(204 days)
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
| Feature/Metric | Acceptance Criteria (Stated or Inferred) | Reported Device Performance |
|---|---|---|
| Overall Performance | "met all the acceptance criteria for this device, and which are the same or very similar to the predicate device's specifications" (General Statement) | "at least as safe and effective in monitoring the relaxation of the patient when neuromuscular blockade is administered as Datex-Ohmeda." |
| Electrical Safety | In accordance with IEC 60601-1 | Met acceptance criteria (no specific performance data provided) |
| Electromagnetic Compatibility (EMC) | In accordance with IEC 60601-1-2 and IEC 60601-2-40 | Met acceptance criteria (no specific performance data provided) |
| Biocompatibility | In accordance with ISO10993-1 | Met acceptance criteria (no specific performance data provided) |
| Thermal Performance | (Not explicitly stated, but implied to be within acceptable limits) | Met acceptance criteria (no specific performance data provided) |
| Mechanical Strength | (Not explicitly stated, but implied to be within acceptable limits) | Met acceptance criteria (no specific performance data provided) |
| Environmental Testing | (Not explicitly stated, but implied to be within acceptable limits) | Met acceptance criteria (no specific performance data provided) |
| Usability | (Not explicitly stated, but implied to be acceptable) | Met acceptance criteria (no specific performance data provided) |
| Shelf Life | (Not explicitly stated, but implied) | Met acceptance criteria (no specific performance data provided) |
| Battery Life | (Not explicitly stated, but implied) | Met acceptance criteria (no specific performance data provided) |
| Electrode Performance | As specified in ANSI/AAMI EC12:2000 (including tensile and electrical performance) | Met acceptance criteria (no specific performance data provided) |
| Measurement Technology | Muscle response detection using Electromyography (EMG) | Functions as intended, similar to predicate's EMG/MMG methodology. |
| Stimulation Current Range | 10-60 mA (matching device specification) | Operates within specified range and meets performance for this range. |
| Stimulation Pulse Width | Square wave, constant current: 200 µs or 300 µs (matching device specification) | Operates within specified parameters and meets performance for this output. |
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.
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).