(161 days)
The Neurosign 800 is intended to monitor and to stimulate cranial motor nerves. The motor nerves are monitored by detecting EMG activity in the muscles they innervate.
The Neurosign 800 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.
This 510(k) submission for the Neurosign 800 Motor Nerve Monitor does not contain the kind of detailed information about acceptance criteria and a specific study proving it meets those criteria that is typically found in submissions for AI/ML-driven medical devices.
The provided text focuses on:
- Device Description: What the Neurosign 800 is and how it works.
- Intended Use: Monitoring and stimulating cranial motor nerves.
- Substantial Equivalence: Listing similar predicate devices (Neurosign 100, Brackmann II, NIM-2XL).
- Safety and Effectiveness Justification (General):
- Lack of complaints/adverse effects for predicate devices.
- "Extensive in-house and on-site clinical evaluation" of all products by The Magstim Company.
- Statement that the Neurosign 800 "has met all specifications and expectations for its intended use based on the evaluations conducted thus far."
- Consistency in manufacturing methods with a predicate device.
- Conclusion that it is "safe and effective for its intended use."
It explicitly states: "The Magstim Company performs extensive in-house and on-site clinical evaluation of all its products both prior to and after product release for distribution. Our methods and procedures for acceptance of products as well as our techniques for clinical evaluation are performed using team participation. ... The Neurosign 800 has met all specifications and expectations for its intended use based on the evaluations conducted thus far."
This is a very general statement and does not provide the specific details requested in your prompt, which are more geared towards validating the performance of an algorithm or an AI model against quantifiable metrics.
Therefore, for your specific questions, based only on the provided text, the answer is that this information is not available or not described in the given 510(k) summary.
Here's a breakdown of how the information you requested maps (or doesn't map) to the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in detail. The text generally states "met all specifications and expectations for its intended use." This is not a quantifiable criterion. | Not specified in detail. The text does not provide specific performance metrics, e.g., sensitivity, specificity, accuracy, latency, signal-to-noise ratio, or specific EMG output characteristics. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified. The evaluations are described as "in-house and on-site clinical evaluation." Whether these were formal studies with defined test sets, controlled environments, or specific data collection methodologies (prospective/retrospective) is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not specified. The "team participation" mentioned includes Marketing, Manufacturing, Engineering, Clinical Engineering, Manufacturing Engineering, and Quality Assurance, which are involved in "methods and procedures for acceptance of products" and "techniques for clinical evaluation." This is a product development team, not necessarily a panel of independent clinical experts establishing ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not specified.
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
- Not applicable/Not specified. This device is a nerve monitor and stimulator, not an AI-driven diagnostic tool that assists human readers in interpreting images or data in the way an AI algorithm might. The summary does not mention any AI component or human-in-the-loop assistance for interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable/Not specified. This is a hardware device with associated software for signal acquisition and display, not an algorithm performing a diagnostic or predictive function independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. Given the nature of an EMG and stimulator, typical "ground truth" might relate to direct observation of nerve stimulation response, correlation with surgical findings, or clinical neurological assessment, but this is not detailed in the summary.
8. The sample size for the training set
- Not applicable/Not specified. This device does not describe an AI/ML component that uses a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not specified.
In summary: The provided 510(k) refers to general internal company evaluations and clinical assessments that led to the conclusion of safety and effectiveness, drawing heavily on substantial equivalence to predicate devices and their unblemished safety record. It does not contain the detailed, quantitative study data or acceptance criteria typically provided for AI/ML device submissions, or even for non-AI devices where specific performance claims (e.g., accuracy, precision) need to be validated in a formal study.
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.