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These devices are to be used by a trained physician only. Cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriately-sized cannula within the vessel for cardiopulmonary bypass. The Bio-Medicus™ cannula (18-cm [7.09-in] tip length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as venous return cannula. This product is intended for use up to 6 hours.

Bio-Medicus Cannula Kits contains the necessary components to achieve insertion of a Bio-Medicus cannula and introducer. The included items are: Adult Cannula and Introducer (in various sizes), a Seldinger needle, a guidewire, a scalpel blade, stepped dilators, and or a catheter tip syringe.

The Bio-Medicus Cannula Kit is intended to be used to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriate sized cannula within the vessel for cardiopulmonary bypass.

The Bio-Medicus Cannula Kit set consists of adult arterial and venous cannulae and introducer:

All kits are provided sterile and nonpyrogenic, disposable, and for single use only and comprised of:

• Adult Arterial and Venous Cannulae (in numerous sizes)
• Seldinger Needle
• Scalpel Blade
• Catheter Tipped Syringe
• Appropriately Sized Dilators and Guidewires

This submission will focus on the adult venous cannulae only and there are no other changes to the remaining kit components. The adult venous cannulae are all supplied sterile, and nonpyrogenic and are for single use only.

The adult venous cannula consists of:

• Polyurethane cannula with stainless steel wire-wound multi-port body
  • Non-vented 3/8-in connector
  • The overall length of the cannulae is 25.6-in and 30-in
• Insertion marks that aid in positioning the cannula
• Repositionable suture ring that is radiopaque

The one-piece non-phthalate PVC introducers included with these cannulae have an elongated taper for dilation over a longer distance.

The adult venous cannula package contains a securement clip which can be used near the insertion site for securement of the cannula body which aides in securement as well as an aide for physician organization. The large venous models (23-25 Fr) also contain a 3/8-in x ½-in tubing adapter with an attached length of 3/8-in tubing to allow connection to a ½-in cardio pulmonary bypass circuit.

This new adult venous cannulae consists of increased number of drainage side holes along the insertable length and the increase of depth markings from every 5cm to further aid in positioning of the cannula. The change is taking place on the 15 French (F) through 25 F adult venous cannulae.

The provided text describes a 510(k) premarket notification for a medical device, the Bio-Medicus Adult Cannula Kit. It details the device's indications for use, contraindications, and comparisons to a predicate device. However, the document does not contain acceptance criteria for device performance nor does it describe a study proving the device meets specific performance criteria in terms of effectiveness or clinical outcomes.

Instead, the submission focuses on demonstrating substantial equivalence to a previously marketed predicate device (Medtronic Bio-Medicus Adult Cannula Kit, K153598). This substantial equivalence is primarily established through comparisons of intended use, technological characteristics, operating principles, design features (with minor noted changes), materials, sterilization, and shelf life.

The "Summary of Performance Data" section mentions bench testing as the method used to verify performance characteristics, but it does not provide quantitative acceptance criteria or detailed results of these tests beyond listing the types of tests performed.

Therefore, I cannot fulfill all parts of your request as the information is not present in the provided document. I can, however, extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantitative performance metrics for clinical efficacy. The primary "acceptance criterion" in a 510(k) for substantial equivalence is that the device is as safe and effective as a predicate device.
• Reported Device Performance: The document states that the device is "substantially equivalent" to the predicate device. The specific performance characteristics verified through bench testing are listed, but no quantitative results or acceptance criteria for these tests are provided.

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

• Sample Size: Not specified. The document mentions "bench testing" but does not provide details on the number of units tested.
• Data Provenance: Not applicable in the context of clinical data. It involves bench testing of the device itself.

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

• Not applicable. This information is relevant for studies involving human interpretation or clinical data with expert-adjudicated ground truth. The provided document details bench testing, which does not involve experts establishing ground truth in this manner.

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

• Not applicable. As above, this is relevant for studies involving human interpretation.

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. This is a medical device (cannula kit), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant.

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:

• For the bench tests, the "ground truth" would be established by the specifications and measurable physical/chemical properties of the device and its interaction with test media (e.g., blood for trauma testing, fluid for pressure drop). It's based on engineering and material science principles rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

• Not applicable. This pertains to machine learning algorithms, which are not the subject of this 510(k) submission.

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

• Not applicable. As above, this pertains to machine learning algorithms.

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