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This device is a nerve stimulation device designed to be used by an anesthetist during:

1. General anesthesia, for the purpose of establishing the efficacy of a Neuromuscular Blocking Agent using non-invasive surface electrodes.

2. Regional anesthesia, for the purpose of:

i. nerve mapping using the non-invasive Nerve Mapping Probe (supplied)

ii. nerve locating using invasive needles (not supplied)

The STIMPOD NMS450 is a quantitative Neuromuscular Transmission (NMT) Monitor which provides real-time quantitative feedback utilizing tri-axial accelerometery.

The STIMPOD NMS450 is also a precision nerve locating tool used for localizing specific neural pathways. Localization of nerves by electrical stimulation involves connecting the nerve stimulator to a conducting needle through which local anaesthetics can be injected. The distance of the needle (cathode) from the nerve can be estimated by establishing the minimum threshold current required, to facilitate a neuromuscular response.

The STIMPOD NMS450 currently makes use of 3 dimensional acceleromyography (AMG) as the measurement technology of choice for objective Neuromuscular Transmission (NMT) monitoring in surgery. Although AMG is still the de-facto standard in industry, the use of electromyography (EMG) has gained renewed interest in NMT monitoring applications where the introduction of robotic surgeries, new surgical techniques, and changes in workflow, for instance, made the use of AMG impracticable.

In order to address this steadily increasing market demand for EMG sensor technology in NMT monitoring applications, Xavant identified the need to design and develop a dedicated NMT Monitoring Cable (EMG) that could be used interchangeably with the existing NMT Monitoring Cable (AMG) already in use with the STIMPOD NMS450.

The NMT Monitoring Cable (EMG) was specifically designed for use with the STIMPOD NMS450 to assist anaesthesiologists in theatre with monitoring the efficacy of Neuromuscular Blocking Agents (NMBAs).

The NMT Monitoring Cable (EMG) was designed with an intelligent EMG signal processing module (henceforth referred to as the µEMG) on one end of the cable for connection to an EMG electrode, and with a standard FireWire connector on the other end for connection to the STIMPOD NMS450.

The provided text describes the 510(k) premarket notification for the STIMPOD NMS450 Nerve Stimulator, focusing on its substantial equivalence to a predicate device (STIMPOD NMS450, K102084) and a reference device (Senzime, Tetragraph, K190795) with the addition of a new NMT Monitoring Cable (EMG) accessory.

However, the document does not provide specific acceptance criteria or an explicit study proving the device meets those criteria with detailed performance metrics. Instead, it states that "The subject device met or exceeded the stated acceptance criteria for each performance test." It then lists the types of performance tests conducted.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I detail specific sample sizes, ground truth establishment, or multi-reader multi-case study results, as this information is not present in the provided text.

Based on the available information, here's what can be extracted:

Acceptance Criteria and Reported Device Performance:

The document broadly states that the device met or exceeded acceptance criteria, but it does not provide the specific criteria or quantitative performance results.

Study Information (Based on available text):

2. Sample size used for the test set and the data provenance:
   This information is not provided in the document. The text only lists the types of performance tests conducted, but not the specific methodologies, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature).

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 in the document. The performance tests mentioned are primarily technical and engineering-focused (e.g., electrical safety, biocompatibility), which typically rely on standardized measurements rather than expert-established ground truth in the context of clinical interpretation.

4. Adjudication method for the test set:
   This information is not provided in the document.

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 electrical peripheral nerve stimulator for monitoring neuromuscular blockade, not an AI-assisted diagnostic imaging tool with human readers. No MRMC study or AI-assistance evaluation is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This information is not applicable/provided in the context of an algorithm's performance. The device itself (STIMPOD NMS450 with the new EMG cable) performs measurements and stimulation; its "performance" is evaluated through the technical tests listed.

7. The type of ground truth used:
   For the technical performance tests mentioned (functional, electrical safety, EMC, biocompatibility, battery life, tensile strength, stimulation parameters), the ground truth would be established by engineering standards, specifications, and physical measurements rather than clinical ground truth like pathology or outcomes data. The document states that the device "met or exceeded the stated acceptance criteria," implying these criteria are based on defined technical standards and specifications.

8. The sample size for the training set:
   This information is not applicable/provided. The STIMPOD NMS450 is a hardware device with an accessory. There is no mention of a "training set" in the context of machine learning or AI models, as this is not an AI/ML powered device.

9. How the ground truth for the training set was established:
   This information is not applicable/provided as there is no mention of a training set or AI/ML components.

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