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The Outback Catheter is intended to facilitate placement and positioning of catheters within the peripheral vasculature. The Outback Catheter is not intended for use in the coronary or cerebral vasculature.

The Outback catheter features a 6 Fr. steel-braided polyimide and polyurethane shaft through which a single-lumen steel-braided polyimide guide is housed. The guide is extendable and steerable from the tip of the catheter shaft, and features a radiopaque multi-beveled guide tip allowing for visualization under fluoroscopy. A radiopaque index on the catheter shaft is oriented to the steerable guide tip. The proximal end of the Outback Catheter features a rotating hemostasis valve through which the guide is extended and retracted via a rotational handle mechanism.

The provided document is a 510(k) premarket notification for a medical device called the "Outback™ Catheter." This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a highly structured study with performance metrics in the way that an AI/ML device submission would.

Therefore, the requested information, such as "acceptance criteria," "reported device performance," "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "sample size for the training set" are not applicable to this 510(k) submission.

The document does not contain any information about a study designed to prove the device meets specific performance acceptance criteria in the context of an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to a previously marketed predicate device.

Here's a breakdown of what the document does state in relation to demonstrating equivalence:

1. Acceptance Criteria and Reported Device Performance:

• Not applicable. The document does not define specific performance acceptance criteria for the Outback™ Catheter that would be met through a quantitative study with reported metrics like sensitivity, specificity, etc.
• Instead, the document states: "Results of [costs were introduced] and physical properties are appropriate for the intended use." This refers to internal testing of the device's physical and functional properties to ensure it performs as expected for its intended use, but not against pre-defined clinical performance acceptance criteria.

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

• Not applicable. This information is not relevant to a 510(k) for demonstrating substantial equivalence of a physical medical device. There is no "test set" of data in the AI/ML sense.

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

• Not applicable. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication Method:

• Not applicable.

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

• Not applicable. This type of study is not mentioned as it's typically for assessing the impact of AI on human reader performance, which isn't the focus of this 510(k).

6. Standalone (Algorithm Only) Performance:

• Not applicable. This device is a physical catheter, not an algorithm.

7. Type of Ground Truth Used:

• Not applicable.

8. Sample Size for the Training Set:

• Not applicable.

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

• Not applicable.

Key takeaway from the document:

The basis for clearance is "substantial equivalence" to the predicate device (Outback™ Catheter (K001577)). The argument is that the new device has "the same intended use and technological characteristics as the Outback Catherer has the battle of scientific testing have ensured that all the predicate device (18001977)." This means the manufacturer performed tests to confirm that the materials, design, and function are comparable to the predicate and suitable for its intended use, rather than a clinical trial to establish new performance metrics against a defined ground truth.

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