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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 ROCAMED RocaUS Platinum is intended to be a conduit for passage of endoscopes and other urological devices for the purpose of performing ureteroscopy procedures. The dual working lumen dilator with luer lock connections allows the user to insert guidewires and fluids.

The ROCAMED RocaUS Platinum is designed to create a conduit for urological procedural instruments. The device consists of two components: a flexible, coil reinforced sheath and a semirigid dual lumen dilator catheter with tapered distal tip. Both components are radiopague and have hydrophilic coating. This device is sold in two sizes, 10/12 and 12/14 FR.

The provided documentation is a 510(k) summary for the ROCAMED RocaUS Platinum, a ureteral access sheath. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria in the same way a new AI/ML-driven diagnostic device might.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable or not present in this document because it is not a clinical study report for a diagnostic or treatment outcome device. The "performance data" referred to in this document relates to physical and functional testing, not clinical performance measures like accuracy or sensitivity.

Here's an attempt to fill in the table and address the questions based on the provided text, indicating where information is not applicable (N/A) or not provided (NP):

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a medical device (ureteral access sheath) demonstrating substantial equivalence, the "acceptance criteria" are primarily met through comparison to predicate devices across technological characteristics and intended use, supported by physical and functional testing. There are no explicit performance metrics like sensitivity, specificity, or accuracy derived from a clinical study with a test set that would have numerical acceptance criteria.

• 2 lumens
• Dilator Material: LDPE+BaSO4
• Sheath Material: Pebax-SST-PTFE
• Fr Size: 10/12, 12/14
• Length: 35 cm
• Guidewire compatibility: 0.032", 0.035" |
  | Safety | Implied by substantial equivalence to legally marketed predicate devices and successful physical/functional testing. Changes in dilator material (LDPE instead of PTFE) stated to "ease insertion into the patient and reduce trauma." |
  | Performance (Functional) | Results of physical and functional testing support substantial equivalence. (Specific reported performance values for these tests are not detailed in this summary). |
  | Materials | Materials chosen are considered substantially equivalent or improved (e.g., LDPE for dilator) compared to predicate devices, based on physical and functional testing. |

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

• Sample Size for Test Set: Not applicable. This document refers to physical and functional testing, not a clinical test set of patient data. The specifics of samples used for these engineering tests (e.g., number of devices tested for tensile strength or burst pressure) are not provided in this summary.
• Data Provenance: Not applicable for clinical test data. The physical and functional testing would have been conducted by Promepla SAM.

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

Not applicable. Ground truth as typically understood for diagnostic device performance (e.g., pathology, expert consensus on images) is not relevant for this type of medical device submission, which relies on physical and mechanical properties and comparison to predicates.

4. Adjudication method for the test set

Not applicable.

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 device is not an AI-assisted diagnostic tool and therefore did not undergo an MRMC study related to AI assistance.

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

Not applicable. This device is not an algorithm.

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

Not applicable in the context of clinical "ground truth." The "ground truth" for this device's performance would be against engineering specifications and predicate device characteristics, verified through physical and functional testing.

8. The sample size for the training set

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

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

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

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