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The Datex-Ohmeda S/5™ E-NMT module is intended to be used to monitor the relaxation of the patient and regional block stimulation for nerve location.

Indications for Use:

The Datex-Ohmeda S/5™ E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.

The device is indicated for use by qualified medical personnel only.

The Datex-Ohmeda S/5 NeuroMuscular Transmission Module, E NMT and accessories are used for monitoring neuromuscular transmission (NMT) of hospitalized patients. NeuroMuscular Transmission (NMT) is the transfer of an impulse between a nerve and a muscle in the neuromuscular junction. NMT can be blocked by neuromuscular blocking agents or drugs which cause transient muscle paralysis and prevent the patient from moving and breathing spontaneously. The level of neuromuscular block is measured with the E-NMT module by stimulating a peripheral nerve, usually in the hand, and by evaluating the muscle response. For example, with the Datex-Ohmeda MechanoSensor the motion of the thumb is registered by a piezoelectric sensor, converting the physical motion to a measurable electrical signal. The intended use for the modified device is the same as for the predicate, Datex-Ohmeda M-NMT module and accessories (K955026). There has been no change to the basic technology from the predicate.. The E-NMT module is a facelifted version of the predicate M-NMT module (K955026). The module cover and mechanics have changed, but electronic measurement board is identical to the predicate device (K955026). The module software has some minor modifications for manufacturing and an enhancement saving the supramaximal current and the reference value to the NMT board EEPROM after start-up. The module software version changed from 1.0 to 2.0. The E-NMT module input board connecting the module connector to the measurement board has a minor enhancement for better defibrillation protection.

The provided document is a 510(k) Premarket Notification for the Datex-Ohmeda S/5 NeuroMuscular Transmission Module, E-NMT and Accessories. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a de novo study with acceptance criteria and a detailed performance study.

Therefore, many of the requested details about acceptance criteria, a specific study proving it, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not available in this type of submission.

The document primarily states:

• No new questions of safety and effectiveness are raised compared to the predicate device.
• The device has been thoroughly tested through validation and verification of specifications against various industry standards (IEC, EN, UL, AAMI, FDA guidance documents), but the specific acceptance criteria for these tests are not detailed beyond compliance with the standards themselves.
• The performance of the E-NMT module is considered identical to the predicate M-NMT module because the electronic measurement board is identical, and customer and parameter specifications are the same.

Given these limitations, here's an attempt to address your request based on the provided text, indicating when information is not present:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The submission for the Datex-Ohmeda S/5 NeuroMuscular Transmission Module, E-NMT and Accessories is a 510(k) Premarket Notification, which primarily demonstrates substantial equivalence to a previously legally marketed device (predicate device: Datex-Ohmeda M NMT Module, K955026). As such, the study performed is a comparison study against the predicate device and established safety standards, rather than a de novo clinical trial establishing novel acceptance criteria for a new technology.

The core of the "acceptance criteria" in this context is the demonstration that the modified device (E-NMT) is as safe and effective as the predicate device and complies with relevant medical device standards. The "study" proving this involves verification and validation activities against these standards and a comparison of technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-1 (General requirements for safety)
• EN 60601-1 (European equivalent to IEC 60601-1)
• CAN/CSA C22.2 No. 601.1-M90 (Canadian deviations)
• UL 2601-1 (U.S. deviations)
• IEC 60601-1-2 (Electromagnetic compatibility)
• AAMI ES1 (Safe current limits)
• FDA Guidance for Software Contained in Medical Devices
• IEC 60601-2-10 (Particular requirements for nerve and muscle stimulators)
• IEC 60601-2-40 (Particular requirements for electromyographs)
• FDA Performance standard, 21 CFR Part 898.12 (Electrode lead wires and patient cables) |
  | Intended Use: Same as the predicate device. | "The intended use for the modified device is the same as for the predicate, Datex-Ohmeda M-NMT module and accessories (K955026)." |
  | Basic Technology: No change to the basic technology. | "There has been no change to the basic technology from the predicate." "identical fundamental scientific technology." "identical electronic measurement board." |
  | Software Functionality: Software modifications do not adversely impact performance or safety, and enhance functionality as intended. | "The module software has some minor modifications for manufacturing and an enhancement saving the supramaximal current and the reference value to the NMT board EEPROM after start-up." Software version changed from 1.0 to 2.0. This enhancement is explicitly called out as an improvement. |
  | Electrical Protection: Enhanced defibrillation protection. | "The E-NMT module input board connecting the module connector to the measurement board has a minor enhancement for better defibrillation protection." |

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

• Sample Size for Test Set: Not applicable or not specified. This submission does not describe a clinical study with a "test set" of patients in the typical sense. Instead, it relies on engineering verification and validation testing against standards and a comparison of technical specifications to the predicate device.
• Data Provenance: Not applicable. The data is primarily engineering test data and a comparison of device specifications, not patient-derived data from a specific country or retrospective/prospective study.

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

• Not applicable. There was no "ground truth" to establish for a clinical test set in this type of submission. The ground truth for functional performance is considered established by the predicate device and relevant industry standards.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This device is a measurement module, not an imaging or diagnostic AI tool that would typically involve human readers.

6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Study Was Done

• This is not explicitly described as a "standalone study" in the common AI sense. However, the device's measurement functionality (which involves software/algorithm) was likely tested in isolation (standalone) during verification and validation to ensure it meets its specifications, independent of human interaction. The core assertion is that the electronic measurement board is identical to the predicate device, implying its core "algorithm" remains the same.

7. The Type of Ground Truth Used

• The "ground truth" implicitly referred to is derived from:
  • Predicate Device Performance: The established safety and effectiveness of the legally marketed Datex-Ohmeda M NMT Module (K955026).
  • Industry Standards: The requirements and limits defined in the extensively listed IEC, EN, UL, AAMI, and FDA standards.
  • Engineering Specifications: Internal design and performance specifications for the device, validated through verification testing.

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware module with embedded software, not a machine learning or AI algorithm that undergoes "training" with a dataset of this description. The software "modifications" were for manufacturing and data saving, not for learning from a vast dataset.

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

• Not applicable, as there was no "training set" in the context of machine learning. The "ground truth" for the device's functionality is its design specifications and compliance with established predicate device performance and regulatory standards.

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