Cadwell Spike and Seizure Detector is a software-only product with an algorithm intended to analyze and mark events that may correspond to epileptiform discharge (spike) and electrographic seizure for the purpose of reviewing scalp EEG recordings. The marked events are reviewed, deleted, and interpreted by qualified clinical practitioners who will exercise professional judgment in using the information.

This device does not control the delivery of energy, administration of drugs, or another form of life sustaining function to the patient. It is intended for use in patients who are 18 years or over.

This device does not provide any diagnostic conclusion about the patient to the user.

Device Description

Cadwell Spike and Seizure Detector is a software-only product with an algorithm intended to analyze and mark events that correspond to spikes and seizures for the purpose of reviewing EEG recording. This application is for use by trained users such as neurologists, clinicians, registered EEG technicians. It requires EEG data recorded with a standard montage using the 10/20 electrode placement. The detected events are annotated on the EEG record for review by a trained user.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Cadwell Spike and Seizure Detector, based on the provided 510k summary:

1. Table of Acceptance Criteria and Reported Device Performance

Test Criteria	Acceptance Criteria	Reported Device Performance (Table 2)
Spike Detector	Device effectiveness	Pass
	Substantial equivalence	Pass
Seizure Detector	Device effectiveness	Pass
	Substantial equivalence	Pass

Note: The document states "The validation results show that the Cadwell Spike and Seizure Detector meets the objective for device effectiveness and substantial equivalence." but does not provide specific numerical thresholds for "Pass" for positive percent agreement or negative disagreement rate for either spike or seizure detection. The figures (Figures 1, 2, 3, and 4) graphically compare the device's performance to individual experts and the predicate device (Persyst Reveal) without explicit numerically stated acceptance criteria for each metric.

2. Sample Size for the Test Set and Data Provenance

Sample Size: 76 records from unique patients.
Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is to the US FDA, implying U.S. or internationally applicable standards.
- Retrospective or Prospective: Retrospective, as records were "selected from unique patients" and "acquired in an epilepsy monitoring unit as part of routine clinical protocol."

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Three human experts.
Qualifications: "Three human experts reviewed the complete raw EEG for each record and marked spike and seizure events." Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed beyond "human experts." It can be inferred they are neurologists or highly experienced EEG technicians given the context of epilepsy monitoring units and EEG review.

4. Adjudication Method for the Test Set

Adjudication Method: Majority rule (agreement between any two of three experts) using "any overlap method" was applied to construct the reference set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: Not explicitly stated as a formal MRMC comparative effectiveness study (e.g., comparing human readers with and without AI assistance). However, the study did compare the device's performance against individual human experts and a predicate device (Persyst Reveal) for both spike and seizure detection.
Effect Size of Human Readers Improve with AI vs. without AI Assistance: This specific metric was not reported. The study focused on the standalone performance of the device compared to experts and the predicate.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Standalone Performance: Yes, a standalone performance evaluation was conducted. The study assessed "Cadwell Spike Detector" and "Cadwell Seizure Detector" against the ground truth established by experts, as shown in Figures 1-4. The device analyzes and marks events "for the purpose of reviewing EEG recording" by trained users, implying a standalone analytical component that then feeds into human review.

7. The Type of Ground Truth Used

Ground Truth Type: Expert consensus. Specifically, "Majority rule (agreement between any two of three experts)" was used to establish the reference set for both spike and seizure events.

8. The Sample Size for the Training Set

Training Set Size: The document does not specify the sample size for the training set. The descriptions given relate to the validation/test set.

9. How the Ground Truth for the Training Set Was Established

Training Set Ground Truth: This information is not provided in the 510k summary. The summary focuses solely on the validation/test methodology.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for "OCADVELL" on the left and the text "510k Summary" on the right. The logo consists of a circle with a heartbeat symbol inside, followed by the text "OCADVELL" in bold, sans-serif font. The text "510k Summary" is also in a bold, sans-serif font and is positioned to the right of the logo.

Submitter:	Cadwell Laboratories, Inc.	K140552JUL 2 3 2014
Contact Person:	Chris BolkanSafety / Regulatory SpecialistCadwell Laboratories, Inc.909 N. Kellogg StreetKennewick, WA 99336Phone: (509) 735-6481Fax: (509) 783-6503
Date Prepared:	February 27, 2014
Trade Name:	Cadwell Spike and Seizure Detector
Common Name:	Spike and Seizure Detector
Classification Nameand Number:	Electroencephalograph, Class II, 21 CFR 882.1400
Product Code:	OMB
Classification Panel:	Neurology
Predicate Device:	Persyst Reveal (K011397)
Device Description:	Cadwell Spike and Seizure Detector is a software-onlyproduct with an algorithm intended to analyze and markevents that correspond to spikes and seizures for thepurpose of reviewing EEG recording. This application is foruse by trained users such as neurologists, clinicians,registered EEG technicians. It requires EEG data recordedwith a standard montage using the 10/20 electrodeplacement. The detected events are annotated on the EEGrecord for review by a trained user.
Indications for Use:	Cadwell Spike and Seizure Detector is a software-onlyproduct with an algorithm intended to analyze and markevents that may correspond to epileptiform discharge

(spike) and electrographic seizure for the purpose of reviewing scalp EEG recordings. The marked events are reviewed, deleted, and interpreted by qualified clinical

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Image /page/1/Picture/0 description: The image shows the logo for CADWELL along with the text "510k Summary". The CADWELL logo is on the left side of the image, and the text "510k Summary" is on the right side of the image. The text is in a larger font than the logo.

practitioners who will exercise professional judgment in using the information.

This device does not control the delivery of energy, administration of drugs, or another form of life sustaining function to the patient. It is intended for use in patients who are 18 years or over.

This device does not provide any diagnostic conclusion about the patient to the user.

Summary of technology characteristics:

	Comparison
Key Attributes	Cadwell Spike and SeizureDetector (K123927)	Persyst Reveal(K011397)
Identifies spikes	Yes	Yes
Identifies seizures	Yes	Yes
Displays calculated EEG measures	No	No
User-adjustable seizure detection	No	Yes
Users can add/delete events	Yes	Yes
Type of EEG recording supported	Scalp EEG only	Unknown
Type of EEG analysis	Post-hoc only	Post-hoc only
Population age	Adult	Unknown
Product Code	OMB	GWS

Table 1: Device Comparison Table

Substantial Equivalence: The Cadwell Spike and Seizure Detector is a software package that identifies spike and seizures in scalp EEG recordings. Persyst Reveal is commercially available software package that identifies spike and seizures in scalp EEG recordings and is an accepted standard in automated spike and seizure detection programs.

The Cadwell Spike and Seizure Detector is substantially equivalent to the Persyst Revel in terms of:

Indications for use t
Technology characteristics .
. Performance characteristics

Cadwell Spike and Seizure Detector 510k Summary Rev. 4

Page 2 of 6

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VELL 510k Summary

. Testing results from clinical data
Validation:

76 records were selected from unique patients with the following inclusion criteria:

Patient age 18 years or over on the date of recording ●
. Full montage scalp EEG using the 10-20 montage was acquired
. Total recording duration of minimum 6 hours

All recordings were acquired in an epilepsy monitoring unit as part of routine clinical protocol using the standard 10-20 montage. The patient age range for the selected recordings was 18-92 years with an average age of 48.2 years. The recording duration was in the range of 6-71 hours with an average of 24.6 hours.

Three human experts reviewed the complete raw EEG for each record and marked spike and seizure events. Majority rule (agreement between any two of three experts) using any overlap method was applied to construct the reference set.

The reference set for spike detector validation contained a total of 946 events. Figures 1 and 2 show the performance for each of the experts, Persyst Reveal and Cadwell Spike Detector.

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510k Summary

Image /page/3/Figure/1 description: The image is a plot titled "Spike Detection Sensitivity". The plot shows the positive percent agreement and 95% confidence interval for different experts and systems. The x-axis ranges from 40% to 100%, and the y-axis lists the experts and systems: Expert 1, Expert 2, Expert 3, Persyst, and Cadwell.

Figure 1: Positive percent agreement and 95% confidence interval using bootstrap method.

Image /page/3/Figure/3 description: The image is a plot titled "False Detection Rate for Spike Detection". The x-axis is labeled "Negative Disagreement Rate and 95% Confidence Interval" and ranges from 0 to 300. There are 5 different experts/systems plotted on the y-axis: Expert 1, Expert 2, Expert 3, Persyst, and Cadwell. Each expert/system has a range of values plotted, with a diamond indicating the mean value.

Figure 2: Negative disagreement rate and 95% confidence interval using bootstrop method.

The reference set for seizure detector validation contained a total of 332 events. Figures 3 and 4 show the performance for each of the experts, Persyst Reveal and Cadwell Seizure Detector. «

Cadwell Spike and Seizure Detector 510k Summary Rev. 4

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Image /page/4/Picture/0 description: The image shows the word "CADWELL" in a bold, sans-serif font. To the left of the word is a circle with a line going through it that resembles a heartbeat. The letters are all capitalized and black, and the background is white. The font is uniform in size and thickness.

510k Summary

Image /page/4/Figure/2 description: The image is a plot titled "Seizure Detection Sensitivity". The x-axis is labeled "Positive Percent Agreement and 95% Confidence Interval" and ranges from 40% to 100%. The y-axis shows the labels Expert 1, Expert 2, Expert 3, Persyst, and Cadwell. Each label has a line with a diamond in the middle, representing the range of values for each label.

Figure 3: Positive percent agreement and 95% confidence interval using bootstrap method.

Image /page/4/Figure/4 description: The image is a plot titled "False Detection Rate for Seizure Detection". The x-axis is labeled "Negative Disagreement Rate and 95% Confidence Interval" and ranges from 0 to 8. The y-axis shows the names of experts and systems, including Expert 1, Expert 2, Expert 3, Persyst, and Cadwell. Each expert and system has a horizontal line representing the disagreement rate and confidence interval.

Figure 4: Negative disagreement rate and 95% confidence interval using bootstrap method.

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Image /page/5/Picture/0 description: The image shows the word "CADWELL" in a bold, sans-serif font. To the left of the word, there is a circular graphic with a waveform inside, resembling an EKG or heart rhythm tracing. The letters are closely spaced, creating a solid block of text.

Conclusion:

The validation results show that the Cadwell Spike and Seizure Detector meets the objective for device effectiveness and substantial equivalence.

510k Summary

Test Criteria	Spike Detector	Seizure Detector
Device effectiveness	Pass	Pass
Substantial equivalence	Pass	Pass

Table 2: Summary of the test results for the Cadwell Spike and Seizure Detector

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Public Health Service

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

July 23, 2014

Cadwell Laboratories Jinesh Jain. Software Manager 909 N. Kellogg Street Kennewick, WA 99336

Re: K140552

Trade/Device Name: Cadwell Spike and Scizure Detector Software Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB Dated: June 9, 2014 Received: June 17. 2014

Dear Mr. Jain:

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 cither 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 Part 807): labeling (21 CFR Part 801): medical device reporting (reporting of medical

Image /page/6/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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Page 2 - Jinesh Jain

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 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" (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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Felipe Aquel - S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140552

Device Name Cadwell Spike and Seizure Detector

Indications for Use (Describe)

Cadwell Spike and Scizure Detector is a software-only product with an algorithm intended to analyze and mark evens that may correspond to epileptiform discharge (spike) and clectrographic seizure for the purpose of reviewing scale EFG recordings. The marked events are reviewed, deleted, and interpreted by qualified clinical practitioners who will exercise professional judgment in using the information.

This device does not control the delivery of energy, administration of drugs, or another form of life sustaining function to the patient. It is intended for use in patients who are 18 years or over.

This device does not provide any diagnostic conclusion about the patient to the user.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

- Date: 2014.07.23 19:45:51

-04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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).