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The NM-01/CPT neurometer is a noninvasive electrodiagnostic device intended for verifying nerve integrity in conscious adult patients, with intact skin surface.

The population of subject for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation.

The NM-01/CPT neurometer may be conducted as a part of a routine neurological examination. The measured data can be utilized in evaluating patients suspected of having neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician. The device is intended for use on adults in medical clinics, healthcare practices and out-patient departments of hospitals.

The NM-01/CPT neurometer is a noninvasive device intentity in conscious adult patients, with intact skin surface. The population of subject for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation. The NM-01/CPT neurometer may be conducted as a part of a routine neurological examination. The measured data can be utilized in evaluating patients suspected of having neuropathies. The measured data must be used in the context of other patient information and interpreted by a physician. The device is intended for use on adults in medical clinics, healthcare practices and out-patient departments of hospitals.

The NEUROMETER NM-01/CPT is a unique neurodiagnostic device that painlessly evaluates the functioning of small unmyelinated (C, small myelinated (A) and large myelinated (A) sensory nerve fibers at any cutaneous site by determining neuro selective sensory nerve conduction threshold. The electronic unit emits non-aversive transcutaneous electrical stimuli through a pair of special noninvasive electrodes in three fixed frequency ranges (thick myelincoated fiber 250Hz, thin myelin-coated fiber 2000Hz) with a manually adjustable current value. The emitted stimulus pulses canbe changed between 0.01 and 9.99 mA and their values qiven by the software are in CPT (Current Precipitation Threshold) values accepted in clinical practice (1CPT = 0.01mA). The test method is sensitive to both hyperesthetic abnormalities, and has more than 800 peer reviewed research publications documenting its diagnostic capabilities. The device can measure sensory nerve function at any cutaneous site including mucosal surfaces such as the bladder and the measures are not affected by skin temperature, edema or electromag-netic interference unlike traditional electro-diagnostic and biopsy procedures. The conducted tests are painless, noninvasive and non-aversive procedure is easy to perform and safe and harmless however it is only for profession clinical use. The evaluation of the tests result could only be approved by a medical doctor but the tests could be conducted by a trained assistant.

The provided text describes a 510(k) premarket notification for the NM-01/CPT neurometer (K240189) and its substantial equivalence to predicate devices. It includes a summary of non-clinical testing performed.

Here's an analysis of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a numerically quantified target, but the study implies an acceptance range for the ratio of measurements between the NM-01/CPT neurometer and the predicate device (Neurometer) to be within 10%.

For CPT 10, the mean of the ratio is 1.109, with a 90% confidence interval of (1.0531; 1.1648), meaning the two measurements cannot be considered equivalent within the 10% limit for CPT 10. However, the document states such values are "not expected in the population under study." |

Conclusion on Acceptance: The device generally met the implicit acceptance criteria of equivalence within a 10% limit, with a noted exception for CPT 10 values, which the submitter claims are not clinically relevant for the target population.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The text mentions "Bench testing was performed on the NM-01/CPT neurometer measured values with the results of the Neurometer used in clinical practice," but it does not specify the number of resistance measurements or CPT measurements performed for this comparison.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study is described as "Bench testing," implying it was conducted in a controlled environment as opposed to a clinical trial with human subjects.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The study described is a bench test comparing the performance of the new device against a predicate device, not involving human interpretation for establishing ground truth regarding a medical condition.

4. Adjudication Method

Not applicable for a bench test comparing device measurements.

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

No, a MRMC comparative effectiveness study was not done. The study was a bench test comparing the device's measurements to a predicate device.

6. Standalone Performance Study

Yes, a standalone performance study (bench testing) was done. The NM-01/CPT neurometer's measured values were compared against the results of the legally marketed predicate device (Neurometer). This comparison assesses the algorithm/device's technical performance.

7. Type of Ground Truth Used

The "ground truth" for this bench test was the measurements obtained from the predicate device, the "Neurometer used in clinical practice." This means the new device's performance was evaluated against an established and accepted device's output.

8. Sample Size for the Training Set

Not applicable. This document describes a performance evaluation of a device, not the development of a machine learning algorithm that typically involves a training set. The device appears to be an electrodiagnostic tool that directly measures nerve conduction thresholds, rather than an AI/ML diagnostic system.

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

Not applicable, as there is no mention of a training set or machine learning algorithm.

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The Mediracer NCS is intended to measure sensory and motor neripheral nerves. The measured data can be utilized in evaluating patients suspected of having focal neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician.

The Mediracer NCS is a hand-held NCS Device to stimulate and record the nerve responses from patient. The NCS Device is connected to the disposable surface electrodes with cables provided with the NCS Device. The NCS Device communicates via Bluetooth with a computer which is using The Mediracer Analysis Center (MAC) software. The computer uses the MAC software to store and handle the patient measurement data. With the NCS Device comes a charger and a docking station for charging the NCS Device. Also, solution includes a test module for checking the functionality of the whole test system.

The Mediracer NCS is a nerve conduction velocity measurement device. The provided text outlines the performance data for the device, including bench testing and clinical studies, to support its substantial equivalence determination.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative thresholds in the provided text. Instead, the document focuses on demonstrating substantial equivalence to a predicate device and high agreement with traditional nerve conduction studies. The "performance data" section primarily describes the results of studies rather than pre-defined acceptance criteria with specific numerical targets typical for a 510(k) submission.

However, based on the summary provided, we can infer the reported device performance:

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

The provided text describes two clinical studies used for performance evaluation, which can be considered the test sets.

• Finnish Multicenter Study:

  • Sample Size: 194 patients and 95 healthy control volunteers.
  • Data Provenance: Finland (multicenter study).
  • Retrospective or Prospective: The description strongly suggests a prospective study ("recruited patients," "went through a clinical examination, Mediracer NCS measurement and the traditional NCS").

• United Kingdom Study:

  • Sample Size: 63 patients (selected from 104 referrals).
  • Data Provenance: United Kingdom (Leicester Carpal Tunnel Service).
  • Retrospective or Prospective: Description indicates patients "were recruited from the normal referral stream," "fulfilled the clinical CTS diagnosis after symptom inquiry and clinical assessment," and "went through clinical assessment, Mediracer NCS measurement and the traditional NCS," suggesting a prospective study.

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

The text states that in both clinical studies, participants underwent "traditional nerve conduction studies (NCS)" and "clinical assessment." The "traditional NCS" likely serves as the ground truth. It also mentions that "The data measured is reviewed and interpreted by a specially trained physician or specialist in neurophysiology."

• Number of Experts: Not explicitly stated how many distinct experts were involved in interpreting the traditional NCS for ground truth establishment within the context of the studies. It refers to "a specially trained physician or specialist in neurophysiology" in general terms for interpreting Mediracer NCS data, but does not specify for the ground truth of the studies.
• Qualifications of Experts: Assumed to be "specially trained physician or specialist in neurophysiology," as they are the ones who perform and interpret traditional NCS. Specific experience levels (e.g., "10 years of experience") are not provided.

4. Adjudication Method for the Test Set

The adjudication method for determining the true disease status based on the "traditional NCS" is not explicitly described. It only states that the traditional NCS was performed. It doesn't mention if multiple readers reviewed the traditional NCS, or if there was a consensus process (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not done. The study compares the Mediracer NCS device (which is also used by humans) against traditional NCS devices, not the effect of AI on human reader performance. The Mediracer NCS itself is a measurement device, and while it has accompanying software (MAC), the study is evaluating the device's diagnostic capability, not an AI's interpretative assistance to a clinician.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

• Standalone Performance: No, a standalone (algorithm only) performance study was not done in the context of an AI algorithm. The Mediracer NCS is a device that requires a human operator ("used by physician or by technician on the order of physician") to take measurements, and a physician to review and interpret the data. The "Mediracer Analysis Center (MAC) software" is for storing and handling data, not an AI for autonomous interpretation or diagnosis.

7. The Type of Ground Truth Used

The ground truth used in the clinical studies was based on traditional nerve conduction studies (NCS) and clinical assessment for diagnosing Carpal Tunnel Syndrome (CTS). This would fall under expert consensus/clinical diagnosis derived from established diagnostic procedures.

8. The Sample Size for the Training Set

The document does not mention a training set for the Mediracer NCS device. This is likely because the Mediracer NCS is presented as a measurement device, not an AI/machine learning algorithm that requires a training phase. Its equivalence is established through direct comparison to existing measurement techniques and devices.

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

Since no training set is mentioned for an AI/machine learning model, the method for establishing its ground truth is not applicable here.

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NeuroMetrix ADVANCE is intended to perform nerve conduction studies and needle electromyography procedures. As such, NeuroMetrix ADVANCE is intended to measure neuromuscular signals that are useful as an aid in diagnosing and evaluating patients suspected of having focal or systemic neuropathies. If the elective needle EMG module is used, then the device is also intended to measure signals that are useful as an aid in evaluating disorders of muscles.

This device must be used in the context of other patient information. Its output must be reviewed and interpreted by a physician who will exercise professional judgment when using this information.

The NeuroMetrix ADVANCE System consists of the following components:

• 5.1 A Device that features a high-resolution touch-screen display panel with a stylus. The Device has a cable that connects to disposable surface electrodes for performance of nerve conduction studies. The Device communicates via Bluetooth with an accessory EMG Module that connects to electromyography needles for performance of invasive needle electromyography studies. The Device amplifies, digitizes and stores nerve and muscle signals. It delivers electrical stimuli through the electrodes for nerve conduction studies. Nerve conduction and needle clectromyography waveforms are displayed in real time. The Device reports standard nerve conduction parameters based on operator or computer assigned waveform cursors. Nerve conduction parameters include motor and sensory latency, motor and sensory conduction velocity, F-wave response parameters, A-waves, motor and sensory amplitude and waveform configuration. The Device may optionally upload stored data to the Communications Hub. The Device is powered by a rechargeable battery pack or by three standard AA alkaline batteries.
  The Device may be used with the Proximal Stimulation Adapter, which is an accessory used to extend the physical reach of the Device connector and thereby enables proximal nerve stimulation.

• 5.2 A Charger that also houses the Device. In addition to charging the Device, it features a spare battery pack charger along with three LED indicators and is powered by an AC adapter

• 5.4 A Communications Hub that receives optional data uploads from the Device via Bluetooth and transmits the data to the onCall Information System for data storage and direct transference of acquired waveforms and nerve conduction parameters to a remote printer without further post-processing or data analysis. The Communications Hub is powered by an AC adapter.

• 5.5 A Needle EMG Module that enables invasive needle electromyography The Needle EMG Module connects to standard concentric sterile recordings. EMG needles and a surface electrode. With the needle inserted into a muscle of interest, the Needle EMG Module amplifies myoelectrical signals and transmits them to the Device via Bluetooth where they are continuously displayed. The electromyographic signals are also concurrently played through an integrated loud-speaker.

• 5.6 A Cart that houses and charges the Device and its accessories to facilitate patient testing.

Below is a summary of the acceptance criteria and study information for the NeuroMetrix ADVANCE, based on the provided text.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the NeuroMetrix ADVANCE are not explicitly stated as numerical targets in the provided document. Instead, the study aimed to demonstrate the device's reliability by comparing its performance to established benchmarks. The "reported device performance" is essentially the measured reliability of various nerve conduction parameters.

2. Sample Size and Data Provenance

• Sample Size for Test Set: 15 subjects (14 of whom had symptoms of potential neuropathies).
• Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "clinical neurophysiology specialists" and a "central review laboratory" in the benchmark studies, suggesting medical settings. It appears to be a prospective study as tests were performed at specific intervals (3-7 days apart, and within 10 minutes at each session).

3. Number of Experts and Qualifications for Ground Truth

The provided document does not indicate the number of experts used to establish ground truth specifically for the NeuroMetrix ADVANCE study. However, it mentions that the benchmark studies (Bril et al. 1998, Kohara et al. 2000, Bird et al. 2006) involved measurements performed by "clinical neurophysiology specialists with oversight by a central review laboratory." This implies experienced medical professionals.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth for the ADVANCE test set. The study focused on the reproducibility of the device's measurements rather than comparing them to an independently established "ground truth" diagnosis.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done according to the provided text. The study focused on the reliability and reproducibility of the device's measurements, not on the improvement of human readers with AI assistance.

6. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) was done. The study specifically assessed the "reproducibility of nerve conduction parameters derived from computer based data acquisition and waveform cursor assignments." The "between test" reliability quantified variation attributable to the ADVANCE System "in the absence of operator intervention," indicating standalone algorithmic performance.

7. Type of Ground Truth Used

The concept of a traditional "ground truth" (e.g., pathology, outcomes data, expert consensus diagnosis) as it relates to diagnostic accuracy is not directly applied here. Instead, the study assessed the reliability and reproducibility of the device's measurements. The "truth" in this context is the consistency of the device's own measurements over repeated tests, benchmarked against established physiological variability reported in the literature for nerve conduction studies.

8. Sample Size for the Training Set

The document does not mention a separate training set. The study described appears to be a validation study for the device's performance, not a development or training exercise for an algorithm.

9. How Ground Truth for the Training Set Was Established

Not applicable, as no separate training set is described in the provided text.

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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 XLTEK NeuroPath is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.

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

Not Found

The provided text is a 510(k) clearance letter from the FDA for the XLTEK NeuroPath device. This type of document primarily confirms that a new medical device is "substantially equivalent" to an already legally marketed predicate device.

Crucially, a 510(k) clearance letter itself does NOT typically contain detailed information about specific acceptance criteria or the comprehensive results of performance studies that prove a device meets those criteria.

Instead, the manufacturer (Excel-Tech Ltd. in this case) would have submitted detailed performance data, acceptance criteria, and study protocols to the FDA as part of their 510(k) submission. The FDA reviews this information to make their substantial equivalence determination.

Therefore, based solely on the provided text, I cannot provide the requested information. The text confirms the device name, K-number, regulation number, regulatory class, and its intended use, but it does not delve into the specifics of performance studies or acceptance criteria.

To answer your questions, one would need access to the actual 510(k) submission (traditional or special, which contain more detailed information), which is often publicly available through the FDA's Dockets Management Staff or a Freedom of Information Act (FOIA) request, though summaries are typically available on the FDA's 510(k) database.

In summary, the provided document is an FDA clearance letter, not the study report itself.

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The VT 3000 is designed to conduct a range of tests including Nerve Conduction Studies (NCS) and Evoked Potentials (EP).

Not Found

This document appears to be an FDA 510(k) clearance letter for a medical device (Virtual Medical Systems VT 3000, a nerve conduction velocity measurement device). It does not contain the kind of detailed study information (acceptance criteria, performance data tables, sample sizes, ground truth establishment, expert qualifications, etc.) that would be part of a submission to demonstrate clinical effectiveness or safety as you've requested.

The document primarily focuses on:

• Confirming substantial equivalence to a predicate device.
• Indications for use (Nerve Conduction Studies and Evoked Potentials).
• Regulatory classification (Class II).
• General regulatory requirements for the manufacturer.

Therefore, based solely on the provided text, it is not possible to describe the acceptance criteria and the study proving the device meets them. The information you've requested typically comes from the detailed technical sections of the 510(k) submission itself, which are not included here.

The provided text does not contain any of the following information:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance analysis was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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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 BREVIO is intended for use for the measurement of nerve response latency and amplitude in the diagnosis and monitoring of peripheral neuropathies.

The BREVIO is intended to be used as a waveform display nerve conduction monitor. It displays the latency value derived from an action potential. The display shows the latency value in milliseconds from the trigger to the onset. The internal circuitry has the complete waveform from which the latency value is derived and this is delivered to the digital storage oscilloscope for compete waveform display.

The latency value is important in the diagnosis of median nerve dysfunction. The physician can use the BREVIO to examine the features of the waveform generated by the stimuli. The physician can determine the action potential latency, amplitude configuration and duration.

The BREVIO is a battery powered (4 AA batteries) hand held device that is utilized to perform motor and sensory nerve conduction testing on peripheral nerves in a clinical setting. It consists primarily of two units, a handheld processor with LCD screen and a stimulator. It may also be coupled with a number of HP inkjet printers to print patient information and results.

The BREVIO automatically picks out the latency and amplitude of waveforms presented to determine the values associated with them. The automatically chosen values may be manually adjusted by the user should the user feel the necessity to manually make such a change.

The BREVIO has memory storage of 28 waveforms for later viewing and printing of the test results.

The BREVIO device is a hand-held nerve conduction velocity measurement device intended for use in the diagnosis and monitoring of peripheral neuropathies. The 510(k) summary provides limited details on formal acceptance criteria or detailed study results. Based on the provided text, the device's performance was evaluated through bench testing and comparative human testing against a predicate device.

Here's an attempt to organize the information based on your request, with significant limitations due to the brevity of the study description in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the "comparative human testing." It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature) for this human testing. Given the context of a 510(k) submission in the US, it is implied the testing was likely conducted in the US, but this is not explicitly stated. The testing seems to be prospective in nature, given its description as "comparative human testing" conducted to demonstrate correlation.

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

The document does not provide information on the number of experts or their qualifications for establishing ground truth in the "comparative human testing." The testing was a comparison between the BREVIO device and a predicate device, implying the predicate device's readings served as a comparative reference.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The document does not indicate that a formal Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted to evaluate human reader improvement with AI assistance. The "comparative human testing" described seems to be a direct comparison of device measurements, not a study of human readers using the device with and without AI assistance. Therefore, no effect size for human reader improvement with AI vs. without AI assistance is reported.

6. Standalone (Algorithm Only) Performance

The device is implicitly standalone in its measurement capability, as it "automatically picks out the latency and amplitude of waveforms." The "comparative human testing" involved comparing the BREVIO device's measurements directly against a predicate device, which inherently implies standalone performance of the BREVIO in generating those measurements. However, no specific "standalone" study, separated from human involvement in interpretation or adjudication of those measurements, is explicitly detailed. The statement that "These automatically chosen values may be manually adjusted by the user" indicates that while the algorithm provides initial values, human-in-the-loop interaction is an expected part of its use.

7. Type of Ground Truth Used

For the "comparative human testing," the "ground truth" was established by the measurements obtained from a legally marketed predicate device. The document states, "Comparative human testing was done demonstrating a high correlation between the BREVIO device and a predicate device for latency and amplitude comparison." This implies the predicate device acted as the reference standard.

8. Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. This suggests that the device's automatic latency and amplitude detection capabilities might have been developed through internal engineering and testing, rather than a formal, disclosed machine learning training paradigm with a specific dataset.

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

Since no training set is mentioned, the method for establishing its ground truth is also not provided.

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