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The MEGA and SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories have the following indications for use:

• Refractory Unstable Angina.
• Impending Infarction.
• Acute Myocardial Infarction.
• Refractory Ventricular Failure.
• Complications of Acute MI (ie. Acute MR or VSD or papillary muscle rupture)
• Cardiogenic Shock.
• Support for diagnostic, percutaneous revascularization and interventional procedures.
• Ischemia related intractable ventricular arrhythmias.
• Septic Shock.
• Intraoperative pulsatile flow generation.
• Weaning from cardiopulmonary bypass.
• Cardiac support for non-cardiac surgery.
• Prophylactic support in preparation for cardiac surgery.
• Post-surgical myocardial dysfunction/low cardiac output syndrome.
• Myocardial Contusion.
• Mechanical bridge to other assist devices.
• Cardiac support following correction of anatomical defects

The 8Fr. Introducer Set is comprised of an Introducer Sheath and Introducer Dilator for percutaneous insertion of the MEGA & SENSATION PLUS 8Fr. 50cc IABs. The flexible high density polyethylene (HDPE) dilator is inserted through and twist locked into the 8Fr. introducer sheath for insertion over a quide wire for percutaneous access to the femoral artery. The dilator is then removed from the sheath after which the 8Fr 50cc Intra-aortic Balloon (IAB) Catheter is inserted over a guide wire and through the 8Fr introducer sheath for placement within the thoracic anta for counterpulsation therapy. The introducer sheath is comprised of a hub housing that includes an integral hemostasis valve to prevent bleeding about the IAB catheter and a sheath tube comprised of a flat coiled stainless wire between a layer of PTFE and Pebax for reinforcement to provide kink resistance within the vasculature.

The provided 510(k) summary for the MEGA AND SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter (K133074) describes a device modification, specifically to the introducer set. Therefore, the acceptance criteria and study information pertain to demonstrating the substantial equivalence of this modified introducer set to its predicate device, rather than proving the overall clinical effectiveness of an entirely new device from scratch.

Here's an analysis of the acceptance criteria and the study conducted, based on the provided text:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a modified device, the "acceptance criteria" are not framed as specific performance metrics like sensitivity/specificity for a diagnostic AI. Instead, they are framed around demonstrating that the modified components (the introducer set) perform as safely and effectively as the predicate device and that the modifications do not raise new questions of safety or effectiveness.

Study Details

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

   • The document does not specify sample sizes for any of the non-clinical tests (e.g., how many introducer sets were tested for kink resistance, biocompatibility, etc.).
   • Data provenance: Not explicitly stated, but these are non-clinical (lab/bench) tests conducted by the manufacturer (Datascope Corp.) as part of their "development process." It's assumed to be internally generated data, not patient data from a specific country or retrospective/prospective in the clinical sense.

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

   • Not applicable in the context of this 510(k). The "ground truth" for non-clinical tests is established by passing predefined engineering specifications and compliance with voluntary standards, as evaluated by the manufacturer's development and quality control teams, and then reviewed by the FDA. There is no mention of external "experts" establishing ground truth for these tests.

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

   • Not applicable. This concept typically refers to resolving disagreements among human readers/experts in diagnostic imaging studies. The studies performed were non-clinical bench and lab tests.

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:

   • No. An MRMC study was not done. The device is an Intra-Aortic Balloon Catheter Introducer Set, not an AI diagnostic tool where human readers' performance with/without AI assistance would be relevant.

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

   • No. This is a medical device (introducer set), not an algorithm or AI.

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

   • For the non-clinical tests, the "ground truth" is defined by engineering specifications, performance standards, and regulatory requirements (e.g., biocompatibility standards, mechanical test specifications) that the device must meet to function safely and effectively as an introducer set. There is no "expert consensus" or "pathology" in the typical clinical sense for these verification tests.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set. The "development process" involved design and testing of physical components.

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

   • Not applicable, as there is no training set mentioned or implied.

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