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These single use, disposable, flexible sheath injection needles are intended to be used for the injection of various types of media through flexible endoscopes.

The Carr-Locke and Articulator Injection Needles are single use, disposable, flexible sheath injection needles that are intended to be used for the injection of various types of media through flexible endoscopes. All the needles have the same general design and consist of a handle luer, a handle hypo tube, a compression spring (except for PN 00711808), a PEEK tube, a spring sheath, a distal hub and an injection needle.

The Carr-Locke and Articulator needles are sterile, disposable devices that are used through the working channel of flexible endoscopes for the purpose of injecting media into the gastrointestinal tract.

The information provided is about the substantial equivalence of the STERIS Articulator and Carr-Locke Injection Needles (K232826) to a predicate device. This document is a 510(k) summary, which focuses on comparing a new device to a legally marketed predicate device to demonstrate that it is as safe and effective. It does not describe a study involving algorithms, AI, or human reader performance.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth used, training set sample size, ground truth for training set) are not applicable to this type of device and submission.

However, I can extract the acceptance criteria and device performance from the tables in the "Summary of Nonclinical Tests" section.

Acceptance Criteria and Device Performance

The STERIS Articulator and Carr-Locke Injection Needles (K232826) underwent nonclinical testing to demonstrate substantial equivalence to the predicate device. The following table summarizes the acceptance criteria and reported results:

Study Information (Relevant to this type of device)

1. Sample size used for the test set and the data provenance: The document does not specify the exact sample sizes (number of devices or tests performed) for each nonclinical test. It only states that testing was performed. Data provenance is not described as this is a device performance study, not a clinical trial or AI model validation.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The tests are engineering/performance evaluations, not clinical diagnoses requiring expert ground truth.
3. Adjudication method for the test set: Not applicable for nonclinical device performance tests.
4. 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/imaging device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/algorithm.
6. The type of ground truth used: For these nonclinical tests, the "ground truth" is defined by the "design requirements" which are established engineering and performance specifications for the device.
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

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