The SD20 Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.

Device Description

The Sandman SD20 Amplifer is a fully programmable system which provides a total of 22 analog input channels cach of which can be configured, amplified and converted to digital form (analog to digital conversion). The amplifier receives its power from a dedicated AC/DC adapter, meeting the IEC 601-1 requirements, which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter.

The Sandman SD20 Amplifier is intended to be used to amplify and filter bioelectric signals captured via a lead or transducer on the surface of the human body. It captures the data, converts it into a digital form and passes it on to a host computer running appropriate amplification software. Typical fields of application will be: Electroencephalograph (EEG), Evoked Potentials (EP), Electromyography (EMG), Polysomnography (Sleep Analysis) and General Polygraphy.

The Sandman SD20 Amplifier contains a Pulse Oximeter module. The data measured from this module is passed to the host computer together with the other channels' data. The MP100 Pulse Oximeter module, developed by Nellcor Puritan Bennett, is substantially equivalent to Nellcor Puritan Bennett's MP400 Pulse Oximeter module cleared with EB Neuro's Mizar Amplifier via K003154.

The host computer must use one of the following Operating Systems: Microsoft Windows 98, Microsoft Windows NT or Microsoft Windows XP.

The Sandman SD20 Amplifier system consists of four interconnected units: the headbox, the amplifier box, the PC interface (BE Net/Sandman eLink) and the AC/DC adapter.

AI/ML Overview

The provided text is a 510(k) premarket notification for the Sandman SD20 Amplifier. This document focuses on demonstrating substantial equivalence to a predicate device (EB Neuro Mizar Amplifier K003154) rather than presenting a standalone study with acceptance criteria and performance data in the traditional sense of a clinical trial or performance study for a diagnostic algorithm.

Therefore, the information requested regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details is largely not present in this type of regulatory submission.

The acceptance criteria in this context are implicitly that the new device (Sandman SD20 Amplifier) performs at least as well as, or is substantially equivalent to, the predicate device (EB Neuro Mizar Amplifier K003154) based on technological characteristics and intended use.

Here's an attempt to answer your questions based only on the provided text, highlighting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state "acceptance criteria" as performance metrics with thresholds like sensitivity, specificity, accuracy, or a specific signal quality benchmark. Instead, it presents a comparison of technological characteristics between the proposed device and its predicate, implying that performance is acceptable if these characteristics are substantially equivalent and meet established industry standards for physiological signal amplifiers.

Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Sandman SD20 Amplifier)
Intended Use	Acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations (Same as predicate)	Acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations
A/D conversion	16 bit Sigma-Delta A/D effectively transferred to host	16 bit SAR effectively transferred to host
Sampling rate	User selectable (128, 256, 512...up to 32 KHz/Channel)	User selectable (128, 256, 512...up to 8192 Hz/Channel)
CMMR	>100dB	>100dB
Noise	< 1.5 $\mu$ Vpp	<0.5 $\mu$ Vrms(AC) <7 $\mu$ Vrms(DC)
Safety Standards	IEC 601-1-1, IEC 601-1-2, IEC 601-1-4	IEC 601-1, IEC 601-1-2, IEC 601-1-4
Pulse Oximetry Module (Function)	Provided by Nellcor Puritan Bennett MP404 (with predicate)	Provided by Nellcor Puritan Bennett MP100

Note on "Acceptance Criteria" interpretation: For a 510(k) of a device like a physiological signal amplifier, "acceptance criteria" are generally met by demonstrating that the device meets recognized standards (e.g., IEC 601-1) for electrical safety and EMC, and that its technical specifications (like noise, CMMR, sampling rate) are equivalent or better than a legally marketed predicate device for the same intended use. The table above reflects this comparison of technical specifications, as no specific performance outcomes (e.g., diagnostic accuracy for a specific condition) are being measured or reported in this document. The "Accepatance Criteria" column is essentially reflecting the specifications of the predicate device, which the new device aims to be substantially equivalent to or better than.

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

Sample Size: Not applicable/Not mentioned. This document is for a physiological signal amplifier, not a diagnostic algorithm that processes patient data to generate a finding. The "test set" would refer to the device itself being tested for its technical specifications and compliance with standards.
Data Provenance: Not applicable/Not mentioned. The document describes the device hardware and its intended use for capturing bioelectric signals, not the analysis of pre-existing patient data.

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

Not applicable/Not mentioned. Ground truth in this context would be related to the accurate measurement of electrical signals, typically assessed through engineering tests and calibration against known standards, not by expert interpretation of patient data.

4. Adjudication method for the test set

Not applicable/Not mentioned. Adjudication methods are typically associated with resolving discrepancies in expert interpretations of diagnostic images or clinical data, which is not the subject of this 510(k).

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/Not mentioned. This is a medical device (signal amplifier) and not an AI-powered diagnostic system or an aid for human readers. Therefore, an MRMC study is not relevant to this submission.

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

Not applicable/Not mentioned. The device is a hardware amplifier; it does not contain a standalone algorithm for diagnostic interpretation in the sense of AI. Its function is to acquire and transmit signals to a host computer for further software processing by a physician.

7. The type of ground truth used

Ground Truth: For a physiological signal amplifier, "ground truth" would be the known electrical properties and performance standards against which the device's technical specifications (e.g., noise, Common Mode Rejection Ratio (CMMR), sampling rate accuracy) are measured and verified during engineering and compliance testing. This document does not detail these specific tests but rather presents the device's measured characteristics.

8. The sample size for the training set

Not applicable/Not mentioned. This device does not use machine learning or AI that requires a "training set" of data.

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

Not applicable/Not mentioned. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary

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Ko40113

場

The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR1807.92(a).

807.92(a)(1)

. . . . . .

Submitter Information

Colleen J. Hittle-Densmore, Official Corresondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250

(317) 849-1916 Phone: (317) 577-9070 Facsimile:

Contact Person: Colleen J. Hittle-Densmore

January 14, 2004 Date:

807.92(a)(2)

Trade Name: Sandman SD20 Amplifier

Physiological Signal Amplifier Common Name:

Physiological Signal Amplifier Classification Name(s):

Classification Number: 84GWL

807.92(a)(3)

Predicate Device(s)

EB Neuro, S.p.A.	Mizar Amplifier	K003 154
------------------	-----------------	----------

Additional Substantial Equivalence Information is provided in the following Substantial Equivalence Comparison Table.

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Device Description

The host computer must use one of the following Operating Systems: Microsoft Windows 98, Microsoft Windows NT or Microsoft Windows XP.

The Sandman SD20 Amplifier system consists of four interconnected units: the headbox, the amplifier box, the PC interface (BE Net/Sandman eLink) and the AC/DC adapter.

807.92(a)(5)

Intended Use(s)

The Sandman SD20 Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.

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807 92(a)(6)

Technological Characteristics

Item	EB NeuroMIZAR AmplifierK003154	EB NeuroSD 20 AmplifierThis Submission
Intended Use	Acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations	Acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations
EEG/Polygraphic channel	32/40/64/96/128	19 (16 monopolar + 3 bipolar)
DC channel	32/40	3 (+3 dedicated )
A/D conversion	16 bit Sigma-Delta A/D effectively transferred to host	16 bit SAR effectively transferred to host
Sampling rate	User selectable (128, 256, 512 . .up to 32 KHz/Channel	User selectable (128, 256, 512 . up to 8192 Hz/Channel)
CMMR	>100dB	>100dB
Noise	< 1.5 $\mu$ Vpp	<0.5 $\mu$ Vrms(AC) <7 $\mu$ Vrms(DC)
Power Supply	External IEC 601-1 mains adapter (standard) Internal batteries (optional)	External IEC 601-1 mains adapter
Internal Storage	N/A	N/A
Amplifier - PC Interface	PCMCIA or BE Net	BE Net
Other Interfaces	128x64 graph LCD display 5 push buttons	Power on LED (amplifier) LED matrix Ohm Meter (headbox)
Use standard sensors and electrodes	Yes (electrodes and sensors are not included with the Amplifer)	Yes (electrodes and sensors are not included with the Amplifier)
Dimension	25 x 17 x 6.5 cm	3.5 x 13.5 x 10.5 cm (amplifier)12.6 x 9.6 x 2.5 cm (headbox)
Weight	1.5 Kg	0.3 Kg (amplifier);< 0.3 Kg (headbox)

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Item	EB NeuroMIZAR AmplifierK003154	EB NeuroSD 20 AmplifierThis Submission
Isolation	Fiber optic linkPatient isolation BF type	Fiber optic linkPatient isolation CF type
Safety Standards	IEC 601-1-1IEC 601-1-2IEC 601-1-4	IEC 601-1IEC 601-1-2IEC 601-1-4
System Components	Head boxAmplifierAC/DC AdapterPCMCIA or BE Net Interfaces	Head boxAmplifierAC/DC AdapterBE Net Interface
Firmware	Resident and Runtimedownloadable	Resident and Runtimedownloadable
Head box connection andinputs	32 monopolar; 8 bipolar; 1Thermistor	16 inputs - 16 plugs3 inputs - 6 plugs1 Thermistor dedicated input1 Body position dedicated input1 Pressure sensor dedicated input
Pulse Oximetry Module	Nellcor Puritan Bennet MP404	Nellcor Puritan Bennet MP100
DC Expansion Module	Yes	Yes
Accessory

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

FEB 1 8 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EB Neuro, S.p.A. c/o Ms. Colleen Densmore The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250

Re: K040113

Trade/Device Name: Sandman SD20 Amplifier Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological signal amplifier Regulatory Class: II Product Code: GWL Dated: January 14, 2004 Received: January 20, 2004

Dear Ms. Densmore:

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 10 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.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Colleen Densmore

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

sincerely yours,

Mark N Mulhern

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K040113

SD20 Amplifier Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Milken

(Division Sign-Off)
Division of General, Restorative,
and Heardlogical Devices

510 K040113

510

Regulation Number and Section

§ 882.1835 Physiological signal amplifier.

(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).