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The Navigator™ Delivery System (Navigator DS) is intended for use in the delivery of medication and/or fluids in a controlled manner. The Navigator DS is indicated for use in the intermittent delivery of medications and other fluids in intra-articular applications.

The Navigator Delivery System (Navigator DS) consists of a fluid delivery module, a daily disposable cassette, a per-patient disposable handpiece and tubing set, and wired foot pedal. Image integration with qualified ultrasound units occurs by Ethernet cable connection, if desired, allowing simultaneous display of Navigator treatment information on the ultrasound screen and printing of ultrasound images on the patient treatment record.

This is a 510(k) summary for a minor modification to an existing device, the Navigator™ Delivery System (Navigator DS). The modification involves an "alarm modification" and does not alter the device design, intended use, or indication for use. Therefore, the information provided is limited, and many of the requested criteria for studies would not be applicable or available in this type of submission.

Here's an attempt to answer your questions based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical acceptance criteria in the format typically seen for diagnostic performance studies (e.g., sensitivity, specificity thresholds). Instead, the acceptance criterion for this modification was that the safety and performance of the device are not affected by the alarm modification.

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

• Sample Size for Test Set: Not specified. The document states "Testing of the Navigator DS was carried out, including performance testing." It does not provide details on the number of units or test scenarios.
• Data Provenance: Not specified. Given the nature of a medical device modification, it is almost certainly prospective testing conducted by the manufacturer, rather than retrospective clinical data.

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

• This information is not provided. Given that this is a performance test for a mechanical/software alarm modification, "ground truth" would likely be established by engineering specifications and direct observation/measurement of system behavior by qualified engineers/testers, rather than clinical experts.

4. Adjudication Method for the Test Set

• This information is not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies for diagnostic accuracy, which is not the focus of this submission. The "adjudication" for performance testing of an alarm would be based on whether the alarm triggered correctly under expected conditions and did not trigger incorrectly.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids, assessing how AI impacts human interpretation. The Navigator DS is an infusion pump, and this submission concerns a minor alarm modification, not AI.

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

• This question is not applicable to this device. The Navigator DS is a physical medical device, an infusion pump, not an AI algorithm. "Standalone performance" would refer to the pump's ability to deliver fluids as intended, which was assured to be unaffected by the alarm modification.

7. The Type of Ground Truth Used

• The term "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data) is not directly applicable here. For performance testing of an alarm modification on an infusion pump, the "ground truth" would be the engineering specifications and design requirements for alarm behavior in various conditions (e.g., occlusion, low fluid), and the observed behavior of the device during testing.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This is not an AI/machine learning device that requires a training set. The device's functionality is based on its physical and software design, not learned from data.

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

• Not applicable. As stated above, this device does not use a "training set" in the context of AI/machine learning.

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