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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.

The Bio-Medicus™ Adult Cannulae and Introducer is intended 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™ Adult Cannulae and Introducer set consists of adult arterial and venous cannulae and introducer. This submission will focus on the adult venous cannulae only. The adult venous cannulae are all supplied sterile, and non-pyrogenic and are for single use only.

The adult venous cannula consists of:

• o Polyurethane cannula with stainless steel wire-wound multi-port body
  • o Non-vented 3/8-in connector
  • The overall length of the cannulae is 25.6-in and 30-in o
• Insertion marks that aid in positioning the cannula ●
• o 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 Bio-Medicus™ Adult Cannulae and Introducer 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 ½in cardio pulmonary bypass circuit.

This new Bio-Medicus™ Adult Cannulae and Introducer set consists of increased number of drainage side holes along the insertable length and the increase of depth markings from every 10cm to 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 Bio-Medicus cannulae.

The provided FDA 510(k) summary (K180453) describes a device, the Bio-Medicus™ Adult Cannulae and Introducer. However, it does not contain information related to a study that establishes acceptance criteria for performance metrics typically associated with AI/ML-driven devices, such as sensitivity, specificity, or reader improvement.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench) testing. The acceptance criteria and performance data are related to the physical and functional aspects of the cannulae, not diagnostic accuracy or AI performance.

Therefore, many of the requested details (sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types, training set sample size, and ground truth for training set) are not applicable to this submission as it is not for an AI/ML medical device.

Here's the information that can be extracted from the document:

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

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

This information is not provided in the document as the studies are non-clinical bench tests. The concept of a "test set" in the context of clinical data or AI/ML performance is not applicable here.

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 applicable as the studies are non-clinical bench tests, and ground truth in the context of expert diagnosis is not relevant.

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

This information is not applicable as the studies are non-clinical bench tests.

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. This is not an AI/ML device, and no MRMC study was conducted.

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

This information is not applicable. This is not an AI/ML device.

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

This information is not applicable. For bench testing, the "ground truth" refers to engineering specifications and performance standards against which the device is tested.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device, and therefore no training set was used.

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

This information is not applicable. This is not an AI/ML device.

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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 faciliate 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 a venous return cannula. This product is intended for use up to 6 hours.

The adult venous and arterial cannulae consist of a polyurethane wirewound body with a multiport distal tip. The adult venous cannula also has a multi-port body built with stainless steel wirewinding and reinforced baskets. All adult arterial cannulae come with a vented 3/8-in vented connector and all of the adult venous come with a non-vented 3/8-in connector. The overall length of the cannulae is 12.5-in for the adult arterial/jugular and 25.6-in, 26.5-in and 30in for the adult venous. The Adult cannulae come with a repositionable suture ring that is radiopaque. Insertion depth marks aid in positioning the cannula. The one-piece non-phthalate PVC introducers included with these cannulae have an elongated taper for dilation over a longer distance. The Adult Cannula and Introducer 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 (Sizes 23 - 29 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. Sterile, nonpyrogenic, single use.

The provided text describes the regulatory clearance of a medical device, the "Bio-Medicus Adult Cannulae and Introducer," and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, quantitative performance results, or a detailed study description suitable for populating the requested table and answering all questions about a specific study proving device meets acceptance criteria.

The document primarily focuses on:

• Regulatory clearance (510(k) submission): This is about demonstrating "substantial equivalence" to existing devices, not necessarily proving absolute safety or efficacy against pre-defined performance thresholds in the way a clinical trial would.
• Device description and intended use.
• Comparison to predicate devices: Highlighting similarities and minor differences.
• Summary of performance data: Listing the types of pre-clinical bench and animal testing performed, but without providing the actual results, acceptance criteria, or methodology details of these tests.

Therefore, I cannot fully complete the requested table or answer all questions as the necessary detailed information is not present in the provided text.

Here's what can be extracted and what information is missing:

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

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

• Sample size: Not specified. The document only mentions "Pre-clinical bench testing" and "Animal testing."
• Data provenance: "Pre-clinical bench testing" and "Animal testing." No country of origin is specified. The nature of the testing (bench and animal) implies it's prospective for the specific tests conducted.

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. This device is a physical medical instrument (cannula and introducer) cleared based on pre-clinical and animal testing, not on interpretation of medical images or diagnostic outputs that would require expert ground truth labeling.

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

• Not applicable. (See answer to #3)

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 not an AI/imaging device.

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

• No. This is not an AI/imaging device.

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

• For physical device testing, "ground truth" would typically be derived from engineering standards, validated measurement methods, or physiological parameters observed in animal models. The document doesn't detail the specific benchmarks or "ground truth" for each test type (e.g., what constitutes acceptable blood trauma, pressure drop, or cannula life). It only states that the device "performed as well or better than the legally marketed devices," implying a comparison against established performance of the predicate.

8. The sample size for the training set

• Not applicable. This is not a machine learning device that requires a training set.

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

• Not applicable. (See answer to #8)

Missing Information Summary:

The provided document is a 510(k) clearance letter and summary. It lists the types of tests performed (Blood Trauma, Sterilization, Biocompatibility, Packaging, Pressure Drop, Cannula Life, Cannula and Introducer, Cannula, Introducer, Securement Clip Testing) but does not include:

• Specific quantitative acceptance criteria or threshold values for any of these tests.
• The actual test results in a quantitative format.
• Details on the methodology (e.g., number of units tested, duration, specific metrics measured, statistical analyses).
• Details of the "Animal testing" beyond its mention.

Without these specifics, it's impossible to fully describe "the study that proves the device meets the acceptance criteria" in terms of explicit criteria and reported performance values. The clearance hinges on the conclusion that it performed "as well or better than the legally marketed devices" based on these unspecified tests.

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