The MONARCH 21 system's intended use is to measure sexual response to visual and auditory stimuli in male sexual offenders as an important part of evaluating individual treatment need and determining risk for recidivism.

Device Description

MONARCH 21 Penile Plethysmograph consists of attached sensors, which measure penile tumescence. A laptop computer is used to store, tabulate, display and print out the acquired data.

AI/ML Overview

The MONARCH 21 Penile Plethysmograph's acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria for the MONARCH 21 Penile Plethysmograph. Instead, it focuses on demonstrating substantial equivalence to a predicate device (CAT-600 Penile Plethysmograph, K936115) through functional testing. The "acceptance criterion" in this context is implicitly the successful mimicry of the predicate device's examination results, ensuring that differences do not diminish safety and effectiveness.

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical, electrical safety, software testing demonstrates no diminution of safety and effectiveness compared to predicate.	Differences between MONARCH 21 and predicate devices were subjected to mechanical, electrical safety, software testing to demonstrate that they do not diminish safety and effectiveness. (General statement without specific metrics provided)
Penile sensors accurately measure full range of values.	A precision machined aluminum calibration cone with graduated circumference sizes was used to measure the penile sensors' full range of values. (Specific measurement results are not provided, only the method.)
Secondary agents tested using simulated equivalent values.	Secondary agents were tested using simulated equivalent values. (Specific results for these tests are not provided.)
All testing mimics prior predicate device examination, resulting in substantial equivalence.	All testing mimicked prior predicate device examination resulting in substantial equivalence. (This is the overarching conclusion of the non-clinical tests rather than specific performance metrics.)

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

The study described is a non-clinical, in-vitro validation for functional equivalence, not a clinical study involving human subjects or patient data.

Sample Size: Not applicable. The "test set" consists of a precision machined aluminum calibration cone and "secondary agents" for in-vitro testing. No human data or patient samples were used.
Data Provenance: Not applicable. The data is generated from laboratory testing of the device components (sensors, system functionality) using physical calibration tools and simulated values.

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

Not applicable. This was a non-clinical engineering and functional validation study. Ground truth was established by physical measurements and comparison to known values, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As a non-clinical, in-vitro validation, there was no need for expert adjudication. The comparison was against expected physical measurements and the performance of the predicate device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Affect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No. An MRMC comparative effectiveness study was not done. The MONARCH 21 is a device to measure sexual response, not an AI-assisted diagnostic tool for human readers. It provides data for human interpretation but does not involve AI or "human readers" in the context of diagnostic image or signal interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the loop performance) Was Done

Yes, in essence. The "non-clinical test results" section describes standalone testing of the device's components and system functionality. This involved measuring the penile sensors' range of values using a calibration cone and testing secondary agents with simulated values. This testing assessed the device's intrinsic mechanical and electrical performance without human interpretation as part of the assessment.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)

The ground truth used was based on physical measurement standards and simulated equivalent values.

For sensor calibration: Known circumferences of a precision machined aluminum calibration cone.
For secondary agents: Simulated equivalent values, implying comparison against predefined or calculated values.
Overall: The performance of the predicate device (CAT-600 Penile Plethysmograph) served as a benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. The MONARCH 21 is a medical measurement device, not an AI or machine learning algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

Summary

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K033126 PG. / OF 2

OCT 2 9 2003

Attachment #4

510(k) SUMMARY

Submitter's Name, Contact Person, Address, Phone, Fax, and Email

Behavioral Technology, Incorporated (BTI) Susan E. Olsen 24 M Street Salt Lake City, UT 84103 Phone: (801) 363-9017 Fax: (801) 363-9022 Email: susan@btimonarch.com

Device Name, Common/Generic Name and Classification Name

Proprietary Name:	MONARCH 21 Penile Plethysmograph
Common/Generic Name:	Penile Plethysmograph
Classification Name:	Monitor, Penile Tumescence
Predicate Device
Device Name:	CAT-600 Penile Plethysmograph, K936115

Description of the Device

MONARCH 21 Penile Plethysmograph consists of attached sensors, which measure penile tumescence. A laptop computer is used to store, tabulate, display and print out the acquired data.

Intended Use of the Device

The MONARCH 21's intended use is to measure sexual response to visual and auditory stimuli in male sexual offenders as an important part of evaluating individual treatment need and determining risk for recidivism.

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K033126 PG. 2 DF 2

Technological Summary between MONARCH 21 and its predicate device

MONARCH 21 provides all the functionality of it's predicate devices into a truly portable and easy-to-use system. Differences between MONARCH 21 and predicate devices were subjected to mechanical, electrical safety, software testing and clinical validation to demonstrate that they do not diminish safety and effectiveness. Intercom and auxiliary traces support technicians in making standardized assessments. Non-standardized assessment capability is available for research.

Non-Clinical Test Results

A precision machined aluminum calibration cone with graduated circumference sizes was used to measure the penile sensors full range of values. Secondary agents were tested using simulated equivalent values. All testing mimicked prior predicate device examination resulting in substantial equivalence.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2003

Ms. Susan E. Olsen Executive Vice President Behavioral Technology, Inc. 24 M Street, Suite #1 SALT LAKE CITY UT 84103

Re: K033126

Trade/Device Name: MONARCH 21 Penile Plethysmograph System Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LIL Dated: September 26, 2003 Received: October 2, 2003

Dear Ms. Olsen:

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, nuarket 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 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 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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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 one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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 yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment #2

PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

Behavioral Technology, Incorporated Applicant:

K03312-6 510(k) Number:

MONARCH 21 Penile Plethysmograph System Device Name:

Indications for Use: The MONARCH 21 system's intended use is to measure sexual response to visual and auditory stimuli in male sexual offenders as an important part of evaluating individual treatment need and determining risk for recidivism.

David b. leyman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 133126 510(k) Number _

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

N/A