP Catheter and ancillary devices.

The Abiomed 14Fr Low Profile Introducer Kit (Gen 2) is a sterile, single-use, prescription device. The 14Fr Low Profile Introducer Kit consists of an introducer sheath and a tapered sheath dilator which is compatible with an 0.035" guidewire. The 14Fr Low Profile Introducer Kit is kitted with an 0.035" access guidewire, supplemental dilators and a luer adapter for convenience to help facilitate insertion. The 14Fr Low Profile Introducer Sheath consists of a sheath hub with three-way stopcock and flush port at its proximal end a sheath body at its distal end. The sheath hub features an introducer cap, hemostasis valve, side-port with three-way stopcock and flush port, a butterfly (suture pad), and connects to the dilator hub. The coil reinforced polymer sheath body has an insertion profile of 14Fr to allow the insertion and removal of the Impella CP Catheter and ancillary devices. The 14Fr Low Profile Dilator consists of a dilator body, a tapered tip at the distal end, and a hub at the proximal end, which connects with the sheath hub. Additionally, the 14Fr dilator has a hydrophilic coating to aid in insertion of the device into the vasculature.

This looks like a 510(k) summary for a medical device, specifically an introducer kit. The document describes the device, its intended use, and comparison to a predicate device. However, it does not contain the level of detail regarding acceptance criteria, study design, and performance metrics that would be expected for a typical AI/ML-based medical device described in the prompt's request.

Here's why and what information can be extracted:

This is NOT an AI/ML Medical Device.
The device described, the "Abiomed 14Fr Low Profile Introducer Kit," is a physical medical device (a catheter introducer) and not an AI/ML software device. This means the requested information about AI model performance, training sets, ground truth establishment methods, human reader studies, etc., is not applicable to this document. The "performance testing" section refers to traditional bench tests for physical device characteristics (e.g., visual inspection, mechanical testing, coating integrity, sterility, biocompatibility).

Therefore, I cannot populate most of the requested fields accurately as they pertain to AI/ML models.

However, I can extract the relevant information regarding the device's acceptance criteria and the type of study performed to show it met these criteria, as presented in the document for this physical device.

Information Extracted (Interpreted for a non-AI/ML device):

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

   • Acceptance Criteria for a Physical Device: The document states that performance testing "met the acceptance criteria." While specific numerical criteria are not listed, the implied criteria would be successful completion of each bench test without failure.
   • Reported Device Performance: "showed that the subject device, Abiomed 14Fr Low Profile Introducer Kit (Gen2), met the acceptance criteria and demonstrated substantial equivalence for its intended use."

   Acceptance Criteria (Implied for physical device)	Reported Device Performance
   Device passes specified bench tests	Met acceptance criteria
   Demonstrates substantial equivalence	Demonstrated substantial equivalence for intended use
   Biocompatibility: Safe for patient contact	Passed ISO 10993-1
   No new safety or performance issues identified	None identified

2. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified for individual tests.
   • Data Provenance: Not applicable as these are bench tests on manufactured device samples, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. Ground truth for a physical device is typically established through engineering specifications, material science, and regulatory standards, not expert consensus on patient data.

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

   • Not applicable.

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-assisted device.

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

   • No. This is not an AI algorithm. The device performance (standalone) was assessed through bench testing.

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

   • For a physical device, ground truth is based on engineering specifications, material properties, and established regulatory standards (e.g., ISO 10993 for biocompatibility, defined mechanical test parameters).

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device.

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

   • Not applicable.

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