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1. The MPS Acacia Nerve Block Needle is intended for the administration of local anesthetic agents to provide regional anesthesia or the administration of anti-inflammatory medication to relieve chronic pain conditions, or to facilitate placement of a catheter.
2. The MPS Acacia Nerve Block Stimulating Needle version is also intended to aid in locating specific peripheral nerves or nerve plexuses for the precise delivery of local anesthetic agents or anti-inflammatory medication for the relief of chronic pain conditions or to provide regional anesthesia, or to facilitate placement of a catheter.
3. Routes of administration may include Peripheral nerve blocks, Sympathetic blocks, Selective nerve blocks, Intra-articular injections (i.e. Facet blocks), Interlaminar and Transforaminal approaches.

The MPS Acacia Nerve Block Needle consists of a stainless steel cannula with various tip types (Blunt, Housted, Touhy, Crawford, Quincke, Chiba, Sprotte, Freeman) and a molded plastic hub. A stylet is also provided consisting of a stainless steel shaft and a molded plastic hub.

The MPS Acacia Nerve Block Stimulating Needle version is electrically conductive at the distal end of the device.

The Nerve Block Needle will be provided as a sterile, single use, non-pyrogenic, disposable device and will be available in a variety of lengths and gauges.

The Nerve Block Needle may be packaged individually or as part of a kit consisting of a catheter, various syringe sizes, introducer, extension set, gauze sponge, sponge applicator, drape, absorbent towel, hospital wrap, sterile gloves, and other commonly used FDA approved accessories dependent on the application as determined by the clinician.

The provided text is a 510(k) summary for the MPS Acacia Nerve Block Needle. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. This type of submission, particularly for devices like needles, typically focuses on demonstrating equivalent physical and technical characteristics, and intended use as already approved devices, rather than conducting new clinical studies with acceptance criteria and performance metrics as might be seen for more complex or novel devices.

Therefore, many of the requested categories (acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of 510(k) submission. The core of this document is a comparison to predicate devices, which implies that the acceptance criteria for "safety and effectiveness" are implicitly met by demonstrating similarity to already approved devices.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

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

• Not applicable / Not provided. This 510(k) relies on demonstrating substantial equivalence to predicate devices based on physical and technical characteristics and intended use, not on a new test set of data.

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

• Not applicable / Not provided. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices.

4. Adjudication method for the test set:

• Not applicable / Not provided.

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 device is a physical medical instrument (needle), not an AI or software-as-a-medical-device that would involve human readers or AI assistance.

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

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

7. The type of ground truth used:

• Predicate device equivalence. The "ground truth" in this context is the regulatory acceptance of the predicate devices based on their established safety and effectiveness through their own approval processes. The new device demonstrates "substantial equivalence" to this established "truth."

8. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/machine learning device.

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

• Not applicable / Not provided.

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