The InnoSense System is indicated for acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Improvement of urethral sphincter closure, Strengthening of pelvic floor muscles, Inhibition of the detruser muscle through reflexive mechanisms. It is also indicated during incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles.

Device Description

The InnoSense Pelvic Floor Stimulation and Electromyography (EMG) System is comprised of a external stimulator/electromyography reader, leadwires (for surface EMG only) and electrodes. The device has a one channel stimulation function and a two channel EMG function. It is battery powered by two 1.5 volt (AA) batteries, with a low battery indication shown on the LCD Panel. The electrodes used to stimulate the pelvic floor muscles consist of either a vaginal or rectal electrode. The EMG function uses two electrodes consisting at the most one Vaginal or Rectal electrode and/or one or two surface EMG electrodes. One electrode is used to sense pelvic floor muscle activity and one is to sense accessory muscle activity such as the abdominal or gluteal muscles.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a table of acceptance criteria or reported device performance metrics. It primarily focuses on the device description, regulatory classification, and a 510(k) clearance letter confirming substantial equivalence to predicate devices. There are no quantitative performance measurements or thresholds presented.

2. Sample size used for the test set and the data provenance

The document does not describe any clinical test set or data provenance for evaluating the device's performance against specific criteria. The 510(k) clearance is based on substantial equivalence to predicate devices, implying that the safety and effectiveness are inferred from the established performance of those existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As no specific test set or clinical study is mentioned, there's no information regarding experts or ground truth establishment for a test set.

4. Adjudication method for the test set

Similarly, since no test set is described, there's no information on adjudication methods.

5. 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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it describe any AI component in the device. The InnoSense system is a physical device for pelvic floor stimulation and electromyography, not an AI diagnostic tool.

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

The InnoSense system is a physical device used by individuals for therapy and biofeedback, often under guidance. It is not an algorithm-only device, so a standalone performance study in that context would not be applicable or described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not describe a specific type of ground truth used for evaluating the InnoSense device. The 510(k) process relies on demonstrating substantial equivalence to legally marketed predicate devices rather than independent verification of the device's efficacy through a new clinical dataset with established ground truth.

8. The sample size for the training set

The document does not mention a training set sample size. There's no indication of any machine learning or AI components that would require a training set.

9. How the ground truth for the training set was established

As no training set is mentioned as applicable to this device, there's no information on how ground truth for a training set was established.

In summary, the provided document is a 510(k) premarket notification for a medical device (InnoSense Pelvic Floor Stimulation and Electromyography System). It focuses on regulatory approval based on demonstrating substantial equivalence to existing predicate devices. It does not contain details about specific clinical studies with acceptance criteria, test sets, expert-driven ground truth, or AI performance metrics that would typically be found in direct performance evaluations of new or AI-powered technologies.

Summary

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JUN 30 1997

Image /page/0/Picture/1 description: The image shows the word "Empi" in a bold, stylized font. Above the word "Empi" is the number "K971527". To the right of the word "Empi" is the number "142" in a handwritten font. The image appears to be a product label or identifier.

Cost Effective Health Care Solutions

SUMMARY OF SAFETY AND EFFECTIVENESS InnoSense Pelvic Floor Stimulation and Electromyography System

Date of Summary June 17, 1997 Page 1 of 2

Empi, Inc. 599 Cardigan Road St. Paul. Minnesota 55126-3965 USA

612-415-9000 FAX 612-415-7305

General Provisions A.

Submitter's Name:	Empi, Inc.
Submitter's Address:	599 Cardigan RoadSt. Paul, Minnesota 55126-3965
Contact Person:	Carolyn M. Steele HustenRegulatory Affairs Manager
Proprietary Name:	InnoSense Pelvic Floor Stimulation andElectromyography System
Common Name:	Pelvic Floor Stimulation and Biofeedback Device
Classification Name:	Non-Implanted Electrical Continence DeviceBiofeedback Device

Name of Predicate Devices B.

Verimed Myoexerciser III, K892649 ◆
Thought Technology InControl, K935213 �
Verimed Veristim, K893220 �
Innova Pelvic Floor Stimulation System, K941911 �
Minnova Pelvic Floor Stimulation System, K970307 �

C. Device Description

List of Components

Electrical Characterization

External Stimulator

The external stimulator function provides stimulus output to the electrode and can be adjusted to deliver stimulation at an peak pulse intensity range of 0 to 100mA.

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Image /page/1/Picture/0 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 figures, represented by flowing lines, suggesting a sense of community and support.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 30 1997

Re: K971527 InnoSense Pelvic Floor Stimulation and Electromyography System -- Dated: April 25, 1997 ------Received: April 28, 1997 Regulatory class: II 21 CFR §876.5320/Product code: 78 KPI 21 CFR §884.1425/Product code: 85 HIR

Ms. Carolyn M. Steele Husten Regulatory Affairs Manager Empi, Inc." 599 Cardigan Road St. Paul, Minnesota 55126-3965

Dear Ms. Husten:

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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of 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 (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 Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 (301) 443-6597 or at its internet address http://www.fda.gov/cdrl/dsmamain.html".

Sincerely yours,

h.J.Liau Yir
Lillian Yin, Ph.D.

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

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510(k) Number: (if known): K971527 Device Name: InnoSense Pelvic Floor Stimulation and Electromyography System Indications for Use:

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert D. Salling
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number K911527

Prescription Use
(Per 21 CFR 801.109)

OR Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 876.5320 Nonimplanted electrical continence device.

(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).