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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™ 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 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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Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract via antegrade and/or retrograde access.

The UASS II is designed to create a conduit for urological procedural instruments. This set consists of two components: an inner tapered semi-rigid dilator and an outer more flexible sheath. The outer flexible sheath fits over the semi-rigid inner dilator and it may be locked into place. These components are radiopaque and have a lubricous hydrophilic coating. The device is offered in two French sizes, 11/13 Fr, and 13/15 Fr. in lengths up to 46cm. The UASS II may be placed retrograde and/or antegrade. 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 working channel of 11 and 13 Fr, respectively. The proposed device is provided sterile single use. The packaging materials used for the proposed UASS 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 double sealed, which will be placed in a labeled, paperboard shelf carton.

The provided document is a 510(k) premarket notification for a medical device called the "Ureteral Access Sheath Set II" (UASS II). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with acceptance criteria for device performance as would be found in a PMA (Premarket Approval) application.

Therefore, the document does not contain the detailed clinical study information typically provided for AI/ML-based devices, such as a table of acceptance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC studies. The device in question is a physical medical instrument, not an AI/ML algorithm.

However, based on the information provided, here's what can be extracted and inferred:

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

The document doesn't provide specific quantitative acceptance criteria or detailed performance results in a table format as would be seen for an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device.

The "performance data" mentioned focuses on physical comparison and functional testing to support this equivalence. The reported "performance" is that the device is determined to be substantially equivalent to the predicate.

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

The document does not describe a "test set" in the context of clinical data for an AI/ML algorithm. For a physical device like this, "testing" would refer to engineering and bench testing. The sample sizes for these tests are not provided in this summary. Data provenance (country of origin, retrospective/prospective) is not applicable here as it's not a clinical data study.

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. "Ground truth" in this context typically refers to clinical diagnoses or outcomes for AI/ML evaluation. For a physical device, testing involves engineering standards and functional verification, not expert interpretation of clinical cases for ground truth.

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

Not applicable, as there's no clinical test set requiring expert adjudication mentioned.

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. MRMC studies are specific to evaluating human performance with and without AI assistance, which is not relevant for a physical ureteral access sheath.

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

Not applicable. This device is a physical instrument, not an algorithm.

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

Not applicable. The "ground truth" for a physical device is its adherence to design specifications, material properties, and functional performance as determined by engineering tests and manufacturing standards, not clinical diagnostic outcomes.

8. The sample size for the training set:

Not applicable. "Training set" refers to data used to train an AI/ML model, which this device is not.

9. How the ground truth for the training set was established:
Not applicable.

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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 via antegrade and/or retrograde access.

The UASS is designed to create a conduit for urological procedural instruments. This set consists of two components: an inner tapered semi-rigid dilator and an outer more flexible sheath. The outer flexible sheath fits over the semi-rigid inner dilator and it may be locked into place. These components are radiopaque and have a lubricous coating UroGlide™. The device is offered in two French sizes, 11/13 Fr, and 13/15 Fr. in lengths up to 49cm.

The UASS may be placed retrograde and/or antegrade. 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 xray (fluoroscopy) during placement to confirm location. The proposed device can accept other urological instrumentation with OD's compatible with the sheath's working channel of 11 and 13 Fr, respectively.

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

I am sorry, but based on the provided document, I cannot find the information requested regarding acceptance criteria and the study that proves the device meets them. This document is a 510(k) substantial equivalence letter for the UASS (Ureteral Access Sheath Set). It focuses on regulatory approval based on demonstrating equivalence to predicate devices, rather than presenting detailed study results against specific performance acceptance criteria.

The document discusses:

• The device name and its regulatory classification.
• The determination of substantial equivalence to predicate devices.
• General regulatory requirements for the device.
• Indications for Use.
• A summary of safety and effectiveness, including device description and intended use.

It does not contain:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or expert qualifications for a test set.
• Details on adjudication methods.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone performance data.
• The type of ground truth used or details about training set size and ground truth establishment.

The purpose of this type of FDA document is to formally communicate the FDA's decision regarding substantial equivalence for marketing, not to provide the underlying performance studies in detail.

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The Ureteral Access Sheath Set is indicated for use in endoscopic urology procedures, by facilitating the passage of endoscopes and other instruments through the urinary tract.

The Ureteral Access Sheath Set is a single use sterile device, indicated for use in endoscopic urology procedures, to facilitate the passage of endoscopes and other instruments through the urinary tract. It is comprised of two components: a dilator with a tapered tip and a tapered sheath. Both the sheath and the dilator are made from polyurethane. The sheath length varies from 20 cm (shortest) to 60 cm (longest) by model. A luer fitting made attached to the proximal end of the dilator may be used to introduce contrast during a retrograde pyelogram procedure. The dilators range in length from 25 cm (shortest) to 70 cm (longest). The thru-lumen of the dilator tip is 0.040 - 0.045 inches and it can be used over a guidewire of up to .038 inches diameter. The sheath and the dilator are coated with a hydrophilic coating, which is activated by wetting the device in saline or sterile water. The hydrophilic feature allows for easier insertion and removal of the ureteral sheath. The luer fitting on the dilator cannot be pushed through the lumen of the cone shaped handle because of its larger size and therefore acts as a safety feature by preventing the dilator from being over inserted into the sheath. A latch mechanism is added to the ureteral access sheath set, which locks the dilator in place inside the sheath during insertion of the dilator and sheath in the urological tract. Two suture loops are attached at the cone of the sheath, which may be used to secure the sheath to the drapes of the patient to retain the sheath in position during surgery.

The provided text describes a 510(k) summary for a medical device, the Ureteral Access Sheath Set, not an AI/ML-powered device. Therefore, the requested information regarding AI/ML-specific study design elements (such as sample sizes for test/training sets, ground truth establishment for AI, MRMC studies, standalone performance, and expert qualifications/adjudication methods) is not applicable and not present in the given document.

The document discusses performance data related to the physical characteristics and functionality of the device, which are traditional engineering and material science tests, not clinical performance studies involving a test set, ground truth, or human-in-the-loop performance.

Here's a breakdown of the available information regarding acceptance criteria and the study, adapted to the context of this traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Performance Data Summary" section, which lists the types of tests performed to demonstrate the device's functionality and equivalence to predicate devices. The reported device performance is that these tests were successfully completed, indicating substantial equivalence.

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

• Sample Size: Not specified. This type of device performance testing typically involves a specific number of units from manufacturing lots, but the document does not detail this.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The data comes from internal laboratory testing of the device itself.

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

Not applicable. Ground truth, in the context of AI/ML, refers to clinically validated diagnoses or outcomes. For this device, "ground truth" is adherence to engineering specifications and functional requirements. The "experts" would be the engineers and quality control personnel performing or overseeing the tests.

4. Adjudication method for the test set

Not applicable. There is no ambiguous clinical data requiring adjudication. Tests have objective pass/fail criteria based on specifications.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

7. The type of ground truth used

For this device, the "ground truth" is the engineering specifications and quality control standards against which the device's physical and functional properties are measured. For example, a "Fluid Flow" test would have an expected flow rate range that constitutes a "pass."

8. The sample size for the training set

Not applicable, as this is not an AI/ML device and therefore has no training set in that context.

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

Not applicable, as this is not an AI/ML device.

Summary of the Study:

The study referenced in the document is a series of performance and functional tests conducted on the Ureteral Access Sheath Set. These tests were designed to verify the device's physical and functional properties, specifically:

• Surface Friction
• Hydrophilic Coating Adhesion
• Fluid Flow
• Handle Pull Strength
• Luer Fitting Pull Strength

The stated purpose of these tests was to demonstrate that the device is substantially equivalent to predicate devices and introduces no new safety and effectiveness issues. The document explicitly states that "The performance and functional testing demonstrates that the Ureteral Access Sheath Set is substantially equivalent to the predicate devices and it introduces no new safety and effectiveness issues when used as instructed." This implicitly means the device met the pre-defined acceptance criteria for each of these tests.

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The Ureteral Access Sheath Set is indicated for use in endoscopic urology procedures, by facilitating the passage of endoscopes and other instruments through the urinary tract.

The Ureteral Access Sheath is comprised of two components: a dilator with a tapered tip and a tapered sheath.

The provided 510(k) summary for the Ureteral Access Sheath Set does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

Instead, this document is a summary of the regulatory submission that declares the device as substantially equivalent to predicate devices. Substantial equivalence claims typically mean that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, and does not raise new questions of safety and effectiveness. This often relies on comparative testing to show similar performance, or demonstrating that the differences do not affect safety or efficacy, rather than establishing and meeting novel acceptance criteria through a dedicated study with performance metrics.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text, as this information is not present. The document focuses on regulatory classification and substantial equivalence, not a detailed performance study against specific acceptance criteria.

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