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The AC3™ Range ™ Intra-Aortic Balloon Pump is clinically indicated for use for the following conditions:

• 1. Acute Coronary Syndrome
• 2. Cardiac and Non-Cardiac Surgery
• 3. Complications of Heart Failure

The AC3 Range IABP system is a professional use device that provides counter-pulsation therapy to adult patients with impaired Left Ventricular (LV) Function. It provides hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles.

The AC3 Range IABP system consists of two (2) components: (1) the pump control/display module which incorporates a display, touch screen, and keypad for system operation and (2) the pneumatic drive module with attached wheels for easy transport.

The IABP is attached to an intra-aortic balloon (IAB) catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta. The pump display incorporates a high-definition touchscreen with color coded icons and a keypad for system operation. The AC3 Range IABP uses software to select and maintain precise IAB catheter inflation timing and triggering based on real time physiological data from the patient. The system offers two modes of operation, (1) the AutoPilot mode, where most functions are automatically selected and controlled by IABP and (2) the Operator mode where the user has control over most settings and selections.

This document describes the AC3™ Range™ Intra-Aortic Balloon Pump (IABP), a device intended for counter-pulsation therapy in adult patients with impaired Left Ventricular (LV) Function, providing hemodynamic support.

Based on the provided text, the device is a new version of the AC3™ Series IAB Pump (K232343), and the submission is for substantial equivalence. Therefore, the study details are focused on demonstrating that the new device is as safe and effective as the predicate device, rather than establishing de novo clinical performance.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity, or error rates for an AI system) and corresponding reported device performance values. Instead, it relies on demonstrating substantial equivalence to a predicate device through Mechanical and General Safety Testing.

The "acceptance criteria" implicitly are that the new device performs equivalently to the predicate and raises "no new questions of safety or effectiveness."

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

The document only mentions "Mechanical and General Safety Testing." This typically involves bench testing, engineering evaluation, and electrical safety tests, rather than a clinical trial with a "test set" of patient data in the context of an AI/software device. Therefore, a sample size of patient data or its provenance is not applicable here.

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

Not applicable. As this is not a study establishing clinical ground truth for a diagnostic or prognostic AI algorithm, there is no mention of experts establishing a ground truth for a test set. The evaluation focuses on engineering and safety equivalence.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of an adjudication method, as the study type does not involve human interpretation or complex clinical endpoints requiring such a process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This device is not an AI-assisted diagnostic tool or an imaging device directly evaluated for human reader improvement. The focus is on the safety and functional equivalence of the IABP system itself.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

While the device uses software to select and maintain IAB catheter inflation timing and triggering, this is presented as an integral part of the device's function, not a separate standalone AI algorithm being evaluated. The "Mechanical and General Safety Testing" would encompass the performance of the integrated software as part of the overall device functionality. No separate standalone algorithm performance study is described.

7. Type of Ground Truth Used:

Ground truth, in the typical sense of clinical outcomes or expert labels, is not directly applicable. For "Mechanical and General Safety Testing," the "ground truth" would be established engineering standards, performance specifications (e.g., pressure, flow, timing accuracy), and safety requirements, against which the device's measured performance is compared.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device where a separate training set is used for algorithm development and then a test set for evaluation. The device is a medical pump system with embedded software.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. Similar to point 8, there isn't a training set for an AI algorithm in the context described in this document.

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The Arrow(R) Pressure Injectable Midline Catheter is indicated for short-term (≤ 30 days) peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

The Arrow Pressure Injectable Midline Catheter is a non-coated, single use catheter designed to provide short-term peripheral access to the venous system. The midline catheter is a peripherally inserted intravenous catheter manufactured with medical grade, flexible polyurethane. It consists of a non-tapered, radiopaque polyurethane extruded catheter body with a single opening or double opening at the distal end and centimeter markings placed along its length to facilitate its positioning. The catheter is available in 4 Fr. Single lumen and 5 Fr. Double lumen configurations with a usable catheter length of 20 cm. Pinch clamps are an integral part of the catheter and are provided on the extension lines to occlude flow through the lumens, as needed. The catheters can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec.

The catheters will be packaged sterile in kits that will include components to facilitate insertion.

The provided text is a 510(k) summary for a medical device (Arrow® Pressure Injectable Midline Catheter) and does not describe acceptance criteria for an AI/ML powered device or a study proving that an AI/ML device meets said criteria. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, biocompatibility testing, and sterilization/packaging testing.

Therefore, most of the requested information regarding AI/ML device acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance simply does not apply to this document.

However, I can extract the information that is present about the device's characteristics and the types of non-clinical tests performed:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria (e.g., "Pass if flow rate >= X mL/s") or specific reported performance values resulting from the tests. Instead, it indicates that "Non-clinical testing related to the device changes has been completed to support the substantial equivalence." This implies that the device met the internal and standard-based requirements for these tests to demonstrate equivalence, but the precise thresholds and results are not detailed.

2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical engineering and biological performance testing, not AI/ML model testing with 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 AI/ML models is not relevant here. The "ground truth" for these tests would be defined by the technical specifications of the standards (e.g., a specific pressure, flow rate, or biological response).

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

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML device. For this device, the "ground truth" for testing is established by recognized international and national standards (e.g., ISO, ASTM, ANSI/AAMI) and internal company test methods, which define acceptable parameters for physical and chemical properties, functionality, and biocompatibility.

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. This is not an AI/ML device.

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