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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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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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For intraosseous access anytime in which vascular access is difficult to obtain in emergent, urgent, or medically necessary cases for up to 24 hours. Insertion sites: ADULTS (≥22 years old): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≤21 years old): proximal humerus, proximal tibia, distal tibia, distal femur Use of the device may be extended for up to 48 hours when alternate intravenous access is not available or reliably established. Insertion sites: ADULTS (≥22 years): proximal humerus, proximal tibia, distal tibia PEDIATRICS (≥12 years through 21 years old): proximal humerus, proximal tibia, distal tibia, distal femur

The EZ-IO System previously cleared with K14117 is designed to allow the user to insert a needle set consisting of a stylet and catheter through the cortex of the bone to a desired depth within the bone marrow to facilitate intraosseous infusion of desired fluids and medications for vascular access. All system materials are biocompatible. Needle sets are single-use and composed of 304 stainless steel with polycarbonate hubs and available in 15 mm (for patients 3-39 kg); 25 mm (for patients 3 kg or over) and 45 mm (for patients 40 kg or over) lengths. Black lines on the needle set serve as depth markers. The reusable cordless driver/drill is powered by lithium batteries with a battery-power indicator light. An extension tubing set accessory, the EZ-Connect, is included with every needle set. The EZ-Connect contains a needleless connector system and Luer lock adapter. An optional dressing, the EZ-Stabilizer, is an accessory to the EZ-IO Vascular Access System. It is designed as a securement device with an adhesive backing that is placed over an EZ-IO Needle to keep the needle securely anchored to the patient; and is recommended in the Instructions for use (IFU).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core change addressed by this submission is the expansion of the "EZ-IO Intraosseous Vascular Access System" indications for use from up to 24 hours to up to 48 hours. Therefore, the primary acceptance criteria revolve around demonstrating the safety and effectiveness of the device for this extended dwell time.

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size (Test Set): 121 evaluable subjects.
     • 79 healthy volunteers
     • 39 with diabetes only
     • 3 with diabetes and renal insufficiency
   • Data Provenance: US single-site, prospective clinical IDE trial.

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

   • Not explicitly stated. The study involved clinical trial procedures and observations, including physical examinations and x-rays, but the specific number or qualifications of "experts" establish ground truth in the sense of a diagnostic consensus is not detailed. The "ground truth" here is the clinical outcome (complications, pain, patency) observed in the subjects under the study protocol.

3. Adjudication method for the test set:

   • Not explicitly stated in detail for all events. However, adverse events were assessed for relatedness to the device, implying a review process. The primary endpoint was the "absence of serious complications," suggesting a clear definition of what constitutes a serious complication and its determination by the study team.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is not an AI/imaging device. It is a medical device for vascular access.

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

   • N/A. This is not an AI/algorithm device.

6. The type of ground truth used:

   • Clinical outcomes data: The ground truth was based on the presence or absence of serious complications, pain reports, patency, and other observed adverse events during the 48-hour indwelling period and subsequent 30-day follow-up of human subjects. This also included objective measures like IO aspirate cultures and x-rays.

7. The sample size for the training set:

   • N/A. This is a medical device approval, not an AI model requiring a training set. The "development" of the device was based on prior predicate devices and engineering principles, with the clinical study serving as a validation of the extended use.

8. How the ground truth for the training set was established:

   • N/A. As above, no training set in the AI sense was used.

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The Arrow Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels.

The subject Arrow Seldinger Arterial Catheterization Devices consist of either an introducer needle or catheter-over-needle assembly, spring wire guide, and a catheter assembly that incorporates an extension tubing segment with a slide clamp and a luer hub with dust cap. These components are used together for catheter insertion using the "Seldinger" catheter-over-guide-wire insertion technique.

The provided text describes a 510(k) summary for the Arrow Seldinger Arterial Catheterization Device, which is a medical device and not an AI/ML powered device. Therefore, the information requested regarding acceptance criteria and study details for an AI-powered device (such as sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device (K093050) through nonclinical bench testing, rather than proving performance against specific acceptance criteria for an AI/ML algorithm.

Here's a summary of the nonclinical testing performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a non-AI medical device and the document describes nonclinical bench testing for substantial equivalence rather than an AI performance study, there isn't a direct "acceptance criteria" table with numerical performance metrics for an algorithm. Instead, the "acceptance criteria" can be inferred from the "applicable requirements" of the referenced ISO standards, and the "reported device performance" is that the device met these requirements, thus supporting substantial equivalence.

2. Sample size used for the test set and the data provenance: Not applicable. The document describes bench testing for a physical medical device, not a test set for an AI algorithm.

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 an AI algorithm is not relevant here. The "ground truth" for a physical device would be compliance with engineering specifications and ISO standards, which is evaluated through laboratory testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This relates to establishing ground truth for AI model evaluation, which is not being done 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: Not applicable. This is not an AI-assisted device.

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 consensus, pathology, outcomes data, etc.): Not applicable in the context of AI. For the device, the "ground truth" is defined by established engineering and medical device standards (e.g., ISO 10993-1, ISO 10555-1, ISO 11070) and internal design specifications.

8. The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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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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The ARROW Endurance catheter system permits access to the patient's peripheral vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids. The catheter may be used for high pressure injection. The safety feature is intended to minimize the risk of sharps injuries.

The Arrow® Endurance™ Extended Dwell Peripheral Catheter System is a sterile, single use peripheral intravascular device designed to permit access to the peripheral vascular system. The insertion device consists of a handle with an integral needle, a passivelyactivated needle protection mechanism, guide wire with slider advancer, catheter release tab, and single-lumen catheter. The catheter is advanced over the needle and threaded over a guide wire into a peripheral vessel. The catheter system consists of a catheter body, juncture hub, integrated extension tubing with Luer hub, vent plug to prevent blood leakage during insertion, and a clamp. The catheter is intended for short-term use to permit delivery of infusion therapies. infusion of blood and blood products, pressure monitoring, high pressure injection at a maximum of 325 psi, and withdrawal of blood. The Arrow Endurance Extended Dwell Peripheral Catheter System is available in single lumen, 18 ga. 20 ga. and 22 ga. configurations with usable lengths of 6 cm (2.36") and 8 cm (3.15").

The provided document is a 510(k) summary for the Arrow Endurance™ Extended Dwell Peripheral Catheter System (K163513). It describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, but it does not include performance data typically found in clinical studies, nor does it define acceptance criteria in a quantifiable manner for device performance.

Therefore, many of the requested items cannot be answered from the provided text. The document focuses on demonstrating that modifications made to an existing device (guide wire design and catheter release colorant) do not raise new questions of safety or efficacy.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and reported device performance:

• Acceptance Criteria: Not explicitly stated in a quantifiable table format. The document implies acceptance criteria are met if the device performs comparably to the predicate and passes standard tests.
• Reported Device Performance: Not provided in quantifiable metrics. The document states that testing "verified that the changes presented no different questions of safety or efficacy" and that "the results of the risk assessment and resultant testing performed have demonstrated that the proposed guide wire design and catheter release colorant change present no different questions of safety or effectiveness."

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: The testing is "Bench testing," meaning it's performed in a laboratory setting, not with human or animal subjects. Thus, data provenance in terms of country of origin or retrospective/prospective is not applicable.

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

• Not applicable. This is not a study involving ground truth established by human experts for a diagnostic or interpretative AI device.

4. Adjudication method for the test set:

• Not applicable. This is not a study involving human adjudication of results.

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 document describes a medical device (catheter system), not an AI imaging or diagnostic algorithm. No MRMC study was performed.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Not applicable in the context of expert consensus, pathology, or outcomes data, as this is bench testing for a physical device. The "ground truth" for this type of testing is largely based on engineering specifications, material properties, and performance against established industry standards (e.g., ISO 10993-1, ISO 11070).

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable.

Summary of what can be extracted/inferred from the document:

• Device Name: Arrow Endurance™ Extended Dwell Peripheral Catheter System
• Purpose of the Submission: To demonstrate substantial equivalence for a modified version of an already marketed device (K152272 & K151513). The modifications are a guide wire design change (shortening flexible distal portion, removal of stainless steel coil/spring) and a catheter release colorant change.
• Nonclinical Testing Performed: Bench testing, including:
  • Biocompatibility (in accordance with ISO 10993-1)
  • Applicable requirements from ISO 11070 (Surface: Extraneous Matter and Defects, Surface: Lubricant, Guide wire Radio Detectability, Guide wire Fracture, Guide wire Flexure, Guide wire Tensile)
  • Guide wire Stiffness
  • Simulated Use Testing
• Conclusion of Testing: The testing verified that the changes presented no different questions of safety or efficacy, and the device is considered substantially equivalent to the cited predicate devices.

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The VPS Rhythm Device is indicated for the positioning of central venous catheters including PICCs. It provides catheter tip location information by using the patient's cardiac electrical activity. The VPS Rhythm Device is indicated for use as an alternative method to chest x-ray or fluoroscopy for confirmation of central venous catheter tip placement in adult patients. The TipTracker Technology is an optional accessory for use with the VPS Rhythm Device, indicated for visual navigation of a peripherally-inserted central catheter (PICC) as it is inserted through the vasculature. The TipTracker technology is used for catheter tip navigation purposes only; it is not used to determine final catheter tip placement.

Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated, for patients where cardiac rhythms may change presentation of the P-wave; including

• Atrial fibrillation
• Atrial flutter
• Severe tachycardia
• Pacemaker-driven rhythm
• Chronic obstructive pulmonary disease (COPD)
  Such patients are easily identified prior to central catheter insertion. In these specific cases, use of an additional confirmation method is necessary to confirm catheter tip location.

The VPS Rhythm Device with Optional TipTracker Technology is a medical device system consisting of nonsterile, reusable electronic components and accessories, as well as single-use, sterile components. All of which are utilized together to facilitate the final confirmation of central venous catheter tip placement by using the patient's cardiac electrical waveform. The system features an electronic monitor with graphical user interface display, as well as connection cables and accessories which allow for the display of the patient's external and intravascular cardiac ECG waveforms. Interpretation - by the clinician - of changes in the patient's intravascular cardiac ECG waveform morphology, which are displayed in real-time on the VPS Rhythm Device monitor as the central venous catheter is inserted, is utilized for confirmation of the final position of the catheter tip as an alternative to radiographic confirmation.

The optional TipTracker Technology includes software algorithms and accessory components (the TipTracker T-piece and Stylet) which facilitate the real-time visualization of the catheter's track and direction as it is inserted by the clinician through the vasculature. The TipTracker T-piece is a non-sterile, reusable component consisting of a magnetic emitter array that is connected to the VPS Rhythm Device monitor. In use, the TipTracker T-piece is placed externally on the patient's chest. When the sterile, singleuse TipTracker Stylet is assembled with the PICC which is to be inserted by the clinician, the VPS Rhythm Device with Optional TipTracker Technology facilitates the visualization of the catheter's insertion track and direction relative to the location of the TipTracker T-piece. The TipTracker Technology is not intended as an indicator of specific catheter location nor is it intended to be utilized for confirmation of final PICC tip location.

The provided document is a 510(k) premarket notification for the "VPS Rhythm™ Device with Optional TipTracker™ Technology." It indicates that no human clinical data was provided to support substantial equivalence (Section 8). Therefore, it is not possible to describe a study that proves the device meets acceptance criteria based on clinical performance.

However, the document does list non-clinical performance data that was submitted. This non-clinical data focuses on verifying the device's technical performance, electrical safety, electromagnetic compatibility, software, material properties, sterilization, biocompatibility, and usability.

Based on the provided information, I can address the available non-clinical performance data and the usability study.

Here's a breakdown of the requested information based on the non-clinical data and the usability study:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) and no clinical studies are reported, specific acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity) for the device are not described in the document. The non-clinical testing, however, implies meeting industry standards and internal design requirements.

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

• Human Factors Study Test Set (Usability): The document mentions "independent clinician participants" but does not specify the sample size for this test set.
• Data Provenance for Human Factors Study: This was a prospective study conducted with clinicians. The country of origin is not explicitly stated, but given the context of a US FDA submission, it can be inferred to be a US-based study or following US regulatory guidelines.
• Other Non-Clinical Testing: Sample sizes for material integrity, electrical, EMC, and software testing are not specified. These are typically lab-based tests.

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

• For the Usability Study (Human Factors): The "ground truth" here would be the predefined usability criteria and the assessment of whether clinicians could successfully perform tasks. The "experts" would be the independent clinician participants, but their specific qualifications (e.g., years of experience) are not detailed. The study assessed the device's functions against predetermined usability criteria.
• For other non-clinical tests: Ground truth is established by engineering specifications, international standards (IEC, ISO, ASTM), and internal design requirements.

4. Adjudication Method for the Test Set

• For the Usability Study (Human Factors): An explicit adjudication method (e.g., 2+1) is not described. The document states that "The results of the human factors study were compiled and assessed," suggesting an analysis against predefined usability criteria rather than an expert consensus on a subjective outcome.
• For other non-clinical tests: Adjudication is typically against established engineering specifications and standards.

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

• No MRMC study was done. The document explicitly states "No human clinical data was provided to support substantial equivalence." An MRMC study would fall under clinical data.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

• Yes, in the context of the device's ECG technology and TipTracker navigation:
  • The "VPS Rhythm Device" as a standalone component uses software algorithms to acquire, process, and display ECG waveforms for catheter tip location. Its performance in this function relies on the algorithm interpreting cardiac electrical activity.
  • The "TipTracker Technology" also involves "software algorithms" to facilitate real-time visualization of the catheter's track and direction using magnetic field-based technology. This is also a standalone algorithmic function.
• The non-clinical testing, particularly "Software Verification and Validation Testing" and "TipTracker Stylet Performance," would evaluate these standalone algorithmic and system performances against specified requirements.

7. Type of Ground Truth Used

• For the Human Factors Study (Usability): "Predetermined usability criteria" established prior to the study, likely by device designers and regulatory/human factors experts.
• For TipTracker Stylet Performance and Physical Integrity: Engineering specifications, material science standards (e.g., ISO 11070), and internal design requirements.
• For Electrical Safety, EMC, Sterilization Residuals, Biocompatibility: International and national standards (e.g., IEC 60601 series, ISO 10993 series, ASTM F2096).

8. Sample Size for the Training Set

• The document does not mention a training set for any AI/machine learning models. The description of the device's technology points to signal processing and magnetic tracking algorithms rather than learnable AI models in the modern sense. Therefore, "training set" is not applicable in the context described.

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

• As no training set is mentioned (see point 8), this information is not applicable/provided.

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The Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag+ard® Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) is indicated for short-term (30 days) access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure injector equipment used with the Arrow Pressure Injectable JACC 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.

Chlorag+ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness was evaluated using in vitro and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.

The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter with Chlorag arde Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC) has the following characteristics:

• 4.5 French, 1-Lumen, 35 cm pressure injectable, antimicrobial and antithrombogenic catheter
• 5.5 French, 2-Lumen, 35 cm pressure injectable, antimicrobial and antithrombogenic catheter ●
• 6 French. 3-Lumen. 35 cm pressure injectable, antimicrobial and antithrombogenic catheter ●

The CG+ Arrow JACC is a short-term or long-term, single use catheter designed to provide access to the central venous system. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The CG+ Arrow JACC consists of a non-tapered, radiopaque polyurethane extruded catheter body, a juncture hub, extension lines for each lumen and printed extension line hubs. The extension lines each contain a clamp. The catheter can be used for the injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for the 1-lumen and 2-lumen catheters and 6 mL/sec for the 3-lumen catheter. The external catheter body and the internal fluid path of the device are treated with chlorhexidine-based, Chlorag-ard technology. There are no modifications subject to this premarket notification related to the material design of the devices included in this submission, nor are there any modifications to the Chlorag+ard technology that is incorporated in the modified device's physical design.

The subject device is a CG+ Arrow JACC without a Blue FlexTip that will be provided in sterile kit configurations. A catheter-compatible tunneling device will be offered as an optional kit component. In addition to the catheter tip modification, the printed text on the catheter body and the extension lines has also been modifications, as well as the addition of the tunneling device as an optional kit component, require additions to the recommended procedural technique; procedure steps related to the tunneler and updated graphic representation of the catheter have been included in the instructions for use. All other portions of the catheter design and instructions for use remain unchanged.

The provided text describes a 510(k) premarket notification for a medical device, the ARROW Pressure-Injectable Jugular Axillo-Subclavian Central Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology (CG+ Arrow JACC). This document outlines the device's characteristics, its comparison to a predicate device, and the nonclinical testing performed to support its substantial equivalence.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of quantified numerical targets in the way typically seen for performance evaluation studies (e.g., sensitivity, specificity thresholds). Instead, for this 510(k) submission, the primary acceptance criteria revolve around demonstrating substantial equivalence to a predicate device and confirming that the modifications made do not negatively impact safety or effectiveness. The device performance is reported as "SAME" for most characteristics, indicating that the performance remains consistent with the predicate.

Here's a table summarizing the relevant performance aspects based on the provided text, and the implicit 'acceptance criteria' are that these aspects are substantially equivalent or confirmed to be safe/functional after modifications.

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

The document does not explicitly state "sample sizes" in terms of number of patients or specific items for the nonclinical testing. It only states that "Design verification testing was conducted to mitigate identified risks and is summarized in the submission to support the substantial equivalence of the modified device."

• Test Set Sample Size: Not explicitly stated. The nature of biocompatibility and mechanical testing usually involves a certain number of units or replicates, but these specifics are missing.
• Data Provenance: The testing appears to be prospective as it was conducted specifically for this 510(k) submission to demonstrate the safety and effectiveness of the modified device. The country of origin for the data is implied to be where the manufacturer (Arrow International, Inc., subsidiary of Teleflex Inc.) performed their R&D and testing, which is in the USA (Reading, PA). However, this is not formally stated.

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

This type of information (experts, ground truth for a test set) is typically relevant for studies evaluating diagnostic accuracy, where human interpretation is compared against a gold standard. The provided document describes a device modification for a physical medical device (catheter) and the testing outlined is nonclinical (benchtop/in vitro) to demonstrate substantial equivalence in performance and safety characteristics. Therefore, the concept of "experts establishing ground truth" in the clinical imaging sense is not applicable here. The "ground truth" for these tests would be the established scientific methods and engineering specifications for biocompatibility, mechanical properties, etc.

4. Adjudication Method for the Test Set

As the testing is nonclinical and focuses on physical and biological properties rather than human interpretation, a formal "adjudication method" as seen in clinical reader studies (e.g., 2+1, 3+1) is not applicable. The results of the nonclinical tests are compared against predefined engineering specifications or performance of the predicate device.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic algorithm or digital health tool on human reader performance. The device in question is a physical central venous catheter, not a diagnostic imaging or AI tool.

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

Not Applicable. This question relates to AI or algorithm performance. The device is a physical catheter, so there is no "algorithm" or standalone software performance to evaluate in this context.

7. The Type of Ground Truth Used

For the nonclinical tests, the "ground truth" would be:

• Biocompatibility: Established ISO standards for biocompatibility (e.g., cytotoxicity, material characterization).
• Mechanical Performance (e.g., tip penetration, detachment force): Engineering specifications, validated test methods, and comparison data from the predicate device.
• Antimicrobial/Antithrombogenic Efficacy: Results from in vitro and in vivo laboratory test methods designed to assess these properties. The document notes that a correlation between these test methods and clinical outcomes has not been ascertained, indicating the ground truth here is the demonstration of efficacy in a controlled lab setting, not necessarily clinical outcome.

8. The Sample Size for the Training Set

Not Applicable. The device is a physical catheter; there is no "training set" in the context of machine learning or AI models.

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

Not Applicable. As there is no training set, this question is not relevant.

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