SudoPath is a Galvanic skin response measurement device. The SudoPath 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

SudoPath 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 4 tactile electrodes placed on the sole of the feet and on the palm of the hands. 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 document is a 510(k) Premarket Notification for the SudoPath device, a Galvanic Skin Response (GSR) measurement device. It details the device's characteristics and compares it to a previously cleared predicate device (EIS-GS).

However, the document does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria in the context of AI/ML or comparative diagnostic performance.

Here's why and what information is missing:

Type of Device: The SudoPath is described as a hardware device (with an electronic box, cables, and electrodes) and accompanying software for measuring galvanic skin response. This is a measurement device, not a diagnostic AI/ML system that would typically have acceptance criteria related to accuracy, sensitivity, specificity, or reader improvement.
Focus of the 510(k) Summary: The summary focuses on demonstrating substantial equivalence to a predicate device. This is primarily achieved by showing that the SudoPath has the same intended use, similar hardware, and the same fundamental scientific technology as the predicate device. The "modifications" listed (change of trade name, removal of two frontal electrodes, and changes in software for number and sequence of measurements) are presented as minor and not affecting safety or effectiveness.
"Performances and Effectiveness" Section: This section only lists:
1. New risk management (generic for medical devices).
2. Software verification (SRS/SDS/STD/STR - standard software development lifecycle documentation).
3. Summary of Design Control Activities and Declaration of Design control conformity (again, standard quality system requirements).
  None of these refer to clinical performance studies, AI/ML model performance metrics, or human reader studies.
Substantial Equivalence Justification: The conclusion explicitly states: "The SudoPath device is equivalent in performances, technology, safety and efficacy to the legally marketed (unmodified) predicate device." This equivalence is established through the technical comparisons provided, not through a comparative clinical study.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study data, ground truth, expert involvement, or MRMC studies because this information is not present in the provided 510(k) summary.

Specifically, the document DOES NOT provide:

A table of acceptance criteria and reported device performance (in terms of diagnostic accuracy, sensitivity, specificity, etc.) relevant to AI/ML or a diagnostic claim. The "performance" mentioned refers to the device's functionality and equivalence, not its diagnostic output accuracy.
Sample size used for the test set or data provenance because no clinical performance test set, in the sense of a diagnostic evaluation study, is described.
Number of experts used to establish ground truth or their qualifications.
Adjudication method.
Information on any Multi Reader Multi Case (MRMC) comparative effectiveness study or effect size of human readers improving with AI assistance. This device is a measurement device, not an AI assistance tool for image interpretation.
Information on standalone algorithm performance.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
Sample size for the training set.
How ground truth for the training set was established.

The document primarily focuses on demonstrating that the changes made to the predicate device (EIS-GS) to create SudoPath are minor enough that new clinical performance data is not required, as it is fundamentally the same type of measurement device.

Summary

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L.D Technology LLC.

Image /page/0/Picture/2 description: The image shows a logo with the words "LID Technology" next to a circular graphic. The graphic contains a circle with a design inside that resembles a stylized plant or electronic component. The word "LID" is in a simple, blocky font, while "Technology" is in a more stylized, italicized font.

510{k) Premarket Notification Number: Special 510k Preparation date: February 16, 2013

JUN 2 8 2013

Special 510(k) Summary SudoPath

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

Device Trade Name of the device: SudoPath 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: EIS-GS, Common name: Galvanic skin response 510K number K102166 Applicant and Manufacturer: LD TECHNOLOGY LLC (Same as new device SudoPath) Product code GZO.

4. Intended use

SudoPath is a Galvanic skin response measurement device.

The SudoPath 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 and Comparison Devices' comparison Table SudoPath / EIS -GS

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Specifications	SudoPath	EIS-GS k 102166
Intended use	Galvanic Skin Response device	Galvanic Skin Response device
Prescription for use	Physician	Physician
Hardware	Same Hardware with exactly thesame specification	EIS-GS Hardware
Material used in contactwith the patient	Stainless steel	Stainless steelAgAgCl disposable electrodes
Fundamental Scientific	Sympathetic skin response and	Sympathetic skin response and sweat
Technology	sweat glands	glands
Number of electrodes incontact with the patient	4	6
Number of conductancevalues	4	22
Sequence of	Software control and simplified	Software control , all the possibilities
measurement	sequence between feet and hands	of measurements between the 6tactile electrodes
Time of measurement	Software control , each pathway is	Software control , each pathway is
for each pathway	measured during 30 seconds and 4times (2 pathways 2 times)	measured during 1 seconds and 88times (22 pathways 4 times)
Cleaning anddisinfection	Ethyl or isopropyl alcohol (70-90%)	Ethyl or isopropyl alcohol (70-90%)
Standards met	IEC 60601-1-1IEC 60601-1-2	IEC 60601-1-1IEC60601-1-2
Range of conductancemeasurements	1 to 120 micro Siemens	1 to 120 micro Siemens
Data acquisitionduration	120s	128s
electrical output to skin	1.28V	1.28V
active surface area of	272 cm2 for the hand plates330 cm2 for the foot plates	15.75 cm2 for forehead electrodes272 cm2 for the hand plates330 cm2 for the foot plates
current density atelectrodes	< 0.01 UA/mm2	< 0.01 UA/mm2

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Type of device

SudoPath 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 4 tactile electrodes placed on the sole of the feet and on the palm of the hands.
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 modified device SudoPath has the following similarities to EIS-GS which has previously received 510(k) clearance:

. has the same intended use,
uses the same Hardware and not affect the hardware manufacture process .
Has the same material in used accessories ●
Do not affect the Fundamental Scientific Technology .
Do not change the prescription use .

Modifications:

Trade name: Change of the Trade name of the device

Accessories: The 2 frontal disposable electrodes are no longer used

Software: New design and change in time and sequence of measurement and therefore in displayed results of conductance value (Only 4 values and not 22)

Indication for use were updated to match with the cleared devices with the same intended use Labeling :Label on the box was modified with the new trade name of the device (SudoPath Replace EIS-GS)

Instructions for Use were modified according to the new design of the software and new process of measurement and displayed results of conductance values .

6. Substantial Equivalence

The modified device SudoPath is complying with the Items required under §807.87 for a special 510k submission.

Performances and Effectiveness

1. New risk management

Software verification (SRS/SDS/STD/STR)
Summary of Design Control Activities and Declaration of Design control conformity

12. General Safety Concerns

The new device uses the same Hardware and not affects the hardware manufacture process and has the same material in used accessories

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Conclusions

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

Signature:

Albert MAAREK

Premarket notification [510K] Number: K131568

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

June 28, 2013

LD Technology LLC c/o Mr. Albert Maarek 100 N. Biscayne Blvd. Ste 500 Miami, FL 33132

K131568 Trade/Device Name: SudoPath Regulation Number: 21 CFR 882.1540 Regulation Name: Galvanic Skin Response Measurement Device Regulatory Class: Class II Product Code: GZO Dated: May 28, 2013 Received: May 30, 2013

Dear Mr. Maarek:

Re:

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 device-related adverse events) (21 CFR 803); good manufacturing

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Page 2 - Mr. Albert Maarek

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Mishranding 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.ida.gov/MedicalDevices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting 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): K131568

Device Name: SudoPath

Indications For Use:

SudoPath device is a medical device for the measurement of galvanic skin response.

The SudoPath 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M. Whang -S

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

K131568 510(k) Number

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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.