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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

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.

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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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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 handheld, 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, display information on the LCD readout, and transmit data to the docking station. LCD displays include the distal motor latency (DML) 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 Management Service via an analog phone line.
• Single-use, disposable biosensors for the median, ulnar, tibial, and peroneal nerves. The tibial and peroneal biosensors are the only new accessories for the NC-stat.
• The onCall Information Management Service for generation of the hardcopy patient test report, which includes test results (distal motor latency, F-wave latency, and associated waveforms) and a comparison of patient results to reference ranges. Reports are sent to the user by facsimile.

The provided 510(k) Summary for NC-stat does not contain specific acceptance criteria or an explicit study description with detailed performance metrics. The document focuses on demonstrating substantial equivalence to predicate devices for the 510(k) submission.

However, based on the information provided, we can infer some aspects relevant to device performance and study design:

1. Table of Acceptance Criteria and Reported Device Performance:

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."

This implies that the acceptance criteria for the NC-stat's performance were based on its ability to produce measurements (Distal Motor Latency, F-wave latency, and associated waveforms) that are comparable or substantially equivalent to existing, legally marketed nerve conduction velocity measurement devices.

Without specific numerical thresholds or statistical metrics, a direct table of acceptance criteria and reported device performance cannot be created from this document. The "comparable" statement serves as the general performance claim.

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

• Sample Size: The document does not specify the sample size used for the clinical data.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "Clinical data submitted in the 510(k)."

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

The document does not provide any information about the number of experts, their qualifications, or how ground truth was established for the test set. It describes the device's output (DML, F-wave latency, waveforms) but not the process of ground truth validation. Since the comparison is to "conventional nerve conduction measurement equipment," it's likely that the ground truth would be measurements obtained from such established equipment, potentially interpreted by trained medical professionals (e.g., neurologists or clinical neurophysiologists) as standard practice.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method for the test set.

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

A MRMC comparative effectiveness study is not mentioned. The focus is on the device's ability to produce comparable measurements to conventional equipment, not on how human readers improve with AI assistance.

6. Standalone Performance Study (Algorithm Only):

The device itself is a measurement tool, not an AI algorithm in the contemporary sense. Its performance is inherently "standalone" in that it directly measures neuromuscular signals and calculates parameters. The comparison is between the NC-stat's measurements and those from conventional equipment. The document implies that the device's accuracy in these measurements was evaluated to show "comparability."

7. Type of Ground Truth Used:

The ground truth implicitly used for comparison would be measurements obtained from conventional nerve conduction measurement equipment. This would be considered a form of expert consensus/established clinical practice or a reference standard rather than pathology or outcomes data in this context. The "comparable measurements" statement suggests that a gold standard for nerve conduction measurements already exists.

8. Sample Size for the Training Set:

The document does not mention any specific training set or its sample size. This is consistent with the device design, which appears to be a direct measurement system rather than a machine learning model that requires a discrete training phase. The device relies on established biophysical principles for nerve conduction measurement.

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

As there is no mention of a training set for a machine learning model, this information is not applicable and therefore not provided in the document.

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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 is intended to be used as an adjunct to and not a replacement for conventional electrodiagnostic measurements.

The NC-stat consists of a hand-held, battery-operated monitor and a disposable sensor. The NC-stat measures two median nerve electrophysiological parameters, the distal motor latency (DML) and the median F-wave latency (F-LAT). The DML is the interval, in milliseconds, between the onset of the stimulus and the onset of the resultant compound muscle action potential (CMAP) in the thenar muscles. The F-LAT is the median interval, in milliseconds, between the onset of the stimulus and the onset of a CMAP in the thenar muscle resulting from antidromic activation of the motor neurons in the spinal cord. The primary and secondary functions of the NC-stat are controlled by software routines. The primary function of the NC-stat software is to carry out nerve conduction measurements. Secondary functions of the software include displaying previously acquired measurement data, communicating stored data to an external target such as a printer and operating hardware diagnostics when the device is initially powered on. The single-use disposable sensor, containing a proprietary electrode array, is placed on the patient's wrist in alignment with the distal most wrist crease and connected to the monitor non-invasively stimulates the patient's median nerve and detects the subsequent CMAP as an electrical potential on the skin, via the sensor. The sensor also contains a temperature electrode that monitors surface temperature of the patient's skin. All this data is analyzed and digitally stored in a non-volatile manner by the monitor. The resulting DML and F-LAT are displayed on the NC-stat L.C.D.

The provided 510(k) summary for the NC-stat device does not contain a specific table of acceptance criteria and reported device performance metrics in the format requested. However, it does outline the performance testing conducted and states that these tests demonstrate the device "yields the appropriate outcome with a high probability" and "conforms to the safety related system and software requirements."

Here's a breakdown of the requested information based on the document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a quantitative table of acceptance criteria and specific performance metrics (e.g., accuracy, sensitivity, specificity, or specific error rates) with numerical values. Instead, it broadly states that the NC-stat was tested to ensure appropriate outcomes and conformance to safety and software requirements.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document dedicates a section to "PERFORMANCE TESTING" but does not specify the sample size used for the test sets (e.g., number of patients or measurements). It also does not mention the country of origin of the data or whether the study was retrospective or prospective.

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)

The document does not provide information on the number or qualifications of experts used to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method for the test set.

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

The document describes the NC-stat as a "Nerve Conduction Monitoring System" that measures electrophysiological parameters (DML and F-LAT). It is a device that directly measures and displays data, not an AI system designed to assist human readers in interpreting images or other complex data. Therefore, an MRMC comparative effectiveness study involving human readers' improvement with AI assistance would not be applicable to this device as described.

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

The NC-stat is described as a "hand-held, battery-operated monitor and a disposable sensor" that directly measures and displays DML and F-LAT. It operates to "carry out nerve conduction measurements" and "display previously acquired measurement data." This implies it functions as a standalone measurement device, providing direct output without requiring human interpretation as part of its primary function. The performance testing section describes "System testing" in which "several complete tests were simulated to obtain all possible test outcomes," which further supports a standalone evaluation of the device's measurement capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document mentions "evaluation of DMLs acquired by volume conduction and those signals acquired and measured using conventional methods." This suggests that conventional nerve conduction measurement methods were used as the reference or ground truth to compare the NC-stat's measurements.

8. The sample size for the training set

The document does not refer to a "training set." The NC-stat is a measurement device that directly acquires and processes electrophysiological signals, not a machine learning model that requires a training set in the conventional sense.

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

As there is no mention of a training set, the establishment of its ground truth is not applicable.

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