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The Cardeon® Ascending Balloon Cannula is intended to perfuse the aorta during open chest (sternotomy) procedures on cardiopulmonary bypass up to 6 hours. The occlusion balloon isolates the heart from the ascending aorta when inflated. The ABC also allows delivery of antegrade cardioplegia and venting of the aortic root.

The Ascending Balloon Cannula is substantially equivalent to currently marketed devices used to directly cannulate and perfuse from a general cardiac surgery patients undergoing coronary artery bypass grafting or valve replacement and/or repairs on CPB via sternotomy. Aortic occlusion is achieved by the fluid inflation of an integrated balloon thereby preventing the backflow of blood into the surgical field. Additional lumens allow delivery of antegrade cardioplegia or venting of the aortic root. The subject and predicate devices use standard attachments for connection(s) to cardiopulmonary bypass circuit.

The provided text describes the Cardeon® Ascending Balloon Cannula (ABCTM) and its regulatory clearance (K022042). However, it does not contain a detailed study report with specific acceptance criteria, reported device performance metrics, or data provenance as requested.

The submission is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive study with quantitative acceptance criteria and detailed performance data.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantitative metrics (e.g., specific force limits, flow rates, failure rates thresholds). The general "acceptance criteria" are implied to be that the device functions "as safely and effectively as predicate arterial return cannulae and aortic occlusive balloons."
• Reported Device Performance:
  • "Results of product testing demonstrated that the Ascending Balloon Cannula functions as safely and effectively as predicate arterial return cannulae and aortic occlusive balloons."
  • This is a qualitative statement of equivalence, not specific quantitative performance data against defined criteria (e.g., "burst pressure > X mmHg", "flow rate > Y L/min with < Z mmHg pressure drop").

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

• Sample Size: Not specified for any specific in vitro or in vivo tests. The document only mentions "product testing."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

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

• Not applicable as this is not a study involving expert review for diagnostic accuracy. The "ground truth" for this device would be its functional performance and safety, assessed through engineering tests and potentially animal studies, not expert interpretation of image data.

4. Adjudication Method for the Test Set:

• Not applicable for the type of device testing described.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images with and without AI assistance. The Cardeon Ascending Balloon Cannula is a therapeutic/surgical device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

• Not applicable. This device is a physical medical device, not an algorithm, so "standalone algorithm performance" is not a relevant concept here. The "standalone" performance refers to the device's functional integrity as a physical product (e.g., material strength, flow characteristics), which was assessed via "product testing" (in vitro and in vivo).

7. The Type of Ground Truth Used:

• For a device like the Ascending Balloon Cannula, the "ground truth" for performance assessment is based on:
  • Engineering specifications and standards: The device must meet predefined physical and functional parameters (e.g., material strength, burst pressure, flow rates, occlusion capability).
  • Biocompatibility testing: Compliance with ISO 10993 standards or similar.
  • In vivo functional assessment: Performance in animal models (if applicable) or benchtop models simulating physiological conditions.
  • Clinical experience with predicate devices: The "ground truth" for safety and effectiveness is largely benchmarked against the established performance of existing, legally marketed predicate devices.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device.

In summary:

The provided 510(k) summary for the Cardeon Ascending Balloon Cannula demonstrates substantial equivalence primarily through comparison to predicate devices and general "product testing" (biocompatibility, in vitro, and in vivo performance). It does not provide the detailed, quantitative study specifics often expected for AI/ML devices or studies focused on precise diagnostic accuracy metrics. The regulatory pathway for this device emphasizes demonstrating that it performs "as safely and effectively" as similar devices already on the market, rather than meeting specific novel performance benchmarks established through a detailed, publicly documented study with specified sample sizes and expert adjudication.

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