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The AIR-BAND™ Radial is a compression device to assist hemostasis of the radial artery after a transradial procedure.

AIR-BAND™ is a sterile, single use, 6-month shelf life, disposable device. It has a clear medical grade polyurethane window and bulb that facilitates visualization of the puncture site, a clear medical grade PVC flexible tube, and a pressure sensitive, self-adhesive peel backing. A luer valve on the end of the fill tube enables a luer lock syringe to be connected to inflate and deflate the bulb with air to provide compression of the transradial puncture site.

The provided text describes the Datascope Corp.'s AIR-BAND™ Radial Compression Device, including its intended use, design characteristics, and performance data used for its 510(k) submission. However, it does not contain the specific acceptance criteria or a detailed study that proves the device meets those criteria in the format requested.

The document states that "Bench top testing was used to demonstrate substantial performance equivalence to the predicate devices." and lists the types of testing conducted:

• Biocompatibility Testing
• Pressure Equivalence to Predicate (TR Band)
• Packaging Performance
• Product Stability (Shelf Life)
• Product Sterilization

It concludes that "The results of all testing demonstrate that the AIR-BAND™ Radial Compression Device is as safe, as effective, and performs as well as the predicate devices."

Based on the provided information, I can only provide limited details about the acceptance criteria and study as they are not explicitly detailed in the prompt in the format requested.

Here's an attempt to answer the questions based on the available text:

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

The document does not explicitly state numerical acceptance criteria and reported numerical performance values in a table format. It generally states that "Bench top testing was used to demonstrate substantial performance equivalence to the predicate devices" for the listed tests.

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

The document mentions "Bench top testing," but does not specify the sample sizes for these tests. It also does not provide information about the country of origin or 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)

This information is not provided in the document. The testing described is benchtop, not clinical, so "ground truth" in the context of expert review for clinical performance is not applicable here.

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

This information is not provided in the document. As the testing was benchtop, a clinical adjudication method would not be relevant.

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 MRMC study was mentioned. The device is a physical medical device (radial compression device), not an AI/software product, so this type of study is not applicable.

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

This question is not applicable as the device is a physical medical device, not an algorithm.

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

For the benchtop tests, the "ground truth" would be established by validated test methods and specifications relevant to each test (e.g., biocompatibility standards, pressure measurement standards, packaging integrity standards, sterilization standards). No expert consensus, pathology, or outcomes data are mentioned as ground truth.

8. The sample size for the training set

This information is not provided and is not applicable, as the device is not an AI/machine learning model that requires a training set.

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

This information is not provided and is not applicable, as the device is not an AI/machine learning model.

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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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Datascope's 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories are used for intra-aortic balloon counterpulsation therapy in the aorta. whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle. This is the same intended use as previously cleared for all other Datascope Intra-Aortic Balloon Catheters.

The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:

• Refractory unstable angina
• Impending infarction
• Acute MI
• Refractory ventricular failure
• Complications of acute MI (i.e. 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 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

Datascope's 8Fr. 50cc Intra-aortic Balloon Catheters and Accessories are used for intra-aortic balloon counterpulsation therapy in the aorta. whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.

The modification to the Datascope's predicate 8Fr. IAB is dimensional only. The modified 8Fr. IAB membrane's volume will increase and the polyimide inner lumen dimension will decrease.

The provided text is for a 510(k) premarket notification for a medical device (Intra-Aortic Balloon Catheter and Accessories). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than the performance of an AI algorithm or a novel medical device. Therefore, the information requested about acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies evaluating AI algorithms or novel diagnostic devices, cannot be found in this document.

The document states that there was "no clinical evaluation of the new device in the U.S." and that non-clinical (in-vitro) tests were conducted to demonstrate comparability to currently marketed devices for functionality and performance.

Here's an explanation of why the specific questions about acceptance criteria and study design are not applicable to the provided text:

• Acceptance Criteria and Reported Device Performance: This document doesn't define quantitative acceptance criteria in terms of clinical performance metrics that would be applicable to AI (e.g., sensitivity, specificity, AUC). It's focused on showing that the modified device (a dimensional change to an existing IAB) is functionally equivalent to existing cleared devices.
• Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance: These are all concepts relevant to studies that generate new clinical performance data, often for diagnostic devices or AI algorithms. Since no clinical evaluation was performed for this device, these details are absent. The ground truth for training data is also irrelevant here as no AI model is being "trained."
• Training Set Sample Size and Ground Truth Establishment: Again, these are for AI/ML models, not for a device with only dimensional modifications and no clinical testing.

The core of the submission is the claim of "substantial equivalence" based on:

1. Same Intended Use: The device is used for intra-aortic balloon counterpulsation therapy for the same indications as previously cleared Datascope IABs.
2. Technological Characteristics: The modification is described as "dimensional only," increasing the balloon membrane's volume and decreasing the polyimide inner lumen dimension.
3. Non-Clinical Tests: "In-vitro tests" were conducted to demonstrate that the functionality and performance characteristics are "comparable to the currently marketed devices." No specific results from these in-vitro tests are provided, nor are explicit acceptance criteria for these tests.

Therefore, I cannot populate the table or answer the questions as requested based on the given text, because the document describes a 510(k) for a modified medical device with no new clinical data or AI component.

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