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The Impella CP Introducer is intended for introduction of pacing leads or catheters into the body.

The Impella CP Introducer is packaged as a sterile kit. which includes an introducer sheath (consisting of sheath with sideport tubing, stopcock and hemostasis valve assembly), and dilators, and a guidewire. It is identical to the commercially available predicate device, Oscor Introducer set, Model Adelante-S2 Introducer (cleared under K122084).

This document (K192769) outlines the 510(k) submission for the Impella CP Introducer. However, it explicitly states that no additional qualification testing was required for the substantial equivalence determination because the device is identical to its commercially available predicate device, the Oscor Introducer set, Model Adelante-S2 Introducer (cleared under K122084).

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria is not present in this document, as such a study was deemed unnecessary for this submission.

Here's a breakdown of why this information isn't available based on the provided text:

1. A table of acceptance criteria and the reported device performance: This is not available because no new performance testing was conducted. The device is considered to perform identically to its predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no new test set was used.

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, as no new test set was used.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no new test set was used.

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 introducer, not an AI or imaging device, so MRMC studies are irrelevant.

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 (expert concensus, pathology, outcomes data, etc): Not applicable, as no new testing or ground truth establishment was required.

8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

In summary, the K192769 submission for the Impella CP Introducer relies entirely on its substantial equivalence to a predicate device (Oscor Introducer set, Model Adelante-S2 Introducer, K122084) due to their identical design, manufacturing, and performance characteristics. Therefore, the document does not contain details about new acceptance criteria or a study to prove their fulfillment.

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The IMPELLA 2.5 PLUS Catheter is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.

The IMPELLA 2.5 PLUS Catheter also provides pressure measurements which are useful in determining intravascular pressure.

The Impella 2.5 Plus is an update to the design of the IMPELLA 2.5, which was cleared by the FDA in 2008 (under K063723). The predicate device, the IMPELLA 2.5, and the Impella 2,5 Plus have identical designs and materials of construction. The only design modifications made to the IMPELLA 2.5 for the Impella 2.5 Plus are slight increases in the diameters of the inflow can ula impeller and pump housing (from 12 F to 14 F). As a result of this increase, the Impella 2.5 Plus has approximately 30% higher flow than the IMPELLA 2.5.

This 510(k) summary describes a medical device, the Impella 2.5 Plus, which is an updated version of a previously cleared device, the Impella 2.5. The submission focuses on demonstrating substantial equivalence to the predicate device due to minor design modifications (increased diameters of the inflow cannula impeller and pump housing).

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state formal acceptance criteria with numerical targets. Instead, the "acceptance criteria" are implied to be substantially equivalent performance to the predicate device, the IMPELLA 2.5, and compliance with general design and safety standards.

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

The submission indicates that the studies conducted were bench tests and verification & validation (V&V) testing. It does not specify a "test set" in the context of patient data or clinical samples.

• Sample Size: Not applicable in the sense of patient-based test sets. The sample size would refer to the number of devices tested in bench experiments. This detail is not provided in the summary.
• Data Provenance: Not applicable in the sense of country of origin or retrospective/prospective clinical data for this type of submission. The performance data is derived from in vitro (bench) testing.

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

Not applicable. The ground truth for this device's performance is established through engineering and scientific measurements and comparisons against established specifications and the predicate device's performance. It does not involve expert image interpretation or clinical diagnosis.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies where expert consensus is required. This device relies on direct physical measurements and engineering verification.

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

Not applicable. This device is a mechanical circulatory support device, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., Algorithm-only without human-in-the-loop) Performance Study Was Done

Not applicable. This device is a physical medical device, not an algorithm. Its "standalone" performance is its bench-test performance as described.

7. The Type of Ground Truth Used

The "ground truth" for this submission is established by:

• Engineering specifications and design requirements: The device's ability to meet its intended design parameters.
• Performance of the predicate device (IMPELLA 2.5): The Impella 2.5 Plus is compared against the known performance characteristics of its legally marketed predecessor.
• International standards: Compliance with relevant standards like IEC 60601-1 for electrical safety.
• Functional operation: Verification that the device "operated as intended."

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI model, so there is no training set.

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

Not applicable, as there is no training set for this device.

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The IMPELLA Controller with Flow Control is an extracorporeal bypass control unit intended to be used to provide circulatory support for periods up to 6 hours. It is also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella Controller with Flow Control is intended to be used by trained healthcare professionals in healthcare facilities and medical transport (i.e. ambulance, helicopter, or fixed-wing aircraft) environments.

The IMPELLA Controller with Flow Control also displays pressure measurement readings, which are useful in determining intravascular pressure.

The IMPELLA Controller with Flow Control is identical to the IMPELLA Controller in its physical characteristics. The only difference is that an additional operating mode. Flow Control Mode, has been implemented via a software modification. Both the IMPELLA Controller and the IMPELLA Controller with Flow Control are identical microprocessor-based pump motor drivers incorporating an infusion system. They both are intended to be used by trained healthcare professionals in hospital and medical transport environments.

The provided text describes a 510(k) summary for the IMPELLA Controller with Flow Control. This submission primarily focuses on the device's substantial equivalence to a predicate device and its compliance with various electrical, safety, and software standards. It doesn't present an acceptance criteria table with reported device performance in the typical format of clinical or diagnostic studies. Instead, the "acceptance criteria" are implied by the standards and testing performed to demonstrate that the new Flow Control Mode is safe and effective and that the device as a whole is substantially equivalent to its predicate.

Here's an attempt to structure the information based on your request, with significant caveats due to the nature of the provided document:

Acceptance Criteria and Study Summary for IMPELLA Controller with Flow Control

The IMPELLA Controller with Flow Control is a medical device (a non-roller type cardiopulmonary blood pump) that received 510(k) clearance based on its substantial equivalence to a predicate device, the IMPELLA Controller (K093801). The primary change in the new device is a software modification to include a "Flow Control Mode." The studies performed were largely in vitro bench tests and compliance assessments against recognized standards to demonstrate that this new mode did not introduce new safety or effectiveness concerns and that the device's overall performance remained consistent with its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary based on substantial equivalence, specific numerical performance metrics for acceptance criteria and device performance, as might be found in a diagnostic accuracy study, are not explicitly provided. Instead, the acceptance criteria are met by demonstrating compliance with established standards and proper functioning of the new feature.

2. Sample Size for Test Set and Data Provenance

The "studies" described are primarily in vitro (bench) tests and compliance assessments for a medical device's control unit, not clinical trials involving human subjects or diagnostic image analysis. Therefore, concepts like "test set sample size" and "data provenance" (country of origin, retrospective/prospective) in the context of clinical data are not directly applicable here. The "test set" would refer to the physical device prototypes and test setups used in the various engineering and performance evaluations.

• Sample Size: Not specified in terms of units or duration beyond mentioning "System Durability Testing," "System Characterization Test," and "System Flow Characterization Test." These would involve testing an unspecified number of device units or components under defined conditions.
• Data Provenance: The tests are in vitro (bench testing) and compliance assessments performed by the manufacturer, ABIOMED, Inc., presumably at their facilities. There's no mention of country of origin for clinical data as no clinical data is presented for this specific 510(k) submission.

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

This 510(k) summary does not involve determining "ground truth" through expert review in the sense of clinical diagnosis or image interpretation. The "ground truth" for the engineering and performance tests would be defined by the technical specifications, international standards, and the expected behavior of the device as designed. The expertise involved would be that of the engineers and quality assurance personnel conducting the tests and verifying compliance. No specific number or qualification of "experts" is provided in the document for establishing such ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or diagnostic interpretation that would require an adjudication method like 2+1 or 3+1. The results of the engineering tests would be documented, analyzed against predefined acceptance criteria (specifications and standards), and validated by engineers and quality control personnel.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This 510(k) pertains to a hardware/software control unit for a blood pump, not an imaging device or diagnostic algorithm that would typically involve human readers interpreting cases with and without AI assistance. The "AI" in this context is the software's "Flow Control Algorithm," which controls the mechanical pump.

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

Yes, a form of standalone performance study was done for the algorithm, albeit in an in vitro context. The document states:

• "Performance characteristics of the IMPELLA Controller with Flow Control were tested in vitro to verify that the new Flow Control Mode met its specifications."
• "Additional specialized performance testing was completed to verify that the 2 control modes are substantially equivalent. This testing showed that the Flow Control Algorithm behaves as designed, and that the 2 control modes are equivalent for use with the IMPELLA pump catheters."

This demonstrates that the "Flow Control Algorithm" operating within the device was tested independently (without human intervention during the test itself, although humans initiated and monitored the tests) to ensure it performed as designed and met its specifications in vitro.

7. Type of Ground Truth Used

The "ground truth" for the in vitro performance studies and compliance testing was based on:

• Engineering Specifications: The pre-defined design requirements and specifications for the device's functionality, especially the new Flow Control Mode.
• International Standards: Adherence to established and recognized standards for medical devices (e.g., IEC 60601-1-2 for EMC, IEC 60601-1 Part 1 for electrical safety, RTCA/DO-160C for altitude/vibration).
• Predicate Device Performance: The established, safe, and effective performance of the existing IMPELLA Controller (K093801), against which the new device's overall safety and effectiveness were compared to establish substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This submission does not describe a machine learning algorithm that requires a "training set" of data in the typical sense. The software modification is explicitly stated as implementing a "Flow Control Mode" and its algorithm's behavior was verified through in vitro testing. There's no indication that machine learning was used where a training set distinct from a test set would be defined.

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

Not applicable, as there is no "training set" in the context of the information provided.

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The IMPELLA Controller is an extracorporeal bypass control unit intended to be used to provide circulatory support for periods up to 6 hours. It is also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass. The Impella Controller is intended to be used by trained healthcare professionals in healthcare facilities and medical transport (i.e. ambulance, helicopter, or fixed-wing aircraft) environments.

The IMPELLA Controller also displays pressure measurement readings, which are useful in determining intravascular pressure.

The IMPELLA Controller is a microprocessor-based pump motor driver and purge system. It is designed to operate on AC current (110-240 VAC, 47-63 Hz) or on an internal, rechargeable battery. The IMPELLA Controller generates the signals required to power the drive motor of one of ABIOMED's IMPELLA Percutaneous Support Catheters (the IMPELLA RECOVER LP 2.5 (cleared under K063723), the IMPELLA 5.0 LP and the IMPELLA 5.0 LD (cleared under K083111). The IMPELLA Controller also serves to deliver an infusate of the catheter's drive motor, and to provide useful information regarding the catheter's performance. It is intended to be used by trained healthcare professionals in hospital and medical transport environments. It is lightweight, portable and has an accompanying cart for ease of transport within the hospital.

The provided text describes the IMPELLA Controller's acceptance criteria and the study that proves it meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the IMPELLA Controller were its conformity to established international and internal performance standards, and its equivalence to the predicate device.

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

The text does not specify a sample size for a "test set" in the context of patient data or clinical trials. The performance testing was conducted in vitro, meaning in a controlled laboratory environment, not on human subjects. Therefore, there is no direct patient data or provenance mentioned. The testing focused on the device's technical specifications and compliance with standards.

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

This information is not provided in the document section related to performance data. As the tests were in vitro, the "ground truth" would be established by technical specifications and reference standards, rather than expert consensus on patient data.

4. Adjudication method for the test set:

An adjudication method for a "test set" in the context of reviewing clinical cases or images is not applicable here, as the study was in vitro and focused on engineering and functional performance, not clinical scenarios requiring expert interpretation.

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

An MRMC comparative effectiveness study was not performed. The IMPELLA Controller is a medical device for circulatory support and not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases.

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

The performance testing described was primarily "standalone" in the sense that it evaluated the device's technical capabilities and compliance with standards without a human operator's variable input being a primary focus of the performance assessment (though it is intended for use by trained healthcare professionals). The tests focused on the device's inherent design and functionality, such as system durability, flow characterization, and sensor response.

7. The type of ground truth used:

The ground truth used for the in vitro testing was established based on:

• Established engineering design specifications (e.g., specific flow rates, pressure readings, durability benchmarks that the device was designed to meet).
• International and national standards for medical device safety, electromagnetic compatibility, electrical safety, biocompatibility, sterility, software design, packaging, and transport (e.g., IEC 60601 series, ISO 10993 series, FDA guidance documents).
• Performance characteristics of the predicate device, which served as a benchmark for equivalence in internal performance testing.

8. The sample size for the training set:

The concept of a "training set" is typically associated with machine learning or AI algorithm development. Since the IMPELLA Controller is a hardware-based medical device with microprocessor control, and the provided text does not mention any machine learning components, there is no training set in that context.

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

As there is no mention of a training set for machine learning in the provided document, the mechanism for establishing its ground truth is not applicable. The "ground truth" for the device's development and verification would stem from engineering principles, medical requirements for circulatory support, and regulatory standards.

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The IMPELLA 5.0 Catheters are intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. They are also intended to be used to provide circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.

The IMPELLA 5.0 Catheters also provide pressure measure-ments which are useful in determining intravascular pressure.

The IMPELLA 5.0 catheter family (IMPELLA 5.0) is an extension of the IMPELLA Percutaneous Cardiac Support product line. The IMPELLA 5.0 is capable of providing up to 5 liters per minute blood flow. The IMPELLA 5.0 are catheter based pumps intended for placement in the left ventricle. There are currently two versions of IMPELLA 5.0 Catheters, one inserted through the femoral artery via cutdown (the IMPELLA 5.0 LP) and the other through the aorta (the IMPELLA 5.0 LD). The only difference between the two versions is the shape of the inflow cannula. The IMPELLA 5.0 catheters provide a means for temporary extracorporeal circulatory support that returns blood to the patient's systemic circulation.
Each IMPELLA 5.0 Catheter runs as a system comprised of: 1) a catheter which contains an integrated pump motor/ infusate lumen, integrated intravascular pressure sensor and integral cannula, 2) a controller/console and 3) infusion system designed to work together, and 4) accessories.

The provided text describes the IMPELLA 5.0 Catheters, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the typical format requested. Instead, it focuses on demonstrating substantial equivalence to predicate devices through various tests and a general statement about clinical data.

Therefore, for aspects like "Acceptance Criteria," "Reported Device Performance," "Sample size used for the test set," "Number of experts," "Adjudication method," "MRMC study," "Standalone performance," and details about "Training set," the information is not available in the provided document.

However, I can extract information related to the pre-clinical and clinical testing performed to support the device's safety and effectiveness for its intended use, which indirectly serves to "prove" its suitability.

Here's a breakdown of the available information:

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

This information is not explicitly provided in the format of a table with specific acceptance criteria (e.g., "flow rate > X L/min," "biocompatibility pass/fail") and corresponding reported performance metrics. The document generally states that "All tests were acceptable" for in vitro performance and biocompatibility.

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

• Test Set Sample Size (Clinical Data): A combination of 88 OUS (Outside US) and 17 US patients, totaling 105 patients.
• Data Provenance: A combination of OUS (Outside US) and US patients. The document does not specify if 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 available in the provided text. The clinical data is described as "a detailed analysis," but the method of establishing ground truth or the involvement and qualifications of experts are not mentioned.

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

This information is not available in the provided text.

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 information is not applicable/available. The device described is a medical pump (Extracorporeal Circulatory Support System), not an AI-powered diagnostic tool that would involve human readers.

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

This information is not applicable/available. The device is a physical pump, not an algorithm. However, in vitro performance testing ("ABIOMED conducted a full range of testing demonstrating that the IMPELLA 5.0 Catheters operate as intended") could be considered "standalone" technical performance testing of the device itself.

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

For the clinical data, the "ground truth" is implied to be patient safety and the device's ability to provide circulatory support as intended, analogous to outcomes data. However, the exact methods for defining and evaluating this "ground truth" are not detailed. For pre-clinical tests, the ground truth is against established standards for sterilization, biocompatibility, and in vitro performance.

8. The sample size for the training set:

This information is not applicable/available as the document describes a physical medical device and its validation, not an AI or algorithm that typically uses a "training set."

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

This information is not applicable/available as there is no mention of a training set for an algorithm.

Summary of Device Performance and Supporting Studies (as described in the document):

The device's performance is demonstrated through a combination of pre-clinical and clinical data, primarily aiming to show substantial equivalence to predicate devices.

Pre-Clinical Studies:

• Sterilization, Packaging, and Shelf-life:
  • Method: EtO gas sterilization with SAL of 10-6. Validated using EN 550.
  • Performance: EtO sterilization residual values for EO and ECH were within allowable limits of ISO 10993-7. LAL test used for pyrogen-free determination. Packaging material integrity validated.
  • Acceptance Criteria/Outcome: All results acceptable.
• Biocompatibility Testing:
  • Method: Testing of all patient-contacting materials on finished sterilized devices. Conducted in accordance with ISO 10993, Part 1.
  • Performance: Not specified in detail, but stated all testing results were acceptable.
  • Acceptance Criteria/Outcome: All results acceptable.
• In Vitro Performance Testing:
  • Method: A full range of testing conducted.
  • Performance: Demonstrated that the IMPELLA 5.0 Catheters operate as intended.
  • Acceptance Criteria/Outcome: All tests were acceptable. This demonstrates the device can achieve its stated flow rate of up to 5 liters per minute and other operational parameters.

Clinical Study:

• Purpose: To address patient safety.
• Sample Size: 105 patients (88 OUS, 17 US).
• Provenance: Combination of OUS and US data.
• Outcome: ABIOMED provided a "detailed analysis" based on this data, which was part of the submission to demonstrate substantial equivalence and acceptable patient safety for the intended use and duration (up to 6 hours). No specific performance metrics or statistical results from this clinical analysis are provided in the summary.

Conclusion stated by the manufacturer: The IMPELLA 5.0 catheters are substantially equivalent to the listed predicate devices. This implies that the performance data (pre-clinical and clinical) supported this claim to the FDA's satisfaction.

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The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System is intended for partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass.

The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System also provides pressure measurements which are useful in determining intravascular pressure.

The IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System (IMPELLA RECOVER LP 2.5 System) provides circulatory support with the ability to deliver anticoagulant through an infusion system. The System is comprised of: 1) a catheter which contains an integrated pump motor/infusate lumen, integrated intravascular pressure lumen and integral cannula, 2) a controller/console and 3) infusion system designed to work together, and 4) accessories.

The provided text describes a 510(k) premarket notification for the IMPELLA RECOVER® LP 2.5 Percutaneous Cardiac Support System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting performance against such criteria.

Therefore, the requested information (acceptance criteria, device performance, sample size, ground truth details, MRMC study, standalone performance) is not available in the provided text.

The document mainly includes:

• Device Description: The IMPELLA RECOVER® LP 2.5 System comprises a catheter with an integrated pump motor/infusate lumen and intravascular pressure lumen, a controller/console, an infusion system, and accessories.
• Intended Use: Partial circulatory support for up to 6 hours, including during procedures not requiring cardiopulmonary bypass, and for intravascular pressure measurements.
• Technological Characteristics and Comparison to Predicate Devices: Similar to TANDEM HEART systems and the Vascular Solutions Langston catheter, with differences in pump location, certain materials, and pump speed.
• Test Results (Pre-Clinical):
  • Sterilization: EtO gas, validated by EN 550, residuals within ISO 10993-7 limits. LAL test for pyrogen-free determination. Packaging integrity validated.
  • Biocompatibility: Tested per ISO-10993 on finished sterilized devices; all results acceptable.
  • Software Validation: Compliant with FDA 2005 guidance for premarket submissions for software in medical devices.
  • Electromagnetic Compatibility & Electrical Safety: Tested per EN 60601 and EN 61000; conformance demonstrated.
  • In vitro performance testing: Full range of testing demonstrating the system operates as intended; all tests acceptable.
• Test Results (Clinical): A detailed analysis based on clinical data from 109 OUS (Outside US) and 20 US patients to address patient safety was provided. No specific performance metrics or acceptance criteria for this clinical data are mentioned.
• Predicate Devices: TandemHeart PTVA System (K991783, K052570), Medtronic Biomedicus 15F arterial cannula and introducer (K924642, K924643), and Vascular Solutions Langston Dual Lumen Catheter (K050168).

In summary, the provided document does not contain the specific information requested regarding acceptance criteria, quantitative device performance against those criteria, or the details of ground truth establishment relevant to an AI/algorithm-based device study. The review is for a conventional medical device, not an AI/ML-driven one.

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The iPulse IABP Console is an electromechanical system used to inflate and deflate 8F 40 cc intra-aortic balloons (IABs). It provides temporary support to the left ventricle via the principle of counterpulsation. For this therapy, the IAB is placed in the descending aorta, just distal to the left subclavian artery. After positioning the balloon, the user can adjust the balloon to trigger in synchrony with either the ECG or arterial pressure waveform to ensure that both inflation and deflation occur at the proper point during the cardiac cycle.

Indications for Use:

Appropriate patient groups for IAB counterpulsation therapy using the iPulse IABP Console are adults suffering from:

• Unstable refractory angina .
• Impending infarction ●
• Post Infarction Angina or Threatening Extension of Myocardial Infarction .
• Refractory ventricular failure .
• Mechanical complications because of myocardial infarction ●
• Cardiogenic shock .
• Support and stabilization of high risk patients undergoing diagnostic and non-surgical ● procedures
• Ischemic related intractable ventricular arrhythmias .
• Septic shock .
• Interoperative pulsatile flow generation
• Weaning from cardiopulmonary bypass .
• Cardiac support for high risk surgical patients and coronary angiography and angioplasty ● patients
• Prophylactic support in preparation for cardiac surgery .
• . Post-surgical myocardial dysfunction
• Cardiac Contusion .
• Mechanical bridge to other assist devices ●
• Cardiac support following correction of anatomical defects ●
• Support for failed angioplasty and valvuloplasty

The iPulse Intra-Aortic Balloon Pump (IABP) Console is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. The iPulse IABP Console is designed to work in conditions which are unique to the operating room, catheterization laboratory, critical care unit and during transport. The iPulse IABP Console has two operation modes; auto and manual. The auto operation mode provides simplicity and minimizes operator intervention. The manual operation mode provides operators with flexibility for difficult clinical cases.

The iPulse IABP Console is an electro-mechanical system used to inflate and deflate 8 French, 40 cc intra-aortic balloon catheters.

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:

Acceptance Criteria and Device Performance Study

The iPulse Intra-Aortic Balloon Pump Console's acceptance criteria primarily revolved around demonstrating equivalence to two legally marketed predicate devices: the Datascope CS100 Intra-Aortic Balloon Pump (K031636) and the Arrow AutoCAT2 Intra-Aortic Balloon Pump (K002256).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "test set" in terms of patient data or a specific number of devices tested for comparative performance. The pre-clinical testing mentioned involves "laboratory tests" which are typically in-house engineering and performance evaluations.

• Sample Size: Not specified in terms of number of devices or clinical cases. The testing was conducted on the iPulse IABP Console itself.
• Data Provenance: The testing was "pre-clinical laboratory testing" conducted by ABIOMED, Inc. (manufacturer). There is no mention of country of origin for any external data, and it is entirely retrospective in the sense that it's a report of completed internal testing.

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

Not applicable. The ground truth for this device's performance relies on engineering specifications, adherence to functional requirements, and comparison to the published specifications and performance characteristics of predicate devices. There is no mention of human expert evaluation in establishing a "ground truth" for the device's technical performance in the way one would for diagnostic imaging.

4. Adjudication Method for the Test Set

Not applicable, as there was no "test set" requiring adjudication by human experts in a clinical context. The "adjudication" for the device's performance was an assessment against established engineering and regulatory standards and comparison to predicate device 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 Intra-Aortic Balloon Pump Console, not an AI-powered diagnostic tool requiring a MRMC study for human reader performance. Its effectiveness is measured by its mechanical and electrical performance in assisting the heart, not by improving human interpretation of medical images or data.

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

Not applicable. This is a medical device (hardware and embedded software) that operates in conjunction with human operation (human-in-the-loop is inherent to its use in a clinical setting). It is not solely an "algorithm" in the sense of an AI model being evaluated for standalone diagnostic performance. The pre-clinical testing did evaluate its standalone technical performance against specifications.

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

The ground truth for evaluating the iPulse IABP Console's performance was:

• Engineering specifications and functional requirements: The device was tested against its design specifications for parameters like maximum beat rate, battery runtime, drive system, etc.
• Regulatory standards: Compliance with applicable electrical standards (EMI, EMC, Electrical Safety) and software verification methods.
• Predicate device performance: The performance of the iPulse console was specifically compared to the Datascope CS100 and Arrow AutoCAT2, aiming for "equivalence" in performance and reliability. FDA guidance for IABP catheters and consoles was also referenced.

8. The sample size for the training set

Not applicable. This document describes a medical device, not a machine learning model that requires a training set.

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

Not applicable. This document describes a medical device, not a machine learning model that requires a training set and corresponding ground truth.

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

• . Unstable refractory angina
• Impending infarction .
• Post Infarction Angina or Threatening Extension of Myocardial . Infarction
• Refractory ventricular failure .
• Mechanical complications because of myocardial infarction
• Cardiogenic shock .
• Support and stabilization of high risk patients undergoing . diagnostic and non-surgical procedures
• Ischemic related intractable ventricular arrhythmias .
• Septic shock .
• Interoperative pulsatile flow generation .
• Weaning from cardiopulmonary bypass .
• Cardiac support for high risk surgical patients and coronary . angiography and angioplasty patients
• Prophylactic support in preparation for cardiac surgery .
• Post-surgical myocardial dysfunction .
• . Cardiac Contusion
• . Mechanical bridge to other assist devices
• . Cardiac support following correction of anatomical defects
• Support for failed angioplasty and valvuloplasty .

The SupraCor Balloon Catheter is a 40cc symmetrical polyurethane balloon attached to an 8 Fr dual lumen catheter, designed to provide counterpulsation cardiac assist therapy. The outer lumen is a channel for helium used to inflate and deflate the balloon, and the inner lumen is used for a guidewire and blood pressure measurement.

The balloon inflation and deflation cycle is synchronized (using a commercially available control console) with the ECG or arterial pressure to provide counterpulsation synchronized with the heartbeat. It is intended to increase coronary perfusion, decrease the workload of the left ventricle and allow healing of the myocardium.

The provided text describes a 510(k) premarket notification for the SupraCor Balloon Catheter. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with specific acceptance criteria and performance metrics against ground truth in the way a diagnostic AI device would.

Therefore, many of the requested points, such as sample sizes for test sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types for training/test sets, are not applicable to this type of device and submission.

Here's an attempt to answer the questions based on the provided text, highlighting the non-applicability of certain points:

Acceptance Criteria and Device Performance for SupraCor Balloon Catheter

This submission demonstrates substantial equivalence to predicate devices, focusing on technological characteristics and pre-clinical test results, rather than clinical performance against specific acceptance criteria in the manner of a diagnostic device. The "acceptance criteria" here implicitly refer to meeting the substantial equivalence requirements by demonstrating similar design, materials, and performance to the predicates.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This submission relies on substantial equivalence through comparison of technical characteristics and pre-clinical laboratory testing, not a clinical test set with human subjects or a dataset for an algorithm.
• Data Provenance: Not applicable in the context of a "test set" for performance metrics. The data comes from pre-clinical laboratory testing of the device itself and comparison to specifications of predicate devices.

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

• Not applicable. There is no "test set" with ground truth established by experts in the context of this 510(k) submission for a physical medical device. Substantial equivalence is determined by regulatory review based on comparison of technical specifications and pre-clinical test results.

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

• Not applicable. There is no "test set" requiring 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 physical medical device (intra-aortic balloon catheter), not an AI device or a diagnostic tool involving human "readers."

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 (expert consensus, pathology, outcomes data, etc.)

• Not applicable in the common sense of clinical ground truth. The "ground truth" for this submission are the established specifications and performance characteristics of the legally marketed predicate devices, against which the new device's engineering specifications and pre-clinical test results are compared to establish substantial equivalence.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. As above, this is a physical medical device.

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