Search Results

URUS System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

The URUS System is a software-controlled single-use digital flexible ureteroscope system. That consist of the single-use digital flexible ureteroscope (DMG-SU100R) and a video processing unit (VP-100). The URUS System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney.

The provided text is a 510(k) summary for the URUS System, a digital flexible ureteroscope. This document outlines the device's characteristics and its substantial equivalence to a predicate device, but it does not contain details about a clinical study comparing the device's performance to specific acceptance criteria in a human cohort.

Instead, the performance data section primarily discusses bench testing, compliance with standards, and software validation. There is an explicit statement: "The subject of this premarket submission did not require clinical studies were considered necessary and performed." This means there won't be information on sample sizes, ground truth establishment, expert qualifications, or MRMC studies that typically derive from clinical trials.

Therefore, I cannot fulfill all parts of your request as the provided document lacks a description of a clinical study that proves the device meets acceptance criteria defined by performance metrics like sensitivity, specificity, or reader improvement.

However, I can extract information related to the bench testing and other validations performed, which can be presented in a modified format to address the parts that are available.

Here's a summary based on the provided document:

Acceptance Criteria and Device Performance Study for the URUS System

The URUS System, a single-use digital flexible ureteroscope, underwent various types of testing, primarily bench testing, to demonstrate its performance and substantial equivalence to a predicate device (WiScope™ Digital Endoscope System, K181977). A clinical study was not considered necessary or performed for this premarket submission.

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit "acceptance criteria" for clinical performance (like sensitivity, specificity) and "reported device performance" against those in a clinical setting are not available from the provided document, I will present the performance items tested in bench studies, which serve as a form of acceptance criteria for engineering and optical performance.

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

• Test Set Sample Size: Not applicable in the context of clinical performance evaluation as no clinical studies were performed. For bench testing, the document states, "All testing was performed on test unit representative of finished devices." The exact number of units tested is not specified but implies a sufficient number to meet standard validation requirements.
• Data Provenance: Not applicable for a clinical test set. Bench test data originates from in-house or contracted laboratory testing as part of the device development and validation process.

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

• Not applicable as no clinical studies assessing human interpretation or diagnosis were conducted. Bench testing involves engineering and quality assurance personnel and potentially external testing laboratories with relevant accreditations.

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

• Not applicable as no clinical studies involving adjudication of diagnostic findings were 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

• No MRMC comparative effectiveness study was done. The device does not explicitly mention AI assistance for human readers in the provided text.

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

• No standalone algorithm performance study (in the sense of AI/software for diagnosis) was conducted or reported. The device is a ureteroscope which is a visualization and intervention tool, with software functions for basic device operation.

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

• For optical and mechanical bench testing, the "ground truth" is defined by established engineering specifications, industry standards (e.g., ISO 8600-1), and physical measurements. For biocompatibility, it's defined by the results of standardized biological assays (e.g., cytotoxicity, sensitization). For sterilization and shelf-life, it's defined by validated protocols and observed stability. These are not clinical ground truths in the diagnostic sense.

8. The sample size for the training set

• Not applicable as no clinical studies involving training sets for AI algorithms were conducted.

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

• Not applicable as no clinical studies involving training sets for AI algorithms were conducted.

Ask a specific question about this device