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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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