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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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The Infinity Trident NMT pod is intended for use as an objective neuromuscular transmission monitor that measures the muscle response to electrical stimulation of a peripheral nerve.

The Infinity Trident NMT Pod is an addition to Draeger Medical Systems' Infinity patient monitoring series that provides automatic measurements of muscle response to electrical stimuli transmitted via surface electrodes placed over a peripheral nerve. The NMT sensors capture the muscle response as well as skin temperature. The pod then processes this information and relays it to the Infinity patient monitor for display.

The provided text describes the Infinity Trident NMT Pod and its 510(k) submission (K042003) to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device, the Organon Teknika Corp. Tof-Watch Sx (K992598). However, it does not explicitly detail acceptance criteria in a quantitative table or a study proving the device meets specific acceptance criteria, as one might find for a novel device undergoing extensive clinical trials with predefined performance metrics.

Instead, the submission relies on demonstrating equivalence to an existing device through non-clinical and clinical performance data. Therefore, the information provided below is extracted from the available text, and specific details that are not present in the document (like exact sample sizes for clinical studies, expert qualifications, or detailed ground truth establishment methods) will be noted as "Not specified in the provided text."

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a table of specific quantitative acceptance criteria. Instead, the "acceptance criteria" can be inferred as demonstrating equivalence to the predicate device in terms of safety and effectiveness for its intended use, particularly for measurements of Train of Four (TOF), Post Tetanic Count (PTC), and Single Twitch Percentage.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified in the provided text for either non-clinical or clinical performance data. The text mentions "the analysis of the data collected" but gives no numbers.
• Data Provenance: Not specified. It's unclear if the data was collected retrospectively or prospectively, or its country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not specified in the provided text. The submission focuses on direct comparison of device measurements rather than interpretation by human experts to establish ground truth for clinical cases.

4. Adjudication Method for the Test Set

Not specified in the provided text. It appears the "ground truth" or reference for comparison was the measurements from the predicate device itself, not an adjudicated expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done? No. The document describes a comparison between devices, not a study evaluating human reader performance with and without AI assistance.
• Effect Size: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in principle. The assessment of the 'Infinity Trident NMT pod' is described as a standalone device performance comparison against the predicate device. The device automatically measures muscle response, processes the information, and relays it for display. The "analysis of the data collected demonstrates that the measurement values of the test device are equivalent to that of the referenced predicate device." (Section 8). This implies an algorithm-only comparison of readings.

7. Type of Ground Truth Used

The "ground truth" for the performance assessment appears to be the measurements provided by the predicate device (Organon Teknika Corp. Tof-Watch Sx). The study's aim was to demonstrate that the new device's measurements were equivalent to those of the predicate device.

8. Sample Size for the Training Set

Not specified in the provided text. The document refers to "testing" and "data collected" but does not distinguish between training and test sets, nor does it provide sample sizes for any data collection. This device is an NMT monitor, and typically such devices are not "trained" in the machine learning sense, but rather validated through engineering and clinical performance testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable in the context of a "training set" for an AI algorithm, as this is a device performance validation, not an AI model. For the performance validation, the predicate device served as the reference standard (ground truth for "equivalence"). The document states the device was "tested in accordance with applicable standards and internal design control procedures."

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