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The Uroplasty Rigid Endoscopic Needle is an accessory to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media.

The Uroplasty Rigid Endoscopic Needle is an accessory for endoscopes with a working channel inner diameter of 5 French or larger. The Rigid Endoscopic Needle is supplied sterile and is intended for single use only. The 5 French stainless steel cannula is 380 to 500 mm long with an 18-gauge tip (10 mm in length) and a metal luer lock connector; the needle also has a protective polyethylene sheath.

Here's a breakdown of the acceptance criteria and study information for the Uroplasty Rigid Endoscopic Needle, based on the provided document:

This document is a marketing submission (510(k)) for a medical device. These submissions generally aim to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies like those for novel high-risk devices.

Based on the provided information, the "study" described is a declaration of substantial equivalence to a predicate device rather than a performance study with acceptance criteria in the typical sense of a diagnostic or therapeutic accuracy study.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This submission relies on substantial equivalence to a predicate device, not on a new performance study with a test set.

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

Not applicable.

4. Adjudication Method for the Test Set

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a comparative effectiveness study involving human readers and AI.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

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

7. Type of Ground Truth Used

Not applicable. The "ground truth" here is the established performance and safety profile of the predicate device, K982890, as determined by its prior clearance. The submission argues that the new device shares those characteristics.

8. Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI/algorithm-based device.

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

Not applicable.

Summary of the Device's "Acceptance Criteria" Met by the "Study":

The acceptance criteria for the Uroplasty Rigid Endoscopic Needle, within the context of this 510(k) submission, is to demonstrate Substantial Equivalence to a legally marketed predicate device (Advanced UroScience Injection Needle, K982890).

The "study" that proves the device meets this acceptance criteria is the comparison provided in Section 8: 510(k) Summary under "Technological Characteristics" and "Performance."

• Technological Characteristics: The submission explicitly states, "The new and predicate devices are technologically the same; they are both rigid endoscopic needles intended to be accessories for standard endoscopes for the use of administering injectable materials. Both devices have similar intended uses and principles of action; they are both supplied sterile and are for single use only." It further notes, "In the few instances where the devices differ, no concerns about safety or effectiveness are raised."
• Performance: The document states, "The Uroplasty Rigid Endoscopic Needle allows delivery of injectable materials into tissues during an endoscopic procedure, thereby achieving its intended use." This implies its performance is aligned with its intended use, which is consistent with the predicate device.
• Conclusion: The submission explicitly concludes, "The subject device, the Uroplasty Rigid Endoscopic Needle, is substantially equivalent to the previously cleared endoscopic needle by Advance UroScience (K982890)."

The FDA's decision letter (K051905) confirms that the FDA reviewed the submission and "determined the device is substantially equivalent...". This FDA determination is the ultimate "proof" in the regulatory sense that the "acceptance criteria" of substantial equivalence were met.

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