The TS3201/6401 amplifier system is designed for use in the recording of routine EEG, long-term EEG with patient video and overnight sleep/EEG recording applications (Polysomnography). This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in electroencephalography.

Device Description

The Grass TS3201/TS6401 systems are 32-channel and 64-channel (respectively) devices for acquiring and conditioning EEG signals and transmitting them to a personal computer for display and storage. The system consists of one or more miniature pager-size 32channel preamplifier units, which plug into a small "belt-pack" designed to be worn by the patient. The belt-pack provides further signal conditioning, safety isolation and communication to a remotely located interface panel and data acquisition computer. Up to two TS3201 or TS6401 belt-packs, in any combination, can be plugged into the interface panel to provide for up to 128 channels of EEG monitoring from a single subject. Each belt-pack includes one additional pair of inputs for standard electrodes for monitoring EOG (eye movement) or ECG. Additionally, each belt-pack also includes a patient call pushbutton, which can be used to signal the control room or automatically trigger event marks or recording devices.

AI/ML Overview

The provided text describes the Grass® TS3201/6401 EEG Amplifier System, but it does not contain acceptance criteria or a detailed study proving the device meets specific acceptance criteria in the format requested.

The document is a 510(k) Summary of Safety and Effectiveness, which typically focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study outcome against them.

Here's an analysis of what is available in relation to your request, and where information is missing:

Analysis of Provided Information

Missing Information:
The document does not explicitly state specific quantifiable acceptance criteria for performance characteristics (e.g., sensitivity, specificity, accuracy for a diagnostic task), nor does it present a detailed study with sample sizes, data provenance, ground truth establishment, or statistical results that would directly prove the device meets such criteria.

Instead, the document relies on demonstrating:

Technological Equivalence: The device has similar design, function, and intended use as legally marketed predicate devices.
Performance Specifications Equivalence: "Each system has similar performance specifications, which are well agreed upon by the EEG community (amplifier filter settings, gain, and resolution)." (This implies that the device meets industry-standard performance inherent to its class, but doesn't quantify them here).
Safety and EMC Standards Compliance: "The Grass TS3201/6401 system has been extensively tested to the applicable safety, EMI and EMC standards for medical electrical devices, and specifically EEG equipment. Third party testing and certification to IEC601-1-2, UL2601-1-2, UL2601-1. CSA22.2#601-1 has been completed or is in process." This is compliance with regulatory standards, not diagnostic performance acceptance criteria.
Functional Requirements Verification: "Additional performance testing and bench testing has been completed to verify operation of all functional requirements and performance specifications." This indicates testing was done, but no details are provided.

Response to your specific points based on the provided text:

A table of acceptance criteria and the reported device performance
- Not Available. The document states that the device has "similar performance specifications, which are well agreed upon by the EEG community (amplifier filter settings, gain, and resolution)" to predicate devices. However, no specific numerical acceptance criteria or reported device performance values are provided in a table or otherwise. The focus is on equivalence rather than meeting absolute thresholds.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The document mentions "performance testing and bench testing" but does not provide any details on sample size, data provenance, or study design (retrospective/prospective). This type of detail is typically not included in a 510(k) summary focused on substantial equivalence for a non-diagnostic AI device.
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)
- Not Applicable/Not Available. This device is an EEG amplifier system, which conditions and transmits physiological signals. It is not an AI/diagnostic device that produces an interpretation or diagnosis requiring expert-established ground truth on a test set in the way a medical imaging AI would. The "ground truth" for an amplifier would relate to the fidelity of the signal acquisition, which is typically assessed against known input signals or reference equipment in bench testing, not expert interpretation of patient data for a diagnostic outcome.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Available. See point 3. This concept does not apply to the type of device and testing described.
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 Applicable/Not Available. The device is an EEG amplifier system, which provides the raw signal data. It is not an AI-assisted diagnostic tool that aids human readers in interpretation. Therefore, an MRMC study with AI assistance is irrelevant to this device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable/Not Available. This device is hardware for signal acquisition; it is not an algorithm, nor does it operate in a "standalone" interpretative capacity that would be measured like an AI algorithm. It's a foundational component for EEG monitoring.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable (in the context of diagnostic AI). For an EEG amplifier, the "ground truth" would be the accurate capture and transmission of bioelectrical signals. This is verified through engineering tests (e.g., inputting known electrical signals and verifying output fidelity, noise levels, frequency response) rather than a clinical ground truth like pathology for a diagnostic device. The document does not specify the exact methods for verifying these engineering characteristics beyond "performance testing and bench testing."
The sample size for the training set
- Not Applicable/Not Available. This is not an AI-driven device with a training set.
How the ground truth for the training set was established
- Not Applicable/Not Available. This is not an AI-driven device with a training set.

In conclusion: The provided 510(k) summary focuses on demonstrating that the Grass® TS3201/6401 EEG Amplifier System is substantially equivalent to existing predicate devices by having similar design, function, intended use, and meeting applicable safety and EMI/EMC standards. It explicitly states that "Each system has similar performance specifications, which are well agreed upon by the EEG community (amplifier filter settings, gain, and resolution)." However, it does not provide the kind of detailed performance study and acceptance criteria specific to AI/diagnostic efficacy that your request seeks. The "testing" mentioned refers to compliance with safety regulations and verification of functional requirements, not a clinical trial comparing diagnostic accuracy.

Summary

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MAR - 6 2000

Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '994142'. The characters are written in a bold, handwritten style, with varying stroke thicknesses.

EXHIBIT A

Grass® Instrument Division Astro-Med, Inc. West Warwick, RI 02893 USA Tel: (401) 828-4000 Fax: (401) 822-2430 Contact Person: Steve Johnson December 1, 1999

510(k) Summary of Safety and Effectiveness

Grass® TS3201/6401 EEG Amplifier

1. Submitter Information

Submitter's Name:	Stephen E. JohnsonV.P. or Research & Development
Company:	Grass Instrument Division, Astro-Med, Inc570 Liberty StreetBraintree, MA 02185
Telephone:	(781) 848-2970
Facsimile:	(781) 848-2974

2. Identification of the Device

Name of Device: Grass® TS3201/6401 EEG Amplifier System OLV Classification: Electroencephalograph, GWQ, Class II, per 882.1400

3. Equivalent Devices

This product is similar in design, function, and intended use to the Bio-Logic CEEGRAPH 128-channel Recording System (K973883) and the Telefactor H2O "Tethered-option" EEG recorder system (K992291).

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Like these equivalent products, the Grass® TS3201/6401 is designed to provide the signal conditioning interface (EEG signal amplification, filtering, and safety isolation) between the patient and a personal computer platform. When paired with a computer and EEG software, these equivalent systems are designed to monitor the EEG signals in a real-time graphical "chart" view on the computer monitor, store the signals to the computer's hard drive, replay the data on-screen, simplify the marking and tabulation of diagnostically significant events and measurements, and generate summary reports and graphs for technologist/physician review. These products share intended use and essential performance and safety characteristics.

4. Description of the Device

Up to two TS3201 or TS6401 belt-packs, in any combination, can be plugged into the interface panel to provide for up to 128 channels of EEG monitoring from a single subject. Each belt-pack includes one additional pair of inputs for standard electrodes for monitoring EOG (eye movement) or ECG. Additionally, each belt-pack also includes a natient call pushhutton. which can be used to signal the control room or automatically trigger event marks or recording devices.

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5. Indications for Use

The TS3201/6401 aniplifier system is designed for use in the recording of routine EEG, long-term EEG with patient video and overnight sleep/EEG recording applications (Polysomnography). This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in electroencephalography.

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6. Comparison of Technological Characteristics

The design and technological features of the TS3201/6401 and the predicate devices are similar. All of the systems provide connections to the patient via a standardized plug-in interface for commonly used EEG electrodes and are intended to record from the same anatomical sites. All of the systems perform pre-amplification and filtering of the biopotential signals acquired from these electrodes. Each has a means for sampling the channels at a predetermined or configurable rate and transmitting the sampled EEG data to a personal computer. Each system has similar performance specifications, which are well agreed upon by the EEG community (amplifier filter settings, gain, and resolution).

The essential safety characteristics of the devices are identical. Each is powered from a low-voltage DC power supply via a medical-grade power supply as the primary AC safety isolation. Each rclies additionally on a second level of safety isolation using either optical, capacitor, or transformer isolation means to isolate the patient leads from ground. Finally, each device is designed to be operated with recording and review software separately approved and provided by or recommended by the device manufacturer.

The major difference between these devices is only in the physical packaging, expansion capabilities, and communication interface. The B10-Logic device is all contained within onc large box that can be internally expanded with additional amplifier modules from 32 channels to 128 channels. The Telefactor unit is limited to only 32 channels, but is substantially smaller than the Bio-logic device and can be worn by the patient. The Grass TS3201/6401 sub divides the systems into separate functional modules that can be externally combined to provide both light-weight, wearable amplifiers with the ability to expand from 32 to 128 channels in 32 channel increments.

7. Testing

The Grass TS3201/6401 system has been extensively tested to the applicable safety, EMI and EMC standards for medical electrical devices, and specifically EEG equipment. Third party testing and certification to IEC601-1-2, UL2601-1-2, UL2601-1. CSA22.2#601-1 has been completed or is in process.

Additional performance testing and bench testing has been completed to verify operation of all functional requirements and performance specifications.

In conclusion, the Grass TS3201/6401 system is as safe and effective as the predicate devices currently marketed by Bio-Logic Corporation and Telefactor Corporation and raises no new safety or effectiveness concerns.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

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

Mr. Stephen E. Johnson Vice President, Research and Development Grass Instrument Division Astro-Med. Inc. 570 Liberty Street Braintree. Massachusetts 02185

APD - 3 2012

Re: K994142

Trade/Device Name: Grass TS3201/6401 EEG Amplifier System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE Itr): December 1, 1999 Received (Date on orig SE ltr): December 8, 1999

Dear Mr. Johnson:

This letter corrects our substantially equivalent letter of March 6, 2000.

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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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,

Malvina B. Eydelman, M.D. 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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510(k) NUMBER (IF KNOWN): K 994142

DEVICE NAME: TS3201/6401

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
☑

Over-The-Counter-Use
(Optional Format 1-2-96)

Stypf Rurde

(Division Sign-Off)
Division of General Restorative Devices

510(k) Number K994142

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).