KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM) by UROMETRICS, INC.

The UroMetrics Knoll/MIDUS System is an office based Doppler ultrasound system designed to measure blood velocity in the penile cavernosal arteries. The system consists of a portable or desktop IBM compatible personal computer containing a proprietary circuit board and transducers. Blood velocity is determined by detecting the Doppler shifts of an 8 MHz ultrasound signal. Proprietary software converts this data into a useable waveform display, which is shown on the computer video display.

AI/ML Overview

This a 510(k) premarket notification for the Knoll/MIDUS System, a bi-directional vascular Doppler with spectral analysis, which was submitted in 1997. As such, the document largely focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and a structured study to prove them, as would be expected for a more recent AI/ML-based device submission.

Therefore, much of the requested information regarding acceptance criteria, specific study design for proving those criteria, sample sizes, ground truth establishment for training and test sets, expert involvement, and MRMC studies is not explicitly available in this document.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria for performance metrics of the device in the way one would see for an AI/ML device (e.g., minimum sensitivity, specificity, or F1-score). Instead, the "acceptance criteria" can be inferred to be related to demonstrating substantial equivalence to the predicate device in terms of:

Intended Use: Measurement of penile cavernosal artery velocities.
Technological Characteristics: Bi-directional vascular Doppler with spectral analysis, 8 MHz ultrasound signal.
Safety and Effectiveness: Implied by being substantially equivalent to a legally marketed device.

The document does not report specific device performance metrics (e.g., accuracy, precision) in a table format against predefined acceptance criteria for a study proving these. The entire submission acts as the "study" demonstrating substantial equivalence of the Knoll/MIDUS to the predicate device (SPECS USA, Inc. Stenodoc/EPC bi-directional vascular Doppler with spectral analysis, K946349).

Study Details (Based on available information)

Given the nature of a 1997 510(k) for a Doppler ultrasound system, the concept of "AI" and associated study methodologies (like those for AI/ML devices) are not applicable here. The device itself is a measurement tool, not an AI algorithm.

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly defined in quantitative performance terms. The overarching "acceptance criterion" for this submission is demonstrating substantial equivalence to the predicate device (SPECS USA, Inc. Stenodoc/EPC) regarding intended use, technological characteristics, and safety/effectiveness.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, mean absolute error) are reported for the Knoll/MIDUS device directly against acceptance criteria. The performance is indirectly supported by its substantial equivalence to a predicate device that was already deemed safe and effective.
Sample sizes used for the test set and the data provenance: Not applicable. This submission does not describe a clinical performance study with a test set of patient data to measure device performance against. It's a submission for a hardware-based medical device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set requiring expert-established ground truth is described.
Adjudication method for the test set: Not applicable. No test set adjudication is described.
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. This device is not an AI product, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm, but a hardware system for measuring blood velocity, intended for human operation and interpretation.
The type of ground truth used: Not applicable in the context of an AI study. For a traditional medical device, "ground truth" might refer to established clinical methods or physical standards to validate measurements. The submission relies on the predicate device's established safety and effectiveness.
The sample size for the training set: Not applicable. There is no AI/ML model, so no training set.
How the ground truth for the training set was established: Not applicable.

Summary of Device and Regulatory Context for K971790:

Device: Knoll/MIDUS, a bi-directional vascular Doppler with spectral analysis.
Intended Use: Measurement of penile cavernosal artery velocities.
Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence to a predicate device.
Predicate Device: SPECS USA, Inc. Stenodoc/EPC bi-directional vascular Doppler with spectral analysis (K946349).
Key Information Provided: Device description, intended use, classification, and a statement of substantial equivalence by the FDA.
Missing Information (from an AI/ML perspective): No detailed performance study, no specific quantitative acceptance criteria for performance, no data on training/test sets, no expert involvement for ground truth, and no AI-specific evaluations (like MRMC or standalone algorithm performance).

The submission focuses entirely on the technical classification and equivalence to a previously cleared device, which was the standard regulatory approach for many medical devices in 1997.

Summary

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

Attachment 1

K97/790

DEC 17 1997

Summary of Safety and Effectiveness

This summary of safety and effectiveness is submitted in accordance with the requirements of 21 CFR 807.92 and was prepared November 25, 1997.

Submitter:	UroMetrics Inc.445 Etna StreetSuite 56St. Paul, MN. 55106612-774-1552
Contact Person:	Philip A. MessinaPresident, COO
Common Name:	Bi-directional Vascular Doppler with Spectral Analysis
Proprietary Name:	Knoll/MIDUS
Classification Name:	Ultrasonic transcutaneous blood flowmeter (w/wo calibration),21 CFR 8970.2100
Classification:	Class II
Predicate Device:	The Knoll/MIDUS is substantially equivalent to the SPECSUSA, Inc. Stenodoc/EPC bi-directional vascular Doppler withspectral analysis (K946349).
Description:	The UroMetrics Knoll/MIDUS System is an office basedDoppler ultrasound system designed to measure blood velocity inthe penile cavernosal arteries.The system consists of a portable or desktop IBM compatiblepersonal computer containing a proprietary circuit board andtransducers. Blood velocity is determined by detecting theDoppler shifts of an 8 MHz ultrasound signal. Proprietarysoftware converts this data into a useable waveform display,which is shown on the computer video display.
Intended Use:	Measurement of penile cavernosal artery velocities. Notintended for fetal use.

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

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 1997

Phillip A. Messina President & COO UroMetrics, Inc. 445 Etna Street, Suite 56 Saint Paul, MN 55106

Re: K971790 Knoll/MIDUS™ System (with SureAngle™ probes and
Gold Guard™ cradle) Dated: December 5, 1997 Received: December 8, 1997 Regulatory Class: II 21 CFR 892.1550/Procode: 90 IYN 21 CFR 870.2100/Procode: 74 DPW

Dear Mr. Messina:

We have reviewed your section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Knoll/MIDUS™ System, as described in your premarket notification:

Transducer Model Number

TD1 (8MHz, CW Doppler)

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

{2}------------------------------------------------

Page - 2 - Mr. Phillip Messina

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your 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 market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo Perez at (301) 594-1212.

Sincerely vours.

Utind C. Bergman

Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

1 of ใ Ultrasound Device Indications Statement Fage_

K971790 510(k) Number (if known); _ K971790
Device Name: Knoll/MIDUS Male Intracavernosal Doppler UltraSound Transducer Model TDI

Fill out one form for each ultrasound system and each transducer.

Attachment 1

Diagnostic ultrasound imaging or fluid flow analysis of the Intended Use : human body as follows:

node of Operation

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorvelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular				X
Laparoscopic
musculo-skeletal
Other (Specify)

(PLAASE LINES-CONTINUE ON ANOTHER PAGE IF

Concurrence of OSE, Office of Service Evaluation (OSE)

Prescription Use (Per 21 CFR 801

801/109)

(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological I 510(k) Number

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.