Cadwell AmpliScan is a software-only device indicated for use with electroencephalographic (EEG) data from Cadwell Arc application software. Cadwell AmpliScan is distributed solely for use with Cadwell Arc software.
The Cadwell AmpliScan device is for prescription use only by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgement when using the information.
This device does not provide any diagnostic conclusion about the patient's condition to the user.
Cadwell AmpliScan uses electroencephalographic (EEG) data to calculate and display a quantitative aEEG measure. This quantitative measure should always be interpreted by the user in conjunction with review of the original EEG waveforms. The aEEG quantitative measure of Cadwell AmpliScan is intended to monitor the state of the brain.

Device Description

Cadwell AmpliScan is a software-only device distributed solely for use with the application software commonly known and marketed as Cadwell Arc software. Cadwell Ampliscan software is installed with installation of Arc software, and does not require installation or removal separate from the Arc application. The Cadwell AmpliScan software-only device applies the Amplitude-Integrated EEG (aEEG) algorithm referred to as the Cerebral Function Monitor (CFM) to stored data within the Cadwell Arc software, and stores and displays the results.

AI/ML Overview

The provided text appears to be a 510(k) summary for the Cadwell AmpliScan, a software-only device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and detailed performance metrics as one might find in a clinical trial report for an innovative device.

Therefore, the information requested by the user, particularly regarding acceptance criteria, sample sizes, expert qualifications, and detailed performance metrics, is not explicitly provided in the document in the format anticipated for a standalone clinical study. The document focuses on comparing the Cadwell AmpliScan to a predicate device based on technological characteristics and software verification/validation.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or quantify device performance in terms of metrics like sensitivity, specificity, accuracy, or similar measures commonly found in a study proving a device meets specific criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device.

The "Performance Data" section states: "In the Substantial Equivalence Discussion, a comparison of outputs from Cadwell AmpliScan and the predicate with like input data demonstrate the resulting equivalence of analysis and display." This implies that the 'acceptance criterion' was that the output of Cadwell AmpliScan should be equivalent to that of the predicate device when given the same input data.

Acceptance Criterion (Implied)	Reported Device Performance
Outputs are equivalent to predicate device for like input data.	"Comparison of outputs from Cadwell AmpliScan and the predicate with like input data demonstrate the resulting equivalence of analysis and display."
Software Verification and Validation conducted as per FDA guidance.	"Software Verification and Validation Testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA staff."
No new issues of safety or effectiveness introduced by differences.	"No new issues of safety or effectiveness are introduced by the differences."

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

The document does not specify a "test set" in terms of patient data. The evaluation was likely performed using various EEG data files (the "like input data") to compare outputs, but the number of such files or their origin (country, retrospective/prospective) is not mentioned. Given it's a software device processing existing data, the data would inherently be retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The concept of "ground truth" established by experts for a test set is not discussed in this document. The evaluation was focused on the software's ability to produce equivalent outputs to an existing, legally marketed device (the predicate). The assessment of equivalence typically involves technical comparisons of algorithm implementation and output, not expert clinical interpretation of novel results.

4. Adjudication Method for the Test Set:

Not applicable, as no expert-adjudicated test set is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. The document does not mention human readers or AI assistance in a comparative effectiveness study. The device is software that calculates and displays a quantitative aEEG measure, not an AI to assist human readers directly in diagnosis.

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

Yes, this was a standalone (algorithm only) evaluation. The device itself is "software-only" and its performance was assessed by comparing its outputs to a predicate device. The document explicitly states, "Cadwell AmpliScan uses electroencephalographic (EEG) data to calculate and display a quantitative aEEG measure." It also clarifies that "This device does not provide any diagnostic conclusion about the patient's condition to the user." and "This quantitative measure should always be interpreted by the user in conjunction with review of the original EEG waveforms." This indicates that the device operates as an algorithm generating a measure, with interpretation left to a qualified medical practitioner.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the output generated by the predicate device for the same input data, as the study aims to show equivalence. The document states a "comparison of outputs from Cadwell AmpliScan and the predicate with like input data demonstrate the resulting equivalence of analysis and display." This implies the predicate's output served as the reference for equivalence.

8. The Sample Size for the Training Set:

The document does not mention any "training set." This type of 510(k) submission, particularly for a device implementing a known algorithm (Cerebral Function Monitor/CFM), typically doesn't involve machine learning training on a large dataset. The substantial equivalence is based on the algorithm's implementation matching that of the predicate.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as no training set or ground truth for a training set is mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a wing-like shape above them.

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

November 8, 2016

Cadwell Industries, Inc. John Cadwell Jr. Electrical Engineer 909 N. Kellog St. Kennewick, Washington 99336

Re: K161027

Trade/Device Name: Cadwell AmpliScan Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMA Dated: August 12, 2016 Received: October 3, 2016

Dear Mr. Cadwell:

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Michael J. Hoffmann -A

for

Carlos L. Peña. PhD. MS 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

510(k) Number (if known) K161027

Device Name Cadwell AmpliScan

Indications for Use (Describe)

Cadwell AmpliScan is a software-only device indicated for use with electroencephalographic (EEG) data from Cadwell Arc application software. Cadwell AmpliScan is distributed solely for use with Cadwell Arc software.
The Cadwell AmpliScan device is for prescription use only by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgement when using the information.
This device does not provide any diagnostic conclusion about the patient's condition to the user.
Cadwell AmpliScan uses electroencephic (EEG) data to calculate and display a quantitative aEEG measure. This quantitative measure should always be interpreted by the user in conjunction with review of the original EEG waveforms. The aEEG quantitative measure of Cadwell AmpliScan is intended to monitor the state of the brain.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510k Summary

1) Submitter:

Cadwell Industries, Inc. 909 N. Kellogg Street Kennewick, Washington 99336

Phone: 509-735-6481

Contact Person: John A Cadwell Jr. Date Prepared: August 12, 2016

2) Device:

Trade Name of Device: Cadwell AmpliScan Common or Usual Name: Cadwell AmpliScan aEEG software Classification Name: Electroencephalograph (21 CFR 882.1400) Regulatory Classification: Class II Product Code: OMA

3) Predicate Device:

Persyst 12 EEG Review and Analysis Software (K132306) is a predicate. This predicate has not been subject to a design-related recall.

Olympic CFM6000 (K031149) is a reference predicate. This reference predicate has not been subject to a design-related recall.

4) Device Description:

The Cadwell AmpliScan software-only device applies the Amplitude-Integrated EEG (aEEG) algorithm referred to as the Cerebral Function Monitor (CFM) to stored data within the Cadwell Arc software, and stores and displays the results.

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510k Summary

5) Indications for Use:

1. Cadwell AmpliScan is a software-only device indicated for use with electroencephalographic (EEG) data from Cadwell Arc application software. Cadwell AmpliScan is distributed solely for use with Cadwell Arc software.
1. The Cadwell AmpliScan device is for prescription use only by qualified medical practitioners, trained in Electroencephalography, who will exercise professional judgement when using the information.
1. This device does not provide any diagnostic conclusion about the patient's condition to the user.
Cadwell AmpliScan uses electroencephalographic (EEG) data to calculate and display a 4) quantitative aEEG measure. This quantitative measure should always be interpreted by the user in conjunction with review of the original EEG waveforms. The aEEG quantitative measure of Cadwell AmpliScan is intended to monitor the state of the brain.

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VELL

6) Comparison of Technological Characteristics with the Predicate Device:

A comparison is made between Cadwell AmpliScan and the aEEG functionality of the predicate.

Cadwell AmpliScan and the predicate device both utilize the Maynard and Prior "Cerebral Function Monitor (CFM)" implementation to perform amplitude-integrated EEG analysis on stored patient data and display the results. The CFM requires input filtering, signal compression, low pass filtering, and specific display characteristics. Given that the Cadwell AmpliScan and the predicate implement the required analysis on input data in the same way, the respective outputs of Cadwell AmpliScan and the predicate are equivalent.

The following table illustrates technological characteristics of Cadwell AmpliScan and the predicate.

	Persyst 12 EEGReview and AnalysisSoftware (K132306)	Cadwell AmpliScanaEEG
Device Type	Software-only	SAME
aEEG	YES	SAME
Product Codes	OMA, ORT, OLT	OMA
aEEG Algorithm	Cerebral Function MonitorMaynard and Prior	SAME
Input Filter	Per CFM, Maynard and Prior	SAME
Signal Compression	Linear 0-10 uV, Log10 10-100uV	SAME
Low Pass FilterTime Constant	0.5 S	SAME
Vertical Display	Linear 0-10 uV, Log10 10-100uV	SAME
Horizontal Display	Vertical line display from minto max within each epoch	SAME
aEEG Indicationsfor Use	"The aEEG functionality...isintended to monitor the stateof the brain"	SAME
Supported InputData	"As recorded by OEM EEGequipment being usedto acquire the EEG signal"including: Cadwell, Natus,Compumedics, Nihon-Kohden, and others.	CADWELL ARC EEG Data

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510k Summary

The following technological differences exist between the subject and predicate devices:

. The predicate device can utilize stored EEG data from a wide range of sources, including Cadwell, Natus, Compumedics, Nihon-Kohden and others. The Cadwell AmpliScan limits the supported input data to EEG data stored in the Cadwell Arc environment.
The predicate device is a standalone software product that can be integrated into a . variety of vendor's application software. The Cadwell AmpliScan software is integrated only into Cadwell Arc application software.

No new issues of safety or effectiveness are introduced by the differences.

7) Performance Data:

The following performance data was provided in support of the substantial equivalence determination:

Software Verification and Validation Testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for the device was considered moderate level of concern.

In the Substantial Equivalence Discussion, a comparison of outputs from Cadwell AmpliScan and the predicate with like input data demonstrate the resulting equivalence of analysis and display.

Given that the Cadwell AmpliScan is a software-only device, biocompatibility, electrical safety and electromagnetic compatibility, mechanical testing, bench testing, clinical testing, and animal testing were not applicable.

Summary:

Based on the device performance as documented in this submission. Cadwell AmpliScan was found to have a safety and effectiveness profile that is similar to the predicate device.

8) Conclusions:

The Cadwell AmpliScan is substantially equivalent to predicate device in design, intended use, technology, and function. The included data supports the safety and efficacy of the device, and software verification and validation demonstrate Cadwell AmpliScan performance is comparable to the predicate for the intended use.

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).