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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 device consists of a fluid delivery module (motor driven piston syringe pump), a daily disposable cassette, a per-patient disposable handpiece and tubing set. and a wired foot pedal. The fluid delivery module delivers the medications or fluids from off-the-shelf vials via aspirated dispense. The user interface is via touch screen that allows the user to define per-delivery treatment volumes and regimens of off-the-shelf medications or fluids in accordance with their labeled indication and proposed dosage. Delivery of the user-defined regimen occurs through depression of the foot pedal that actuates dispense of the fluids through three individual fluid lines within the cassette. The fluid is then transported through the per-patient tubing and handpiece set where off-the-shelf needles are attached.

The provided text describes the Navigator™ Delivery System (Navigator DS), an infusion pump, and its regulatory submission. It does not contain information about acceptance criteria and a study proving the device meets these criteria in the typical format of a clinical or performance study with specific metrics and results. The document focuses on regulatory approval based on substantial equivalence to a predicate device and various engineering and safety tests.

Therefore, most of the requested information cannot be extracted from this text.

Here's what can be gathered based on the provided input:

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

   • The document states: "The test results demonstrated that the Navigator DS functions as designed and can be operated by the user as intended through the user interface and instructions provided. The results demonstrate that the Navigator DS is as safe and effective and performs as well as the predicate device."
   • Specific quantitative acceptance criteria (e.g., flow rate accuracy within X%, volume accuracy within Y%) and corresponding reported performance values are not provided in this summary.
   • The tests mentioned include:
     • Characterization of system functionality over viscosity, temperature, and pressure extremes.
     • Flow rate characterization.
     • Accuracy of volumes dispensed.
     • Flow profiles and rate accuracy.
     • Occlusion testing.
     • Integrity of fluid pathway components.
     • Software verification and validation.
     • Design verification and validation.
     • Sterilization validation.
     • Microbial ingress testing.
     • Viral ingress testing.
     • Dye ingress testing.
     • Cleaning validation.
     • Disinfection validation.
     • Biocompatibility.
     • IPA residuals assessment.
     • Chemical compatibility and extractables/leachables testing.
     • Simulated use/human factors studies.
     • Electrical safety testing.
     • Shipping validations.

2. Sample sized used for the test set and the data provenance

   • The document mentions "simulated use study of human factors" and "performance testing" but does not specify sample sizes for any of these tests.
   • Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned.

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

   • Ground truth or expert review in the context of device performance metrics is not explicitly discussed. The "simulated use study" involved "intended users," but their qualifications for establishing a "ground truth" are not detailed.

4. Adjudication method for the test set

   • An adjudication method (e.g., 2+1, 3+1) is not mentioned as this type of study was not conducted.

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

   • An MRMC study is relevant for imaging devices or AI-assisted diagnostic tools. The Navigator DS is an infusion pump. Therefore, an MRMC comparative effectiveness study was not conducted, and AI assistance is not applicable to this device's stated function.

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

   • This question is typical for AI/algorithmic devices. The Navigator DS is a mechanical infusion pump with software control. Its "standalone performance" is implicitly covered by the various engineering and functional tests mentioned (flow rate accuracy, volume dispensed, etc.), which assess the device's inherent capabilities separate from a human operator's specific actions, although the human factors study evaluates device operation by users.

7. The type of ground truth used

   • For an infusion pump, "ground truth" would typically refer to established engineering standards, physical measurements (e.g., actual vs. desired fluid volume, actual vs. desired flow rate), and safety specifications. The document implies these were used as the basis for performance evaluation, stating tests were "carried out to meet all elements of FDA's Draft Guidance 'Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions'." However, specific details are not provided.

8. The sample size for the training set

   • The concept of a "training set" is relevant for machine learning models. This device is an electromechanical infusion pump, not an AI/ML device. Therefore, a "training set" in this context is not applicable. The device's software was subject to "software verification and validation," which involves testing against requirements, but not "training" in the ML sense.

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

   • As a "training set" is not applicable, the establishment of its ground truth is also not applicable.

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