The POLYGRAM NET™ Biofeedback Application is intended for the assessment and treatment of pelvic floor dysfunction through biofeedback in patients 4 years of age or older.

Device Description

The POLYGRAM NET™ Biofeedback Application is used to assess and treat pelvic floor dysfunction. Data is collected in the anorectal canal, using sensors, and is displayed to the patient in a simple graphical format. The patient can modulate the activity of the anorectal muscles, thereby reeducating the pelvic floor muscles.

During a biofeedback study, a manometry catheter and/or EMG sensors are placed in the patient's anorectal canal at the sphincter. EMG sensors are then inserted anally and applied to the side of the anus. These EMG sensors, which are the same as used with the POLYGRAM Anorectal Function Testing Software (K000386), sense the patient's pelvic floor muscle activity during sequences of squeezing and relaxing maneuvers. These sensors and catheters are connected to the Medtronic Polygraf ID (K992713), which acquires the data to be displayed by the POLYGRAM NET™ Biofeedback Application.

The POLYGRAM NET™ Biofeedback Application displays a lane, that the patient navigates using their pelvic floor muscles. By squeezing and relaxing the pelvic floor muscles, the patient moves the signal level indicator up and down, trying to keep the signal level within the limits of the lane.

AI/ML Overview

This document is a 510(k) summary for the Medtronic POLYGRAM NET™ Biofeedback Application, submitted to the FDA in 2004. It outlines the device description, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically understood for performance testing related to accuracy, sensitivity, or specificity.

Here's a breakdown of why the requested information cannot be fully provided based on the input text:

The document explicitly states: "No applicable mandatory performance standards or special controls exist for this device." and "In-vitro testing was performed to support substantial equivalence to the predicate devices. In vitte testing was points indicate that the Medtronic POLYGRAM NET™ Biofeedback Application meets all of the design and performance requirements."

This indicates that the submission focuses on demonstrating that the new device functions similarly to previously cleared devices (predicate devices) and adheres to general design and performance requirements, rather than presenting a study against specific, quantified acceptance criteria for a novel clinical performance claim.

Therefore, many of your requested items, which are typical for clinical performance studies, are not present.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified as quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy)	Device meets "design and performance requirements" through in-vitro testing. It is considered "substantially equivalent" to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document states "In-vitro testing was performed". This is laboratory-based testing, not human-subjects testing that would involve a test set with data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no human-subjects "test set" for clinical performance is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human-subjects "test set" for clinical performance is described.

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
Not applicable. This device is a biofeedback application, not an AI or imaging diagnostic tool that would typically involve MRMC studies or human reader improvement with AI assistance. It aids patients in modulating muscle activity.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is a biofeedback application designed for human-in-the-loop interaction (patient modulating muscles based on software display). The "in-vitro testing" mentioned would be analogous to standalone testing, focusing on the software's ability to accurately process sensor data and display it, but not against clinical outcomes or diagnoses.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not specified, as the testing was in-vitro. For in-vitro testing, the "ground truth" would likely be known electrical or physiological signals generated by testing equipment, or calibrated sensor inputs, to verify the system accurately acquires and displays data.

8. The sample size for the training set
Not applicable. This document describes a traditional medical device submission, not a machine learning or AI algorithm where a "training set" would be explicitly used in the context of model development.

9. How the ground truth for the training set was established
Not applicable, as no "training set" is mentioned in the context of machine learning.

Summary of the study that proves the device meets the acceptance criteria (based on the provided text):

The device's acceptance was based on in-vitro testing to confirm it met its "design and performance requirements" and was "substantially equivalent" to predicate devices. The nature of these "design and performance requirements" is not detailed beyond implying that the device functions as intended for acquiring and displaying biofeedback data. The 510(k) submission largely relies on demonstrating that the new device does not raise new questions of safety or effectiveness compared to devices already on the market with similar technological characteristics and intended uses. No clinical performance study against specific, quantified acceptance criteria (like accuracy, sensitivity, specificity) is described.

Summary

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

8.0 510(K) SUMMARY	AUG 1 2 2004
Applicant:	Medtronic Gastroenterology and Urology4000 Lexington Ave NShoreview, MN 55126
Contact:	Julie GoodeSenior Regulatory Affairs SpecialistMedtronic Gastroenterology and Urology4000 Lexington Ave NShoreview, MN 55126(763) 514-9670(763) 514-9703
Trade Name:	POLYGRAM NETTM Biofeedback Application
Common Name:	Biofeedback software application
Classification Name:	Gastrointestinal motility monitoring system
Name of Predicate Device	POLYGRAM Anorectal Functional Testing Application, K000386Regain Desktop, K003127Orion Platinum, K003367

Device Description

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

Performance Standards

K041244
Page 2 of 2

No applicable mandatory performance standards or special controls exist for this device.

Statement of Intended Use

The POLYGRAM NET™ Biofeedback Application is intended for the assessment and The I OLA GRANA NET - Blorection through biofeedback in patients 4 years of age or older.

Substantial Equivalence

This premarket notification is being submitted for the Medtronic POLYGRAM NET™ This promance includes . Other Gastrointestinal motility monitoring systems, previously cleared by FDA, and currently marketed include:

Medtronic POLYGRAM NET™ Anorectal Functional Testing Application (K000386) .
SRS Medical Systems Orion Platinum (K003367) .
SRS Medical Systems Regain Desktop (K003127) .

Summary of Testing

In-vitro testing was performed to support substantial equivalence to the predicate devices. In vitte testing was points indicate that the Medtronic POLYGRAM NET™ Biofeedback Application meets all of the design and performance requirements.

Conclusion

Through the data and information presented, as well as similarities to a legally marketed I mough are aans , Inc. considers the Medtronic POLYGRAM NET™ Biofeedback device, incutrome, the substantially equivalent to the previously discussed legally marketed predicate devices.

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

Image /page/2/Picture/1 description: The image shows a logo with a stylized bird in flight. The bird is composed of three curved lines that suggest movement and feathers. The logo is encircled by a ring of text, though the text is not legible due to the image quality. The overall design is simple and conveys a sense of freedom or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 12 2004

Ms. Julie Goode Semor Regulatory Affairs Specialist Medtronic Gastroenterology and Urology 4000 Lexington Avenue North SHOREVIEW MN 55126-2983

Re: K041244

Trade/Device Name: POLYGRAM NET™ Biofeedback Application Regulation Number: 21 CFR §882.5050 Regulation Name: Biofeedback device Product Code: 84 HCC Regulation Number: 21 CFR §876.1725 Regulation Name: Gastrointestinal motility monitoring system Product Code: 78 FFX Regulatory Class: II Dated: May 7, 2004 Received: May 11, 2004

Dear Ms. Goode:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your boctor 9 re(s) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enviosars) to regary at ment date of the Medical Device Amendments, or to conninered prior to May 20, 1976, the encounce with the provisions of the Federal Food, Drug, devices that have been recurse in avere approval of a premarket approval application (PMA). and Costinetto Act (Rel) that do not require subject to the general controls provisions of the Act. The r ou may, dicience, market the act include requirements for annual registration, listing of general controls provisions of the fies 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 your device is classified (500 above) in existing major regulations affecting your device can be It may of Subject to additional collience in the 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 r trass oc advised that + Dr. 3185aanted or our device complies with other requirements of the Act that I 127 has made a deceminations administered by other Federal agencies. You must of any Pederal Statues and regulations as manifical to: registration and listing comply with an the Act stequirements, menting. .
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 807), labemig (21 CFR Part 820), and if applicable, the electronic fordly in the quanty by stems (20) = (sections 531-542 of the Act); 21 CFR 1000-1050.

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

This letter will allow you to begin marketing your device as described in your Section 510(k) This lefter will allow you to begin marketing your active of your device of your dever to a legally premarket notification. The FDA momg of bassification 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 Cirk Part 801), please
s the same of the same of the same of the same of the regulation it you desire specific advice for your don'ts be following numbers, based on the regulation in 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 Additionally, Tor questions on the promotion and more the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, please now Othice of Compliance at (301) 374-1657. Part 807.97) you may obtain. Other general by reterence to premarked nomication (210) For Friday of Stan the Division of Strating of Stration of Stration information on your responsionnes and consumer Assistance at its toll-friend democrain burgh Manufacturers, International and Collaumer - Secondants - Second Colors of Section of September 1991.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmama

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

{4}------------------------------------------------

INDICATIONS FOR USE 3.0

44 510(k) Number:

Device Name; POLYGRAM NET™ Biofeedback Application

Indications for use:

The POLYGRAM NET™ Biofeedback Application is intended for the assessment and treatment of pelvic floor dysfunction through biofeedback in patients 4 years of age or older.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broydon

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devi 510(k) Number

Regulation Number and Section

§ 882.5050 Biofeedback device.

(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.