(146 days)
The NeuroMetrix NC-stat is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entraponent neuropathies.
The NC-stat system consists of the following four components:
- An instrument that contains the electronic circuitry and software required to control a nerve conduction study, including determination of the supramaximal stimulus intensity, acquisition and analysis of motor and sensory waveforms, and display of latency/conduction velocity, amplitude and response configuration parameters. The instrument saves patient and study data for optional transmission to a docking station for real-time hard copy report generation. The instrument displays nerve conduction data in real-time on the LCD readout, including the distal motor latency (DML), Compound Muscle Action Potential (CMAP) amplitude, CMAP duration, CMAP area, motor conduction velocity (CV), F-wave latency, distal sensory latency (DSL), the Sensory Nerve Action Potential (SNAP) amplitude, SNAP duration, sensory CV, 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 stationary docking station is used to download the test data from the instrument via an infra-red communication link to the onCall Information System via an analog phone line. The docking station is non-transportable and connected to both a power outlet and an analog phone line.
- Single-use, disposable biosensors are available for the median motor, ulnar motor, median motor & sensory, ulnar motor & sensory, deep peroneal, posterior tibial, and sural nerves. The biosensors contain electrodes for nerve stimulation, response detection, and skin surface temperature measurement.
- 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 comparison of patient results to normal ranges. Reports are sent to the user by facsimile or e-mail.
The provided document describes a 510(k) premarket notification for the NeuroMetrix NC-stat device (K060584), which is a nerve conduction testing system. This submission primarily focuses on changes to an existing, previously cleared device (NC-stat, K982359, K000565, K003508, K013459, and K041320) and considers it substantially equivalent to its predecessors and the TECA TD-10/TD-20.
The document states: "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." However, it does not provide specific details on acceptance criteria, reported performance values, sample sizes, data provenance, ground truth establishment, or study designs (e.g., MRMC, standalone).
Therefore, based solely on the provided text, a comprehensive answer to your request is not possible. I will extract the information that is present and explicitly state what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Metric / Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Comparability to Conventional Equipment | (Not explicitly stated in the provided text, but implied as equivalence) | "nerve conduction measurements obtained using the NC-stat are comparable to those obtained using conventional nerve conduction measurement equipment." |
| Specific parameters (DML, CMAP amplitude, etc.) | (Not specified) | (Not specified) |
Missing Information:
- Specific numerical acceptance criteria (e.g., ranges, statistical thresholds) for comparability.
- Actual reported performance values for parameters like Distal Motor Latency (DML), Compound Muscle Action Potential (CMAP) amplitude, Conduction Velocity (CV), etc., from the study.
2. Sample Size Used for the Test Set and Data Provenance
Missing Information:
- The exact sample size (number of subjects/nerves tested) for the test set used in the clinical data submission is not provided.
- The data provenance (e.g., country of origin, retrospective or prospective nature of the study) is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Missing Information:
- The document does not detail how ground truth was established for the clinical data. It refers to "conventional nerve conduction measurement equipment" as the comparator, implying that the ground truth would be the measurements from this equipment, likely interpreted by qualified personnel. However, the number of experts and their specific qualifications are not explicitly stated.
4. Adjudication Method for the Test Set
Missing Information:
- The adjudication method (e.g., 2+1, 3+1, none) used for the test set is not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
Missing Information:
- There is no mention of an MRMC comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. The device is a "Nerve Conduction Testing System," not explicitly an AI-assisted diagnostic tool in the context of human reader improvement. The "comparability" study described focuses on device-to-device equivalence.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- The document states that the "NC-stat... is intended to stimulate and measure neuromuscular signals." It is a measurement device that provides data for diagnosis and evaluation. The clinical data demonstrated "nerve conduction measurements obtained using the NC-stat are comparable to those obtained using conventional nerve conduction measurement equipment." This indicates a standalone performance assessment in the sense that the device's measurements are validated against a reference standard. However, the exact methodology and whether this constitutes an "algorithm-only" performance in the modern sense (e.g., image analysis without human input) is not detailed. It's more of a hardware/software system performance validation.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the comparison was established by "conventional nerve conduction measurement equipment." This implies that measurements from established, predicate devices or standard methodologies for nerve conduction studies served as the reference standard.
8. The Sample Size for the Training Set
Missing Information:
- The document does not refer to a "training set" in the context of machine learning or AI models. The study discussed is a clinical comparison for regulatory clearance, not a model development study. Therefore, no information on a training set sample size is provided.
9. How the Ground Truth for the Training Set Was Established
Missing Information:
- As there's no mention of a "training set" in the context of model development, how its ground truth was established is not applicable or provided in this document.
Summary of available information:
The 510(k) submission for the NeuroMetrix NC-stat (K060584) claims comparability of its nerve conduction measurements to those obtained using conventional equipment. This claim allowed for substantial equivalence to predicate devices. However, the document lacks specific details regarding the clinical study's design, sample sizes, precise acceptance criteria, quantitative performance metrics, and the detailed methodology for establishing ground truth or expert involvement. The clinical data appears to validate the device's measurement capabilities against established standards.
§ 882.1550 Nerve conduction velocity measurement device.
(a)
Identification. A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.(b)
Classification. Class II (performance standards).