Search Results

The Uroject 12 Syringe Lever Device is intended for use in the administration of sterile materials under aseptic conditions, in a clinical urology setting, by a clinician and in accordance with the best judgment of a physician.

The Uroject12 Syringe Lever body contains syringe housing for holding a standard 20 mL syringe and a dispensing mechanism that is manually operated by rotating a knob that presses the syringe piston. A clutch mechanism facilitates fast adaptation of the injection mechanism to the syringe piston position. The Uroject12 Syringe Lever is a reusable, reprocessed device to be sterilized before each use and cleaned after use.

The compatible syringes to be used with the Uroject12 are: 20 mL MEDALLION® syringe (Catalog Number MSS121, Merit Medical, Salt Lake City, UT, USA) and 20 mL MEDALLION® COP syringe (Catalog Number COP121PC, Merit Medical, Salt Lake City, UT, USA).

Here's an analysis of the provided text regarding the Uroject12 Syringe Lever, extracting information about its acceptance criteria and the study proving it meets them.

It's important to note upfront that this document is an FDA 510(k) K180345 clearance letter and summary for a medical device, not an AI/ML medical device. Therefore, the questions related to AI/ML specific aspects like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only without human-in-the-loop performance)," "training set," and "ground truth for the training set" are not applicable to this submission. This document describes a physical medical device (a syringe lever) and its performance through bench testing, not an AI algorithm.

Acceptance Criteria and Study Proving Device Meets Criteria

The document focuses on demonstrating the substantial equivalence of the Uroject12 Syringe Lever to a predicate device through performance data from bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The summary states that performance was "demonstrated through" these tests but does not provide the specific quantitative acceptance criteria or the actual quantitative performance results. This is typical for a 510(k) summary, where detailed test reports are submitted to the FDA but not always fully enumerated in the public summary document.

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of devices or test repetitions) used for each bench test. It generically states "Performance of the Uroject12 Syringe Lever has been demonstrated through the following," referring to the list of bench tests.
• Data Provenance: The testing was conducted as part of the regulatory submission process for the Uroject12 Syringe Lever. While the company (UroGen Pharma Ltd.) is based in Ra'anana, Israel, the specific location where the bench tests were performed is not mentioned. It is implicitly prospective testing conducted to support this premarket notification.

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

This question is not applicable to this type of device and submission. "Ground truth" in the context of expert consensus is typically relevant for diagnostic imaging or AI algorithms where human interpretation is involved. For a physical medical device like a syringe lever undergoing bench testing, "ground truth" is established by direct measurement against engineering specifications and industry standards. The "experts" would be the engineers and technicians performing and validating the tests, adhering to established protocols. Their qualifications would involve relevant engineering, materials science, and quality control expertise, but no specific details are provided in this summary.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human readers/interpreters to resolve discrepancies in their assessments (e.g., in clinical trials for diagnostic devices). For bench testing of a mechanical device, there is no "adjudication" in this sense; the results are quantitative measurements against predefined specifications. Any discrepancies would be resolved through re-testing or investigation of the testing methodology.

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

This question is not applicable. This is a physical medical device (syringe lever), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

This question is not applicable. As a physical medical device, there is no "algorithm only" performance to evaluate. The device operates mechanically.

7. The Type of Ground Truth Used

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

• Engineering Specifications: The device's design requirements, such as expected pressure, dispensing force, residual volume, and mechanical functionality.
• Industry Standards: Compliance with recognized international and national standards (e.g., AAMI TIR30:2011 for cleaning, and standards for sterility assurance level - SAL).
• Predicate Device Performance: Implicitly, the Uroject12's performance is compared against the known safe and effective operating characteristics of the predicate device (iSecure Syringe Cartridge Holder).

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this is not an AI/ML device.

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

This question is not applicable. There is no "training set" or corresponding ground truth establishment process for a physical device.

In summary, the provided document details the regulatory clearance of a mechanical medical device based on bench testing results demonstrating its functional performance and reprocessing capabilities against engineering and industry standards, proving substantial equivalence to a legally marketed predicate device. It does not involve AI/ML components or studies.

Ask a specific question about this device