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

Device Description

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.

AI/ML Overview

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.

Summary

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K 013459

510(k) Summary for NC-stat

JAN 1 7 2002

1. SPONSOR

NeuroMetrix, Inc. 62 Fourth Avenue Waltham, MA 02451

Joseph Burke Contact Person: (781) 890-9989 Telephone:

October 17, 2001 Date Prepared:

2. DEVICE NAME

Proprietary Name:	NC-stat
Common/Usual Name:	Nerve Conduction Monitoring System
Classification Name:	Nerve Conduction Velocity Measuring Device

PREDICATE DEVICES 3.

NC-stat (K982359, K000565 and K003508) .
TECA TD-10/TD-20 (K802637) .

INTENDED USE 4.

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

DEVICE DESCRIPTION ..

The NC-stat consists of the following four components:

A handheld, battery-powered monitor. The monitor contains the electronic રે ત circuitry and software required to provide initiate and control the nerve conduction study, acquire and save patient and test information, display

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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 5.2 Management Service via an analog phone line.
Single-use, disposable biosensors for the median, ulnar, tibial, and peroneal ર.3 nerves. The tibial and peroneal biosensors are the only new accessories for the NC-stat.
5.4 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.

BASIS FOR SUBSTANTIAL EQUIVALENCE ર્.

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 tibial and peroneal biosensors for use in diagnosing lower 6.1 limb neuropathies.
6.2 Engineering changes necessary to enable the NC-stat to be used for nerve conduction studies of the lower limbs.
6.3 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 NC-stat are comparable to those obtained using conventional nerve conduction measurement equipment.

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Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of three stylized, interconnected shapes that resemble abstract human figures or flowing forms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2002

NeuroMetrix, Inc. c/o Ms. Sheila Hemeon-Heyer, Esq. RAC Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K013459

Trade/Device Name: NC-stat Regulation Number: 882.1550 Regulation Name: Nerve conduction velocity measurement device Regulatory Class: JXE Product Code: II Dated: October 17, 2001 Received: October 18, 2001

Dear Ms. Hemeon-Heyer :

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, Drug, 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, listing 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 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.

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Page 2 - Ms. Sheila Hemeon-Heyer, Esq. RAC

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mach N Millan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 《 013459

Device Name: NC-stat

Indications for Use:

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Mellman

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K013459

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).