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The Top Neuropole Needles are injection needles used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.

Top Neuropole Needles are teflon insulated injection needles for safe thermolesion procedures and regional anesthesia. There are 5 models offered, the ST, X, RC, XE and TL. The Top Neuropole Needle models TL, XE and RC are for pain management, while models ST and X are for local anesthesia. The needles are available in multiple sizes. The needle gauge ranges from 20 to 24 and the length from 30 to 200 mm. They are for single use only and supplied sterile.

They may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The nerve is localized either through the needle or by injecting contrast medium through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic or a radiofrequency lesion may be made.

The provided text describes a 510(k) summary for the "Top Neuropole Needles," which seeks substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as an already legally marketed device, rather than proving performance against specific acceptance criteria through a clinical study in the way a novel AI or diagnostic device might.

Therefore, many of the typical questions for AI/diagnostic device studies (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable in this context. The "study" mentioned is one that demonstrates compliance with applicable industry standards and US regulations, rather than a performance study measuring clinical endpoints.

Here's the breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the submission is a 510(k) for substantial equivalence, not a clinical performance study with a test set of patient data. The "tests" mentioned refer to engineering and biocompatibility tests to meet standards, rather than tests on patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth, in the sense of clinical diagnoses or interpretations, is not established for this type of device submission.

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

This information is not applicable. There is no "test set" in the context of clinical images or data requiring adjudication.

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. No MRMC study was conducted as this device is a physical medical needle, not an AI or imaging assistance tool.

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

This information is not applicable. This is not an algorithmic device.

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

The "ground truth" for this device's acceptance is based on demonstrating that its technological characteristics (materials, dimensions, intended use) are identical to a legally marketed predicate device, and that it complies with applicable industry standards and US regulations for performance and safety (e.g., sterilization, biocompatibility, mechanical integrity). This is primarily established through design specification comparisons and engineering testing, not clinical "outcomes data" or expert consensus on clinical cases.

8. The sample size for the training set

This information is not applicable. This device does not involve machine learning or a "training set."

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

This information is not applicable. There is no training set for this device.

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