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The Jostra Arterial Cannulae (adults) are designed to be used as perfusion cannulae during extracorporeal circulation during cardiopulmonary bypass up to 6 hours or less.

The Jostra Adult Arterial Cannulae are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to return arterial blood to the patient via the antic root or other large artery during extracorporeal circulation. to the cannulae are made from polyvinyl chloride (PVC) and range in size from 20fr. to 24fr. with a variety of tips, with or without attached connectors. The cannulas are specifically designed for use on patients requiring more than 3L/Min. of blood flow.

The Jostra Adult Arterial Cannulae is a medical device designed for use in cardiopulmonary bypass procedures. The device's acceptance criteria and performance were assessed through a non-clinical testing study to demonstrate substantial equivalence to a predicate device, the Medtronic DLP Adult Arterial Cannulae.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not specify the exact sample sizes used for each individual performance test (Flow-Pressure curves, Kink Resistance, Bond Strength, Leakage Test, and in-vitro testing for cellular effects). The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given it is a premarket notification for a new device, the testing would typically be prospective, carried out by the manufacturer.

3. Number of Experts and Qualifications:

Not applicable. This was a non-clinical performance and biocompatibility study, not a clinical study involving expert judgment for ground truth.

4. Adjudication Method:

Not applicable. Adjudication methods are typically relevant for clinical studies involving multiple reviewers; this was non-clinical testing.

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

No MRMC comparative effectiveness study was mentioned. The study focused on technical performance and biocompatibility rather than human reader performance with or without AI assistance.

6. Standalone Performance Study:

Yes, a standalone study of the device's performance was done. The non-clinical testing evaluated the device's physical properties and biocompatibility as a standalone entity. There is no mention of human-in-the-loop performance since the device is a physical cannula, not an AI or imaging diagnostic tool.

7. Type of Ground Truth Used:

The "ground truth" for this type of device is established through engineering and biological standards. For example:

• Performance Tests: The ground truth for flow-pressure curves, kink resistance, bond strength, and leakage tests would be established by validated engineering specifications and industry standards for cardiopulmonary bypass cannulae. The "truth" is whether the device meets these pre-defined physical and functional requirements.
• Biocompatibility: The ground truth is compliance with relevant biological safety standards (e.g., ISO 10993 series) and demonstration that the device material does not cause adverse biological reactions or affect cellular components.

8. Sample Size for the Training Set:

Not applicable. This device is a physical medical instrument, not an AI/machine learning model, so there is no "training set" in that context. The testing involved samples of the manufactured device.

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

Not applicable, as there is no training set for this type of device. The "ground truth" for evaluating the performance and biocompatibility of the Jostra Adult Arterial Cannulae was based on established engineering principles, industry standards, and biological safety guidelines for similar medical devices. The predicate device (Medtronic DLP Adult Arterial Cannulae) also served as a benchmark for comparison.

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The Jostra Pediatric Arterial Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracoproeal circuit to the patient during cardiopulmonary bypass up to 6 hours or less.

The Jostra Pediatric Arterial Cannulae are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to return arterial blood to the patient via the aortic root or other large artery during extracorporeal circulation. The cannulaer are made from polyvinyl chloride (PVC) and range in size from 8fr. to 16fr. with a variety of tips, with or without attached connectors. The cannulas are specifically designed for pediatric use.

Here's a breakdown of the acceptance criteria and study information for the Jostra Pediatric Arterial Cannulae, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states "Performance testing included" a list of tests, but does not provide details on the number of cannulae tested for a "test set."
• Data Provenance: Not specified. The document does not mention the country of origin of the data or whether it was retrospective or prospective. Given the nature of medical device testing for 510(k) (pre-market notification), it would typically involve prospective, controlled laboratory testing.

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

This information is not applicable and not provided as this submission is for a physical medical device (cannulae) and not an AI/software device that requires expert-established ground truth for image or data interpretation. The "ground truth" for this device's performance is established by direct physical measurements and laboratory tests against engineering specifications and comparison to an established predicate device.

4. Adjudication Method for the Test Set

This information is not applicable as the testing involved direct physical measurements and comparison to a predicate device, not subjective interpretation requiring adjudication among experts.

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

• Was it done?: No.
• Effect size: Not applicable, as this is a physical medical device and not an AI system being evaluated for its impact on human reader performance.

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

• Was it done?: Not applicable. This is not an AI/algorithm. The performance studies detailed are for the physical device itself.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily:

• Engineering Specifications / Performance Standards: Implied for tests like kink resistance, bond strength, leakage, and flow-pressure curves.
• Predicate Device Performance: The primary "ground truth" for substantial equivalence is the performance of the legally marketed Medtronic DLP Pediatric Arterial Cannulae. The Jostra device performance is directly compared to it across various attributes ("operation, materials, design, and performance").

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• How established?: Not applicable, as there is no training set for this type of device submission.

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