The AS40 amplifier system is designed for use in the recording of routine EEG, overnight sleep/EEG (PSG, Polysomnography), and other neurophysiological monitoring applications (EMG and Evoked Potentials). This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in either electroencephalography or polysomnography.

Device Description

The AS40 is a compact 40-channel AC amplifier unit designed for electroencephalography and polysomnography recording applications. The AS40 provides for patient safety isolation, signal conditioning (physiological signal amplification and filtering), and digitization. Communications with a single host computer are accomplished using TCP/IP protocol over a 10BaseT Ethernet network or dedicated cable. A host computer, using the appropriate software, sets the sample rate, starts and stops the data transmission, monitors the digital data, and stores it to hard disk.

AI/ML Overview

This document is a 510(k) Summary for the Grass-Telefactor AS40 Amplifier System, submitted to the FDA. It details the device's characteristics and its comparison to predicate devices to establish substantial equivalence.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the formal sense that would be typically established for a new clinical study. Instead, it presents a comparison of the AS40's technical characteristics with those of two predicate devices, implying that meeting or being comparable to these established specifications demonstrates sufficient performance for a substantially equivalent device.

The table below summarizes the key technical characteristics presented and states the performance of the AS40 as reported in the document. The implicit "acceptance criteria" for a 510(k) submission like this are that the new device's performance should be essentially equivalent to or better than the predicate devices, or that any differences do not raise new questions of safety or effectiveness.

Technical Characteristic	Implicit Acceptance Criterion (based on predicates)	Reported Grass-Telefactor AS40 Performance
Device Class, Category	Class II Electroencephalography (same as predicates)	Class II Electroencephalography
Power Supply	Medical-grade power supply (same as predicates)	Medical-grade power supply
Patient Safety	Patient connections isolated from ground (same)	Patient connections isolated from ground
Safety and Electrical Standards Met	IEC601-1, UL2601-1, IEC601.2.26, CSA 22.2No.601.1, IEC601-1-2	IEC601-1, UL2601-1, IEC601.2.26, CSA 22.2No.601.1, IEC601-1-2 (in process)
Recording Capacity	Comparable channel count (40-57 channels, including AUX DC)	48-channel capacity including 8 non-isolated AUX DC channels
Direct support for integrated Oximeter	Yes (same as predicates)	Yes, manufacturer Nonin
Calibration/Use Modes	Yes (same as predicates)	Yes
Built-in electrode impedance test	Yes, with displayed results (same as predicates)	Yes, results displayed on host controlled LCD display on the device
Photic (flash unit) Stimulation Control integrated	Yes (same as predicates)	Yes
Host Computer to Device Connection	Industry standard Ethernet interface (same)	Industry standard Ethernet interface
Data Output	Digital (same as predicates)	Digital
Anatomical Sites	Same (same as predicates)	Same
A/D Resolution	8, 12, 16-bit or better (predicates range)	16-bit, simultaneous sampling
Sampling Rate	Up to 512 Hz - 2048 Hz (predicates range)	Up to 800 Hz
Noise	< 2μVpp or 0.5μVrms (predicates range)	< 2μVpp
CMRR	>80dB (predicates range >100dB, >115dB)	>80dB
Input Impedance	10 MOhms or >100MOhms	10 MOhms
Low-Frequency Cutoff	~0.1 Hz - 0.16 Hz (same as predicates)	0.16 Hz
High-Frequency Cutoff	~100 Hz - 107 Hz (same as predicates)	100 Hz

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

The document does not describe a clinical study with a specific test set, patient sample size, or data provenance (e.g., country of origin, retrospective/prospective). The "testing" section primarily describes bench testing and compliance with safety, EMI, and EMC standards for the device itself, rather than performance evaluation using patient data.

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

Not applicable. As no clinical test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method for the test set

Not applicable. As no clinical test set is described, there's no mention of an adjudication method.

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 applicable. The device is an amplifier system for physiological signal acquisition, not an AI-assisted diagnostic tool for human readers. No MRMC study or AI component is mentioned.

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

Not applicable. This is a hardware amplifier system, not an algorithm. Its performance is evaluated through technical specifications and compliance with standards, not as a standalone algorithm.

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

Not applicable. For this device submission, the "ground truth" for its performance is assessed against established engineering and safety standards (e.g., IEC601-1, UL2601-1) and the technical specifications of legally marketed predicate devices, which represent accepted performance parameters in the EEG community.

8. The sample size for the training set

Not applicable. There is no mention of a training set as the device is a hardware amplifier, not an AI-driven system.

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

Not applicable. There is no mention of a training set.

Summary

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AUG 2 9 2002

K 021807

EXHIBIT A

Grass-Telefactor Product Group

Astro-Med, Inc. West Warwick, RJ 02893 USA Tel: (401) 828-4000 Fax: (401) 822-2430 Contact Person: Peter L Fuller May 31, 2002

510(k) Summary of Safety and Effectiveness

Grass-Telefactor AS40 Amplifier System

1, Submitter Information

Submitter's Name:	Peter L FullerAssistant Chief Engineer
Company:	Grass-Telefactor Product Group, Astro-Med, Inc.570 Liberty StreetBraintree, MA 02185
Telephone:	(781) 848-2970
Facsimile:	(781) 848-2974

2. Identification of the Device

Name of Device: Grass-Telefactor AS40 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 SleepScan NETLINK, 510(k) No: K003681 and the Compumedics E-SERIES EEG System, 510(k) No: K000068.

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Like these equivalent products, the Grass-Telefactor AS40 is designed to provide the signal conditioning interface (physiological signal amplification, filtering, safety isolation, and digitization) between the patient and a computer platform. When connected by an Ethernet cable or network to a computer with the appropriate software these equivalent systems are designed to monitor physiological signals such as EEG and store the signals to the computer's hard drive. These products have the same intended use and essential performance and safety characteristics.

4. Description of the Device

The AS40 is enclosed in a plastic housing approximately 7" x 6" x 2" (17.78 x 15.24 x 5.08 cm) in size and it can be attached to a cart arm, mounted on a wall next to a patient bed, or sit flat on a tabletop. It can be configured for up to 40 AC and 8 DC channels. An integrated pulse oximeter connection is built into the unit that supports an optional tethered OEM pulse oximeter manufactured by Nonin. The patient connection module or electrode input box is referred to as a personality module in the AS40 system. The personality module connection is located on the top surface of the unit (two 32-pin connectors). The housing for this is a small plastic enclosure that can bave up to 40 AC channels with 'SafeLead' (protected) electrode connections, along with a reference and ground 'SafeLead' electrode connection. A customized overlay can be made for customer specific labeling schemes. The personality module can be attached either directly to the AS40 or tethered for easier positioning next to a patient bed. An LCD display with menu controls is located on the top surface of the unit along with the personality module connection. Menu selections can be made for configuring the unit, communicating with the host computer, and implementing the electrode impedance test. The LCD also displays status information such as electrode impedance test values.

Power is supplied to the AS40 through a rear side connector that attaches to a medical-grade regulated power supply (+12 volts DC). A 36-pin connector is also located on the rear side and it allows for the connection of a small plastic tethered auxiliary DC input box (DCM8) with 8 available connections for 3.5 mm jacks. Auxiliary DC inputs can come from devices such as an oximeter, a CPAP unit, or a capnometer. Also available through this 36-pin connector is a patient/event push

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button. All other connections (Ethernet, oximeter, photic stimulation control, etc.) are also located on the rear side of the AS40.

5. Indications for Use

6. Comparison of Technological Characteristics

The design and technological features of the AS40 and the predicate devices are similar. All of the systems provide connections to the patient via a standardized plugin interface for commonly used EEG electrodes and are intended to record from the same anatomical sites. All of the systems perform amplification and filtering of the bio-potential signals acquired from these electrodes. Each system has an integrated (built-in) oximeter. Each has a means for digitizing the channels and transmitting the sampled EEG and physiological data to a computer over an Ethernet cable or network. Each system has a calibration mode, the means of testing electrode impedances, and means of controlling a flash unit. The performance specifications are also similar for each system, 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 relies 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 operate 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, input connection capabilities, and total channel count. The Bio-Logic device is slightly larger with the patient connection box contained in the main unit with an optional tethered version available and it has support for 40 channels. The Compumedics device is smaller than both the Grass-Telecfactor AS40 and the Biologic device but consists of two modules one being the main unit and the other the patient connection box and it has support for up to 57 channels. The Grass-Telefactor AS40 can be a one-piece unit with the patient connection box directly connected to the base unit or separated with the patient connection box tethered and it has support for up to 50 channels.

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The following table is provided to demonstrate the AS40's technical characteristics present no significant differences when compared to those of the predicate devices.

Comparison Table

TechnicalCharacteristic	Grass-TelefactorAS-40	Bio-logicSleepScan NetLink	CompumedicsE-series EEG
Device Class,Category	IIElectroencephalography	Same	Same
Power Supply	Medical-gradepower supply	Same	Same
Patient Safety	Patient connectionsare isolated fromground	Same	Same
Safety andElectricalStandards Met	IEC601-1UL2601-1IEC601.2.26CSA 22.2No.601.1IEC601-1-2	Not available	IEC601-1IEC601-2-26IEC601-1-2
RecordingCapacity	48-channel capacityincluding 8 non-isolated AUX DCchannels	40-channel capacityincluding 8 AUX DCchannels	57-channel capacityincluding 8 non-isolated AUX DCchannels
Direct supportfor an integratedOximeter	Yes, manufacturerNonin	Yes, manufacturerNonin	Yes, manufacturernot specified
Calibration/UseModes	Yes	Yes	Yes
Built-in(integrated)electrodeimpedance test	Yes, resultsdisplayed on hostcontrolled LCDdisplay on the device	Yes, results displayedusing an array ofLEDs on the device	Yes, resultsdisplayed on hostcontrolled LEDs onthe device
Photic (flashunit)	Yes	Yes	Yes
StimulationControlintegrated
Host Computerto DeviceConnection	Industry standardEthernet interface	Same	Same
Data Output	Digital	Same	Same
AnatomicalSites	Same	Same	Same
TechnicalCharacteristic	Grass-TelefactorAS-40	Bio-logicSleepScan NetLink	CompumedicsE-series EEG
A/D Resolution	16-bit, simultaneoussampling	22-bit, simultaneoussampling	8, 12, or 16-bitsimultaneoussampling
Sampling Rate	Up to 800 Hz	128 - 2048 Hz	Up to 512 Hz
Noise	< 2μVpp	< 2μVpp	0.5μVrms
CMRR	>80dB	> 100dB	>115dB differentialmode, >105dBsingle ended
InputImpedance	10 MOhms	Not available	> 100MOhms
Low-FrequencyCutoff	0.16 Hz	0.1 Hz	0.16 Hz
High-FrequencyCutoff	100 Hz	Not available	107 Hz

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Comparison Table (Continued)

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7. Testing

The Grass-Telefactor AS40 system is in the process of being 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, IEC601-1-2, IEC601-2-26, UL2601-1, CSA22.2No.601-1 is also in process and will be completed before we commence shipment of this device.

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

In conclusion, the Grass-Telefactor AS40 amplifier system is as safe and effective as the predicate devices currently marketed by Bio-Logic Corporation and Compumedics and raises no new safety or effectiveness concerns.

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Image /page/6/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings.

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

Grass-Telefactor Product Group, Astro-Med, Inc. Peter L. Fuller Assistant Chief Engineer 570 Liberty Street Braintree, Massachusetts 02185

APR - 9 2012

Re: K021807

Trade/Device Name: Grass-Telefactor AS40 Amplifier System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE ltr): May 31, 2002 Received (Date on orig SE ltr): June 3, 2002

Dear Mr. Fuller:

This letter corrects our substantially equivalent letter of August 29, 2002.

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 (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

for

Malvina B. Evdelman, 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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http://www.fda.gov/cdrh/ode/indicate.html

Page 1 of 1

510(k) Number (if known): A

Device Name: Grass-Telefactor AS40 Amplifier System

Indications for Use:

The AS40 amplifier system is designed for use in the recording of routine BBG, overnight sleep/EEG (PSG, Polysomnography), and other neurophysiological monitoring applications (EMG and Evoked Potentials). This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in either electroencephalography or polysomnography.

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

Concurence of CDRH, Office of Device Evaulation (ODE)

Prescription Use $\checkmark$

Hut R. Rurly (Optional Format 3-10-98)

(Posted July 1, 1998)

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K021807

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).