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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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The Intra-Aortic Balloon (IAB) is clinically indicated for the following conditions:
a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery
c. Complications of Heart Failure

IAB's are designed to provide cardiac assist therapy. The devices are dual lumen percutaneously inserted Intra-Aortic IAB catheters, with two independent non-communicating lumen is comprised of an inflatable bladder connected to the catheter distal tip and to the IAB tip outer surface. The inner lumen is comprised of a luer adapter connected to the proximal end of the inner lumen and to the IAB tip inner surface. The IAB inner lumen is used for placement of the device with a guidewire and the outer lumen is used to shuttle helium gas to and from the inflatable bladder. IABs are timed to inflate within the aota during the diastolic relaxation of the heart and deflate during the systolic contraction of the heart, resulting in increased blood supply to the heart muscle and decreased work load for the left ventricle.

This appears to be a 510(k) summary for an Intra-Aortic Balloon (IAB) device. The document does not describe a study involving an AI component or a specific algorithm. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is common for medical device clearances that are not novel AI/ML devices.

Therefore, most of the requested information about acceptance criteria, study design, and AI performance metrics is not applicable to this document. The document primarily focuses on the device description, indications for use, and a list of predicate devices used to establish substantial equivalence.

Here's an attempt to answer the questions based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" given the nature of the document:

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

   • Acceptance Criteria: Not explicitly stated as quantifiable metrics in the manner typically seen for AI/ML performance. The document implies the acceptance criterion is "substantial equivalence" to predicate devices based on technological characteristics and intended use.
   • Reported Device Performance: The document states, "The results of the laboratory tests demonstrate that the device is substantially equivalent." No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are provided, as this is not a study reporting on diagnostic or predictive output.

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

   • Not applicable/Not provided. The document refers to "laboratory tests" but does not detail the sample size or provenance of data used in those tests, as it's a submission for an IAB device, not an AI study.

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. Ground truth establishment by experts is not relevant in this context, as it's about the physical and functional characteristics of an IAB device.

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

   • Not applicable/Not provided.

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 not an AI/ML device, and no MRMC study is mentioned.

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

   • Not applicable. This device does not involve an algorithm with standalone performance.

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

   • Not applicable. For a substantial equivalence claim for an IAB, ground truth would relate to its physical and functional specifications meeting design requirements and performance similar to predicate devices, rather than a diagnostic 'truth'.

8. The sample size for the training set

   • Not applicable/Not provided. There is no AI training set for this device.

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

   • Not applicable/Not provided.

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The Arrow Intra-Aortic Balloon (IAB) Catheter With a Fiber Optic Sensor and a Measurement System is clinically indicated for the following conditions:

• a. Acute Coronary Syndrome
• b. Cardiac and Non-Cardiac Surgery
• c. Complications of Heart Failure

IAB's are designed to provide cardiac assist therapy. In cardiac assist therapy a standard electronic pressure transducer can be connected externally to the central lumen of an IAB as a means of monitoring arterial pressure.

The purpose of the IAB device modification is to provide an alternative means for obtaining arterial pressure readings directly from the tip of an IAB catheter, as opposed to a standard electronic pressure transducer that is connected externally to the central lumen of an IAB.

A pressure sensor is attached to a flexible optical fiber in the IAB catheter. The sensor is positioned within the tip of the IAB catheter and the fiber runs the length of the inner lumen, exiting at the trifurcation and attaches to an optical connector. The sensor in the IAB catheter optically transmits light to a sensor measurement system. The sensor measurement system displays and outputs an arterial pressure.

Because the fiber optic sensor is positioned directly in the aorta, an arterial pressure can be directly obtained as opposed to obtaining arterial pressure readings through the end of a fluid-filled column and transducer. Additionally the fiber optical not electrical, therefore, the pressure signal is immune to any electrical noiselinterference that can affect a standard electronic pressure transducer. The fiber optic measurement system outputs the pressure via a digital or analog signal. The output signal can be input into a patient monitoring system or Intra-Aortic Balloon Pump (IABP).

This FDA 510(k) premarket notification describes the Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System. However, it does not contain the detailed study information required to fully answer your request regarding acceptance criteria and device performance.

The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is a regulatory pathway that often relies on demonstrating that a new device is as safe and effective as an already legally marketed device, rather than requiring extensive de novo clinical trials or detailed performance studies with acceptance criteria.

Here's what information can be extracted and what is missing based on your request:

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

• Missing. The document states, "The results of the laboratory tests demonstrate that the device is substantially equivalent," but it does not provide a table of specific acceptance criteria or the quantitative reported performance of the device against those criteria (e.g., accuracy, precision, bias of the fiber optic sensor pressure readings).

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

• Missing. No information on the sample size of any test sets, the type of study (retrospective or prospective), or the data provenance is provided. The evaluation seems to be based on "laboratory tests" rather than clinical or extensive animal studies detailed in this summary.

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)

• Missing. There is no mention of experts or ground truth establishment for a test set.

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

• Missing. No information on adjudication methods is present.

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 / Missing. This device is an IAB catheter with a fiber optic pressure sensor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or AI assistance effect size is not relevant to this specific device.

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

• Partially Applicable / Missing Details. The device's primary function is to measure arterial pressure via a fiber optic sensor. The description implies it acts as a standalone measurement system, outputting pressure via a digital or analog signal to a patient monitoring system or IABP. However, the document does not contain details of specific standalone performance studies (e.g., detailed accuracy studies comparing its readings to a gold standard, independent of an IABP or human interpretation). It only states "laboratory tests" were performed.

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

• Missing. The document does not specify the ground truth used for validating the "laboratory tests." For a pressure sensor, a typical ground truth would involve comparison to a highly accurate calibrated reference pressure transducer.

8. The sample size for the training set

• Not Applicable / Missing. This device does not appear to involve a machine learning algorithm that would require a "training set" in the conventional sense. If there were any statistical models involved in the sensor's calibration or processing, details are not provided.

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

• Not Applicable / Missing. See point 8.

Summary of available information:

• Device Name: Arrow Intra-Aortic Balloon (IAB) Catheter With A Fiber Optic Sensor And A Measurement System
• Intended Use: Clinically indicated for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, and Complications of Heart Failure.
• Technological Characteristics: The device provides an alternative means for obtaining arterial pressure readings directly from the tip of an IAB catheter using a fiber optic sensor. It is described as "technologically equivalent" to previously cleared pressure sensors and the Camino Ventrix Subdural Tunneling Pressure Monitoring Kit (K982702) for its fiber optic aspect.
• Testing: "Laboratory tests" were performed, and the results "demonstrate that the device is substantially equivalent." No details of these tests, specific acceptance criteria, or quantitative results are provided in this summary.
• Regulatory Pathway: 510(k) "Substantial Equivalence" to predicate devices.

To obtain the detailed information requested, one would typically need to review the full 510(k) submission and supporting documentation, which is generally much more extensive than this summary letter.

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