The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are EMG OR Stimulation perineometer sensors used to monitor OR stimulate the pelvic floor muscles for the treatment of incontinence. This sensor is connected to a surface EMG device to provide Bio-feedback to the patient. This allows the patient to monitor their pelvic muscle activity which is otherwise difficult due to the anatomical location of the pelvic floor muscles. This sensor is connected to a stimulator device to provide stimulation to the patient. This assists the patient with muscle contractions.
The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are single-user plastic sensors with stainless steel electrode contacts. The patient inserts the sensor into the vagina or rectum and uses a surface EMG instrument to monitor the muscle activity during contraction and relaxation of the pelvic floor muscles. The patient can instead use a stimulator to electrically stimulate the pelvic floor muscles to assist the contraction. The aim is to improve the strength and control of the pelvic floor muscles.

AI/ML Overview

Here's a summary of the acceptance criteria and the studies performed for the Pathway Vaginal EMG/Stimulation Perineometer Sensor and Pathway Anal EMG/Stimulation Perineometer Sensor, based on the provided text:

Acceptance Criteria and Device Performance

The device aims to accurately measure EMG signals and provide stimulation for pelvic floor muscles, performing similarly to predicate devices. The acceptance criteria used are based on demonstrating equivalence rather than specific performance metrics for novel technology.

Acceptance Criteria / Feature (from summary of technical characteristics comparison to predicate device)	Reported Device Performance
Accurately measures EMG signals (Non-Clinical)	"accurately measure EMG signals"
Performs similarly to predicate device (Non-Clinical)	"perform similarly to the predicate device"
Readings obtained generally within 2% of predicate device (Non-Clinical)	"readings obtained using ... were generally within 2% of the readings obtained using the predicate device."
Accurately monitors and provides stimulation to pelvic floor muscles (Clinical)	"accurately monitor and provide stimulation to the pelvic floor muscles."
Performs similarly to predicate device (Clinical)	"perform similarly to the predicate device."
Biocompatibility (Safety of materials)	Found to be safe under required standards.
- Skin Sensitization (Kligman Maximization Test)	0% Sensitization; Weak allergenic potential
- Systemic Injection Test	Negative; No significant biological reaction
- L929 MEM Elution Test	Non-cytotoxic
- Pyrogen Test (Material Mediated)	Non-pyrogenic
- Primary Vaginal Test - Repeated Exposure	Minimal irritant
- Rectal Irritation Test - Repeated Exposure	Non-irritant

Detailed Study Information:

The document describes both non-clinical (bench) and clinical performance testing, along with biocompatibility testing. The studies focus on demonstrating substantial equivalence to existing predicate devices.

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

Non-Clinical Performance Data (Bench Tests): Not explicitly stated. The tests involved measuring known input signals and comparing them to predicate device readings.
Clinical Performance Data: "A test subject" was used. This indicates a very small sample size, likely N=1.
Data Provenance: Not explicitly stated but implied to be internal testing by The Prometheus Group (US company). The data would be prospective, generated specifically for this submission.

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

No external experts are mentioned for establishing ground truth in the performance studies.
For the non-clinical tests, the "ground truth" was a "known input signal."
For the clinical tests, the "ground truth" was likely inferred from the pressure perineometer sensor used in an alternate placement, and visual/qualitative assessment of muscle contractions, all relative to the predicate device, rather than an expert medical diagnosis.

4. Adjudication method for the test set:

No formal adjudication method (like 2+1, 3+1) is mentioned. The comparison seems to be direct against known inputs (bench tests) or direct comparison against the predicate device's performance (clinical tests).

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:

No MRMC comparative effectiveness study was done.
This device is a perineometer sensor for EMG and stimulation, not an AI or imaging diagnostic device where human reader performance with/without AI assistance would be a relevant metric. The focus is on the sensor's ability to accurately measure and stimulate.

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

The device itself is a standalone sensor that measures EMG signals and provides stimulation. Its performance was evaluated without explicit human interpretation in the loop for the performance metrics shown, though a human would be using the device. The non-clinical tests directly assess the sensor's measurement capabilities.

7. The type of ground truth used:

Non-Clinical Performance Data: "Known input signal."
Clinical Performance Data: Comparison to the predicate device, and monitoring of resulting contractions using a pressure perineometer sensor. This acts as a comparative measurement, rather than an independent "gold standard" ground truth like pathology for a diagnostic device.

8. The sample size for the training set:

Not applicable. This device is a sensor and does not involve AI or machine learning models that require 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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The Prometheus Group
----------------------

One Washington Street, #303 Dover , NH 03801
Phone:	603-749-0733
Fax:	603-749-0511

K993976 PG. 1 of 5

FEB 2 2 2 2000

510(k) SUMMARY Safety and Effectiveness Summary

Pathway Vaginal EMG/Stimulation Perineometer Sensor Pathway Anal EMG/Stimulation Perineometer Sensor

Submitted by:

Peter A Sullivan One Washington Street Suite 303 Dover, NH 03820 Phone: 603-749-0733 Fax: 603-749-0511

Contact Person:

Richard Horton

Date Submitted: Feb 4, 2000

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NAME OF DEVICE

Pathway Vaginal EMG/Stimulation Perineometer Sensor Trade name: Pathway Anal EMG/Stimulation Perineometer Sensor Common name: Perineometer Sensor Classification name: Perineometer (per 21 CFR section 884,1425)

IDENTIFICATION OF PREDICATE DEVICE

The device to which we claim substantial equivalence is the Pathway Vaginal/Rectal EMG Perineometer Sensor 510(k) number K974036, the InCare Vaginal EMG/Stimulation Perineometer Sensor and the InCare Anal EMG/Stimulation Perineometer Sensor 510(k) numbers K891773 and K930530. The Pathway Vaginal/Rectal EMG Perineometer Sensor, the InCare Vaginal EMG/Stimulation Sensor and the InCare Anal EMG/Stimulation Sensor are also singleuser plastic sensors with stainless steel electrode contacts.

DESCRIPTION OF DEVICE

The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are single-user plastic sensors with stainless steel electrode contacts. The patient inserts the sensor into the vagina or rectum and uses a surface EMG instrument to monitor the muscle activity during contraction and relaxation of the pelvic floor muscles. The patient can instead use a stimulator to electrically stimulate the pelvic floor muscles to assist the contraction. The aim is to improve the strength and control of the pelvic floor muscles.

INTENDED USE

Indications For Use:

- Urinary Incontinence : Stress, Urge and Mixed Incontinence
- Neuromuscular Reeducation
- Fecal Incontinence (EMG use only)

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SUMMARY OF TECHNICAL CHARACTERISTIC COMPARISON TO PREDICATE DEVICE

Feature	PathwayVaginal	PathwayAnal	PathwayVag/Rect	InCareVaginal	InCareAnal
Single-User Perineometer Sensor	Yes	Yes	Yes	Yes	Yes
Plastic Sensor with Metal Contacts	Yes	Yes	Yes	Yes	Yes
Three Electrode Contacts	Yes	Yes	Yes	No	No
Two Active, One Ground Contact	Yes	Yes	Yes	No	No
Separate Ground Connection for EMG	No	No	No	Yes	Yes
Shielded Cable	Yes	Yes	Yes	Yes	Yes
Safety 1/8" Stereo Plug Connector	Yes	Yes	Yes	No	No
1/8" Stereo Plug Connector	No	No	No	Yes	Yes
Urinary Incontinence	Yes	Yes	Yes	Yes	Yes
Fecal Incontinence(EMG use only)	Yes	Yes	Yes	No	No
Vaginal Use	Yes	No	Yes	Yes	No
Rectal Use	No	Yes	Yes	No	Yes
Clinic, Hospital & Home Use	Yes	Yes	Yes	Yes	Yes
Bulb at Tip of Sensor to Assist Retentionof Sensor During Use	Yes	Yes	No	No	Yes
Tab at Base of Sensor for Insertion/Removaland Control Insertion Depth	Yes	Yes	Yes	No	No
Arrow on Bottom of Sensor for Orientation	Yes	Yes	No	No	No
Tab at Base of Sensor for Orientation	Yes	Yes	Yes	No	No
Use for EMG measurement	Yes	Yes	Yes	Yes	Yes
Use for Stimulation	Yes	Yes	No	Yes	Yes
Overall Length	2.9"	2.4"	2.9"	4.3"	2.3"
Sensing Diameter	.70"	.50"	.73"	1.0"	.47"

NON-CLINICAL PERFORMANCE DATA

A series of bench tests were performed using the Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor to show the sensor accurately measures EMG signals and is substantially equivalent to the predicate device, The sensors were used to measure a known input signal and the measured value was compared to the known input signal to check the accuracy of the measurement. The same bench tests were performed on the predicate device.

The bench tests show the Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor accurately measure EMG signals. The bench tests also show that the Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor perform similarly to the predicate device. The readings obtained using the Pathway Vaginal EMG/Stimulation Perineometer Sensor and the

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Pathway Anal EMG/Stimulation Perineometer Sensor were generally within 2% of the readings obtained using the predicate device.

CLINICAL PERFORMANCE DATA

The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor were used in a series of simple clinical tests to show the sensors accurately measured EMG signals and provided stimulation and to show they were equivalent to the predicate device. A test subject was instructed to perform a series of contractions and relaxations using the Pathway Vaginal EMG/Stimulation Perineometer Sensor, the Pathway Anal EMG/Stimulation Perineometer Sensor, and also the predicate device. These EMG sessions were recorded using a personal computer. The test subject also used a viariety of stimulators with the sensors to generate contractions. The resulting contractions were monitored using a pressure perineometer sensor in the alternate placement (vagina or rectum) to compare the performance of the sensors.

The clinical tests show the Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor accurately monitor and provide stimulation to the pelvic floor muscles. The clinical tests also show the Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor perform similarly to the predicate device

BIOCOMPATIBILITY TESTING

The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor have been laboratory tested for the safety of the materials. The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor were found to be safe under the standards required for each test. A listing of each performed test and the result:

Test	Result
SKIN SENSITIZATION KLIGMAN MAXIMIZATION TESTDate of Test: 9/25/97	0% Sensitization;Weak allergenic potential
SYSTEMIC INJECTION TESTDate of Test: 9/9/97	Negative;No significant biologicalreaction
L929 MEM ELUTION TESTDate of Test: 8/21/97	Non-cytotoxic
PYROGEN TEST (Material Mediated)Date of Test: 9/3/97	Non-pyrogenic
PRIMARY VAGINAL TEST - REPEATED EXPOSUREDate of Test: 10/14/97	Minimal irritant

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RECTAL IRRITATION TEST - REPEATED EXPOSURE Non-irritant Date of Test: 9/26/97

CONCLUSION

The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are safe and effective for their intended use. The Pathway Vaginal EMG/Stimulation Perineometer Sensor and the Pathway Anal EMG/Stimulation Perineometer Sensor are substantially equivalent to the predicate device.

END OF 510(k) SUMMARY

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Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird.

FEB 2 2 2000

Mr. Richard Horton The Prometheus Group 2 Mallards Cove Duxbury, MA 02332

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K993976 Pathway Vaginal EMG/Stimulation Perineometer Sensor and Pathway Anal EMG/Stimulation Perineometer Sensor Dated: February 4, 2000 Received: February 8, 2000 Requiatory Class: II 21 CFR §876.5320/Procode: 78 KPI 21 CFR §884.1425/Procode: 85 HIR

Dear Mr. Horton:

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 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). 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.

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 requirements, 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 regult 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 the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 additionaily 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 requlation 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

K993976 510(k) Number (if known): Pathway Vaginal EMG/Stimulation Perineometer Sensor and Device Name: _________________________________________________________________________________________________________________________________________________________________ Pathway Anal EMG/Stimulation Perineometer Sensor

Indications for Use:

Indications For Use

- Urinary Incontinence : Stress, Urge and Mixed Incontinence
- Neuromuscular Reeducation
- Fecal Incontinence (EMG Use only)

Torish a. Hegeman

(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:_ X (Per 21 CFR 801.109)

Over-the-Counter Use:_

A-S

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).