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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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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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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. Qualified ultrasound imaging units include the SonoSite M-Turbo and SonoSite M-MSK, (configuration part numbers L05323 and L05600, respectively).

This document describes the 510(k) submission for the Navigator™ Delivery System (Navigator DS) with added image integration capability. The submission asserts that this modification does not introduce new safety or effectiveness concerns, and thus, a full clinical evaluation was not required. The study focuses on demonstrating that the added image integration feature does not negatively impact the device's original safety and performance.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the traditional sense of a clinical or retrospective data set for evaluating an algorithm's performance on patient data. Instead, it appears the "test set" refers to the device itself and its interaction with the added feature. Therefore, there is no mention of sample size for patient data or data provenance (e.g., country of origin, retrospective/prospective). The testing described focuses on the device's engineering performance.

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

Not applicable. This is an engineering and functional performance evaluation of a device modification, not an assessment of an AI's diagnostic or predictive capabilities requiring expert-established ground truth on medical data.

4. Adjudication Method for the Test Set

Not applicable, as there is no mention of a human-in-the-loop diagnostic task requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "A Clinical Evaluation was determined not to be required as the device design, intended use and indication for use are preserved." This indicates the focus was not on comparing human reader performance with or without AI assistance but rather on the safety and functionality of the device with a new feature.

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

The primary focus of this submission is a device modification. The "image integration capability" described is about displaying treatment information from the Navigator DS on an ultrasound screen and printing ultrasound images on patient treatment records. It does not appear to be an AI algorithm with standalone diagnostic or predictive performance. Therefore, a standalone algorithm performance study as typically understood for AI-driven devices was not conducted. The "software validation" mentioned would cover the functionality of this integration.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this context refers to the expected functional performance and safety of the device. This was established through:

• Software Validation: Ensuring the software for image integration works as intended.
• Electrical Testing: Verifying safe electrical operation of connected devices.
• Simulated Use Testing: Confirming the device performs safely and effectively in simulated scenarios.
• Safety Case and Hazard Analysis: Identifying potential risks and ensuring mitigation measures are effective.

These are engineering and safety benchmarks, not clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. The described image integration is a functional modification to a device and does not involve an AI algorithm that would typically require a "training set" of medical data.

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

Not applicable, for the same reason as point 8.

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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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