The SudoC provides values. It is the physician's responsibility to make proper judgments based on these numbers. The device is indicated for use in general adult population.

Prescription Use: Federal law restricts this device to sale by or on the order of a physician.

Device Description

The SudoC is a programmable electro medical system including:

USB plug and play hardware device including an electronic box, 2 reusable cables to connect . the box to electrodes and 2 tactile electrodes placed on the sole of each foot.
Software installed on a computer. ●

As a galvanic skin response measurement device, it measures the skin resistance (i.e., conductance).

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a device named SudoC. This document primarily focuses on demonstrating that the SudoC device is substantially equivalent to a previously cleared predicate device (SudoPath K131568) and does not contain detailed information about specific acceptance criteria, study designs, or reported device performance for the SudoC as an independent, de novo submission would.

Therefore, many of the requested details cannot be extracted directly from this document. However, I can provide the information that is present and explain why other information is not available.

Here's a breakdown based on the provided text:

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

This document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy) or reported performance values for the SudoC. The core of this submission is to demonstrate substantial equivalence to a predicate device, meaning it asserts that the modifications to SudoC do not change its performance.

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

This information is not provided. The document states that the modifications to the proposed device "do not change the performance of the device" as shown with:

New risk management
Software verification (SRS/SDS/STD/STR)
Summary of Design Control Activities and Declaration of Design control conformity.
Comparison of the conductance values using stainless steel electrodes versus conductive disposable cloth electrode.
The removal of the hand electrodes does not affect the performance of the galvanic skin response measurement.

The crucial point is the "Comparison of the conductance values" which suggests some testing was done, but details like sample size, provenance, or whether it was a "test set" in the context of a clinical study are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. The SudoC is a galvanic skin response measurement device, which measures physiological responses. "Ground truth" in this context would likely refer to the accuracy of the measurements themselves or their correlation with a specific physiological state, which is not detailed in this type of submission for substantial equivalence.

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

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The device (SudoC) is described as a measurement device that provides values, and "It is the physician's responsibility to make proper judgments based on these numbers." This indicates it's a diagnostic aid, not an AI-assisted detection or interpretation system that would typically involve human reader performance studies.

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

The SudoC is a measurement device. It provides raw "values." The "algorithm" here would be the processing of the galvanic skin response to produce those values. The document asserts that the fundamental scientific technology and the range of conductance measurements (1 to 120 micro Siemens) are the same as the predicate. While software verification was done, a standalone performance study with specific metrics is not detailed as per the typical requirements for a new, complex algorithm or AI.

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

This information is not explicitly stated. For a galvanic skin response device, the ground truth would likely be the accurate measurement of skin conductance. The document states "Comparison of the conductance values using stainless steel electrodes versus conductive disposable cloth electrode," suggesting that the accuracy of the conductance measurement itself with the new electrodes was assessed against the prior electrode type.

8. The sample size for the training set

This information is not provided. Since this is a 510(k) for a measurement device and not an AI/ML algorithm requiring extensive training data, such details are typically not included unless the specific modifications involved significant new algorithmic development or a new intended use. The software changes primarily relate to "New design and change in time and sequence of measurement."

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

This information is not provided, for the same reasons as point 8.

Summary

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

September 24, 2015

LD Technology LLC Albert Maarek CEO 100 N. Biscayne Blvd. Suite 502 Miami. Florida 33132

Re: K152216 Trade/Device Name: SudoC Regulation Number: 21 CFR 882.1540 Regulation Name: Galvanic Skin Response Measurement Device Regulatory Class: Class II Product Code: GZO Dated: July 28, 2015 Received: August 7, 2015

Dear Albert Maarek:

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. 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 Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR 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.

Sincerely yours,

Michael J. Hoffmann -S

for 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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Indications for Use

510(k) Number (if known) K152216

Device Name SudoC

Indications for Use (Describe)

SudoC device is a medical device for the measurement of galvanic skin response related to the sweat glands.

The SudoC provides values. It is the physician's responsibility to make proper judgments based on these numbers. The device is indicated for use in general adult population.

Prescription Use: Federal law restricts this device to sale by or on the order of a physician.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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L.D Technology LLC.

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510(k) Premarket Notification Number: Special 510k number K152216 Preparation date: July 28, 2015

Special 510(k) Summary SudoC

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.87

1. Device Trade Name of the device: SudoC Device Common name: Galvanic Skin Response Regulation number: 21 CFR 882.1540 Product Code: GZO Classification: Class II Classification Advisory: Neurology
  Submitter's Identification: 2. Manufacturer: L.D TECHNOLOGY LLC CEO of LD Technology: Albert MAAREK Address: L.D Technology 100 N. Biscayne Blvd, Suite 502 Miami, FL, 33132, USA Tel: 305-379-9900 Fax: 305 397 1115 Email: albert.ldteck@gmail.com

3. Predicate legally marketed (unmodified) device

Trade name: SudoPath, Common name: Galvanic skin response 510K number K131568 Applicant and Manufacturer: LD TECHNOLOGY LLC (Same as new device) Product code GZO.

4. Intended use

SudoC is a Galvanic skin response measurement device related to the function of the sweat glands.

The SudoC provides values. It is the physician's responsibility to make proper judgments based on these numbers.

The device is indicated for use in general adult population

Prescription Use: Federal law restricts this device to sale by or on the order of a physician.

5. Device Description and Comparison Devices' comparison Table modified SudoPath / unmodified SudoPath 13

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Specifications	SudoC	SudoPath k 131568
Intended use	Galvanic Skin Response measurement device related to the function of the sweat glands	Galvanic Skin Response device measurement
Prescription for use	Physician	Physician
Hardware	Same Hardware with exactly the same specification	SudoPath Hardware
Material used in contact with the patient	Conductive disposable cloth electrode	Stainless steel
Fundamental Scientific Technology	Sympathetic skin potential response and sweat glands	Sympathetic skin potential response and sweat glands
Number of electrodes in contact with the patient	4	4
Sequence of measurement	Software control and sequence between feet.	Software control and sequence between feet and hands
Time of measurement for each pathway	Software control , each pathway is measured during 30 seconds	Software control , each pathway is measured during 30 seconds
Cleaning and disinfection	Ethyl or isopropyl alcohol (70-90%) for lead wires and cables. Electrodes are single use.	Ethyl or isopropyl alcohol (70-90%) for electrodes, lead wires and cables
Standards met	IEC 60601-1 -1IEC 60601-1-2	IEC 60601-1-1IEC60601-1-2
Range of conductance measurements	1 to 120 micro Siemens	1 to 120 micro Siemens
Data acquisition duration	120s	120s
electrical output to skin	1.28V	1.28V
active surface area of electrode	44 cm2 for each disposable electrode placed on the feet	272 cm2 for the hand plates330 cm2 for the foot plates
current density at electrodes	< 0.01 UA/mm2	< 0.01 UA/mm2

Type of device

The SudoC is a programmable electro medical system including:

USB plug and play hardware device including an electronic box, 2 reusable cables to connect . the box to electrodes and 2 tactile electrodes placed on the sole of each foot.
Software installed on a computer. ●

As a galvanic skin response measurement device, it measures the skin resistance (i.e., conductance).

Comparison with the legally marketed (unmodified) device:

The submission is complying with the Items required under §807.87 Similarities:

The SudoC has the following similarities to unmodified SudoPath which has previously received 510(k) clearance:

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has the same intended use,
uses the same Hardware and not affect the hardware manufacture process
does not affect the Fundamental Scientific Technology ●
does not change the prescription use ●

Modifications:

Accessories: The hand electrodes are no longer used and the stainless steel foot electrodes has been replace by a conductive disposable cloth electrodes.

Software: New design and change in time and sequence of measurement.

Indication for use were updated the addition of the phrase "related to the function of the sweat glands" which does not constitute a new intended use. It clarifies the utility of the device.

Labeling: Instructions for Use were modified according to the changes.

6. Performances and Effectiveness

The modifications perform to the proposed device do not change the performance of the device has shown with:

1. New risk management
1. Software verification (SRS/SDS/STD/STR)

Summary of Design Control Activities and Declaration of Design control conformity.
Comparison of the conductance values using stainless steel electrodes versus conductive disposable cloth electrode.
The removal of the hand electrodes does not affect the performance of the galvanic skin response measurement is performed in the area with the higher density of sweat glands (sole of the feet).

7. General Safety Concerns

The electrical and EMC risk are not affected since the new device using the same hardware The removal of the hands electrodes cannot affect the device safety. The new material used for the foot electrodes is 510k cleared.

8. Conclusions

The SudoC device is equivalent in performances, technology, safety and efficacy to the legally marketed (unmodified) predicate device

Signature:

Albert MAAREK

Premarket notification [510K] Number: K152216

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Regulation Number and Section

§ 882.1540 Galvanic skin response measurement device.

(a)
Identification. A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.