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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).

The provided text describes the Uroject12 Syringe Lever, a device for administering sterile materials in a clinical urology setting. This document is a 510(k) summary submitted to the FDA, asserting substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not list specific numerical acceptance criteria for performance metrics (like accuracy, precision, or specific failure rates) and their corresponding reported device performance values in a table. Instead, it states:

"The results of the validation testing demonstrated that the Uroject12 Syringe Lever is considered safe and effective for its intended use."

The primary "acceptance criterion" appears to be demonstrating substantial equivalence to the predicate device, especially concerning the new reprocessing instructions.

Study Information

Based on the provided document, the study conducted was focused on the reprocessing instructions for the device, not its core operational performance, as the device itself hasn't changed.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated in terms of the number of devices or cycles tested for the high-level disinfection and automated cleaning processes.
   • Data Provenance: Not specified, but generally, validation testing for medical devices is conducted in controlled laboratory settings. The applicant is UroGen Pharma Ltd., located in Israel. The data would be prospective, as it's validation testing for new instructions.

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

   • Not applicable/Not mentioned. The validation testing pertained to the efficacy of cleaning and disinfection processes, which typically involve microbiological and chemical testing against established standards, not expert clinical interpretation.

3. Adjudication Method for the Test Set:

   • Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., imaging studies) to resolve discrepancies among experts. This validation focused on objective performance metrics related to reprocessing.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC comparative effectiveness study was not done. The document focuses on performance validation related to reprocessing, not a comparison of human reader performance with or without AI assistance.

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

   • Not applicable. The Uroject12 Syringe Lever is a physical medical device, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.

6. The Type of Ground Truth Used:

   • For the validation of high-level disinfection and automated cleaning processes, the "ground truth" would be established microbiological and chemical standards for cleanliness, sterility, and material compatibility after reprocessing. The document implicitly states that the validation "demonstrated that the Uroject12 Syringe Lever is considered safe and effective for its intended use" after these processes.

7. The Sample Size for the Training Set:

   • Not applicable. The device is not an AI/ML algorithm, so there is no "training set."

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no training set for this type of device.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence for a physical medical device, specifically addressing new reprocessing instructions. It does not contain the detailed study design, performance metrics, and expert-based ground truth information typically found for AI/ML devices or clinical trials assessing diagnostic accuracy. The "study" mentioned refers to validation testing of cleaning and disinfection protocols.

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