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The Navigator™ AE is an infiltration pump used with the Cellfina handpiece to cause a flow of dilute Lidocaine from a bag for subcutaneous delivery of anesthetic in a manner controlled manually by a healthcare professional. The Navigator is not intended for use as an IV infusion pump.

The Navigator AE is an optional fluid delivery mechanism for use with the Cellfina Aesthetic handpiece. The device is comprised of the following major components: (1) a fluid delivery module (pump drive unit); (2) a disposable cassette that is designed for single use; and, (3) a wired USB foot pedal. The Navigator AE components interface with a commercially available single-use handpiece and tubing set that is discarded following use on a specific patient.

The provided text describes the acceptance criteria and performance testing of the Navigator Aesthetic Delivery System (Navigator AE), an infiltration pump.

Here's the breakdown of the information requested:

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

The document doesn't present a direct table of acceptance criteria with corresponding performance metrics in a concise format. Instead, it describes various performance tests and the overall conclusion that the device "functions as designed and can be operated by the user as intended," and that "The performance data demonstrates that the Navigator Aesthetic Delivery System is substantially equivalent to the named predicates."

However, we can infer the acceptance criteria from the "Performance Testing Summary" and list the reported performance implicitly:

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

The document does not explicitly state the sample sizes for the "test set" for most of the performance criteria. The testing discussed seems to involve engineering, laboratory, and simulated use studies rather than clinical data with a traditional "test set" of patient cases.

• Functionality: Number of units or test conditions are not specified.
• Software: "Zero unresolved software anomalies were reported," but the exact scope or sample size of testing is not detailed.
• Electrical Safety and EMC: Not specified.
• Biological and Drug Compatibility: Not specified (e.g., number of samples for each test).
• Sterility and Shelf Life: Not specified for sterilization validation, but a "Shelf Life of 6 months" was established.
• Human Factors: A "simulated use study" was conducted with "intended users," but the number of users or sessions is not specified.

Data Provenance: The studies appear to be laboratory-based and simulated use studies, rather than retrospective or prospective human clinical data from specific countries.

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 provided in the document. The studies described are primarily engineering, software, and laboratory tests, and a simulated human factors study. There is no mention of experts establishing a "ground truth" for a test set in the context of clinical evaluation or image interpretation. A "Clinical Evaluation was determined not to be required for the Navigator AE."

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

This information is not applicable/not provided. The performance tests are technical validations (e.g., flow rate accuracy, electrical safety, software V&V) and a simulated human factors study, not clinical studies requiring adjudication of outcomes or diagnoses.

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

There is no mention of an MRMC study or AI assistance in the document. The Navigator AE is an infusion pump, a hardware device, and not an AI-powered diagnostic or assistive tool for human readers.

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

This concept is not applicable as the device is an infusion pump. However, much of the performance testing (functionality, software, electrical safety, biological compatibility, sterility) can be considered "standalone" in the sense that it evaluates the device's inherent technical performance without a human operator performing clinical tasks. The human factors study involved human interaction, but its purpose was to evaluate usability and potential use errors.

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

The "ground truth" for the Navigator AE's performance is established by engineering specifications, recognized national and international standards (e.g., ISO, IEC, UL, ASTM, USP), and documented design requirements. For example:

• Fluid flow accuracy tested against defined flow rate and volume specifications.
• Software performance verified against design requirements and EN 62304.
• Electrical safety tested against UL60601-1, IEC 60601-2-24, and IEC 60601-1-2.
• Biocompatibility against ISO 10993-1.
• Sterility against ISO 11135 and a specified Sterility Assurance Level.

For the human factors study, the "ground truth" would be the expected safe and effective operation of the device by intended users according to its design and instructions, with deviations representing potential use errors.

8. The sample size for the training set

This information is not provided and is largely not applicable in the context of device performance testing for an infusion pump. The device does not appear to involve machine learning or AI models that require a "training set." The development process follows engineering and software development methodologies (e.g., V&V per EN 62304), not AI model training.

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

As there is no mention of a training set for machine learning/AI, this question is not applicable. The "ground truth" for the device's design and operation is established by engineering principles, regulatory requirements, and international standards, as described in point 7.

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