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510(k) Data Aggregation
(12 days)
NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR
The Neurosign 400 is intended to monitor and to stimulate cranial motor nerves. Cranial motor nerves are monitored by detecting EMG activity in the muscles they innervate.
To locate and identify cranial motor nerves during ENT and intra-cranial procedures.
The Neurosign 400 is an EMG machine and nerve stimulator. The machine consists of a central control unit to which a pre-amplifier pod and intramuscular, or surface, electrodes are attached for EMG recordings. Additionally, connected to the main unit is a stimulator pod to which a stimulating probe, which delivers current to nerve tissue, may be connected. The Neurosign 400 is intended to monitor and to stimulate cranial motor nerves. Cranial motor nerves are monitored by detecting EMG activity in the muscles they innervate.
Here's an analysis of the provided text regarding the Neurosign 400 Motor Nerve Monitor, focusing on acceptance criteria and the study proving its effectiveness:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document extensively describes the Neurosign 400 as being "similar" to previously cleared devices (Neurosign 800 and Neurosign 100), and relies heavily on the safety and effectiveness history of these predicate devices. The acceptance criteria aren't explicitly quantified with specific performance metrics (e.g., minimum accuracy percentages, sensitivity, specificity). Instead, the criteria are qualitative and based on equivalence and lack of adverse events from predicate devices.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Safety: No complaints related to safety for similar products. | "The history of the similar products listed above lacks complaints related to safety and effectiveness, and as far as we are aware there have been no reports of adverse effects or reportable incidents connected with them, or in any published papers on nerve monitoring." The Neurosign 400 "has met all the specifications and expectations for its intended use." |
| Effectiveness: No complaints related to effectiveness for similar products. | "The history of the similar products listed above lacks complaints related to safety and effectiveness..." The Neurosign 400 "has met all the specifications and expectations for its intended use based on the evaluations conducted thus far." |
| Equivalence to Predicate Devices: Performance similar to existing cleared devices. | The Neurosign 400 is marketed as "similar to the following products which are currently in commercial distribution in the U.S.A.: Neurosign 800 Nerve Monitor, The Magstim Company, K964869; Neurosign 100 Nerve Monitor, The Magstim Company, K923056/A." The FDA's 510(k) clearance explicitly states the device is "substantially equivalent" to predicate devices. |
| Meeting Specifications for Intended Use: Ability to monitor and stimulate cranial motor nerves. | "The Neurosign 400 has met all the specifications and expectations for its intended use based on the evaluations conducted thus far." |
| Manufacturing Quality: Materials and methods are consistent with current Magstim Company practices. | "The materials and methods used to manufacture the Neurosign 400 do not vary from the current materials and methods used by the Magstim Company in the manufacture of the Neurosign 800." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a test set sample size or describe any specific clinical study involving a "test set" in the traditional sense of a new, independent dataset for evaluation.
Instead, the safety and effectiveness are established through:
- Historical data of predicate devices: Review of complaints and adverse events for the Neurosign 800 and Neurosign 100. The provenance is implied to be historical market data from the U.S. and potentially other regions where these devices were distributed. This is retrospective data.
- In-house and on-site clinical evaluation: Performed by The Magstim Company for "all its products, both prior to, and after product release for distribution." The data provenance for these internal evaluations is not detailed (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
No specific "test set" with ground truth established by external experts is described. The acceptance relies on:
- Market feedback on predicate devices: The absence of reported adverse events or complaints is implicitly the "ground truth" for proving safety and effectiveness of the existing technology.
- Internal "team participation" for evaluations: "Team members include, but are not limited to Marketing, Manufacturing, Engineering and Quality Assurance." While these individuals are experts in their respective fields, they are internal to the company and not independent clinical experts establishing ground truth for a defined test set. Their qualifications are not specified beyond their departmental roles.
4. Adjudication Method for the Test Set:
No specific test set or adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as there was no formal independent clinical study with a predefined test set and expert review for this 510(k) submission. Acceptance is based on the lack of complaints for predicate devices and internal company evaluations.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is presented or referenced. The submission does not involve comparing human reader performance with or without AI assistance, as the device is a nerve monitor/stimulator and not an AI-driven image analysis tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This detail is not applicable in the context of the Neurosign 400. The device is an EMG machine and nerve stimulator designed for direct use by a clinician during surgical procedures. Its functionality is not based on a standalone algorithm or AI performance that would be evaluated without human interaction. The "performance" is its ability to accurately detect EMG activity and stimulate nerves, which is inherently part of a human-in-the-loop diagnostic/monitoring process.
7. The Type of Ground Truth Used:
The ground truth mainly relies on:
- Historical safety and effectiveness data of predicate devices: Absence of adverse events and complaints for Neurosign 800 and Neurosign 100. This is essentially "outcomes data" in a broad sense, demonstrating safe and effective use in real-world clinical practice over time.
- Internal company specifications and expectations: The device passed internal evaluations against established product specifications.
8. The Sample Size for the Training Set:
The document does not describe a "training set" in the context of machine learning or algorithm development. The device's functionality is based on established electrophysiological principles and hardware design, not on a data-driven learning model. Therefore, sample sizes for training sets are not applicable or mentioned.
9. How the Ground Truth for the Training Set Was Established:
As there is no described training set for an algorithm, the concept of establishing ground truth for a training set is not relevant to this 510(k) submission. The safety and effectiveness are established through substantial equivalence based on the history of predicate devices and internal validation processes.
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