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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.

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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.

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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.

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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.

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

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

8. The Sample Size for the Training Set

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

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

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

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The Passport V monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the Passport V include the monitoring of the following human physiological parameters:

• ECG waveform derived from 3 or 5 lead measurements
• Heart Rate derived from selected sources (ECG, SpO2, IBP)
• Pulse Oximetry (SpO2 )
• ST Segment Analysis derived from 3 or 5 lead measurements
• Arrhythmia Detection derived from 3 or 5 lead measurements
• Non Invasive Blood Pressure (NIBP)
• Invasive Blood Pressure (IBP) up to two (2) channels .
• Carbon Dioxide (CO2)
• Respiration Rate derived from ECG or CO2
• Temperature
• IV Drug Calculations

The Passport V has the capability of interfacing with Datascope Patient Monitoring Central Station and Gas Module products.

The Passport V Monitor is a vital signs monitor intended for use in a health care facility under the direct supervision of a licensed healthcare practitioner. The Passport V provides high and low alarm limit settings for systolic, diastolic, mean arterial pressure, pulse rate, and pulse oximetry (SpO2). The Passport V may be powered by a rechargeable Lithium ion battery or through line-power. The Passport V may be equipped with optional infrared or predictive temperature and recorder modules, and may be mounted on an optional rolling stand for easy portability.

The provided 510(k) summary for the Passport V Monitor does not contain specific acceptance criteria or a dedicated study section with detailed performance metrics. It generally states:

"The Passport V Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards. A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards. The device's software has been verified and validated in accordance with the appropriate test requirements."

This indicates that various performance tests were conducted to demonstrate compliance with relevant standards, but the summary does not explicitly list the acceptance criteria or the reported device performance in a table format.

Therefore, many of the requested details cannot be extracted from the given text.

Here's a breakdown of what can be inferred or stated as not available based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. The document refers to compliance with "recognized safety, performance and electromagnetic compatibility standards" and "appropriate test requirements" for software verification and validation, but specific numerical or qualitative criteria for each parameter (e.g., accuracy for heart rate, SpO2) are not provided.
• Reported Device Performance: Not explicitly stated in the document. The document confirms that the device was tested and found to be in compliance, but it does not present the results of those tests (e.g., measured accuracy, bias, or precision of physiological parameters).

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: Not specified.
• Data Provenance: Not specified.

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 specified.
• Qualifications of Experts: Not specified.

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

• Not specified.

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:

• This device is a patient monitor, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant or expected for this type of device and is not mentioned.

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

• The Passport V monitor is a standalone device with algorithms for various physiological measurements (ECG, SpO2, NIBP, etc.). The statement "The Passport V Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards" implies that its standalone performance was evaluated against these standards. However, specific details of these standalone performance tests (e.g., how accuracy of Heart Rate was measured without human intervention) are not provided.

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

• For a patient monitor, ground truth would typically involve reference measurement devices (e.g., a calibrated ECG simulator for heart rate accuracy, a reference oximeter for SpO2, a calibrated pressure transducer for blood pressure). The document does not specify the exact methods or reference standards used to establish ground truth for its performance tests.

8. The sample size for the training set:

• This device is not described as utilizing a machine learning algorithm that requires a "training set" in the conventional sense (i.e., for an AI model learning from data). It is a traditional patient monitor. Therefore, this information is not applicable and not provided.

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

• As a traditional patient monitor, the concept of a "training set" and its associated ground truth establishment is not applicable.

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Datascope's 8Fr. 50cc Intra-Aortic Balloon Catheters and Accessories are used for intra-aortic balloon counterpulsation therapy in the aorta. whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle. This is the same intended use as previously cleared for all other Datascope Intra-Aortic Balloon Catheters.

The intra-aortic balloon is placed in the descending aorta just below the subclavian artery and is intended to improve cardiovascular functioning during the following situations:

• Refractory unstable angina
• Impending infarction
• Acute MI
• Refractory ventricular failure
• Complications of acute MI (i.e. 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 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

Datascope's 8Fr. 50cc Intra-aortic Balloon Catheters and Accessories are used for intra-aortic balloon counterpulsation therapy in the aorta. whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.

The modification to the Datascope's predicate 8Fr. IAB is dimensional only. The modified 8Fr. IAB membrane's volume will increase and the polyimide inner lumen dimension will decrease.

The provided text is for a 510(k) premarket notification for a medical device (Intra-Aortic Balloon Catheter and Accessories). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than the performance of an AI algorithm or a novel medical device. Therefore, the information requested about acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies evaluating AI algorithms or novel diagnostic devices, cannot be found in this document.

The document states that there was "no clinical evaluation of the new device in the U.S." and that non-clinical (in-vitro) tests were conducted to demonstrate comparability to currently marketed devices for functionality and performance.

Here's an explanation of why the specific questions about acceptance criteria and study design are not applicable to the provided text:

• Acceptance Criteria and Reported Device Performance: This document doesn't define quantitative acceptance criteria in terms of clinical performance metrics that would be applicable to AI (e.g., sensitivity, specificity, AUC). It's focused on showing that the modified device (a dimensional change to an existing IAB) is functionally equivalent to existing cleared devices.
• Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance: These are all concepts relevant to studies that generate new clinical performance data, often for diagnostic devices or AI algorithms. Since no clinical evaluation was performed for this device, these details are absent. The ground truth for training data is also irrelevant here as no AI model is being "trained."
• Training Set Sample Size and Ground Truth Establishment: Again, these are for AI/ML models, not for a device with only dimensional modifications and no clinical testing.

The core of the submission is the claim of "substantial equivalence" based on:

1. Same Intended Use: The device is used for intra-aortic balloon counterpulsation therapy for the same indications as previously cleared Datascope IABs.
2. Technological Characteristics: The modification is described as "dimensional only," increasing the balloon membrane's volume and decreasing the polyimide inner lumen dimension.
3. Non-Clinical Tests: "In-vitro tests" were conducted to demonstrate that the functionality and performance characteristics are "comparable to the currently marketed devices." No specific results from these in-vitro tests are provided, nor are explicit acceptance criteria for these tests.

Therefore, I cannot populate the table or answer the questions as requested based on the given text, because the document describes a 510(k) for a modified medical device with no new clinical data or AI component.

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The intended use of the Accutorr V is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The physiologic parameters measured includes: noninvasive blood pressure (NIBP), pulse oximetry (SpO2), pulse rate and temperature.

The Accutorr V Monitor is a vital signs monitor intended for use in a health care facility under the direct supervision of a licensed healthcare practitioner. The Accutorr V provides high and low alarm limit settings for systolic, diastolic, mean arterial pressure, pulse rate, and pulse oximetry (SpO2). The Accutor V may be powered by a rechargeable Lithium ion battery or through line-power. The Accutorr V may be equipped with optional infrared or predictive temperature and recorder modules and may be mounted on an optional rolling stand for easy portability.

The provided text K091068 is a 510(k) Summary for the Accutorr V Monitor. This document does not contain the detailed study information regarding acceptance criteria and performance as requested. It states that "The Accutorr V Monitor has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards" and that a "risk analysis has been developed... The device's software has been verified and validated in accordance with the appropriate test requirements." However, it does not provide the specific acceptance criteria, reported device performance metrics, study details such as sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot populate the requested table and answer the study-related questions based on the information provided in K091068. The document serves as a summary for regulatory submission, rather than a detailed report of the performance studies.

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The Navigator 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 Navigator System is intended for use by licensed clinicians, for patient requiring anesthesia within a health care facility, and can be used in both adult and pediatric populations.

The Navigator Anesthesia Delivery System is a continuous flow anesthesia system which offers manual or automatic ventilation, easily adjustable fresh gas delivery, anesthetic agent delivery, ventilation monitoring, convenient ergonomics, and state-of-the-art safety systems. The Navigator System is designed to decrease the risk of hypoxic mixtures and the inadvertent movement of the air flow control knobs. Additionally, the Navigator provides battery power in the event of an AC power outage. Multiple ventilation modes, i.e., CMV, PCV, SIMV and PSV, are offered by the Navigator System with electronic PEEP available in each of the modes. The fresh gas dosing subsystem offers features of a traditional anesthesia system along with dual flow tubes which display the gas flows at all times. The Navigator contains two vaporizers and a heated breathing system to minimize condensation and return moisture to the patient.

The provided text describes the 510(k) summary for the Navigator Anesthesia Delivery System. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, the information required to fully answer your request (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not provided in the given text.

Here's what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated as specific performance thresholds. The document generally states compliance with "recognized safety, performance and electromagnetic compatibility standards."
• Reported Device Performance: Not quantified. The document states it has been "tested and found to be in compliance" with these standards.

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: Not mentioned.
• Data Provenance: Not mentioned.

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 "testing" mentioned refers to compliance with engineering/safety standards, not clinical ground truth established by experts.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable.

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

• MRMC Study: No, this is an anesthesia delivery system, not an AI-assisted diagnostic tool for human readers.
• Effect Size of AI: Not applicable.

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

• Standalone Performance: Not applicable as it's not an algorithm, but a medical device. The "software has been validated" refers to internal software validation, not a standalone performance evaluation in the context of AI.

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

• Type of Ground Truth: Not applicable in the traditional sense of diagnostic AI. The "ground truth" for this device would be established by validated engineering tests and compliance with recognized standards.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that uses a training set.

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

• How Ground Truth was established: Not applicable.

Summary of available information regarding the "study" (Performance Testing):

The document mentions a "Summary of Performance Testing" which states:

• "The Navigator System has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards."
• "A risk analysis has been developed to identify potential hazards and document the mitigation of the hazards."
• "The device's software has been validated in accordance with the requirements set forth in the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)."
• The conclusion states that based on this performance testing, the device is "safe, effective and substantially equivalent to the predicate device."

In essence, the "study" proving the device meets acceptance criteria is a series of engineering and software validation tests demonstrated to comply with established medical device standards and FDA guidance for substantial equivalence, rather than a clinical study with detailed performance metrics, patient cohorts, or expert ground truth.

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