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The CardioGard Emboli Protection Cannula combines the function of a standard arterial cannula with an added suction mechanism to capture debris that may result from cardiac surgery.

The CardioGard Emboli Protection Cannula is intended for perfusion of the ascending aorta during short term (<6 hours) cardiopulmonary bypass (CPB) procedures. The CardioGard suction lumen is intended for the removal of particulate emboli during surgical procedures that require CPB.

The CardioGard Emboli Protection Cannula (CardioGard Cannula) is a sterile, single-use, disposable double lumen arterial cannula. The CardioGard Cannula features a tip configuration that diffuses oxygenated blood from the heart-lung machine into the ascending aorta through the Cannula Outlet, while also aspirating blood and embolic matter through the Suction Lumen Inlet. The flow rates through the two cannula lumens are carefully controlled so that emboli are suctioned back to the heart-lung machine for filtration while still enabling sufficient blood flow to the patient.

This document describes a 510(k) premarket notification for the CardioGard Emboli Protection Cannula, assessing its substantial equivalence to a previously cleared device (K141465). The focus of the changes in the modified device is to reduce device bulk and improve ease of use, while maintaining safety and effectiveness.

Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document provides a comparative table (starting on page 5) outlining various design and performance characteristics between the "Cleared Device" (predicate) and the "Modified Device" (current submission). It doesn't explicitly state "acceptance criteria" for each row, but rather describes how the modified device compares to the predicate and notes whether they are "Same" or "Substantially equivalent" with a discussion of differences.

   Parameter	Acceptance Criteria (Implied)	Reported Device Performance (Modified Device)
   Intended Use	Same as predicate.	Same as predicate.
   Use Duration	Same as predicate (≤ 6 hours).	Same as predicate (≤ 6 hours).
   Cannula Design	Substantially equivalent to predicate, aiming for reduced bulk and improved ease of use.	Two lumen, curved tip with two ports (aortic perfusion, embolic particle suction). Suction tube angles 90° to reduce cannula profile.
   Tip Angle	30° to 60° (same as predicate).	30° to 60° (substantially equivalent).
   Tip Shape	Substantially equivalent to predicate, with features for ease of insertion and reduced back pressure.	Angled and tapered with dispersion side holes. Tip tapered for ease of insertion, dispersion side holes added to reduce back pressure.
   Flange	Redesigned for ease of suturing.	Redesigned flange to facilitate suturing in place.
   Dimensions	Substantially equivalent to predicate, with slight modifications to reduce bulk and improve ease of use.	Tip Size: Starts at 24Fr, ends at 22Fr. Main tube: diameter: 5/16" tapered to 3/8", length: 19–21 cm. Suction tube: diameter: 3/16" tapered to 1/4", length: 18–19 cm. (Slight modifications from predicate for bulk reduction/ease of use).
   Connectors	Addition of connector to suction tube for user convenience.	Connectors on both main and suction tubes (added connector to suction tube for user convenience).
   Caps	Color-coded caps on both tubes for user convenience.	Caps on both tubes: red for main tube and yellow for suction tube (color-coded for user convenience).
   Main (perfusion) Flow Rate	1 - 6 L/min (same as predicate).	1 - 6 L/min (same).
   Suction Flow Rate	0 - 1.0 L/min (reduced maximum from predicate to ensure 5 L net forward flow).	0 - 1.0 L/min (substantially equivalent, max suction flow rate reduced to provide for 5 L net forward flow).
   Pressure Drop	Within accepted range for aortic cannulas (substantially equivalent to predicate).	Pressure drop for both devices within accepted range for aortic cannulas (graphical comparison indicates substantial equivalence).
   Biological Safety - Materials	Biocompatibility confirmed in accordance with ISO 10993.	Tip: Polycarbonate (changed from PVC). Tubes: PVC (Plastisol) with stainless steel inner spring (same). Connectors: Polycarbonate (changed from ABS plastic). Caps: Polyethylene with PVC (Plastisol) outer cover (changed from Polyethylene). Biocompatibility confirmed.
   Sterilization	EtO sterilized, single-use, disposable, non-pyrogenic (same method and characteristics).	EtO sterilized, single-use, disposable, non-pyrogenic (same).
   EtO Sterilization Validation	SAL 10^-6^ using overkill method, half-cycle technique (EN ISO 11135-1:2008), EO/ECH residuals < ISO 10993-7:2008 limits.	Validated to SAL 10^-6^; EO and ECH residual levels comply with ISO 10993-7.
   LAL Endotoxin Testing	Endotoxin levels < 0.5 EU/mL extract or < 20 EU/device.	Verified endotoxin levels well below limits for medical devices in contact with cardiovascular system (≤0.5 EU/mL extract or ≤20 EU/device).
   Pyrogenicity Testing	Pyrogen-free.	Verified pyrogen-free.
   Biocompatibility Testing	Meet acceptance criteria of applicable standard (ISO 10993-1:2009 for externally communicating devices, <24 hours contact with blood).	All tests (cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity/mutagenicity, hemolysis, partial thromboplastin time, complement activation, in-vivo thrombogenicity) met acceptance criteria.
   Packaging Integrity	Meet pre-defined acceptance criteria at all time periods (time 0, env. conditioning, simulated transport, 3-year accelerated aging).	All tests (Peel Strength, Burst, Dye Penetration, Package Label integrity) met pre-defined acceptance criteria.
   Device Integrity	Meet pre-defined acceptance criteria at all time periods (time 0, env. conditioning, simulated transport, 3-year accelerated aging).	All tests (Visual Inspection, Dimensional Verification, Force at Break, Tip force at break, Pressure Drop, Back pressure, Liquid Leakage, Tube kinking, Tube bending, Tube hardness, Resistance to clamping, Tube printing ink integrity) met pre-defined acceptance criteria.
   Dynamic Hemolysis	Similar gradual increases in plasma free hemoglobin as compared to a commercially available arterial cannula (Medtronic Select 3D II).	Demonstrated similar gradual increases in plasma free hemoglobin to the Medtronic Select 3D II (K043179).
   Functional Performance	Substantially equivalent embolic particle capture as compared to the original CardioGard Cannula under simulated use conditions.	Demonstrated substantially equivalent embolic particle capture as compared to the original CardioGard Cannula (K141465) in a simulated use test.

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

   • Functional Performance (Simulated Use Test): The document states "The functional performance of the modified CardioGard Cannula was validated a simulated use test set-up with direct comparison to the predicate device." It does not specify the numerical sample size for this test. It refers to "test conditions simulating aortic manipulation, maximum flow rates, and typical flow rates."
   • Dynamic Hemolysis Testing: Conducted in an "in vitro blood loop with bovine blood circulating at a net forward flow of 5 L/min for 6 hours." No specific numerical sample size for devices is given.
   • Packaging and Device Integrity Tests: Performed at "time 0 and after environmental conditioning, simulated transportation, and 3-year accelerated aging." No specific numerical sample size for devices is given.
   • Provenance: All nonclinical data appears to be from in-vitro laboratory testing or simulated environments, not from human or animal subjects, therefore data provenance in terms of country of origin or retrospective/prospective clinical study is not applicable in the usual sense.

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

   Not applicable. The tests performed are non-clinical (laboratory and simulated use tests), not involving human interpretation or clinical ground truth established by medical experts for a "test set" as typically understood in AI/imaging studies.

4. Adjudication method for the test set:

   Not applicable, as this is not a study requiring expert adjudication of results.

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

   No, an MRMC comparative effectiveness study was not done. This device is a medical cannulation tool, not an AI software/diagnostic device that would involve human readers or AI assistance in interpretation.

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 or AI system. The "functional performance" mentioned refers to the device's physical ability to capture particles in a simulated environment.

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

   The "ground truth" for the non-clinical tests is established by:

   • Standardized testing methodologies: Adherence to international standards (e.g., EN ISO 11135-1:2008 for sterilization, ISO 10993-7:2008 for residuals, USP <85> for endotoxins, USP <151> for pyrogenicity, ISO 10993-1:2009 for biocompatibility).
   • Direct comparison to a legally marketed predicate device: For dynamic hemolysis and functional performance (embolic particle capture), the performance of the modified device was compared against the predicate device (K141465) or another commercially available arterial cannula (Medtronic Select 3D II).
   • Pre-defined acceptance criteria: For packaging and device integrity, explicit acceptance criteria were used.

8. The sample size for the training set:

   Not applicable. This is a physical medical device, not an AI/machine learning system that requires a "training set."

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

   Not applicable, as no training set was used.

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The CardioGard Emboli Protection Cannula combines the function of a standard arterial cannula with an added suction mechanism to capture debris that may result from cardiac surgery. The CardioGard Emboli Protection Cannula is intended for perfusion of the ascending aorta during short term (≤ 6 hours) cardiopulmonary bypass (CPB) procedures. The CardioGard suction lumen is intended for the removal of particulate emboli during surgical procedures that require CPB.

The CardioGard Emboli Protection Cannula, shown below, is a disposable 24 French double lumen arterial cannula. The cannula functions to deliver oxygenated blood to the heart during procedures requiring cardiopulmonary bypass (CPB), while at the same time suctioning blood and embolic matter away from the surgical field. The arterial cannula is inserted centrally in the ascending aorta. The CardioGard Emboli Protection Cannula features a tip configuration which diffuses oxygenated blood from the heart-lung machine to the ascending aorta through the Cannula Outlet, while also aspirating blood and embolic matter through the Suction Lumen Inlet. The flow rates through the two cannula lumens are carefully controlled so that emboli are suctioned back to the CPB machine for filtration while still enabling sufficient blood flow into the aorta.

Based on the provided text, the device being discussed is the CardioGard Emboli Protection Cannula. It's important to note that this document is a 510(k) summary for a medical device and not a submission for an AI/ML-based device. Therefore, the questions about "AI vs without AI assistance," "standalone algorithm performance," and "ground truth establishment for training set" are not directly applicable in the context of this device's approval process as described.

However, I can extract information related to the device's acceptance criteria and the study that proves it meets them, adapting the requested structure to fit the available details.

The core of the "acceptance criteria" here is "substantial equivalence" to a predicate device, demonstrated through various non-clinical and clinical tests.

Acceptance Criteria and Device Performance for CardioGard Emboli Protection Cannula

The acceptance criteria for the CardioGard Emboli Protection Cannula are primarily demonstrated through its substantial equivalence (safety and effectiveness) to predicate devices, namely the Embol-X Access Device/Aortic Cannula and the Embol-X Intra-Aortic Filter. This equivalence is shown through comparative testing against specific performance attributes.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document describes "acceptance criteria" primarily through comparative performance to a predicate device and meeting pre-defined thresholds in various non-clinical tests. "Reported device performance" here refers to the outcomes of these tests. As this is not an AI/ML context, metrics like sensitivity/specificity are not applicable.

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

• Non-Clinical In Vitro Testing: Not explicitly stated for each test (e.g., number of devices tested for pressure drop, hemolysis, embolic capture).
• Animal Testing: 10 pigs (7 using CardioGard, 3 controls using commercially available aortic perfusion cannula).
• Clinical Testing: A prospective, randomized, multi-center, double-blind clinical study. The exact number of subjects is not explicitly stated in the provided abstract, but comparison percentages (42.8% vs 66.7%) imply a sufficient sample size to achieve statistical significance (p<0.05).
• Data Provenance: The manufacturer is CardioGard Medical Ltd. in Israel. The clinical study is described as "multi-center," which typically implies data from various institutions, potentially in different geographical locations, but the specific countries are not mentioned. It was a prospective study.

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

• For Clinical Study: "Core-lab evaluators" are mentioned for the diffusion weighted magnetic resonance imaging (DW-MRI) evaluation of new brain lesions. The number and qualifications of these evaluators are not specified in the provided text.

4. Adjudication Method for the Test Set

• The clinical study was "double-blind (subject and core-lab evaluators)," suggesting independent evaluation. However, the specific adjudication method (e.g., 2+1, 3+1 consensus) for discrepancies among evaluators is not described. For non-clinical tests, "acceptance criteria" imply objective measurements rather than expert consensus adjudication.

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

• No. This is not an AI/ML-based device where human reader improvement with AI assistance would be relevant. The clinical study compares device effectiveness in patients (CardioGard vs. control cannulas), not human reader performance.

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

• Not applicable. This is a physical medical device (cannula), not an algorithm or software. Its "standalone" performance is assessed through its physical properties and function in in-vitro, animal, and clinical settings.

7. The Type of Ground Truth Used

• Non-Clinical/Bench Testing: The "ground truth" is based on objective physical measurements and validated testing protocols (e.g., standardized methods for pressure drop, flow rates, hemolysis levels, particle capture rates).
• Animal Study: The "ground truth" for embolic particle capture was the direct measurement of injected osseous embolic particles captured.
• Clinical Study: The "ground truth" for efficacy was based on quantitative and qualitative assessment of diffusion weighted magnetic resonance imaging (DW-MRI) for new brain lesions, and adverse event reporting for safety. This is a form of outcomes data (imaging markers and clinical events).

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI/ML model that requires a training set. The "development" and "validation" involve engineering design, material science, and testing, not model training.

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

• Not applicable. See point 8.

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