For long term unattended EEG or other electrophysiological signal monitoring and recording.
This device is intended for use by physicians skilled in electroencephalography. These individuals are typically Board Certified Neurologists or Neurophysiologist or the equivalent or Ph.D. level Electroencephalographers.
We recommend placement of electrodes in accordance with the 10.20 International System.

Device Description

Like the predicate WARATAH® and Cardinal® Digital EEG and Sleep Acquisition Devices (WARATAH® Devices), the PANBUS® Digital EEG and Sleep Acquisition Devices (PANBUS® Devices) are provided to Original Equipment Manufactures (OEM) for creation of an electroencephalography (EEG) recording system. Significant PANBUS® Devices are:
I ) Personal computer (PC) interface board;
2) Electrode interface connection (Jackbox);
3) Communication protocol and port (PANBUS);
4) Amplifier(s);
5) Electrode lead wire sets.

AI/ML Overview

The provided text describes a 510(k) summary for the PANBUS® Digital EEG and Sleep Acquisition Devices. It's important to note that a 510(k) application focuses on demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness from scratch through extensive clinical trials. Therefore, the information typically found in such a document regarding detailed acceptance criteria and a study proving device performance against those criteria is limited.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence to Predicate Device	"The fundamental technical characteristics of the PANBUS Devices are the same as those of the predicate WARATAH Devices. Both apply analog to digital conversion technology to record EEG and polysomnography signals. These signals are transmitted over cables to a computer. The computer contains an interface card to interface the received signals to the computer."
Similar Intended Use	"The intended uses of the modified devices are the same as the predicate system: For long term unattended EEG or other electrophysiological signal monitoring and recording. ... This device is intended for use by physicians skilled in electroencephalography."
Compliance with Recognized Consensus Standards	"Testing to recognized consensus standards" was performed. (Specific standards are not listed in the provided text.)
Software Verification and Validation	"Software verification and validation" was performed.
Hardware Verification (Design Output meets Design Input)	"Hardware verification of design output meeting design input requirements" was performed.
Safety and Effectiveness (Implied by 510(k) conclusion)	"The safety and effectiveness of use of the PANBUS Devices as a modification of the WARATAH Devices was demonstrated by testing in compliance with the Design Control process. ... No new questions of safety or effectiveness are raised."
No Safety or Effectiveness Concerns Remain (Post-testing)	"Testing is completed. No safety or effectiveness concerns remain."

Study Details and Ground Truth Establishment

Given that this is a 510(k) summary for an EEG and sleep acquisition device (hardware and interface components, not an AI diagnostic algorithm), the typical elements for evaluating AI-based diagnostic devices (like sample size for test sets, experts for ground truth, MRMC studies) are not applicable or not explicitly detailed in this type of submission.

Here's a breakdown of what can be inferred or is explicitly absent:

Sample size used for the test set and the data provenance:
- Not Applicable/Not Provided: This document describes a medical device's technical equivalence, not an AI algorithm's performance on a specific dataset. There is no mention of a "test set" in the context of clinical data for performance evaluation of an AI algorithm. The "testing" mentioned refers to engineering verification and validation of the device components.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Provided: Ground truth in the context of medical image interpretation or AI model training/testing is not relevant here, as this is a hardware device for signal acquisition.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Provided: See explanation above.
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:
- No: This is a hardware device for acquiring physiological signals (EEG, PSG). It does not involve human readers interpreting data with or without AI assistance. Therefore, an MRMC study is not relevant to this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable/No: This device is a system for acquiring biological signals. It's not an "algorithm only" device in the sense of an AI diagnostic tool. Its function is to facilitate the recording of physiological data for human interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable/Not Provided: The "ground truth" for this type of device would relate to the accuracy and fidelity of its signal acquisition and processing capabilities, typically verified against known electrical signals or established measurement standards, rather than clinical outcomes or expert consensus on a diagnosis. The document mentions "Hardware verification of design output meeting design input requirements," which implies that the device was tested against its technical specifications.
The sample size for the training set:
- Not Applicable/Not Provided: There is no mention of a "training set" as this is not an AI/ML algorithm that learns from data.
How the ground truth for the training set was established:
- Not Applicable/Not Provided: See explanation above.

In summary, the provided document describes a 510(k) submission for a hardware device (EEG and sleep acquisition components) that aims to demonstrate substantial equivalence to a predicate device. The "study" referenced is primarily the design control process, including engineering verification and validation against technical specifications and consensus standards, rather than a clinical performance study with human readers or AI algorithms with defined test sets and ground truths.

Summary

{0}------------------------------------------------

SEP 3 0 7004

042364

510(k) Summary of Safety and Effectiveness

Company Name:	LaMont Medical, Inc.
Device Name:	PANBUS® Digital EEG and Sleep Acquisition Devices
510(k) Sponsor:	LaMont Medical, Inc.
510(k) Contact:	Tony MontgomeryPresident and CEOLaMont Medical, Inc.555 D'Onofrio DriveMadison, WI 53719
Phone:	(608) 827-9000
Fax:	(608) 827-8600
Summary Date:	September 24, 2004
Trade Name:	PANBUS® Digital EEG and Sleep Acquisition Devices
Common Name:	Electroencephalograph
Classification Name:	Electroencephalograph, CFR 882.1400, Product Code: GWQ, Class I
Predicate Device:	K990522 WARATAH and CARDINAL Digital EEG and Sleep Acquisition Devices

K023771Neuroscan SynAmps2

1.0 Description of Device

I ) Personal computer (PC) interface board;
1. Electrode interface connection (Jackbox);
1. Communication protocol and port (PANBUS);
1. Amplifier(s);
1. Electrode lead wire sets.

{1}------------------------------------------------

1.2 Clinical Application

The PANBUS® Devices are used in hospital and clinical environments where recording of EEG patterns and sleep (polysomnography) are of clinical interest. The user applies commercially available EEG electrodes to the patient in an internationally recognized pattern ( 10-20) recommended by the PANBUS® Devices labeling and their clinical standards.

Other sensors may be applied to the patient. These sensors support Polysomnography (PSG) recording. Typical PSG signals include:

I. Air flow,
1. Respiration effort,
1. Limb movement.

These signals can be interfaced to the PANBUS® amplifiers.

2.0 Intended use of Device

The intended uses of the modified devices are the same as the predicate system:

For long term unattended EEG or other electrophysiological signal monitoring and recording.
This device is intended for use by physicians skilled in electroencephalography. These individuals are typically Board Certified Neurologists or Neurologists or the equivalent or Ph.D. level Electroencephalographers.
Wc recommend placement of electrodes in accordance with the 10.20 International System.

3.0 Technological Characteristics

The fundamental technical characteristics of the PANBUS Devices are the same as those of the predicate WARATAH Devices. Both apply analog to digital conversion technology to record EEG and polysomnography signals. These signals are transmitted over cables to a computer. The computer contains an interface card to interface the received signals to the computer.

Both are OEM device components supporting the creation of EEG Recording Systems. Application Programmer Interface software is available to support the creation of an EEG recording system.

File: K042364 Reply to questions 9-27-2004

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4.0 Data Summary

Testing of the modifications was performed in compliance with the LaMont Medical, Inc. design control process. Testing included:

I. Testing to recognized consensus standards,
1. Software verification and validation,
1. Hardware verification of design output meeting design input requirements,

Testing is completed. No safety or effectiveness concerns remain.

5.0 Conclusions

The safety and effectiveness of use of the PANBUS Devices as a modification of the WARATAH Devices was demonstrated by testing in compliance with the Design Control process. The intended use and technology of the PANBUS Devices are the same as the predicate WARATAH Devices. No new questions of safety or effectiveness are raised.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

LaMont Medical. Inc. c/o Mr. Gary Syring Quality and Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589

APR - 9 2012

Re: K042364

Trade/Device Name: PANBUS® Digital EEG and Sleep Acquisition Devices Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, GWQ Dated (Date on orig SE ltr): August 26, 2004 Received (Date on orig SE ltr): August 31, 2004

Dear Mr. Syring:

This letter corrects our substantially equivalent letter of September 30. 2004.

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. Gary Syring

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 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/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Alexander

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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Indications for Use

04236 510(k) Number (if known): __

Device Name: PANBUS® Digital EEG and Sleep Acquisition Devices

Indications for Use:

For long term unattended EEG or other electrophysiological signal monitoring and recording.
This device is intended for use by physicians skilled in clectroencephalography. These individuals are typically Board Certified Neurologists or Neurophysiologist or the equivalent or Ph.D. level Electroencephalographers.
We recommend placement of electrodes in accordance with the 10.20 International System.

Prescription Use X (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)

(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number	K042364

Page 1 of 1Confidential

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).