SUDOSCAN device is based on two well-known principles, reverse iontophoresis and electrochemistry. SUDOSCAN device collects physiological data by means of chronoamperometry and processes them with analysis software. SUDOSCAN device uses both technologies, coupled and complemented with exclusive software which analyzes cutaneous conductance data collected through the chronoamperometric measurements.

SUDOSCAN device is composed of:

-> The analog acquisition electronic circuitry with low-noise front end
→ The multiplexing control unit for selecting the appropriate acquisition channels
-> The signal formatting and processing capabilities
The optically isolated USB interface controller
-> The power converter,
The connection circuitry to 6 electrodes placed on the feet, the hands and the forehead of the patient. is integrated into a customized touch-screen Windows XP-based Industrialgrade personal computer running the proprietary SUDOSCAN acquisition control and analysis software also responsible for archiving measurements taken on all patients.

AI/ML Overview

The provided 510(k) summary for the Impeto Medical SUDOSCAN device focuses on demonstrating substantial equivalence to a predicate device (EDX Epi-Scan) for the measurement of galvanic skin response. It does not contain information about clinical studies with specific acceptance criteria that demonstrate device performance against a defined ground truth in a clinical context.

Therefore, many of the requested details regarding acceptance criteria, study design, expert involvement, and ground truth establishment are not available in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) or the results of a study designed to meet such criteria. It focuses on comparing the technical specifications of the SUDOSCAN to its predicate.

Characteristic	Acceptance Criteria (Not explicitly stated for clinical performance)	Reported Device Performance (SUDOSCAN)
Measurement range (Skin conductance)	N/A (Compared to predicate)	10-100,000 nS/cm²
Measurement lower (Resolution)	N/A (Compared to predicate)	1 nS/cm²
Acquisition duration total	N/A (Compared to predicate)	120s
Electrical output to the skin	N/A (Compared to predicate)	4V max
Electrical output frequency	N/A (Compared to predicate)	Continuous
Electrical output unit duration	N/A (Compared to predicate)	1s
Power Density (at electrode)	N/A (Compared to predicate)	0.01 uA/mm²
User Display	N/A (Compared to predicate)	VGA Color LCD 1024*768
User control	N/A (Compared to predicate)	Touch screen
Audible Indicators	N/A (Compared to predicate)	Integral Speaker Optional Headphone
Interface	N/A (Compared to predicate)	USB (Internal)
Power source	N/A (Compared to predicate)	5V provided by USB
Electrodes surface area	N/A (Compared to predicate)	7 to 300 cm²

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not mentioned. The document refers to "verification of specifications and validation, including software validation," but does not detail a clinical test set or its sample size.
Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not mentioned, as a clinical test set with ground truth established by experts is not described.

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

Not mentioned, as a clinical test set with ground truth is not described.

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:

Not performed or mentioned. The SUDOSCAN device measures galvanic skin response and does not involve human readers interpreting images or data where AI assistance would be applicable in the context of an MRMC study. It is an objective measurement device.

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

The device performs a standalone measurement of galvanic skin response. The "study" mentioned is "verification of specifications and validation," which implies technical performance rather than clinical performance against a diagnostic endpoint. No clinical standalone performance metrics (e.g., sensitivity, specificity) are reported.

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

Not mentioned. For a device measuring galvanic skin response, ground truth would typically refer to the accuracy of the measurement itself against a known standard or a biological correlate. The document states "SUDOSCAN device is able to obtain measurements from a larger area at one time whereas EDX Epi-Scan obtains the measurements by taking several measurements over a period of time and then averaging the data," implying the "truth" is the physiological measurement.

8. The sample size for the training set:

Not mentioned. This device does not appear to use a training set in the sense of machine learning/AI for diagnostic classification. It is a measurement device.

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

Not applicable/Not mentioned, as no training set or its ground truth establishment is described.

Summary of what is available from the document:

The provided 510(k) summary focuses on demonstrating the technical equivalence of the SUDOSCAN device to its predicate, EDX Epi-Scan, for the purpose of measuring galvanic skin response. It highlights similarities in their intended use, measurement principles, and compliance with electrical safety and EMC standards. The "study" referenced is primarily non-clinical testing, including "verification of specifications and validation, including software validation," rather than a clinical study evaluating diagnostic performance against established acceptance criteria using a ground truth.

Summary

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`impetomedical

510(k) Summary

1. Contact Details

K100233

Applicant Name: IMPETO MEDICAL

Address:17 rue Campagne Première, 75014 PARIS, France Phone: +33 1 43 20 16 40 Fax: +33 1 43 22 80 75

JUN 1 4 2010

Name of contact person:

Kye Cheung Authorized Correspondent 4479 Shorepointe Way San Diego, CA 92130 Phone: (619) 665-2796 Fax: (858) 630-3829 Email address: kye.cheung@impeto-medical.com

Date Prepared: June 11, 2010

2. Device Name

Trade Name: SUDOSCAN

Common Name: SUDOSCAN

Classification Name: Galvanic Skin Response Measurement Device

Device Class: Class II

Device Code: GZO

Classification: 882.1540

3. Legally Marketed Predicate Device(s)

The Impeto Medical SUDOSCAN device is substantially equivalent to the EDX Epi-Scan device cleared under 510(k) K032935.

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510(k) Number	Product Code	Trade Name	Manufacturer
K032935	GZO	EDX Epi-Scan	EDX Epi-Scan
			130 Main Road
			Huntsville, AL

4. Device Description

SUDOSCAN device is composed of:

-> The analog acquisition electronic circuitry with low-noise front end
→ The multiplexing control unit for selecting the appropriate acquisition channels
-> The signal formatting and processing capabilities
The optically isolated USB interface controller
-> The power converter,
The connection circuitry to 6 electrodes placed on the feet, the hands and the forehead of the patient. is integrated into a customized touch-screen Windows XP-based Industrialgrade personal computer running the proprietary SUDOSCAN acquisition control and analysis software also responsible for archiving measurements taken on all patients.

5. Intended Use/Indications for use

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

6. Substantial Equivalence Comparison

A comparison of the characteristics of the SUDOSCAN and the Epi-Scan predicate device is provided above.

Characteristics	SUDOSCAN	Predicate DeviceEDX Epi-Scan
Indications for use	Measurement of galvanic skinresponse	Measurement of galvanic skinresponse
Presentation	Desktop device	Handheld device
Measurementrange(Skinconductancerange)	10-100,000 nS/cm²	1 - 80,000 nS/ cm²
Characteristics	SUDOSCAN	Predicate DeviceEDX Epi-Scan
Measurement lower(Skin conductanceresolution)	1nS/cm²	1nS/cm²
Acquisition durationtotal	120s	54 time 3s=162s (6 locations with9 points of measurement each)
Electrical output tothe skin	4V max	3V max
Electricaloutputfrequency	Continuous	Continuous
Electrical output unitduration	1s	3s
Power Density(atelectrode)	0,01 uA/mm²	0.03 uA/mm²
User Display	VGA Color LCD 1024*768	Liquid Crystal
User control	Touch screen	6 push button switches (keys)
Audible Indicators	Integral Speaker OptionalHeadphone	Integral Speaker OptionalHeadphone
Interface	USB (Internal)	USB (cable supplied)
Power source	5V provided by USB	2 disposable (non rechargeable)AA batteries
Electrodes surfacearea (*)	7 to 300 cm²	1 to 3 cm²
Standards met	IEC60601-1-1, EN60601-1-2Medical Device Directive93/42/EEC	IEC60601-1-1, EN60601-1-2MedicalDeviceDirective93/42/EEC
Test report	Subject details (patient data).Indication for referral, enteredby examining physician.Method.Result.Impressions entered byexamining physician.The measured STC values of thetest.Three average value of 18 STCmeasurements.	Subject details (patient data).Indication for referral, entered byexamining physician.Method.Result.Impressions entered byexamining physician.The measured STC values of thetest.One average value of 36 STCmeasurements.

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(*) SUDOSCAN device, with its larger pre-configured electrodes, has simplified Galvanic Skin Response reading by collecting average information primarily on hands, feet and forehead. Both SUDOSCAN and the predicate device measure the Galvanic Skin Response. SUDOSCAN device is able to obtain measurements from a larger area at one time whereas EDX Epi-Scan obtains the measurements by taking several measurements over a period of time and then averaging the data.

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7. Non-clinical Testing

SUDOSCAN device has been thoroughly tested through verification of specifications and validation, including software validation. Electrical safety and electromagnetic compatibility testing in compliance with IEC 60601-1, IEC 60601-1-2 were also completed.

8. Conclusions

Conclusions drawn from SUDOSCAN device testing demonstrate that SUDOSCAN is as safe and effective to perform measurement of Galvanic Skin Response as the legally marketed predicate device EDX Epi-scan and is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure with outstretched arms, representing care and protection.

Public Health Service

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

Impeto Medical c/o Mr. Kye Cheung 4479 Shorepointe Way San Diego, CA 92130

JUN 1 4 2010

Re: K100233

Trade/Device Name: Impeto Medical SudoScan Regulation Number: 21 CFR 882.1540 Regulation Name: Galvanic skin response measurement device Regulatory Class: Class II Product Code: GZO Dated: June 4, 2010 Received: June 4, 2010

Dear Mr. Cheung:

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.

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Page 2 - Mr. Kye Cheung

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) (2.1 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Esa Rimin k

Malvina B. Eydelman, MOD Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

K100233 510(k) Number: To Be Assigned By FDA

Device Name: Impeto Medical SudoScan

Indications for Use:

The SudoScan system is a medical device for the measurement of galvanic skin responses.

Prescription Use X (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)

PETER G. Como

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices .

510(k) Number K100233

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.