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The Top NRFit Lock Tip and Slip Tip LOR Syringes and the Additive Slip Tip Syringe are intended to be used with the ISO 80369-6 NRFit neuraxial compliant epidural needles for locating the epidural space, for local administration, and regional administration excluding subarachnoid/spinal block.

The TOP NRFit™ Tip Syringes are provided sterile. They are single use devices consisting of rigid USP 2 glass plungers and glass barrels with metal slip tips designed as the ISO 80369 - 6 compliant neuraxial connector which allows for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe barrels are printed with graduated markings in cc (milliliters) indicating the volume of liquid inside the syringe barrel.

This document, a 510(k) Summary for the TOP Corporation NRFit™ Tip Glass Syringes (K182765), outlines the device's characteristics and performance testing to demonstrate substantial equivalence to predicate devices. However, it does not describe a study involving an AI or algorithm-driven device.

The document details the physical characteristics and performance of syringes, which are mechanical medical devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility tests for the syringes, not a study of an AI's performance.

Therefore, I cannot provide the information requested in the prompt as it pertains to AI/algorithm performance. The document explicitly states: "Clinical tests were not required to demonstrate performance of between the subject and predicate devices. Product functionality has been adequately assessed by nonclinical tests." This further confirms the absence of a study that would involve the elements of AI performance evaluation you've listed (e.g., sample size for test/training sets, expert consensus for ground truth, MRMC studies, standalone performance).

Instead, the document focuses on demonstrating that the TOP Corporation NRFit™ Tip Glass Syringes meet established industry standards for mechanical and material properties, as well as biocompatibility. The performance testing section lists numerous non-clinical tests based on ISO standards for medical devices and syringes.

If you have a document describing an AI or algorithm-driven medical device, I would be happy to analyze it for the requested information.

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The Top Neuropole Needles are injection needles which may be 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 injection needles which are used for temperature controlled radiofrequency lesioning. A nerve is localized either by using electrical stimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. After injection of anesthetics the nerve may then be blocked by radiofrequency lesion. Top Neuropole Needles are supplied sterile and are labeled for Single Use Only.

This submission is for a Traditional 510(k) for the Top Neuropole Needles. This device is an injection needle for nerve blocks and radiofrequency lesioning. This submission relies on substantial equivalence to predicate devices, and therefore does not contain acceptance criteria or a study to prove the device meets acceptance criteria. A summary of the device information available in the provided text is included below.

Device Description:
Top Neuropole Needles are injection needles used for temperature-controlled radiofrequency lesioning. They can localize a nerve using electrical stimulation through the needle or by injecting contrast medium and using radiography. After anesthetic injection, the nerve can be blocked by a radiofrequency lesion. The needles are supplied sterile and are for single use only.

Intended Use:
The Top Neuropole Needles are injection needles for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. They localize a nerve by electrostimulation through the needle or by injecting contrast medium with radiography. The nerve can then be blocked by local anesthetic or a radiofrequency lesion.

Technological Characteristics:
The Top Neuropole Needles have the same device characteristics, materials, dimensions, and intended use as their predicate devices. They have been tested to comply with applicable industry standards and US regulations.

Conclusion:
The intended use and performance characteristics of the Top Neuropole Needles are the same as the predicate devices, raising no new questions of safety and effectiveness. The device is substantially equivalent to the predicate devices.

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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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