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The NeuroMetrix NC-stat is intended to measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.

The NC-stat consists of the following four components:

• A battery-powered monitor. The monitor contains the electronic circuitry and software required to provide initiate and control the nerve conduction study, acquire and save patient and test information including the response waveforms, display information on the LCD readout, and transmit data to the docking station. LCD displays include the distal motor latency (DML) value, the distal sensory latency (DSL) value, the Sensory Nerve Action Potential (SNAP) amplitude value, the F-wave latency value. limb indicator (left or right), low battery indicator, the memory slot being used to store the test data. and user messages (menu selections, sensor serial numbers, device status. operator instructions, and error conditions).
• A docking station used to download the test data to the onCall Information System via an analog phone line.
• Single-use, disposable biosensors are available for the median motor, ulnar motor, median motor & sensory, ulnar motor & sensory, posterior tibial, deep peroneal and sural nerves. The sural biosensor is the only new biosensor for the NC-stat.
• The onCall Information System for automatic generation of the hardcopy patient test report, which includes test results (DML, Compound Muscle Action Potential - CMAP - amplitude, DSL, SNAP amplitude, conduction velocity, F-wave latency, and associated response waveforms) and a comparison of patient results to normal ranges. Reports are sent to the user by facsimile or e-mail.

The 510(k) summary for the NeuroMetrix NC-stat (K041320) does not provide a detailed table of acceptance criteria and reported device performance. Instead, it states that "Clinical data submitted in the 510(k) demonstrates that nerve conduction measurements obtained using the NC-stat are comparable to those obtained using conventional nerve conduction measurement equipment." This indicates that the primary acceptance criterion was likely equivalence to predicate devices.

Here's an attempt to structure the information based on the provided document, acknowledging the limitations in detail:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It generally refers to "Clinical data submitted in the 510(k)."

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

This information is not provided in the 510(k) summary. The document does not describe how ground truth was established for "clinical data".

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The evaluation focuses on the device's measurements compared to conventional equipment, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The evaluation described in the 510(k) summary pertains to the NC-stat device measuring neuromuscular signals. This implies a standalone performance assessment of the device itself (the algorithm and hardware) in producing nerve conduction measurements, rather than human-in-the-loop performance.

7. Type of Ground Truth Used

The type of ground truth used is implied to be measurements obtained from "conventional nerve conduction measurement equipment." This suggests that the ground truth was "expert consensus" or "established clinical practice" as performed by these conventional devices.

8. Sample Size for the Training Set

The document does not mention a separate "training set" or its sample size. The description of the NC-stat's purpose (510(k) for changes including a new biosensor) suggests that the device's algorithms were already established and the clinical data was to demonstrate equivalence for the modified device.

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

Since a dedicated "training set" is not explicitly mentioned, and the focus is on demonstrating equivalence, the method for establishing ground truth for any underlying algorithm development is not detailed. However, it's safe to assume that the underlying algorithms of the NC-stat and the predicate devices were developed using established medical knowledge and potentially clinical data where "ground truth" would have been derived from expert-validated nerve conduction studies using standard clinical procedures.

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