(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.
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510(k) Summary for NeuroMetrix NC-stat
JUL 3 1 2006
1. SPONSOR
NeuroMetrix, Inc. 62 Fourth Avenue Waltham, MA 02451
Contact Person: Rainer Maas Telephone: (781) 314-2781
Date Prepared: July 26, 2006
2. DEVICE NAME
| Proprietary Name: | NC-stat |
|---|---|
| Common/Usual Name: | Nerve Conduction Testing System |
| Classification Name: | Nerve Conduction Velocity Measuring Device |
3. PREDICATE DEVICES
4. INTENDED USE
The NeuroMetrix NC-stat is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entraponent neuropathies.
ട. DEVICE DESCRIPTION
The NC-stat system consists of the following four components:
- An instrument that contains the electronic circuitry and software required 5.1 to control a nerve conduction study, including determination of the supramaximal stimulus intensity, acquisition and analysis of motor and -
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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 5.2 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, 5.3 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 5.4 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.
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The NC-stat that is the subject of this 510(k) Premarket Notification is substantially equivalent to the NC-stat as previously cleared for marketing and to the TECA TD-10/TD-20 EMG and nerve conduction velocity measurement device. The purpose of this 510(k) is to describe changes made to the NC-stat, including:
- Addition of the modified median motor-sensory biosensor for use in 6.1 diagnosing neuropathies affecting the median motor-sensory nerves.
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6.2 Modifications to the labeling.
None of the changes to the NC-stat have altered the intended use of the device, the basic device design or the device operation. Clinical data submitted in the 510(k) demonstrates that nerve conduction measurements obtained using the NCstat are comparable to those obtained using conventional nerve conduction measurement equipment.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2006
NeuroMetrix, Inc. % Rainer Maas Director, Quality Assurance and Regulatory Affairs Associate 62 Fourth Avenue Waltham, Massachusetts 02451
Re: K060584 Trade/Device Name: NC-stat Regulation Number: 21 CFR 882.1550 Regulation Name: Nerve conduction velocity measurement device Regulatory Class: II Product Code: JXE, IKN Dated: July 5, 2006 Received: July 6, 2006
Dcar Rainer Maas:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drue, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device. subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Rainer Maas
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
Helmut Lachenmann
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Intended Use
510(k) Number (if known): K060584
Device Name: NC-stat
Intended Use:
The NeuroMetrix NC-stat is intended to to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE If NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulbert Brewer
(Division Simmal 317 Division of General, Restorative, and Neurologica. Devices
510(k) Number Ko 60584
Page 1 of 1
§ 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).