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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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The SENSATION PLUS™ 7.5Fr. 40cc Intra-Aortic Balloon Catheter 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 SENSATION PLUS™ 7.5 Fr. 40cc IAB Catheter is an enhanced MEGA® 7.5Fr IAB Catheter (K120868) device which includes a catheter, an insertion kit and two STATLOCK® IAB Stabilization Devices. This device incorporates the fiber-optic technology of the SENSATION PLUS™ 8Fr 50cc IAB Catheter (K112327) into the MEGA® 7.5Fr. 40cc IAB Catheter (K120868) design, with one additional change - the stylet wire (a packaging component) was removed. The SENSATION PLUS™ 7.5Fr. 40cc Insertion kit contains the same components as currently used with the MEGA® 7.5Fr 40cc IAB Catheter (K120868), with the sole exception that the SENSATION PLUS™ 7.5Fr. 40cc Insertion Kit contains six extender tubing clips, similar to the predicate SENSATION PLUS™ 8Fr. 50cc Insertion Kit (K112327).

The SENSATION PLUS™ 7.5Fr. 40cc Intra-Aortic Balloon Catheter is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end-diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle. These beneficial effects are caused by the inflation and deflation of the Intra-Aortic Balloon (IAB) Catheter placed in the patient's descending aorta just below the subclavian artery. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB Catheter inflation is initiated at the onset of the diastole at the dicrotic notch and remains inflated through diastole. The IAB Catheter is then deflated at, or just prior to. the onset of systole and the balloon remains deflated throughout systole. Hence, the therapy is also referred to as counterpuisation. This is the same intended use as other IAB Catheters.

Here's an analysis of the acceptance criteria and study information for the Datascope Corp. SENSATION PLUS™ 7.5Fr. 40cc Intra-Aortic Balloon Catheter, based on the provided text:

This device is not an AI/ML device, therefore, some of the requested information (like MRMC study, effect size of human improvement with AI, standalone algorithm performance, number of experts for ground truth, adjudication method, and sample size for training set) is not applicable. The device relies on non-clinical testing for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) for a modified device, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to predicate devices through non-clinical testing. The device's performance is demonstrated by its comparability to these established devices.

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

• Sample Size: Not explicitly stated as a separate "test set" in the context of a traditional clinical study with patients. The performance was established through in-vitro tests. The exact number of samples or trials for each type of in-vitro test (e.g., performance, biocompatibility, sterility, shelf life, package) is not provided.
• Data Provenance: The data comes from non-clinical (in-vitro) testing conducted by Datascope Corp. The location of the testing is not specified, but the company is based in Fairfield, NJ, USA. The testing would be considered prospective in the sense that it was performed specifically for this submission.

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

Not applicable for this type of non-clinical device submission. Ground truth for device performance was established through engineering specifications, material standards, and benchmark testing against predicate devices, rather than expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication.

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

Not applicable. This is a medical device, not an AI/ML diagnostic or assistive tool.

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

Not applicable. This is a medical device, not an algorithm. Its performance is inherent to its physical design and materials.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is derived from:

• Engineering Specifications: Adherence to design requirements and specifications.
• Voluntary Standards: Compliance with recognized industry standards for IAB catheters.
• Predicate Device Performance: Benchmarking against the known performance characteristics of the legally marketed MEGA® 7.5Fr 40cc IAB Catheter (K120868) and SENSATION PLUS™ 8Fr. 50cc IAB Catheter (K112327).
• In-vitro Test Results: Physical, chemical, and mechanical testing results (biocompatibility, sterility, shelf life, package, and functional performance tests).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device; there is no "training set" in the context of machine learning.

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

Not applicable. There is no training set. The "ground truth" for the device's design and manufacturing is established through standard engineering, quality control, and regulatory compliance processes typical for medical devices.

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