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Used to inject legally marketed therapeutic agents into the genitourinary system, most specifically for vesicoureteral reflux (VUR) in the pediatric population and for bladder neck injection for the population as a whole.

The INJEKT™ Filiform Injection Needle consists of a needle and an outer sheath with a filiform tip. Hash marks on the outside of the needle are used to assess proper depth of placement. The filiform tip of the needle acts as a landmark for easier access to precise injection. The needle exits the side of the device to allow precise injection and assures additional safety for the patient against inadvertent stick when the needle is retracted. The devices are provided sterile and are intended for one time use.

The provided text describes a 510(k) submission for the INJEKT™ Filiform Injection Needle but does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding the performance of the device against such criteria. The submission focuses on demonstrating substantial equivalence to predicate devices based on indications for use and technology, rather than presenting a performance study with defined acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be stated based on the given document:

1. Table of acceptance criteria and reported device performance: This information is not provided in the document. The submission states that "Biocompatibility, sterility and performance testing were performed in accordance to Food and Drug Administration guidance's and recognized international standards," but it does not detail the specific acceptance criteria or the reported performance results.

2. Sample size used for the test set and the data provenance: This information is not provided. The document mentions "performance testing" but does not specify any test set, sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. No test set or ground truth establishment process is described in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided. No test set or adjudication method is described.

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 information is not applicable/provided. The device is an injection needle, not an AI-assisted diagnostic or interpretative tool that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not applicable/provided. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided. No ground truth for performance evaluation is described.

8. The sample size for the training set: This information is not applicable/provided. The document describes a medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: This information is not applicable/provided. As above, this document does not describe an AI algorithm or its training.

In summary, the provided 510(k) submission focuses on demonstrating substantial equivalence based on the device's indications for use and technology compared to existing predicate devices, rather than presenting a detailed study with specific acceptance criteria and detailed performance results.

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