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The C2 Xplore is designed for use in the operating room to measure and display the neurophysiological signals. The system supports the application of Electromyography (EMG) for the purposes of intraoperative neuromonitoring of the peripheral nervous system. The system is not intended for monitoring life-sustaining functions.

The C2 Xplore is an electromyography (EMG) monitor for the purposes of intraoperative neuromonitoring of the peripheral nervous system. The C2 Xplore assists the surgeon in nerve identification, helping to locate and identify nerves at risk in the surgical field. The device records the EMG activity from the innervated nerves and provides visual and audible feedback for the surgeon, helping to preserve the nerve structures throughout the procedure. The device is equipped with 8 differential amplifier channels and with two independent stimulators. The C2 Xplore is operated via mechanical turning knobs and a touchscreen on the front. The audio feedback is generated by an integrated loudspeaker. The nerve monitoring provides information about the amplitude and latency of the EMG responses.

The provided text describes the C2 Xplore device, an electromyography (EMG) monitor for intraoperative neuromonitoring of the peripheral nervous system. It outlines various aspects of the device's design, intended use, and comparisons to a predicate device (C2 NerveMonitor System) and a reference device (Medtronic Xomed, Inc Nerve Integrity Monitor 3.0).

However, the document does not contain specific acceptance criteria in numerical or quantitative terms for the device's diagnostic or clinical performance (e.g., sensitivity, specificity, accuracy for nerve identification). Instead, it discusses compliance with general safety, performance, and software standards.

Therefore, I cannot create a table of "acceptance criteria and reported device performance" as defined by specific clinical metrics. The document focuses on regulatory compliance and substantial equivalence rather than a detailed performance study with clinical outcomes.

Based on the information provided, here's what can be extracted and inferred regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance:

As no specific quantitative clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) are provided in the document for the device's primary function of nerve identification, a direct table of "acceptance criteria and reported device performance" in that sense cannot be created.

However, the document does detail compliance with various technical standards and internal requirements, which serve as acceptance criteria for different aspects of the device:

• Compliance with applicable guidance documents and standards (FDA guidance on premarket submissions for software, off-the-shelf software, software validation, cybersecurity).
• Rigorous development process, including software verification and validation. | "Test results demonstrate that the C2 Xplore software complies with its predetermined specifications, the applicable guidance documents and standards."
  "The software was designed and developed according to a rigorous development process, including software verification and validation."
  "The product successfully underwent the bench testing of the requirements at these levels as part of the verification and validation process." |
  | Electrical Safety | - Compliance with IEC 60601-1:2005+A1:2012 (or 2012 reprint).
• Compliance with IEC 60601-1-6:2010+AMD1:2013 (Usability).
• Compliance with IEC 60601-2-40:2016 (Electromyographs and evoked response equipment).
• Class I protection, 4000 V.
• Device type BF (Body Floating) for patient leads. | "The C2 Xplore was tested according to the following standards: [listed standards]. Test results demonstrate that the products comply with the applicable standards."
  "Class I protection 4000 V"
  "Device type BF (Body Floating)" |
  | Electromagnetic Compatibility (EMC) | - Compliance with IEC 60601-1-2:2014. | "The essential performance and safety of the C2 Xplore was tested according to the following standards: [listed standard]. Test results demonstrate that the products comply with the applicable standards." |
  | Bench Performance Testing | - Compliance with internal requirements for general device, functional, external interface, system accessory, and C2 Xplore software/firmware/OS requirements. | "The essential performance and safety of C2 Xplore was tested for performance in accordance with internal requirements."
  "The product successfully underwent the bench testing of the requirements at these levels as part of the verification and validation process." |
  | Human Factors | - Demonstration of mitigation of potential use errors.
• Safety of user interface design. | "Moreover, the testing of the influence of human factors on the device was conducted to demonstrate mitigation of potential use errors and safety of the user interface design." |
  | Overall Safety and Effectiveness | - As safe, as effective, and performs as well as, or better than, the legally marketed predicate device. | "The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate."
  "The results of these activities demonstrate that the devices are as safe, effective and perform as well as or better than the predicate device." |

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

• Test Set Sample Size: Not applicable. The document states, "No additional clinical testing was performed for the C2 Xplore. Therefore, this section does not apply." The performance testing described is primarily technical bench testing and compliance with standards, not a clinical study on patient data.
• Data Provenance: Not applicable for a clinical test set. The data provenance would be from internal lab testing and compliance assessments, not patient data from a specific geographical region or retrospective/prospective study design.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

Not applicable. As no clinical testing with patient data or medical imaging was performed, there was no need for experts to establish ground truth in a clinical context.

4. Adjudication method for the test set:

Not applicable. No clinical test set requiring expert adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

No. The document explicitly states, "No additional clinical testing was performed for the C2 Xplore." Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted or reported.

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

Not applicable in the context of diagnostic AI. The C2 Xplore is a hardware device with integrated software for neuromonitoring, which inherently involves a human (surgeon) interpreting the visual and audible feedback. It is not an "algorithm only" device designed to operate independently of human intervention for its intended use of nerve identification during surgery. Its standalone performance is described through its technical specifications and compliance with safety and performance standards.

7. The type of ground truth used:

For the technical performance (EMG recording, stimulation, electrical safety, EMC, software functionality), the ground truth is established by engineering specifications, international technical standards, and validated test procedures. For example, the accuracy of voltage/current delivery, noise levels, and frequency response would be verified against known, precisely controlled inputs and expected outputs according to design specifications and relevant standards.

8. The sample size for the training set:

Not applicable. The C2 Xplore is described as an electromyography monitor and stimulator, not an AI/ML device that requires a distinct "training set" of data for learning a clinical pattern. Its software compliance involves verification and validation against predetermined specifications and guidance documents, which is a different paradigm from data-driven AI model training.

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

Not applicable, as no AI model training set is mentioned for the device.

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