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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 AC3™ 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™ Series Intra-Aortic Balloon Pump (IABP) system is a professional use device that provides counterpulsation therapy to adult patients with impaired Left Ventricular (LV) Function. The AC3 Series 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. It provides hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles.

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 IABP delivers helium (He) into the IAB catheter during diastole to displace blood above and below the IAB, increasing blood pressure and perfusion to organs close to the IAB catheter. The IABP deflates or removes He from the IAB catheter just prior to or in the early phase of systole, reducing the pressure in the aorta and therefore the LV must generate to open the aortic valve and eject its contents into the circulatory system. This results in a decrease in work and oxygen demand.

The provided text describes a 510(k) submission for the AC3™ Series IABP device and outlines its substantial equivalence to a predicate device. However, the document does not contain information regarding detailed acceptance criteria or the specific study that proves the device meets those criteria in the context of a performance study with human readers or an AI algorithm, as described in the prompt.

The document focuses on demonstrating substantial equivalence through:

• Identical Indications for Use: Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, Complications of Heart Failure.
• Identical Fundamental Technologies, Principles of Operation, and Performance compared to the predicate device (K201112 - AC3™ Series IAB Pump).
• Minor modifications in the subject device, primarily an updated software revision addressing anomalies, an enhancement for disabling data transfer via USB, and other minor reliability/usability changes, along with an alternate SD Card and battery.
• Conclusion based on software verification and validation testing, stating that these tests "raised no new questions of safety or effectiveness and demonstrated that the subject AC3™ IABP is substantially equivalent to the predicate device."

Therefore, I cannot provide the requested information for the following points as they are NOT present in the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe performance metrics for a diagnostic or AI-assisted device. It's for an Intra-Aortic Balloon Pump.
2. Sample size used for the test set and the data provenance: Not applicable in this context.
3. Number of experts and their qualifications for ground truth: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study and effect size: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The provided document is a 510(k) clearance letter for a medical device (Intra-Aortic Balloon Pump), focusing on demonstrating equivalence to an existing device rather than detailing a clinical performance study with AI or human readers. The "software verification and validation testing" mentioned is likely related to the functional integrity and safety of the pump's control system, not a diagnostic accuracy study.

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The AutoCAT®2 Intra-Aortic Balloon Pump (IABP) and AC3™ Series Intra-Aortic Balloon Pump (IABP) arc clinically indicated for use for the following conditions:

1. Acute Coronary Syndrome

2. Cardiac and Non-Cardiac Surgery

3. Complications of Heart Failure

The AutoCAT Series IABP System, including the AutoCAT®2 and AC3™ Series IABP's, provide counter-pulsation therapy to adult patients with impaired left ventricular (LV) function. They provide hemodynamic support of blood pressure and reduced cardiac work through volume displacement principles. 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 IABP delivers helium (He) into the IAB catheter during diastole to displace blood above and below the IAB. increasing blood pressure and perfusion to organs close to the IAB catheter. The IABP deflates or removes He from the IAB catheter just prior to or in the early phase of systole, reducing the pressure in the aorta and therefore the LV must generate to open the aortic valve and eject its contents into the circulatory system. This results in a decrease in work and oxygen demand.

The AutoCAT Series IABP Systems consists of two main components:

• The pump control/display module which incorporates a touch screen and keypad for . system operation, and
• . The pneumatic drive module which is incorporated into the body of the device

The AutoCAT Series IABP are designed to be used with 30, 40 and 50cc IAB catheters with the appropriate connectors. The primary difference between the AutoCAT®2 IABP and AC3TM series IABP is the user interface, where the display is a touchscreen.

This document describes the FDA's 510(k) clearance for the AutoCAT®2 and AC3™ Series Intra-Aortic Balloon Pump (IABP) systems. The clearance is based on the substantial equivalence to predicate devices, and the document primarily focuses on design modifications and verification testing rather than an AI-driven diagnostic or prognositc device.

Therefore, many of the requested categories related to medical AI applications, such as expert consensus, ground truth establishment, sample sizes for training sets, multi-reader multi-case studies, and specific performance metrics like sensitivity, specificity, and AUC, are not applicable to this document. This document describes a medical device (an intra-aortic balloon pump) and its mechanical/electrical performance, not an AI/ML algorithm.

However, I can extract information related to the acceptance criteria and study that proves the device meets the criteria based on the provided text, focusing on the device's functional integrity as a medical pump.

Here's a breakdown of the available information:

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

The document states:

• "The proposed modification to the IABP systems were verified through design verification testing as outlined on the following page."
• "The results of the verification tests met the specified acceptance criteria and performed similar to the predicate device."

While specific numerical acceptance criteria (e.g., pressure ranges, flow rates) and the exact reported performance values are not detailed within this document, the statement confirms that such criteria existed and were met. The "performance" is implicitly stated as "similar to the predicate device."

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

• Sample Size: Not specified in the provided document.
• Data Provenance: Not specified. Given it's a device modification verification for a US-based manufacturer, it's highly likely the testing was conducted internally or with US-based facilities. The document describes "design verification testing" which implies lab or bench testing, not clinical studies with patient data.
• Retrospective or Prospective: Not applicable as this refers to a device's performance verification, not analysis of patient data.

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. This is a medical device (pump) clearance, not an AI/ML algorithm requiring expert interpretation of medical images or data to establish ground truth. The "ground truth" for a pump is its physical and electrical reliability and performance metrics, which would be established by engineering specifications and testing.

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

Not applicable. Adjudication methods are relevant for human interpretation of medical data (e.g., radiologists reviewing images). For device verification, engineers perform tests against predefined specifications.

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 device is an IABP, a mechanical pump, not an AI product designed to assist human readers in tasks like image interpretation.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this device's performance validation is derived from engineering specifications and established performance characteristics of the predicate devices. The testing verifies that the modified device performs according to these engineering and functional standards, similar to the predicate device. It's about meeting designed-for-purpose operational parameters, not diagnostic accuracy against a clinical reference.

8. The sample size for the training set

Not applicable. This is not an AI/ML driven device that requires a training set.

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

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

Summary relevant to the document:

The device clearance relies on the "design verification testing" performed on the modified IABP systems. The document states that "The results of the verification tests met the specified acceptance criteria and performed similar to the predicate device." The primary "study" proving the device met acceptance criteria was this internal engineering and performance testing against established technical and functional specifications. The acceptance criteria themselves are implicitly the functional and safety requirements for an intra-aortic balloon pump, ensuring the modified parts do not introduce new safety concerns or degrade performance compared to the previously cleared predicate devices.

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The FIBEROPTIX IAB Catheter with the Intra-Aortic Balloon Pump as a control system is clinically indicated for use in any of the following conditions:

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

The FiberOptix® Intra-Aortic Balloon (IAB) Catheter consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as Intra-Aortic Balloon Pump (IABP) is utilized to regulate the inflation and deflation of the balloon.
The FiberOptix® IAB Catheter consists of an inner lumen, an outer lumen, and an inflatable balloon. The outer lumen is comprised of an inflatable balloon connected to the distal tip of the catheter shaft and to the IAB catheter 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 catheter tip inner surface.
The FiberOptix® IAB Catheter has a fiber optic pressure sensor which acts as a pressure transducer embedded in the catheter tip.

The provided text is a 510(k) summary for the FiberOptix® Intra-Aortic Balloon Catheter Kit. It describes the device, its intended use, and claims substantial equivalence to a predicate device based on bench testing. However, it does not contain the detailed information necessary to answer all parts of your request, especially regarding a clinical study proving the device meets acceptance criteria, sample sizes for test/training sets, expert qualifications, or MRMC studies.

Here's an analysis of what information is available and what is missing:

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

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

• Sample size for test set: Not specified.
• Data provenance: Not specified. The study described is "bench tests", implying laboratory testing rather than human subject data.

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)

• Number of experts: Not applicable. The study was bench testing of the device's physical performance, not an evaluation of diagnostic or clinical interpretation requiring expert consensus.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable. This was bench testing, not a study involving human adjudication of clinical data.

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

• MRMC study: No, an MRMC study was not done. The document describes a medical device (an intra-aortic balloon catheter) and its physical performance, not an AI or imaging diagnostic tool.

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

• Standalone performance: Not applicable. This is for a medical device (catheter), not an algorithm.

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

• Type of ground truth: Not explicitly stated as "ground truth" in the context of clinical data. For the bench tests, the "ground truth" would be the engineering specifications and performance standards for the device and its predicate, verified through physical measurements and observations during the tests.

8. The sample size for the training set

• Sample size for training set: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described focuses on verifying the modified design's performance against the predicate.

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

• How ground truth for training set was established: Not applicable, as there is no training set for this type of device and study.

Summary of the Study:

The study described is a series of bench tests (laboratory testing) to provide evidence that the modified FiberOptix® IAB Catheter is substantially equivalent to predicate devices. The technological differences relate to a modified fiber optic sensor configuration for improved robustness.

The specific tests performed were:

• Insertion, Durability Test & (FOS) Static Pressure Test
• Simulated Misuse Test & (FOS) Static Pressure Test

The reported conclusion is that "The results of the verification test met the specified acceptance criteria and performed similar to the predicate device." This demonstrates that the subject device is substantially equivalent based on its physical and functional performance characteristics.

The document does not provide information on clinical trials, human subject data, or AI algorithm performance, as it pertains to a mechanical medical device that is being cleared based on substantial equivalence to a predicate through bench testing.

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

• · Acute Coronary Syndrome
• · Cardiac and Non-Cardiac Surgery
• · Complications of Heart Failure

The AC3™ Series IABP System 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 IABP is attached to an intra-aortic balloon catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta.
The IABP delivers Helium (HE) into the IAB catheter during diastole to displace blood above and below the IAB, increasing blood pressure and perfusion to organs close to the IAB catheter. The IABP deflates or removes HE from the IAB catheter just prior to or in the early phase of systole, reducing the pressure in the aorta and therefore the pressure the LV must generate to open the aortic valve and eject its contents into the circulatory system. This results in a decrease in work and oxygen demand.
The AC3™ Series IABP System consists of two main components:

• . The pump control/display module which incorporates a touch screen and keypad for system operation, and
• The pneumatic drive module which is incorporated into the body of the device ●
  The AC3™ Series IABP is designed to be used with 30, 35, 40 and 50cc Intra-aortic balloons with the appropriate connectors.

This document is a 510(k) Premarket Notification from the FDA regarding the AC3 Series Intra-Aortic Balloon Pump (IABP). It focuses on demonstrating the substantial equivalence of an updated version of the device (with software V3.11) to its predicate device (with software V3.7).

Based on the provided text, the device is an Intra-Aortic Balloon Pump, and the submission is for a software update (V3.11). The acceptance criteria and study primarily focus on demonstrating that the updated software does not negatively impact the device's performance compared to the predicate.

Here's an analysis of the provided information against your request:

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

The document does not provide a specific table of quantitative acceptance criteria for the device's performance, nor does it present detailed quantitative performance results for the device. Instead, it states that:

• Software Verification testing has been completed to demonstrate that the software requirements have been met. All testing met the expected results.
• System verification and validation testing was also conducted, and all results met the required specifications.
• The results of the testing met the acceptance criteria and performed similar to the predicate device (AutoCAT2 and AC3 Ver.3.7).

The focus is on qualitative statements of compliance and similarity to the predicate, rather than numerical performance benchmarks. The "acceptance criteria" appear to be meeting the functional requirements of the updated software and ensuring it performs comparably to the previous version and predicate.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing described appears to be internal verification and validation of software and hardware performance, not a clinical study on patient data.

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

This information is not provided. The study is a technical verification and validation of a medical device's software update, not a diagnostic AI system requiring expert-established ground truth from clinical images or data.

4. Adjudication method for the test set

This information is not provided, and it's not applicable to this type of device verification. Adjudication methods are typically used in studies involving human interpretation or labeling of data, which is not the primary focus here.

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 done. This medical device is an Intra-Aortic Balloon Pump (IABP), which is a therapeutic device, not a diagnostic AI intended to assist human readers in interpreting medical images or data. Therefore, this type of study is not relevant to this submission.

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

This concept is not directly applicable in the sense of a diagnostic algorithm's standalone performance. The device itself (the IABP) operates automatically in "Autopilot Mode" based on its software. The "performance" here refers to the pump's ability to correctly deliver counter-pulsation therapy based on physiological signals, not an algorithm providing diagnostic output for human review. The software's independent functioning was verified: "Autopilot Mode, where most functions are automatically selected and controlled by the IABP."

7. The type of ground truth used

The concept of "ground truth" in the context of this submission refers to the correct expected behavior and output of the IABP system and its software. This would be derived from:

• Device specifications and requirements: The defined functional and performance requirements for the IABP and its software.
• Physiological models/simulations: In laboratory settings, the device would be tested against simulated physiological parameters (e.g., ECG signals, arterial pressure waveforms) to ensure it responds correctly.
• Comparison to predicate device: A key "ground truth" for this submission is that the updated device must perform "similar to the predicate device." The predicate's established safe and effective performance serves as a benchmark.

It's not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic tools.

8. The sample size for the training set

This information is not provided and is generally not relevant for 510(k) submissions for iterative software updates on established medical devices. The software development process likely involved internal development and testing cycles, but not typically a "training set" in the machine learning sense for an AI model.

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

As there's no mention of a "training set" in the machine learning context, this information is not applicable. The "ground truth" for the device's functionality is established through engineering specifications, regulatory standards (like IEC 62304 for medical device software), and the performance of the predicate device.

In summary, this 510(k) submission primarily focuses on demonstrating that a software update to an existing Intra-Aortic Balloon Pump (IABP) system does not introduce new safety or effectiveness concerns and maintains substantial equivalence to its predicate device. The "study" referenced is internal software and system verification and validation testing, which confirmed that the updated device met its functional requirements and performed similarly to the predicate.

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UltraFlex™ IAB with Intra-Aortic Balloon Pump as a control system is indicated for use in any of the following conditions:

1. Acute Coronary Syndrome

2. Cardiac and Non-Cardiac Surgery

3. Complications of Heart Failure

The UltraFlex IAB consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as Intra-Aortic Balloon Pump (IABP) regulates the inflation and deflation of the balloon.

The UltraFlex IAB catheter consists of an inner lumen, an outer lumen, and an inflatable balloon. The outer lumen is comprised of an inflatable balloon connected to the distal tip of the catheter shaft and to the IAB catheter 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 catheter tip inner surface.

The provided text is a 510(k) summary for the UltraFlex™ IAB, an intra-aortic balloon catheter. This document describes the device, its indications for use, and a comparison to a predicate device. It also mentions various bench tests conducted to demonstrate substantial equivalence, but it does not contain information about a study proving the device meets acceptance criteria using a test set with expert adjudicated ground truth, multi-reader multi-case studies, or information about training sets and their ground truth establishment.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria by extracting information from the given text.

The closest relevant information extracted is:

Acceptance Criteria Mentioned (but specific values are not provided):

• The results of the verification tests met the specified acceptance criteria and performed similar to the predicate device.

Study Type (Bench Tests, not clinical or image-based AI performance studies):
The document states that technological differences have been evaluated through bench tests. The following tests were performed:

• Catheter Insertion Test
• Aneurysm Test
• Durability Test
• Catheter Tip to Balloon Bond Tensile per ISO 10555-1
• Outer Lumen to Balloon Bond Tensile per ISO 10555-1
• Sheath and Dilator Surface Visual Inspection per ISO 11070
• Sheath and Dilator Tensile Testing per ISO 11070
• Balloon Volume Test
• Catheter Rate Limit Test
• Kink Resistance
• Sheath and Dilator Dimensional Analysis

Data Provenance/Sample Size (Not Applicable in the provided text for a clinical test set):
The document does not describe a clinical test set, nor does it specify sample sizes for the bench tests.

Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Details (Not Applicable/Not Present in the provided text):
The 510(k) summary focuses on demonstrating substantial equivalence based on bench testing of physical and functional characteristics of the device compared to a predicate device, not on diagnostic performance or AI algorithm validation using image data, which would typically involve expert readers, ground truth establishment, and MRMC studies. Therefore, the requested details about expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment methods for training sets are not present in this document.

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FIBEROPTIX® IAB with the Intra-Aortic Balloon Pump as a control system is indicated for use in any of the following conditions:

1. Acute Coronary Syndrome

2. Cardiac and Non-Cardiac Surgery

3. Complications of Heart Failure

The FIBEROPTIX IAB consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning. A computerized control system, also known as the Intra-Aortic Balloon Pump (IABP) is utilized to requlate the inflation and deflation of the balloon.
The FIBEROPTIX IAB consists of an inner lumen, an outer lumen, and an inflatable balloon. The outer lumen is comprised of an inflatable balloon connected to the distal tip of the catheter shaft and to the IAB catheter 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 catheter tip inner surface.

The FIBEROPTIX IAB has a fiber optic pressure sensor which acts as a pressure transducer embedded in the catheter tip.

The provided text describes the 510(k) submission for the FIBEROPTIX IAB, focusing on its substantial equivalence to a predicate device. The information details various tests performed to demonstrate this equivalence.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

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

The provided text lists several design verification tests performed. While it explicitly states that the results "met the specified acceptance criteria and performed similar to the predicate device," it does not provide a specific table detailing the acceptance criteria values for each test or the exact performance metrics observed.

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

The text mentions "bench tests" for design verification. However, it does not specify the sample size used for any of these tests. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective nature), as these are bench tests and not human clinical studies.

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 type of information is usually relevant for studies involving subjective human interpretation (e.g., image analysis). For the described bench tests, no experts were used to establish ground truth in this manner. The ground truth for these engineering tests would be established by objective measurements against predefined engineering specifications.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. Since the described tests are bench tests, no such adjudication method was applicable or employed.

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

The provided information focuses on the substantial equivalence of an intra-aortic balloon catheter, a physical medical device, through a series of engineering bench tests. It does not describe an AI-powered device or an MRMC comparative effectiveness study involving human readers or AI assistance. Therefore, there is no mention of effect size for human readers with or without AI.

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

Similar to the point above, the FIBEROPTIX IAB is a physical medical device, not an algorithm. Therefore, a standalone algorithm-only performance study was not conducted or is not applicable in this context.

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

For the bench tests described, the ground truth would be established by engineering specifications and objective measurements. For example:

• Dimensional Analysis: Ground truth is the specified dimensions (e.g., diameter, length).
• Tensile Testing: Ground truth is the specified material strength or bond strength.
• Volume Test: Ground truth is the specified balloon inflation volume.

There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for these specific tests.

8. The sample size for the training set

The provided text only discusses pre-market submission via a 510(k) pathway, focusing on substantial equivalence to a predicate device through bench testing. It does not mention any training set size, as it does not describe the development or evaluation of a machine learning or AI algorithm.

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

As there is no mention of a training set (because it's not an AI/ML device), this information is not applicable and therefore not provided in the text.

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The CARDIOSAVE IABP (Hybrid Model) is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.

The CARDIOSAVE IABP (Hybrid Model) 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 an intra-aortic balloon (IAB) in the patient's descending aorta. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB inflation is initiated at the onset of diastole at the dicrotic notch and remains inflated through diastole. The IAB 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 counterpulsation. This is the same intended use as other IABPs.

This document is a 510(k) Pre-Market Notification for a modification to an existing device, the CARDIOSAVE Intra-Aortic Balloon Pump (Hybrid Model). The modification involves adding a new Top Protection Cover.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in terms of patient data or a specific number of units used for testing the Top Protection Cover. The testing appears to be focused on engineering verification of the physical modification itself, rather than clinical performance on a sample of patients.

• Sample Size: Not explicitly stated as a number of devices or clinical cases. The testing would likely involve a representative number of units to prove the effectiveness of the cover.
• Data Provenance: The document does not mention data provenance in terms of country of origin or retrospective/prospective studies. This is expected given the nature of the modification (a physical cover) and the type of testing performed (engineering verification).

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

This information is not applicable as the study described is an engineering verification for a physical modification, not a clinical study requiring expert assessment for ground truth determination.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as above. Adjudication methods are typically used in clinical trials or studies where human interpretation or decision-making is being evaluated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The modification is a physical cover, not a software algorithm or a device requiring human interpretation for its function.

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 an Intra-Aortic Balloon Pump, which is a physical device with electromechanical functions, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the engineering design requirements and safety standards for a medical device and its components. The device needs to prove that the new Top Protection Cover effectively prevents liquid spills from entering the unit and causing malfunction or damage, and that it does not negatively impact the existing performance of the IABP.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device requiring model training.

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

This information is not applicable as there is no training set. The "ground truth" in the development process would be established by the design specifications, risk assessment, and regulatory requirements for the device and its modification.

Summary of the Study:

The study performed was focused on design verification testing for a new Top Protection Cover on an existing CARDIOSAVE IABP (Hybrid Model). The primary goal of the cover is to protect against liquid spills.

The manufacturer, Datascope Corp., completed the following activities:

• Risk Assessment: To ensure the modification does not introduce new risks.
• Verification Testing: To confirm the cover meets its intended protective function and does not alter the IABP's performance.

The conclusion is that the modification does not impact the performance characteristics of the predicate device, does not introduce any new risks, and does not raise any new questions of safety and effectiveness. The design verification testing established that the device with the new cover performs the same as the predicate device. No clinical testing was deemed necessary due to the nature of the modification.

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The CS100/CS100i and CS300 Intra-Aortic Balloon Pumps are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.

The CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABPs) are cardiac assist devices. The IABP 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 an intra-aortic balloon (IAB) in the patient's descending aorta. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB inflation is initiated at the onset of diastole at the dicrotic notch and remains inflated through diastole. The IAB 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 counterpulsation.

The provided text is a 510(k) summary for the CS100/CS100i and CS300 Intra-Aortic Balloon Pumps. It states that the device is substantially equivalent to a predicate device and includes information about modifications made to the device. However, it explicitly states that there was no clinical evaluation of the modified device.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, and ground truth, as these details are typically derived from clinical studies or extensive performance testing, which were not conducted for the modified device described in this document.

The document only notes that:

• The changes consist of a revised blood detection software function.
• "Performance data" claims that "The results of the tests conducted demonstrate that the modified CS100/CS100i and CS300 Intra-Aortic Balloon Pumps perform as intended."
• "Datascope Corp. development process required that the following activities be completed...: Requirements specification review, Performance testing, Design verification and validation."

Without a clinical study, there are no specific acceptance criteria for performance metrics that would typically involve human-in-the-loop performance or comparison against a gold standard established by experts.

In summary, based on the provided text, the device's substantial equivalence was determined without a clinical study, meaning the details requested (acceptance criteria, performance, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance) are not available within this document.

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The AC3TM Series IABP (Intra-Aortic Balloon Pump) System is clinically indicated for the following conditions:
a. Acute Coronary Syndrome
b. Cardiac and Non-Cardiac Surgery
c. Complications of Heart Failure

The AC3 Series Intra-Aortic Balloon Pump (IABP) System, which is the subject of this submission, is substantially equivalent to the previously cleared Arrow AutoCAT®2 IABP System which was previously cleared via K060309.
The AC3 Series IABP System is the next generation platform which is based on the existing AutoCAT2 IABP System; cleared Device via K060309 on 6 April 2006.
The AC3 Series IABP System (AutoCAT3) includes a new Graphical User Interface. The primary algorithms that control the therapeutic function of the device have not been altered from the AutoCAT2.
The AC3 Series IABP system 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 IABP is attached to an IAB (Intra-aortic Balloon) catheter which is inserted into the femoral artery and positioned in the descending thoracic aorta.
The IABP delivers Helium (HE) into the IAB during diastole to displace blood above and below the IAB, increasing blood pressure and perfusion to organs close to the IAB catheter. The IABP deflates or removes HE from the IAB just prior to or in the early phase of systole, reducing the pressure in the aorta and therefore the pressure the LV must generate to open the aortic valve and eject its contents into the circulatory system. This results in a decrease in work and oxygen demand.
The AC3 Series IABP System consists of two main components:
The pump control / display module which incorporates a touch screen and keypad for system operation
The pneumatic drive module which is incorporated into the body of the device.
The AC3 is designed to be used with 30, 35, 40, and 50cc Intra-Aortic Balloons with the appropriate connectors. (UltraFlex™, Ultra 80, NarrowFlex®, and RediGuard® Catheters).
The system offers two modes of operation:
Autopilot Mode, where most functions are automatically selected and controlled by the IABP
Operator mode, where an operator can control most settings and selections.

This is a 510(k) premarket notification for an Intra-Aortic Balloon Pump (IABP) system called AC3 Series IABP. It argues for substantial equivalence to a previously cleared predicate device, the AutoCAT2 IABP System.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with corresponding performance metrics in a pass/fail format for clinical performance. Instead, it details various types of performance testing and states that the device "meets all requirements," "is in compliance with the standards," and "meets all acceptance criteria and specifications." The comparison table (Table 5.2) focuses on demonstrating that the new AC3 Series IABP is either "No change," "Same as AutoCAT2," or has "Greater range" or "Improved" features compared to the predicate device.

However, based on the descriptions of the tests, we can infer some implicit acceptance criteria and the device's reported performance:

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

• Human Factors / Usability Testing: 33 users participated. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but given it's a usability test for a medical device seeking FDA clearance, it's highly likely to be prospective data collected in a controlled environment.
• ECG Trigger Validation: "Recordings of real Electro-Cardiogram (ECG) waveforms from the American Heart Association (AHA) database." This suggests a retrospective dataset of real patient ECGs. The specific sample size (number of ECG waveforms or patients) is not provided.
• Reliability Testing: The "sample" here refers to the number of AC3 pumps. "AC3 pumps were run continuously for 9 days." The exact number of pumps is not specified, but it implies multiple units were used for the continuous run test.
• Cleaning/Disinfection & Electrical Safety/EMC: Sample sizes are not specified, but these are typically tested on a limited number of device units or components.

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

• Human Factors / Usability Testing: There is no mention of "experts" establishing ground truth in the context of clinical outcomes or diagnoses. The "ground truth" for this test is successful task completion and absence of use errors, which is assessed by the participants' performance and observations by the test administrators.
• ECG Trigger Validation: The "ground truth" for ECG triggering would be the accurate detection and timing of specific cardiac events within the AHA ECG waveforms. While the AHA database provides these waveforms, the process for establishing the "truth" of these events (e.g., expert cardiologists annotating them) is inherent to the database itself and not detailed here as part of the AC3 study. The study compares the AC3's detection accuracy against the already established and accepted timing in the database, and against the predicate device.
• For other tests (Electrical Safety, Software, Cleaning, Mechanical), ground truth is established by adherence to recognized standards and specifications, not typically by expert consensus of individual cases.

4. Adjudication Method for the Test Set

• Human Factors / Usability Testing: Not explicitly an adjudication method in the sense of reconciling clinical interpretations. The observed "minor operational difficulty" for 4% of use cases was likely directly observed and categorized by the test administrators, rather than requiring formal adjudication among multiple reviewers.
• ECG Trigger Validation: The comparison seems to be direct against the AHA database and the predicate device. There is no mention of an adjudication panel.
• For other tests, adjudication methods are not applicable as they involve objective measurements against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• Not Applicable: This document describes a traditional 510(k) submission for an Intra-Aortic Balloon Pump system, which is a hardware device with embedded software. It is not an AI-driven diagnostic or interpretative software device. Therefore, MRMC studies and the concept of "human readers improving with AI vs without AI assistance" are not relevant to this submission. The "AI" mentioned ("primary algorithms that control the therapeutic function") in this context refers to the device's control logic, not AI in the sense of machine learning for interpretation or diagnostic aid.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, implicitly for some aspects: The "algorithm" here refers to the embedded control software.
  • Software Verification Testing: This is effectively a standalone test of the software's functionality and adherence to requirements.
  • ECG Trigger Validation: The comparison of the AC3 system's (algorithm's) ECG triggering against the AHA database and the predicate device is a standalone performance assessment of a key algorithmic function.
  • Reliability Testing: The pumps running continuously and performing as intended is a standalone assessment of the device's overall function, which includes its internal algorithms determining inflation/deflation.

7. The Type of Ground Truth Used

• Industry Standards and Specifications: For Electrical Safety & EMC, Software Verification, Cleaning & Disinfection, and Environmental/Mechanical Testing, the ground truth is established by the requirements of the cited international standards (IEC, AAMI, ANSI/AAMI, RTCA DO-160) and the device's own design specifications.
• AHA Database ECG Waveforms: For ECG Trigger Validation, the "ground truth" for cardiac event timing is derived from the established and validated waveforms within the American Heart Association (AHA) database.
• Observed Performance / Absence of Errors: For Human Factors/Usability Testing, the "ground truth" for usability is based on direct observation of user interaction and successful task completion, as defined by the study protocol.
• Predicate Device Performance: In many instances, the "ground truth" or benchmark for demonstrating substantial equivalence is the performance of the legally marketed predicate device (AutoCAT2), particularly for aspects like ECG triggering where direct simultaneous comparison was performed.

8. The Sample Size for the Training Set

• Not Applicable in the traditional ML sense: Since this is not an AI/Machine Learning diagnostic device, there isn't a "training set" in the conventional meaning. The "primary algorithms that control the therapeutic function" are described as largely unchanged from the predicate device (AutoCAT2 IABP System). These are likely deterministic control algorithms developed through engineering design, rather than machine learning models trained on data.

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

• Not Applicable: As there is no traditional ML training set described, the concept of establishing ground truth for it is not relevant to this submission. The "ground truth" that guided the development of the device's core algorithms would have been established through physiological understanding, engineering principles, and clinical/pre-clinical testing over the development cycles of this device and its predicate.

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