The Medi-Dx 7000 is a diagnostic device for the quantitative detection of sensory neurological impairments. The population of subjects for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation.

The Medi-Dx 7000 diagnostic examination may be conducted as part of a routine neurological examination or as a screening procedure for the detection of peripheral neuropathy which may be caused by various pathological conditions or exposures to toxic substances.

Device Description

The Medi-Dx 7000 is a Current Perception Threshold (CPT) device for the examination of peripheral neuropathies. It generates a sinusoidal electrical currents in the 5 Hz, 250 Hz and 2000 Hz frequencies from 0 mA to 9.99 mA.

The Medi-Dx 7000 weighs approximately 15 lbs. and is housed within a 12" x 6" x 11" heavy duty plastic case with metal face and rear panels. The rear panel has an access door for installation and replacement of (8) standard (6) Volt Alkaline Batteries. The Face panel has an 'ON/OFF' switch, a 'Battery Test' switch (also functioning as an automatic calibration switch), and three (3) switches, one for each of the frequencies; 5 Hz, 250 Hz and 2000 Hz respectively. The intensity control is immediately below an LCD which reads mA output. Two ports are available on the from panel for connection with electrodes (which are not provided with the unit and are ordered by the user from suppliers mentioned in the owners manual).

AI/ML Overview

Here's an analysis of the provided text regarding the Medi-Dx 7000, focusing on acceptance criteria and the supporting study, based on your requested categories.

It's important to note that the provided text is a 510(k) summary (or a letter related to an older 510(k) submission), which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials for new device performance. As such, many of your requested points regarding a clinical study or performance metrics won't be fully addressed, as the submission appears to rely heavily on the equivalence of technical specifications.

Acceptance Criteria and Study for Medi-Dx 7000

Based on the provided 510(k) summary, formal acceptance criteria and a structured study to prove the device meets these criteria in the way a modern AI/software device would be evaluated are not presented. The submission primarily establishes substantial equivalence to a predicate device (Neurometer by Neurotron) based on technical similarities and safety improvements, implying that if the predicate device is safe and effective, the Medi-Dx 7000, being "essentially the same" in function and reliability, also is.

Here's an attempt to populate the table and answer your questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state acceptance criteria in terms of performance metrics (sensitivity, specificity, accuracy, etc.) for diagnosing neurological impairments. Instead, the "acceptance" is implicitly tied to its functional equivalence and safety compared to the predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit, based on equivalence)
Functional Equivalence to Predicate Device	"The Medi-Dx 7000 and the equivalent (Neurometer) device are essentially the same" in: - Minimum/maximum output (0.0 mA to 9.99 mA) - Current characteristic (sinusoidal waveform) - Frequencies (5 Hz, 250 Hz, 2000 Hz)
Safety - Absence of RFI	The Medi-Dx 7000 "produces no RFI" due to four independent clocks for frequency production, unlike the predicate device (which uses one crystal-controlled clock and produces RFI).
Safety - Output Isolation	The Medi-Dx 7000 has "isolated output via the transformer," whereas the equivalent device "depends on non-failure of the charger and selector switch to prevent 110v AC leakage."
Safety - Case Material	The Medi-Dx 7000 case is "largely non-conducting plastic," providing a safety advantage over the equivalent device's "all metal case."
Safety - Electrical Field Build-up (No-load conditions)	"No-load conditions will not build up an electrical field at the electrodes, because the output is dampened." It is unknown if the predicate device has this feature.
Safety - Power Supply Disconnect	The Medi-Dx 7000 has a "safety interlock which disconnects the power supply if the case is opened." (Not mentioned for predicate)
Safety - Low Battery Warning	The Medi-Dx 7000 "WARNING" light flashes if power drops below that needed to supply max output. (Predicate device has a "steady on" warning for low batteries and a flashing warning for waveform clipping at intensity increase, or flashing at zero for low battery).
Operational Control	The Medi-Dx 7000 is "fully manually controlled." (Predicate has manual and auto-test modes). The manufacturer contends manual control avoids "over-stimulation."
Accuracy/Calibration	Both devices "manufacturers 'burn in the devices for 168 hours and testing insures accuracy/calibration."
Indications for Use (same as predicate)	"Quantitative detection of sensory neurological impairments" in individuals capable of communicating cutaneous sensation, as part of routine neurological examination or screening for peripheral neuropathy.

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

Test Set Sample Size: Not applicable/Not mentioned. There is no mention of a formal "test set" of patients or data used to evaluate the device's performance in diagnosing neurological impairments. The submission relies on technical comparisons to a predicate device.
Data Provenance: Not applicable.

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

Number of Experts: The document mentions that the manufacturer "has consulted with" neurologists and other medical experts regarding the auto-test mode and its potential to alter thresholds. Several of these physicians "have compared the devices clinically and have agreed to share their opinions if contacted." However, this is not presented as a formal consensus-building process for establishing ground truth on a test set.
Qualifications of Experts: "Neurologists and other medical experts." No specific experience levels are provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not mentioned. There was no formal test set requiring adjudication.

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

MRMC Study: No. The document does not describe an MRMC study comparing human readers with and without AI assistance (as this is an older, non-AI device). The "clinical comparison" by a "several physicians" mentioned is not formal enough to be considered an MRMC study.
Effect Size: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Standalone Study: The Medi-Dx 7000 is a hardware device; it does not contain a complex algorithm or AI that would require a "standalone" performance study in the modern sense. Its function is to generate electrical currents and measure perception thresholds, which directly involve human interaction. The performance of the device itself in terms of output accuracy and stability is "insured" by manufacturing tests (burn-in and calibration).

7. Type of Ground Truth Used

Type of Ground Truth: The concept of "ground truth" for diagnostic performance (e.g., against pathology or clinical outcomes) is not discussed for the Medi-Dx 7000's diagnostic capabilities. The submission implies that the functionality of the device (generating currents at specific frequencies and intensities) is equivalent to the predicate, and therefore its utility in detecting sensory neurological impairments is assumed to be similar to the established utility of the predicate device. The only "truth" mentioned is the opinion of "neurologists and other medical experts" regarding the theoretical advantage of manual testing over auto-test mode to avoid receptor fatigue.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable/Not mentioned. This is a hardware device, not an AI/ML algorithm that requires a training set.

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

Ground Truth for Training Set: Not applicable.

Summary of the Document's Approach:

The 510(k) submission for the Medi-Dx 7000 primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device (Neurometer). This means the manufacturer largely argues that because their device is similar in intended use and technological characteristics to a device already deemed safe and effective by the FDA, it should also be considered safe and effective. The emphasis is on showing that any differences are either minor or lead to improved safety (e.g., RFI reduction, better isolation, non-conducting case). There is no detailed clinical study with performance metrics for diagnosis presented, as is common for many Class I and II devices seeking substantial equivalence where the technology is well-understood.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

MAY i 1 2017

Mr. James L. Hedgecock. Ph.D. Owner Neuro-Diagnostic Associates 445 Dartmoor Street Laguna Beach, California 92651

Re: K964622

Trade/Device Name: Medi-Dx 7000 Regulation Number: 21 CFR 882.1200 Regulation Name: Two-point discriminator Regulatory Class: Class I Product Code: LLN Dated: September 21. 1997 Received: October 2, 1997

Dear Mr. Hedgecock:

This letter corrects our substantially equivalent letter of December 1, 1997.

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809 ); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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Page 2 - Mr. James L. Hedgecock

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours, Michae

Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) SUMMARY 807.92

Submitted:

James L. Hedgecock, DC, PhD 445 Dartmoor Street Laguna Beach, CA 92651 Voice: 714-497-1207 Fax: 714-497-8437 DFC - 1 1997

K964622

Contact person:	Dr. James L. Hedgecock
Date Submitted:	11/06/97
Name of Device:	Medi-Dx 7000 Current Perception Threshold (CPT) device
Equivalent Device:	Neurometer by Neurotron; 510(k) 853608

GENERAL DESCRIPTION OF THE MEDI-DX 7000:

The Medi-Dx 7000 weighs approximately 15 lbs. and is housed within a 12" x 6" x 11" heavy duty plastic case with metal face and rear panels. The rear panel has an access door for installation and replacement of (8) standard (6) Volt Alkaline Batteries. The Face panel has an 'ON/OFF' switch, a 'Battery Test' switch (also functioning as an automatic calibration switch), and three (3) switches, one for each of the frequencies; 5 Hz, 250 Hz and 2000 Hz respectively. The intensity control is immediately befow an LCD which reads mA output. Two ports are available on the from panel for connection with electrodes (which are not provided with the unit and are ordered by the user from suppliers mentioned in the owners manual).

INDICATIONS AND USAGE:

GENERAL COMPARISON:

The Medi-Dx 7000 and the equivalent (Neurometer) device are essentially the same, they weigh and have approximately the same size. Both have the same minimum / maximum output (0.0 mA to 9.99 mA). The same current characteristic (sinusoidal waveform) and the same frequencies (5 Hz, 250 Hz and 2000Hz). The Medi-Dx 7000 does not come with electrodes. However, it is recommended in the owner's manual that to the Medi-Dx 7000 owner purchase the equivalent (Neurometer) electrode system, manual and/or software analytic database from the Manufacturer/Distributor of the equivalent device (Neurometer).

TECHNICAL DIFFERENCES:

The Medi-Dx 7000 does not have a built in battery charger, as does the equivalent device (Neurometer), which is powered by NiCd rechargeable batteries with a built in recharger.
The Medi-Dx 7000 is fully manually controlled and the Neurometer has a manual and an auto-test mode.
The Medi-Dx 7000 uses the voltage as-is without stepping up, so the maximum available voltage is +5 v to -5 v to operate the internal circuitry. The equivalent device has a step up of 10 times with an internal switching power supply, so the maximum voltage is +85 v to -85 v to operate the internal circuitry.

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Page 2 510 (k) SUMMARY 807.92 Medi-Dx 7000 Continued:

The Medi-Dx 7000 has an isolated output via the transformer. No transformer isolation of output is used in the equivalent device, which depends on non-failure of the charger and selector switch to prevent 110v AC leakage.
The Medi-Dx 7000 case is largely non-conducting plastic, whereas the equivalent device has an all metal case.
No-load conditions will not build up an electrical field at the electrodes, because the output is dampened. It is not known if the equivalent device has such output dampening. 7) Four independent clocks for frequency production are used in the Medi-Dx 7000 device. The equivalent device uses one master clock which is Crystal controlled. The result is that the equivalent device produces RFI and the Medi-Dx 7000 does not. 8) The Medi-Dx 7000 has a safety interiock which disconnects the power supply if the case is opened.
The Medi-Dx 7000 has a digital LCD output meter and the equivalent device does not.

SIMILARITIES:

The following technical similarities are noted:

The Medi-Dx 7000 "WARNING" light flashes if the power drops below that needed to supply the maximum output of 9.99 mA. The equivalent device has a "WARNING" light that is "steady on" to warn of low batteries. This same light is used to warn of clipping of the waveform. In the case of clipping, the Warning light will flash when the intensity is increased, whereas the warning light will flash at 0 (zero) when the battery is low. 2) Neither device posses any environmental risk from chemical, thermal, radiation or mechanical factors.
Both devices deliver current to the subject that is biologically compatible and posses no threat of injury to the patient or operator.
Both use an LCD readout of current.
Both use a master power switch.
The Medi-Dx 7000 uses separate switched to isolate each frequency and two switches cannot be turned on at the same time. The equivalent device uses a selector knob to isolate the frequencies.
Both use a digital waveform filter to produce and analog output.
Both manufacturers "burn in the devices for 168 hours and testing insures accuracy/calibration.

Tests and trials:

Since the current output, waveform are the same, it is reasonable to assume that the two devices are the same in function and reliability.

It will be noted that almost all the differences relate to improved safety of the Medi-Dx 7000 as compared to the equivalent device. The only difference in operation is that the Medi-Dx 7000 does not use an auto-test mode, which is employed in the equivalent device. This auto-test mode is employed in such a way that the subject is purposely stimulated above the threshold and then below in such as fashion as to "home in" on the threshold. However, it is the contention of the Medi-Dx 7000 manufacturer and the opinion of neurologists and other medical experts the manufacturer has consulted with. that this practice can in practice actually alter the threshold by "over stimulating" the receptors and any supposed advantage in accuracy by testing in this auto-test mode is out weighed by the fact that this auto-test mode may be slightly increasing the current required to produce a threshold stimulation. In other words the over stimulation of the receptors causes receptor fatigue and more receptors, i.e. more current. is required to reach a threshold stimulation with each stimulation above the threshold. Several of these physicians have compared the devices clinically and have agreed to share their opinions if contacted. Their names and phone numbers will be supplied upon request.

Sincerely.

James Hodgseck

James L. Hedgecock

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510(k) 964622

Medi-Dx 7000

INDICATIONS AND USE:

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off) Division of General Restorative Devices 510(k) Number ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

Regulation Number and Section

§ 882.1200 Two-point discriminator.

(a)
Identification. A two-point discriminator is a device with points used for testing a patient's touch discrimination.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.