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The TetraGraph Neuromuscular Transmission (NMT) Monitor is indicated for monitoring the relaxation of the patient when neuromuscular blockade is administered.

The TetraGraph Neuromuscular Transmission (NMT) Monitor (TetraGraph) is a portable, batteryoperated EMG-based neuromuscular transmission monitor for use perioperative and in recovery and critical care environments following or during the application of Neuromuscular block. TetraGraph undertakes this function by electrical stimulation of the peripheral nerve and directly measuring the evoked response of the muscles (Muscle Action Potential (MAP)), thus providing a quantitative and automatic measurement of muscle response to a stimulus using electromyography (EMG). The TetraGraph is a prescription-only medical device and is indicated for use in hospitals. TetraGraph consists of the following main components: TetraGraph Monitor, TetraSens Electrode, TetraSens Pediatric Electrode (new accessory), Philips Interface (new and optional accessory), and Pole clamp kit (optional accessory).

The provided text describes the 510(k) premarket notification for the Senzime AB TetraGraph Neuromuscular Transmission Monitor, specifically for the addition of new accessories: the TetraSens Pediatric electrode and the Philips Interface. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (TetraGraph Neuromuscular Transmission Monitor, K190795).

Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a clear, summarized format. Instead, it refers to generalized performance testing.

However, it implicitly states that performance testing was conducted for the TetraGraph with the new TetraSens Pediatric electrodes and that "all of the acceptance criteria for this device" were met. These criteria are noted to be "the same or very similar to the predicate device's specifications."

The types of performance testing mentioned are:

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

The document does not specify the sample sizes used for any of the performance tests mentioned (biocompatibility, electrode testing, EMG detection, tensile strength, shelf life, software, electrical, EMC).

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It implies internal testing conducted by the manufacturer or their designated testing facilities.

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 provided in the document. The tests described are largely bench-top and engineering performance tests, which typically do not involve experts to establish ground truth in the same way clinical studies or image-based diagnostics would.

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

This information is not applicable/not provided as the tests described are technical performance tests rather than clinical evaluations requiring adjudication of subjective outcomes.

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 type of study is not applicable and was not conducted. The device is a neuromuscular transmission monitor, not an AI-assisted diagnostic tool that aids human readers. The document explicitly states: "There was no clinical testing required to demonstrate that TetraGraph with the new TetraSens Pediatric electrodes is substantial equivalent to the predicate device as the predicate has similar technological characteristics."

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

The device itself is a measurement and monitoring device, an "algorithm only" or "standalone" performance would refer to its accuracy and reliability in measuring neuromuscular transmission. The performance testing (EMG evoked response detection, compliance with standards) serves this purpose by demonstrating the technical capabilities of the device in isolation, even though it's used by humans. The document confirms that "performance testing made for the device" was completed and met acceptance criteria.

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

For the described performance tests, the "ground truth" would be established by:

• Scientific Standards: For biocompatibility (ISO 10993-1) and electrode testing (ANSI/AAMI EC12: 2000), the ground truth is defined by the requirements and test methods outlined in these international and national standards.
• Engineering Specifications: For EMG evoked response detection, electrode tensile strength, and other performance tests, the ground truth is based on the device's design specifications and expected technical performance against which the measured results are compared.

8. The sample size for the training set:

This information is not applicable/not provided. The TetraGraph is a measurement device and the data provided does not suggest it uses machine learning or AI models that require a "training set" in the conventional sense. The submission focuses on hardware accessories and their technical performance.

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

This information is not applicable/not provided for the same reasons as in point 8.

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The TetraGraph Neuromuscular Transmission (NMT) Monitor is indicated for monitoring the relaxation of the patient when neuromuscular blockade is administered.

The TetraGraph Neuromuscular Transmission (NMT) Monitor (TetraGraph) is a portable, battery-operated EMG-based neuromuscular transmission monitor for use perioperative and in recovery and critical care environments following or during the application of Neuromuscular block. TetraGraph undertakes this function by electrical stimulation of the peripheral nerve and directly measuring the evoked response of the muscles (Muscle Action Potential (MAP)), thus providing a quantitative and automatic measurement of muscle response to a stimulus using electromyography (EMG).

The provided text is a 510(k) summary for the TetraGraph Neuromuscular Transmission (NMT) Monitor. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Datex Ohmeda S/5 NeuroMuscular Transmission Module, E-NMT).

However, the summary does not include a detailed table of acceptance criteria or the reported device performance in those terms. It generally states that "Performance testing show that TetraGraph met all the acceptance criteria for this device, and which are the same or very similar to the predicate device's specifications."

Therefore, for aspects directly requesting specific acceptance criteria and reported performance values, the information is not present in the provided document. Similarly, details about a specific study proving the device meets these criteria (like sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance metrics) are not provided in the depth requested.

Here's a breakdown of the information that can be extracted or inferred based on the prompt's requirements, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document.
• Data Provenance: Not specified. The document describes "performance testing" but does not indicate if it involved human subjects, animal subjects, or purely bench testing, nor does it specify the country of origin or whether it was retrospective or prospective.

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. The document highlights functional and safety performance testing but does not mention the use of experts for establishing ground truth, as would be common in an AI/diagnostic device context. Given that this is a hardware monitoring device, the "ground truth" might be more related to established physical measurements and electrical standards, rather than expert interpretation of medical images or data.

4. Adjudication method for the test set

• Not applicable/Not specified as no expert review or human-in-the-loop diagnostic assessment is described for the performance testing.

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

• No, an MRMC study was not done. The document explicitly states: "There was no clinical testing required to demonstrate that TetraGraph is substantial equivalent to the Datex-Ohmeda Device, as the predicate has similar technological characteristics." This implies the evaluation was primarily based on technical performance and comparison to the predicate's technical specifications, not a clinical effectiveness study involving human readers or AI assistance.

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

• The device itself is a "Neuromuscular Transmission Monitor" operating on electromyography (EMG) signals. Its core functionality is standalone measurement and display of physiological parameters. While it's a "monitor," meaning it presents information to a human operator, the performance testing described is of the device's ability to accurately make these measurements. The document does not describe performance tests specifically for an algorithm distinct from the device's integrated operation. Its performance is its standalone performance.

7. The type of ground truth used

• The specific type of "ground truth" for the performance testing is not explicitly detailed. However, based on the types of tests listed (electrical safety, EMC, biocompatibility, thermal, mechanical, environmental, shelf life, battery, electrode performance), the ground truth would likely be established through:
  • Engineering specifications and standards: Conformance to IEC, ISO, and ANSI/AAMI standards.
  • Reference measurements: Using calibrated equipment to measure electrical outputs, physical properties, etc.
  • Bench testing: Controlled laboratory conditions to verify functional parameters against predefined acceptable ranges.

8. The sample size for the training set

• This device is not described as an AI/machine learning device that would typically have a separate "training set" in the context of learning algorithms for diagnosis or prediction. It is a measurement device. Therefore, this concept of a training set is not applicable as described in the document.

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

• As explained in point 8, the concept of a "training set" for an AI/ML algorithm does not apply to this device as described.

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