Search Results

The Genyx Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.

The Genyx Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure. The Genyx Injection Needle materials are similar to those used in the predicate device. The Genyx Injection Needle is substantially equivalent to both predicate devices in that they all contain a stainless steel shaft and a luer lock hub where a standard syringe can be attached for injection of materials through the lumen of the needle into tissue.

The provided text describes a 510(k) premarket notification for the Genyx Injection Needle, seeking substantial equivalence to predicate devices. It does not contain details about specific acceptance criteria, a study design with test sets, expert involvement, or performance metrics in the way that would typically be described for software or AI/ML device evaluations.

Based on the nature of this submission (a 510(k) for an injection needle), the "acceptance criteria" are compliance with safety standards and equivalent performance to a predicate device in terms of "injection performance." The "study" is a nonclinical test comparing the new device to a predicate device.

Here's an attempt to structure the information based on your request, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance Study for Genyx Injection Needle

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified. The document refers to "nonclinical tests" and states the device "will be tested" and "was found to perform equivalently." This suggests some testing was done, but the number of units or test repetitions is not provided.
• Data Provenance: Not applicable in the context of this device. This is a physical medical device (an injection needle), not a data-driven AI/ML system. The "testing" refers to physical performance assessment.

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

• Not applicable. The evaluation is a technical/engineering assessment of a physical device's performance against a predicate, not an expert-driven ground truth establishment for diagnostic accuracy.

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

• Not applicable. This concept is for resolving disagreements in expert opinions for diagnostic tasks, which is not relevant to the evaluation of this physical medical device.

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 is not an AI/ML device, and no human-reader study was conducted.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" for this device's evaluation is essentially the established performance and safety profile of the predicate device. The performance of the Genyx Injection Needle was compared directly against the predicate device to establish equivalence.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

Ask a specific question about this device