Search Results

The TigerPaw Pro is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).

The TigerPaw Pro is a flexible, implantable occlusion fastener to be placed on the ostium of the left atrial appendage (LAA) during open cardiac surgical procedures. TigerPaw Pro consists of a Fastener implant that is pre-loaded onto a Delivery Tool and is for single use only. It is designed to provide an alternative to conventional suture and surgical staplers for occlusion of the ostium of the LAA. The TigerPaw Pro implantable fastener comes in two lengths; 35mm and 45mm. Surgeon judgment based on patient anatomy should determine what length fastener to apply.

The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) summary for the TigerPaw Pro Left Atrial Appendage Occlusion Fastener and Delivery Tool, which outlines the device's indications for use, technological characteristics, and safety and performance testing conducted to demonstrate substantial equivalence to a predicate device.

While it mentions various performance tests and an animal study, it does not provide:

1. A table of acceptance criteria and reported device performance: The document lists several performance tests (e.g., ability to completely close the fastener, tensile strength of barbs, force required to actuate, corrosion testing) but does not present specific quantitative acceptance criteria or their corresponding results in a table format.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, or how ground truth was established for these specific criteria. The animal study details the sample size (7 canines) and that a board-certified pathologist performed the necropsy, indicating the ground truth assessment method. However, these details are for the animal study, not explicitly linked to acceptance criteria in the tabular form or for a human-in-the-loop or standalone AI performance study.

Information that is present regarding studies and their findings:

• GLP Animal Study:

  • Sample size: 7 canines.
  • Data provenance: Acute Good Laboratory Practices (GLP) animal study.
  • Ground truth experts: Board-certified pathologist for full necropsy examination of local tissues post device implantation.
  • Ground truth type: Pathology and visual assessment of the device's usability, safety, and performance during and after deployment.
  • Results: "All acceptance criteria were met for this animal study performed using the market version of this device."
  • Purpose: To evaluate the usability of the device and the risk of tissue injury on the LAA during deployment and securement of the fastener.

• Performance Testing (In-vitro):

  • Included tests such as:
    • Ability to completely close the fastener after deployment and prevent leakage from a mock LAA.
    • Tensile strength of individual fastener barbs after closure.
    • Assessment of Delivery Tool jaw component characteristics (e.g., angle measurements).
    • Force required to actuate the Delivery Tool trigger, unlock button, and torque for shaft rotation.
    • Corrosion testing (ISO 10555-1 Annex A).
    • Comparison of TigerPaw II and TigerPaw Pro's tool jaw resistance to flexure on a worst-case thickness mock LAA ostium.
    • Comparison of TigerPaw II and TigerPaw Pro's ability to deploy and secure fasteners under different worst-case rotational forces on a mock ostium.
  • Results: "The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the previously cleared TigerPaw System II."

The document concludes that "The performance and other testing established that the TigerPaw Pro is substantially equivalent to the predicate device," but it does not provide the specific acceptance criteria and detailed quantitative results for each test in a format that directly addresses all parts of your request.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The CARDIOSAVE Intra-Aortic Balloon Pump is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.

The CARDIOSAVE Intra-Aortic Balloon Pump (IABP) 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.

The provided text describes a 510(k) premarket notification for a medical device called the CARDIOSAVE Intra-Aortic Balloon Pump (IABP). However, the application is specifically for a modification to the existing device: a new CARDIOSAVE Li-Ion battery transport and storage case.

Therefore, the acceptance criteria and study described are not for the entire IABP device, but rather for the safety and performance of this new battery case.

Here's an analysis based on the provided text, addressing your requested information points:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a numerical sample size (e.g., number of battery cases tested). It generally refers to "tests conducted."
• Data Provenance: The data was generated through "Performance testing" as part of Datascope Corp.'s development process. The country of origin is not explicitly stated. The nature of the testing (bench testing, design validation) makes it inherently prospective in relation to the design of the new case.

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

This type of information is not applicable to this submission. The "ground truth" for the battery case's performance is objective compliance with an international safety standard (IEC 62133) rather than subjective expert interpretation. The performance is assessed via engineering tests, not clinical or diagnostic evaluations requiring expert consensus.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for subjective assessments where there might be disagreement in interpretation (e.g., medical image reading). For objective engineering compliance testing, the results are typically pass/fail based on predefined criteria, not expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or decision support tools that involve human interpretation. This submission is for a medical device accessory (battery case) and its compliance with safety standards.

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

Not applicable. This device is a physical accessory (battery case), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.

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

The "ground truth" for the battery case's performance is objective compliance with regulatory and international safety standards, specifically IEC 62133 Edition 2.0 2012-12. This is not based on expert consensus, pathology, or outcomes data, but rather on engineering test results demonstrating adherence to the specifications of the standard.

8. The sample size for the training set

Not applicable. This submission is not for an AI model or a device that uses machine learning. Therefore, there is no "training set" in this context. The study performed involves testing physical hardware.

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

Not applicable, as there is no training set mentioned or implied by the nature of the device modification.

Ask a specific question about this device

The CARDIOSAVE Intra-Aortic Balloon Pump is indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure.

The CARDIOSAVE Intra-Aortic Balloon Pump (IABP) 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 (K151254/S001) is a 510(k) premarket notification for a modification to an existing device, the CARDIOSAVE Intra-Aortic Balloon Pump. The modification is specifically an "alternative AC/DC Bulk Senior Power Supply with an increased load driving capacity."

Because this is a submission for a minor modification (a Special 510(k)), and not a new device or a significant functional change, there is no AI or software component involved, and therefore no study addressing AI performance. The review focuses on demonstrating that the new power supply does not negatively impact the device's original validated performance.

Therefore, most of the requested information about AI acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, and MRMC studies are not applicable to this document.

However, I can extract information related to the non-clinical tests performed for this specific modification:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated in terms of number of units tested. The testing involved compliance with standards and performance/design validation, which typically involves a representative sample of the hardware component.
• Data Provenance: Not applicable as this is hardware testing against engineering standards and requirements, not biological data. The tests were performed by "Datascope Corp." as part of their development process.

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

• Not applicable. This is hardware safety and performance testing against engineering standards, not clinical or diagnostic ground truth establishment by medical experts.

4. Adjudication method for the test set:

• Not applicable. This is hardware safety and performance testing.

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 refers to a power supply modification, not an AI or software device. There are no human readers or AI involved.

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

• Not applicable. This document refers to a power supply modification, not an AI or algorithm.

7. The type of ground truth used:

• The "ground truth" here is defined by engineering standards (IEC60601-1-2, IEC60601-1) and internal performance specifications for the power supply. The device is expected to meet these predefined technical benchmarks.

8. The sample size for the training set:

• Not applicable. This is hardware testing, not machine learning.

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

• Not applicable. This is hardware testing, not machine learning.

Ask a specific question about this device

The MEGA and SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories have the following indications for use:

• Refractory Unstable Angina.
• Impending Infarction.
• Acute Myocardial Infarction.
• Refractory Ventricular Failure.
• Complications of Acute MI (ie. Acute MR or VSD or papillary muscle rupture)
• Cardiogenic Shock.
• Support for diagnostic, percutaneous revascularization and interventional procedures.
• Ischemia related intractable ventricular arrhythmias.
• Septic Shock.
• Intraoperative pulsatile flow generation.
• Weaning from cardiopulmonary bypass.
• Cardiac support for non-cardiac surgery.
• Prophylactic support in preparation for cardiac surgery.
• Post-surgical myocardial dysfunction/low cardiac output syndrome.
• Myocardial Contusion.
• Mechanical bridge to other assist devices.
• Cardiac support following correction of anatomical defects

The 8Fr. Introducer Set is comprised of an Introducer Sheath and Introducer Dilator for percutaneous insertion of the MEGA & SENSATION PLUS 8Fr. 50cc IABs. The flexible high density polyethylene (HDPE) dilator is inserted through and twist locked into the 8Fr. introducer sheath for insertion over a quide wire for percutaneous access to the femoral artery. The dilator is then removed from the sheath after which the 8Fr 50cc Intra-aortic Balloon (IAB) Catheter is inserted over a guide wire and through the 8Fr introducer sheath for placement within the thoracic anta for counterpulsation therapy. The introducer sheath is comprised of a hub housing that includes an integral hemostasis valve to prevent bleeding about the IAB catheter and a sheath tube comprised of a flat coiled stainless wire between a layer of PTFE and Pebax for reinforcement to provide kink resistance within the vasculature.

The provided 510(k) summary for the MEGA AND SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter (K133074) describes a device modification, specifically to the introducer set. Therefore, the acceptance criteria and study information pertain to demonstrating the substantial equivalence of this modified introducer set to its predicate device, rather than proving the overall clinical effectiveness of an entirely new device from scratch.

Here's an analysis of the acceptance criteria and the study conducted, based on the provided text:

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a modified device, the "acceptance criteria" are not framed as specific performance metrics like sensitivity/specificity for a diagnostic AI. Instead, they are framed around demonstrating that the modified components (the introducer set) perform as safely and effectively as the predicate device and that the modifications do not raise new questions of safety or effectiveness.

Study Details

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

   • The document does not specify sample sizes for any of the non-clinical tests (e.g., how many introducer sets were tested for kink resistance, biocompatibility, etc.).
   • Data provenance: Not explicitly stated, but these are non-clinical (lab/bench) tests conducted by the manufacturer (Datascope Corp.) as part of their "development process." It's assumed to be internally generated data, not patient data from a specific country or retrospective/prospective in the clinical sense.

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

   • Not applicable in the context of this 510(k). The "ground truth" for non-clinical tests is established by passing predefined engineering specifications and compliance with voluntary standards, as evaluated by the manufacturer's development and quality control teams, and then reviewed by the FDA. There is no mention of external "experts" establishing ground truth for these tests.

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

   • Not applicable. This concept typically refers to resolving disagreements among human readers/experts in diagnostic imaging studies. The studies performed were non-clinical bench and lab tests.

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. An MRMC study was not done. The device is an Intra-Aortic Balloon Catheter Introducer Set, not an AI diagnostic tool where human readers' performance with/without AI assistance would be relevant.

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

   • No. This is a medical device (introducer set), not an algorithm or AI.

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

   • For the non-clinical tests, the "ground truth" is defined by engineering specifications, performance standards, and regulatory requirements (e.g., biocompatibility standards, mechanical test specifications) that the device must meet to function safely and effectively as an introducer set. There is no "expert consensus" or "pathology" in the typical clinical sense for these verification tests.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that requires a training set. The "development process" involved design and testing of physical components.

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

   • Not applicable, as there is no training set mentioned or implied.

Ask a specific question about this device

The A5 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A5 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric populations.

The A5 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.

The provided text describes the A5 Anesthesia Delivery System and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or a study detailing device performance against such criteria in the manner requested.

The document indicates:

• Summary of Performance Testing: "The A5 has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards." It then lists numerous IEC, ISO, CGA, and ASTM standards.
• User Evaluation: "The A5 has been evaluated by end-users and found to meets performed within its intended use and met their specific needs."

However, it does not provide:

• A table of specific acceptance criteria (e.g., accuracy +/- X%, sensitivity, specificity) with reported device performance metrics against those criteria.
• Details on sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Sample size or specific ground truth establishment methods for a training set.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about a study proving the device meets acceptance criteria, because this information is not present in the provided text. The document focuses on regulatory compliance through adherence to standards and user evaluations rather than detailed performance metrics.

Ask a specific question about this device

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

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

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

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

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

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

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

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

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

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

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

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

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

No MRMC study was mentioned. The device is a physical medical device (radial compression device), not an AI/software product, so this type of study is not applicable.

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

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

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

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

8. The sample size for the training set

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

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

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

Ask a specific question about this device

The SENSATION PLUS™ 7.5Fr. 40cc Intra-Aortic Balloon Catheter and Accessories have the following indications for use:

• Refractory Unstable Angina.
• Impending Infarction. .
• Acute Myocardial Infarction. .
• Refractory Ventricular Failure. .
• Complications of Acute MI (ie. Acute MR or VSD or papillary . muscle rupture)
• · Cardiogenic Shock.
• Support for diagnostic, percutaneous revascularization and . interventional procedures.
• Ischemia related intractable ventricular arrhythmias. .
• . Septic Shock.
• Intraoperative pulsatile flow generation. .
• Weaning from cardiopulmonary bypass. .
• Cardiac support for non-cardiac surgery. .
• Prophylactic support in preparation for cardiac surgery. .
• . Post-surgical myocardial dysfunction/low cardiac output syndrome.
• Myocardial Contusion. .
• Mechanical bridge to other assist devices.
• Cardiac support following correction of anatomical defects

The SENSATION PLUS™ 7.5 Fr. 40cc IAB Catheter is an enhanced MEGA® 7.5Fr IAB Catheter (K120868) device which includes a catheter, an insertion kit and two STATLOCK® IAB Stabilization Devices. This device incorporates the fiber-optic technology of the SENSATION PLUS™ 8Fr 50cc IAB Catheter (K112327) into the MEGA® 7.5Fr. 40cc IAB Catheter (K120868) design, with one additional change - the stylet wire (a packaging component) was removed. The SENSATION PLUS™ 7.5Fr. 40cc Insertion kit contains the same components as currently used with the MEGA® 7.5Fr 40cc IAB Catheter (K120868), with the sole exception that the SENSATION PLUS™ 7.5Fr. 40cc Insertion Kit contains six extender tubing clips, similar to the predicate SENSATION PLUS™ 8Fr. 50cc Insertion Kit (K112327).

The SENSATION PLUS™ 7.5Fr. 40cc Intra-Aortic Balloon Catheter is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end-diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle. These beneficial effects are caused by the inflation and deflation of the Intra-Aortic Balloon (IAB) Catheter placed in the patient's descending aorta just below the subclavian artery. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB Catheter inflation is initiated at the onset of the diastole at the dicrotic notch and remains inflated through diastole. The IAB Catheter is then deflated at, or just prior to. the onset of systole and the balloon remains deflated throughout systole. Hence, the therapy is also referred to as counterpuisation. This is the same intended use as other IAB Catheters.

Here's an analysis of the acceptance criteria and study information for the Datascope Corp. SENSATION PLUS™ 7.5Fr. 40cc Intra-Aortic Balloon Catheter, based on the provided text:

This device is not an AI/ML device, therefore, some of the requested information (like MRMC study, effect size of human improvement with AI, standalone algorithm performance, number of experts for ground truth, adjudication method, and sample size for training set) is not applicable. The device relies on non-clinical testing for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) for a modified device, the "acceptance criteria" are primarily based on demonstrating substantial equivalence to predicate devices through non-clinical testing. The device's performance is demonstrated by its comparability to these established devices.

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

• Sample Size: Not explicitly stated as a separate "test set" in the context of a traditional clinical study with patients. The performance was established through in-vitro tests. The exact number of samples or trials for each type of in-vitro test (e.g., performance, biocompatibility, sterility, shelf life, package) is not provided.
• Data Provenance: The data comes from non-clinical (in-vitro) testing conducted by Datascope Corp. The location of the testing is not specified, but the company is based in Fairfield, NJ, USA. The testing would be considered prospective in the sense that it was performed specifically for this submission.

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

Not applicable for this type of non-clinical device submission. Ground truth for device performance was established through engineering specifications, material standards, and benchmark testing against predicate devices, rather than expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device, not an AI/ML diagnostic or assistive tool.

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

Not applicable. This is a medical device, not an algorithm. Its performance is inherent to its physical design and materials.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is derived from:

• Engineering Specifications: Adherence to design requirements and specifications.
• Voluntary Standards: Compliance with recognized industry standards for IAB catheters.
• Predicate Device Performance: Benchmarking against the known performance characteristics of the legally marketed MEGA® 7.5Fr 40cc IAB Catheter (K120868) and SENSATION PLUS™ 8Fr. 50cc IAB Catheter (K112327).
• In-vitro Test Results: Physical, chemical, and mechanical testing results (biocompatibility, sterility, shelf life, package, and functional performance tests).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device; there is no "training set" in the context of machine learning.

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

Not applicable. There is no training set. The "ground truth" for the device's design and manufacturing is established through standard engineering, quality control, and regulatory compliance processes typical for medical devices.

Ask a specific question about this device

Ask a specific question about this device