The PMT® TruScan® Surface Electrodes are indicated for cutaneous use in the general recording and monitoring of the Electroencephalograph (EEG) and Evoked Potential (EP).

The PMT® TruScan® Surface Electrodes are CT compatible and MR Conditional under the following conditions:

Static magnetic field strength of 1.5-T only
Maximum spatial gradient magnetic field of 5,000 Gauss/cm (50T/m) or less
The connector hub must be placed near the center MR system's bore, and must be at least 20-cm from the wall of the MR system's bore at all times.
The extension cable must be disconnected from the PMT TruScan Surface Electrode before scanning and MUST remain disconnected throughout the entire MR scan.
Normal Operating Mode of operation for the MR system with a maximum whole body averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes of scanning (i.e., per pulse sequence)

Device Description

The PMT® TruScan® Surface Electrodes are non-invasive, cutaneous devices used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG) and Evoked Potentials (EP).

The reusable TruScan® Surface Electrodes have a disc with a diameter of 10 mm coated with silver / silver chloride (Ag/AgCl). Each disc is permanently adhered to an insulated lead wire. An extension cable is required to connect the Truscan® Surface Electrodes to the recording equipment. The extension cable is electrically insulated and terminated by a molded touch proof connector that is compliant to the safety requirements outlined in IEC 60601-1 subclause 56.3(c).

During a MRI examination, the extension cable must be disconnected from the TruScan® Surface Electrodes.

Numbered and color coated lead wires are provided to facilitate identification.

The electrodes are provided non-sterile and can be reused.

AI/ML Overview

This 510(k) summary (K122376) describes the PMT TruScan® Surface Electrodes. The document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's characteristics and MR compatibility conditions.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria in the typical sense (e.g., a specific sensitivity or specificity threshold for a diagnostic device). Instead, the performance is detailed through technical specifications, material characteristics, and compliance with MR conditional guidelines. The "acceptance criteria" here are implied by the conformity to these specifications and the statement of MR conditions.

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use: Cutaneous EEG/EP recording and monitoring.	Indicated for cutaneous use in general recording/monitoring of EEG and EP.
CT Compatibility: Compatible with CT scans.	Stated as CT compatible.
MR Conditional: Safe under specified MRI conditions.	MR Conditional under the following specified conditions: - Static magnetic field strength of 1.5-T only. - Maximum spatial gradient magnetic field of 5,000 Gauss/cm (50T/m) or less. - Connector hub near center MR bore, >= 20-cm from MR system's bore wall. - Extension cable must be disconnected before and during MR scan. - Normal Operating Mode of MR system with max whole body averaged SAR of 2.0-W/kg for 15 minutes of scanning.
Material Composition (Sensor Cup): Silver/silver chloride.	Silver/silver chloride.
Cup Diameter: 10 mm.	10 mm.
Assembly to Cup Material: ABS/Carbon fiber composite.	ABS/Carbon fiber composite.
Lead Wire Core Material: Nichrome.	Nichrome.
Lead Wire Insulation Material: PVC.	PVC.
Electrode + Cable Length: 60".	60".
Lead Wire Connection Compliance: IEC 60601-1 subclause 56.3(c).	1.5 mm Brass/Polypropylene IEC 60601-1 subclause 56.3(c) compliant.
Packaging: Non-sterile, sealed in PE pouch or equivalent.	Non-sterile, sealed in PE pouch or equivalent.

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

The provided 510(k) summary does not contain information about a test set with a specific sample size or data provenance (e.g., country of origin, retrospective/prospective). This device is a surface electrode for physiological signal acquisition, not a diagnostic algorithm. The "testing" referred to in the document involves adherence to material specifications and MR compatibility standards, likely through engineering tests and simulations rather than patient-based clinical studies with specific sample sizes.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and not present in the document. As mentioned above, this filing pertains to a medical device (electrode), not an AI/ML diagnostic system that would require expert-established ground truth from clinical cases. The "ground truth" for this device relates to its physical and electrical properties, and its safe use under MR conditions, which are typically verified through technical testing by engineers and physicists.

4. Adjudication Method for the Test Set

This information is not applicable and not present in the document for the reasons explained in point 3. Clinical adjudication methods (e.g., 2+1, 3+1) are relevant to the evaluation of diagnostic performance where expert disagreement needs resolution, which is not the case for this type of medical device filing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not mentioned. This type of study is specifically designed for evaluating the performance of diagnostic algorithms or imaging interpretations, often comparing human readers with and without AI assistance. The TruScan® Surface Electrodes are hardware devices for signal acquisition, not an interpretation tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study (algorithm only) was not done and is not mentioned. This concept is relevant for AI/ML diagnostic algorithms, not for physical medical devices like electrodes.

7. The Type of Ground Truth Used

The "ground truth" for the PMT TruScan® Surface Electrodes relies on physical measurement, engineering testing, and compliance with recognized standards (e.g., IEC 60601-1) and MR conditional safety guidelines. This is primarily focused on:

Material properties and composition: Verification of specified materials (e.g., silver/silver chloride, Nichrome, PVC, ABS/Carbon fiber composite).
Dimensional accuracy: Verification of cup diameter and electrode/cable length.
Electrical safety and performance: Adherence to standards like IEC 60601-1.
MR compatibility and safety: Demonstration that the device meets the specified MR conditional criteria through testing following guidelines relevant to MR safety (e.g., heating, artifact generation).

8. The Sample Size for the Training Set

This information is not applicable and not present in the document. The concept of a "training set" is relevant for machine learning algorithms, which is not what this device is.

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

This information is not applicable and not present in the document for the reasons explained in point 8.

Summary

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K122376

PMT Corporation 510(k) Summary

·DEC 1 9 2012

Submitter's Name, Address, and Date of Submission

Al Iversen President PMT Corporation 1500 Park Road Chanhassen, MN Phone: 952-470-0866 952-470-0865 Fax:

Establishment Registration: 2182979

Submitted:	Friday, July 27, 2012
Device Name:	TruScan® Surface Electrodes
Trade Name:	TruScan® Surface Electrodes
Classification Name:	21 CFR 882.1350, Cutaneous Electrode GXY
Classification:	Class II
Common/Usual Name:	Surface Electrode, Cutaneous Electrode

Predicate Device

Ambu, Inc (K032278) Grass Instruments (Marketed prior to 1974)

Indication for Use

The PMT® TruScan® Surface Electrodes are indicated for cutaneous use in the general recording and monitoring of the Electroencephalograph (EEG) and Evoked Potential (EP).

The PMT® TruScan® Surface Electrodes are CT compatible and MR Conditional under the following conditions:

Static magnetic field strength of 1.5-T only ●
Maximum spatial gradient magnetic field of 5,000 Gauss/cm (50T/m) or less ●
The connector hub must be placed near the center MR system's bore, and must be at ● least 20-cm from the wall of the MR system's bore at all times.

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The extension cable must be disconnected from the PMT TruScan Surface Electrode . before scanning and MUST remain disconnected throughout the entire MR scan.
. Normal Operating Mode of operation for the MR system with a maximum whole body averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes of scanning (i.e., per pulse sequence)

Device Description

During a MRI examination, the extension cable must be disconnected from the TruScan® Surface Electrodes.

Numbered and color coated lead wires are provided to facilitate identification.

The electrodes are provided non-sterile and can be reused.

Indications	The PMT® TruScan™ Surface Electrodes are indicated for cutaneous use in thegeneral recording and monitoring of the Electroencephalograph (EEG) and EvokedPotential (EP).
MR Conditions	The PMT® TruScan™ Surface Electrodes are CT compatible and MR Conditionalunder the following conditions:Static magnetic field strength of 1.5-T only Maximum spatial gradient magnetic field of 5,000 Gauss/cm (50T/m) or less The connector hub must be placed near the center MR system's bore, and must be at least 20-cm from the wall of the MR system's bore at all times. The extension cable must be disconnected from the PMT TruScan Surface Electrode before scanning and MUST remain disconnected throughout the entire MR scan. Normal Operating Mode of operation for the MR system with a maximum whole body averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes of scanning (i.e., per pulse sequence)
Sensor CupConstruction	Silver/silver chloride
Cup Diameter	10 mm
Assembly to Cup	ABS/Carbon fiber composite
Lead Wire Core	Nichrome
Lead Wire Insulation	PVC

Technological Characteristics and Performance

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Electrode length	60" (electrode + cable)
Lead WireConnection	1.5 mm Brass/Polypropylene IEC 60601-1 subclause 56.3(c) compliant
Packaging	Non-sterile, sealed in PE pouch or equivalent

and the comments of the comments of the comments of the comments of

and the control control control of the control of

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure embracing or protecting another figure, representing the department's mission of protecting the health of all Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 19, 2012

PMT Corporation c/o Mr. Al Iversen President 1500 Park Road, PO Box 610 Chanhassen. MN 55317

Re: K122376

Trade/Device Name: PMT TruScan® MR Conditional Surface Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: December 10, 2012 Received: December 13, 2012

Dear Iversen:

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. Al Iversen

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 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/ucm115809.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 yours,

Victor Krauthamer -A

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 Form

510(k) Number (if known): K122376 Device Name: PMT® TruScan® Surface Electrode

Indications for Use

The PMT® TruScan® Surface Electrodes are indicated for cutaneous use in the general recording and monitoring of the Electroencephalograph (EEG) and Evoked Potential (EP).

The PMT TruScan® Sufface Electrodes are CT compatible and MR Conditional under the following conditions:

Static magnetic field strength of 1.5-T only t
Maximum spatial gradient magnetic field of 5,000 Gaussicm (50T/m) or less .
The connector hub must be placed near the center MR system's bore, and must be . at least 20-cm from the wall of the MR system's bore at all times.
The extension cable must be disconnected from the PMT TruScan Surface . Electrode before scanning and MUST remain disconnected throughout the entire MR scan.
Normal Operating Mode of operation for the MR system with a maximum whole body . averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes of scanning (i.e., per pulse sequence)

Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Qffice of Device Evaluation (ODE)
· Divisior. Sign-Off)Sision of Ophthalmic, Neurological and Ear,4636 Liki Throat Devices	· Page 1 of 1
510(is) Number.

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).