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The Navigator HD Ureteral Access Sheath is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

Navigator™ HD Ureteral Access Sheath Set consists of a semi-rigid outer sheath and a semi-rigid inner dilator with interlocking hub. The set permits utilization of a guidewire to assist in device placement.

Sheath: The Navigator™ HD Sheath has a sheath hub which is over-molded onto the sheath shaft has three layers: Outer Pebax layer, Reinforced stainless steel coil enhancing torqueability and maneuverability, Inner PTFE liner. The sheath outer layer contains Barium Sulphate as a radiopacifier. In addition to the stainlesssteel coil, a radiopaque marker band is sandwiched between the Pebax and PTFE layers. The radiopaque marker band is located at the sheath tip and, along with the radiopacifier added to the sheath outer layer, enhances fluoroscopic visualization of sheath placement during the procedure. A hydrophilic coating is applied to the entire length of the shaft to reduce friction and facilitate placement of the device.

Dilator: The Navigator™ HD dilator has a hub with a standard luer lock at the proximal end. The tab on the dilator hub allows it to lock into the sheath hub. The dilator shaft is made of extruded tube Pellethane to allow for dimensional stability, low moisture absorption, and chemical resistance. The dilator tip is made of a softer grade of Pellethane to improve tip flexibility to assist in atraumatic placement. Both the dilator shaft and tip contain Barium Sulfate as a radiopacifier, enhancing visualization under fluoroscopy during the procedure. A hydrophilic coating is applied to the entire length of the dilator to reduce friction and facilitate placement of the device, either when assembled with the sheath or when used separately as a dilatation device.

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies that prove the device meets these criteria in the context of AI/ML are not applicable here.

The document discusses the substantial equivalence of the Navigator™ HD Ureteral Access Sheath Set to a previously cleared predicate device.

Here's the relevant information that can be extracted, addressing the spirit of the request as much as possible for a non-AI/ML device:

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

The document doesn't present "acceptance criteria" in the typical AI/ML sense (e.g., specific sensitivity/specificity thresholds). Instead, it relies on demonstrating substantial equivalence to an existing predicate device. The performance is assessed by comparing technological characteristics and performing design verification and usability testing related to a minor change.

2. Sample size used for the test set and the data provenance:

This is a physical medical device. The "test set" would refer to samples of the device undergoing engineering performance testing. The document does not specify sample sizes for the "Design Verification" or "Summative Usability" testing, nor does it mention data provenance (e.g., country of origin, retrospective/prospective clinical data). These would typically be detailed in internal test reports referenced by the submission but not included in this summary.

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

This is not applicable as this is not an AI/ML device requiring expert ground truth for classification or diagnosis. The "ground truth" for the device's performance relies on engineering specifications and established safety/efficacy profiles of similar devices.

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

Not applicable for a physical medical device. Adjudication methods are relevant for subjective interpretations of data, typically in clinical studies or AI/ML ground truth establishment.

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:

Not applicable. This is not an AI/ML device, and no human reader study with or without AI assistance was performed or needed.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" for the device's acceptable performance is based on:

• Engineering specifications and standards: Ensuring the device meets its design requirements.
• Performance testing results: Demonstrating functional equivalence and safety (e.g., mechanical performance, biocompatibility).
• Historical performance of predicate device: The K140323 device, which has a proven track record.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

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The Navigator (model: FMNVG15) and Navigator XL (model: FMNVX06) is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The Navigator (model: FMNVG15) and Navigator XL (model: FMNVX06) is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people.

The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, safety belt, pedal, battery box and charger. The device is powered by Li-ion Battery pack (24V 6Ah*2) with 16 Km range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

The provided document, a 510(k) Pre-market Notification for the Navigator and Navigator XL powered wheelchairs, does not describe a study involving an AI/Machine Learning device, expert adjudication, or complex ground truth establishment. Instead, it focuses on demonstrating substantial equivalence to a predicate device through adherence to established performance standards for medical devices like powered wheelchairs.

Therefore, many of the requested details, such as those related to AI/ML performance, human readers, training/test sets, and expert consensus for ground truth, are not applicable to this document.

However, I can extract the acceptance criteria and the "device performance" in terms of meeting those criteria.

Here's a breakdown of the information that is available in the document, formatted to the extent possible according to your request:

Acceptance Criteria and Device Performance (for a Powered Wheelchair)

This section describes the performance evaluation of the Forcemech International LLC Navigator and Navigator XL powered wheelchairs against established international standards for wheelchairs. The study's purpose was to demonstrate substantial equivalence to a predicate device (K232193) by meeting these standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to various parts of the ISO 7176 series of standards and ISO 10993 series for biocompatibility. The reported device performance is that the device meets or complies with these standards.

The document also provides specific performance values for some parameters, as compared to the predicate device, although these are not explicitly presented as "acceptance criteria" but rather as "comparison elements" that need to demonstrate substantial equivalence:

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document describes non-clinical testing performed on the device itself. For each standard mentioned (e.g., ISO 7176 series, ISO 10993 series), tests are conducted on a statistically appropriate number of units or materials according to the specific standard's requirements. This is not a patient-based test set but rather a device-based test set. The exact number of units tested for each standard is not specified in this summary but would be detailed in the full test reports.
• Data Provenance: The tests are "non-clinical tests" conducted to verify compliance with design specifications and substantially equivalence. The location of testing is implicitly China, given the applicant's contact person is in Shanghai, China, and the submission correspondent is also from Shanghai, China. The data would be prospective in the sense that the manufacturer specifically conducted these tests on their device models.

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

Not applicable. This is a non-clinical device performance study against engineering and safety standards, not a diagnostic AI/ML study requiring expert radiologists for image interpretation or clinical ground truth. The "ground truth" here is the adherence to the published ISO/IEC standards, which are developed by international expert committees through a consensus process.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical device performance study. The "adjudication" is met by passing the specified tests against the published standard criteria.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

No. This document explicitly states: "No clinical study is included in this submission." This type of study is for evaluating human performance, typically in diagnostic imaging, and is not relevant for a powered wheelchair's non-clinical safety and performance testing.

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

Not applicable. This is a medical device (powered wheelchair), not an AI/ML algorithm. The performance evaluation is for the physical device and its electrical/mechanical systems.

7. The Type of Ground Truth Used

The ground truth used for this device's acceptance is adherence to well-defined, internationally recognized engineering and safety standards (ISO 7176 series for wheelchairs, ISO 10993 series for biocompatibility, and IEC 60601-1-2 for EMC). These standards dictate specific test methods and acceptance criteria that the device must meet to be considered safe and effective for its intended use.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable. There is no AI/ML training set.

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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™ HD Ureteral Access Sheath Set is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

The Navigator ™ HD Ureteral Access Sheath Set is designed to provide the physician with reliable access to the urinary tract, the ability to inject fluids, and act as a conduit for device exchanges. Like all ureteral access sheath sets, Navigator™ HD also protects the ureter during device exchanges, thus helping reduce tissue trauma. This set consists of two components: an inner tapered semirigid dilator and an outer semi-rigid sheath. The outer sheath fits over the inner dilator, and the design of the hub allows the dilator to lock into the sheath. Both the dilator and sheath are radiopaque and have a lubricous hydrophilic coating. The device is offered in three French sizes, 11/13 Fr, 12/14 Fr and 13/15 Fr, in lengths up to 46cm. The Navigator ™ HD Ureteral Access Sheath Set is intended for single use only.

The provided text is for a 510(k) summary for a medical device called the "Navigator™ HD Ureteral Access Sheath Set" by Boston Scientific. The information pertains to the regulatory submission process and describes the device's characteristics and intended use, comparing it to a predicate device.

Crucially, this document does NOT describe a study that involves an AI or software algorithm, nor does it provide performance metrics in the way you've requested for an AI/software-based device.

The "Performance Testing (Bench Evaluation)" section refers to physical bench tests conducted on the device, such as "Dilator Tip Weld / Shaft Integrity" and "Flexible Tip Weld Integrity (Durability)", to support the addition of a flexural durability specification. This is a hardware device, not a software or AI device.

Therefore, I cannot provide details on:

• Acceptance criteria and reported device performance related to AI/software metrics.
• Sample sizes for test sets, data provenance, or ground truth establishment for AI/software.
• Number of experts, their qualifications, or adjudication methods for AI/software ground truth.
• MRMC comparative effectiveness studies or standalone AI performance.
• Sample size or ground truth for a training set for an AI/software algorithm.

In summary, the provided document does not contain the information requested as it describes a physical medical device (a ureteral access sheath) and its bench testing, not an AI or software-based device.

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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 disposable cassette, a reusable cassette housing, disposable vial clamps, per-patient disposable handpiece and tubing, 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 510(k) submission (K124053) for the Navigator DS Next Generation Disposables is a Special 510(k) which does not include a traditional study with acceptance criteria and device performance as typically expected for new device submissions or AI/ML-driven devices. Instead, it focuses on demonstrating that a modification to an already cleared device (Navigator DS, K122215) maintains the same safety and performance profile.

Therefore, many of the typical elements of a study with acceptance criteria and a table of performance are not explicitly present in the provided document. The submission argues for substantial equivalence based on the preservation of technological characteristics, intended use, and performance characteristics of the predicate device, rather than new quantitative performance metrics.

Here's an analysis based on the provided text, addressing the requested information where applicable, and noting where information is not available due to the nature of a Special 510(k) for a device modification:

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

Given the nature of this Special 510(k) for a modification (next-generation disposables), specific quantitative performance acceptance criteria and reported device performance in a table format, as one might find for an entirely new device or AI algorithm, are not explicitly provided or required. The acceptance criteria are implicitly that the modified device's performance, safety profile, and intended use are not altered compared to the predicate device.

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

This document does not specify a "test set" in the context of clinical data or algorithm validation with a specific sample size. The performance testing and human factors evaluations mentioned are engineering and usability tests, not a clinical study on a patient cohort. Therefore, information on patient sample size, data provenance, or retrospective/prospective nature is not applicable and not provided.

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 applicable and not provided. Since there is no clinical "test set" or diagnostic algorithm requiring ground truth establishment by experts, this detail is absent.

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

This information is not applicable and not provided for the same reasons as #3.

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 comparative effectiveness study is typically performed for AI or imaging devices where human interpretation is involved. This device (an infusion pump with disposables) is a mechanical system, not an AI/imaging device requiring human interpretation, nor does it incorporate AI assistance for human readers. Therefore, no MRMC study was performed, and this information is not applicable.

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

This refers to the performance of an AI algorithm directly. The Navigator DS is an infusion pump, a hardware device, not an AI algorithm. Therefore, no standalone algorithm performance study was done, and this information is not applicable.

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

This information is not applicable and not provided. As noted, there's no clinical "test set" requiring ground truth for a diagnostic purpose. The "ground truth" here is effectively the accepted performance and safety profile of the predicate device, against which the modified device's engineering and human factors performance were compared.

8. The sample size for the training set

This information is not applicable and not provided. The Navigator DS is a mechanical infusion pump, not an AI/machine learning model that requires a training set.

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

This information is not applicable and not provided for the same reasons as #8.

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The UASS is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

The Navigator TM HD Ureteral Access Sheath Set is designed to provide the physician with reliable access to the urinary tract, the ability to inject fluids, and act as a conduit for device exchanges. Like all ureteral access sheath sets, Navigator™ HD also protects the ureter during device exchanges, thus helping reduce tissue trauma. This set consists of two components: an inner tapered semi-rigid dilator and an outer semi-rigid sheath. The outer sheath fits over the inner dilator, and the design of the hub allows the dilator to lock into the sheath. Both the dilator and sheath are radiopaque and have a lubricous hydrophilic coating. The device is offered in three French sizes, 11/13 Fr, 12/14 Fr and 13/15 Fr, in lengths up to 46cm.

To guide the access sheath into the body orifice, the dilator is advanced over up to a .038" guidewire. The device can be visualized under x-ray (fluoroscopy) during placement to confirm location. The proposed device can accept other urological instrumentation with OD's compatible with the sheath's OD of 11, 14 and 13 Fr.

The proposed device is provided sterile single use. The packaging materials used for the proposed Navigator™ HD are commonly used materials for packaging medical devices and similar to the predicate device. The device will be packaged in a labeled, single polyfilm/tyvek peel pouch, which will be placed in a labeled, paperboard shelf carton.

Acceptance Criteria and Study for Navigator™ HD Ureteral Access Sheath

The Navigator™ HD Ureteral Access Sheath is a Class II medical device, and its acceptance criteria and the study proving its compliance were assessed through performance testing (bench evaluation) to demonstrate substantial equivalence to its predicate device, the Navigator™ Ureteral Access Sheath. This is a traditional 510(k) pathway, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy trials for novel devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test were implicitly met if the "results of the performance testing demonstrate equivalence of the Navigator™ HD to the predicate Ureteral Access Sheath Set." The document explicitly states this after listing the conducted tests. The device performance (results) for each specific test are not numerically provided in this summary but are summarized as demonstrating equivalence.

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

• Sample Size: The document does not specify the exact sample sizes used for each individual performance test. It broadly states "Boston Scientific has conducted performance testing with samples aged at T=0 and T=25 months accelerated aging."
• Data Provenance: The data is from retrospective bench testing conducted by Boston Scientific, the device manufacturer. The "country of origin of the data" is not explicitly stated but is implied to be internal testing by Boston Scientific (headquartered in Marlborough, MA, USA).

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

This type of information is not applicable to this submission. The "ground truth" here is based on engineering specifications and performance benchmarks, not human expert interpretation of medical images or conditions. The tests are objective measurements of physical and mechanical properties.

4. Adjudication Method for the Test Set

Not applicable. Performance testing, particularly bench testing for medical devices, involves objective measurements against predefined specifications or comparison to a predicate device's performance, not subjective adjudication by experts.

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

No, an MRMC comparative effectiveness study was not conducted. This device is a physical instrument, and its effectiveness is determined by its mechanical properties and ability to facilitate procedures, not by human interpretation of its output. MRMC studies are typically for diagnostic imaging devices or algorithms that aid in clinical decision-making.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical ureteral access sheath, not an algorithm or AI system. Therefore, no standalone algorithm performance study was performed.

7. Type of Ground Truth Used

The "ground truth" for this device's performance testing is based on engineering specifications and established performance characteristics of the predicate device. The tests quantify physical attributes and functional capabilities (e.g., tensile strength, stiffness, trackability, leak resistance) against acceptable ranges or the performance of a similar, already-approved device.

8. Sample Size for the Training Set

Not applicable. As this is a physical medical device and not an AI/ML algorithm requiring a training set, there is no "training set" in the context of this submission. The "training" for the device's design comes from engineering principles and existing device knowledge.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The device's design and manufacturing processes are established based on engineering standards and regulatory requirements.

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The NavigatorTM 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Navigator™ Delivery System (Navigator DS):

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the submission is for a minor modification to an already cleared device, the Navigator DS (K120830). The modification involves "modified resistance thresholds." The core approach to acceptance criteria is demonstrating that this minor change does not negatively impact safety or performance and that the device remains substantially equivalent to the predicate.

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

The document does not specify a separate "test set" in the context of a clinical study or a distinct, statistically powered performance test with a specific sample size. Instead, it refers to "Performance Data: Testing of the Navigator DS."

• Sample Size for Test Set: Not explicitly stated. The nature of the testing implies engineering/performance testing rather than a patient-based clinical study.
• Data Provenance: Not specified. Given it's a device modification, the testing would likely be internal to the manufacturer (Carticept Medical, Inc.). It is not stated whether this was retrospective or prospective data, but "testing" generally implies prospective data generation. There is no information about the country of origin for the data beyond the manufacturer's location in Alpharetta, GA, USA.

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

This information is not applicable or not provided in the context of this submission. The submission is for a minor device modification and relies on engineering performance testing and risk analysis, not on expert-adjudicated ground truth derived from clinical data (e.g., radiologist reviews of images).

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Since there's no mention of a human-reviewed test set or clinical study requiring adjudication, this concept does not apply to the provided data.

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 type of study would involve human readers evaluating cases, which is not relevant for this device modification.

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

This question is not applicable to the Navigator DS. The Navigator DS is an "Infusion Pump, External" and not an AI or algorithm-based diagnostic device. The performance data discussed refers to the physical and functional performance of the infusion pump itself (e.g., pressure thresholds, fluid delivery mechanics), not a standalone algorithm's accuracy.

7. The Type of Ground Truth Used

The "ground truth" here is the established performance specifications and safety requirements for an infusion pump, and the demonstrated functional equivalence to its predicate device. This is based on:

• Engineering specifications and test methods: To verify the modified resistance thresholds meet the intended design and function.
• Risk analysis (Safety Case and Hazard Analysis): To ensure the device's operation remains safe within defined parameters.
• Comparison to predicate device performance: The predicate (K120830) itself would have had its performance and safety verified against established standards. This submission states "the system has been demonstrated to provide the same level of performance as the predicate device."

8. The Sample Size for the Training Set

This information is not applicable or not provided. The Navigator DS is a hardware device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML development.

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

This information is not applicable or not provided 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 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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