The PolygrafID with POLYGRAM NET™ ElectroGastroGraphy Application is intended to record, store, process and view gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.

Device Description

The system is a stationary electrogastrography system for use in the evaluation of gastrointestinal motility disorders. The system measures the myoelectrical activity of the gastrum using sensors situated on the skin. The parameters measured are presented on a computer screen during the capture and are also stored for later display, review, analysis and reporting.

AI/ML Overview

Here's an analysis of the provided text regarding the EGG system's acceptance criteria and study data:

This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device for a new Electrogastrography (EGG) system. It does not contain detailed information about specific acceptance criteria, a dedicated study proving performance against those criteria, or the typical AI/ML study components you've requested.

The document is a US FDA 510(k) Notification, which aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This process often relies on comparisons of technical specifications, intended use, and safety/performance characteristics rather than new clinical trials with defined acceptance criteria and statistical endpoints, especially for low-risk devices.

Therefore, many of your requested points cannot be directly answered from the provided text.

Here's a breakdown of what can be extracted and where information is missing:

Electrogastrography (EGG) System - Acceptance Criteria and Study Information

Note: This 510(k) submission primarily establishes substantial equivalence to a predicate device. It does not describe a standalone clinical performance study with predefined acceptance criteria as would be typical for a novel AI/ML device or a device requiring new clinical validation. The "acceptance criteria" here implicitly refer to the device performing comparably to the predicate and meeting general safety and electrical standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k), explicit acceptance criteria are not stated in a quantitative performance table. Instead, the "performance" is implicitly deemed acceptable if the device is substantially equivalent to the predicate and adheres to relevant standards.

Feature/Specification	Predicate Device (3CPM EGG Machine K984637)	New Device (Polygram NET EGG Application)	Comparison/Explanation	Implied "Acceptance"
PC Based	Yes	Yes	Same	Comparable functionality
External Data Acq. Device	Yes	Yes	Same	Comparable functionality
External Amplifier	Yes	No	Better (implied)	Improved design, maintains functionality
Use of External Strip Chart Recorder	Yes	No¹	Better, simpler system	Improved design, maintains functionality
Measurement Setup	On HW devices	By use of protocol settings in SW	Better, ensures initial same setting every time	Improved workflow, maintains accuracy
Visualize Signals in Time Domain	Yes	Yes	Same	Comparable functionality
Running Spectrum Analysis	Yes	Yes	Same	Comparable functionality
Gain	100	1, 10, 100²	Same (range extended)	Comparable/Better, maintains signal quality
High-Freq.	0.25 Hz	0.25Hz	Same	Comparable signal filtering
Low Freq.	0.016 Hz	DC, 0.0083Hz, 0.016Hz, 0.030Hz	Better (more options)	Comparable/Better, maintains signal quality
Offset Handling	0	High Pass filter³	Same result	Comparable signal processing
SW high pass filter	NO	Yes	Better, recording can begin immediately	Improved efficiency, maintains signal quality
Number of Channels	1	1 to 4	Better, ability to analyze most significant data	Improved diagnostic utility
Motion Sensor	Yes	Yes	Same	Comparable functionality
Indications for Use	"To be used to record electrogastrog-rams, as a component of a comprehensive clinical evaluation in patients with symptoms consistent with gastrointestinal motility disorders"	"Record, store view and analyze gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders"	Same	Substantially equivalent clinical utility
Intended Populations	Infants, pediatrics to adults	Adults	Less	More restricted, but still substantial equivalence for adults
Sterilization	Accessories not sterile, cleaning instructions	Electrodes disposable, cables not sterile, cleaning instructions	Same	Substantially equivalent infection control
Biocompatibility	Sensors only part in contact	Same	Same	Substantially equivalent patient safety
Digital Resolution	Not specified	Gain 1: 1.12 µV; Gain 10: 0.112 µV; Gain 100: 0.0112 µV	NA	Explicitly stated, implies sufficient precision.
Signal Range	Not specified	+/- 2.5 V	NA	Explicitly stated, implies sufficient range.

Key Implication: The "acceptance criteria" are generally met by demonstrating that the device functions correctly, adheres to electrical safety standards (EN 60601-1, etc.), and provides equivalent or improved data capture and processing capabilities compared to the predicate device for its intended use.

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

Sample Size: Not specified. The document states, "Clinical trials are not performed." It implies that performance was assessed through engineering verifications and comparisons to the predicate device's specifications and functionality rather than a clinical "test set" with patient data.
Data Provenance: Not applicable, as formal clinical test data, in the sense of patient studies, were not conducted for this 510(k).

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

Number of Experts: Not applicable. No clinical test set requiring expert ground truth establishment is described.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This device is an EGG system, not an AI-based interpretation tool for human readers.
Effect Size of AI: Not applicable.

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

Standalone Performance: Not applicable in the context of an AI algorithm. The device measures and processes physiological signals. Its performance is related to the accuracy and reliability of these measurements and processing, which are verified through engineering tests and comparison to the predicate, not in an "algorithm-only" performance study.

7. The type of ground truth used

Type of Ground Truth: For the device itself, the "ground truth" for verification would primarily be:
- Engineering Specifications: Ensuring hardware and software perform according to design (e.g., gain settings, frequency filtering, digital resolution).
- Predicate Device Performance: The predicate device (3CPM EGG Machine) serves as the benchmark for "truth" in terms of clinical utility and output characteristics.
- Regulatory Standards: Compliance with electrical safety and EMC standards (EN 60601-1, etc.) acts as a form of "ground truth" for safety.
- "Verifications results show that the enhanced system performs as its predicate system." This statement implies the predicate's established performance is the de facto ground truth.

8. The sample size for the training set

Sample Size: Not applicable. This is not an AI/ML device that requires a training set of data.

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

Ground Truth Establishment: Not applicable. This is not an AI/ML device.

In summary: The provided 510(k) document is for an Electrogastrography (EGG) system seeking substantial equivalence to a predicate. It relies on non-clinical performance data (engineering verifications, adherence to standards, and feature comparison to the predicate) to demonstrate equivalence rather than a clinical trial with predefined acceptance criteria against new patient data. Therefore, most of the questions related to AI/ML device validation are not applicable.

Summary

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KO14269 OF 4

510(k) Notification Electrogastrography (EGG) System

NOV 2 1 2002

510(k) SUMMARY

as required per 807.92(c)

1. Submitters Name, Address:

Medtronic A/S Tonsbakken 16-18 DK-2740 SKOVLUNDE Tel: + 45 44 57 90 00 Fax: + 45 44 57 90 10 Contact person for this submission: Liselotte Sander Date submission was prepared: August 20, 2002.

2. Trade Name, Common Name and Classification Name:

A. Trade Name: Electrogastrography (EGG) System

B. Common Name, Classification Name, Class and Requlation Number:

Common Name	Classification Number	Class	RegulationNumber
Polygraf ID	MYE	II	21 CFR 876.1735
Polygram NET	MYE	II	21 CFR 876.1735

3. Predicate Device Identification:

The scientific technology and the functionality and intended use of the Polygram NET and the Polygraf ID are equivalent to 3CPM Company's 3CPM EGG Machine (K 984637)

4. Device Description:

In the daily use, a trained technician, nurse and/or a physician are the main users of the system.

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510(k) Notification Electrogastrography (EGG) System

The main tasks when performing an electrogastrography procedure with a stationary EGG system are:

Prepare equipment including verification of correct levels for skin/electrode . impedance levels.
Enter patient/study demographic information ●
Perform procedure and obtain relevant data ●
Review, analysis and post procedure activities ●
Create and print a report ●

The Polygram NET application software runs on the Microsoft Windows® 2000 operating system.

5. Intended Use:

The Polygaf ID with Electrogastrography (EGG) System is intended to record, store view and process gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.

	6. Table of Device Similarities and differences to predicate device

Manufacturer	3CPM CO., Inc.	Medtronic Functional Diagnostics
510(k) nummer	Predicate device	New device
	• 3CPM EGG Machine –	K011468
	K984637	Polygram NET Electrogastro-graphy
		(EGG) Application:
		• Polygraf ID
		• Polygram NET ElectrogastrographyApplication Software

General:	Predicate device3CPM	Modified devicePolygram NETElectrogastrography(EGG) Application	Explanation of thedifferences compared tothe predicate device
PC. Based	Yes	Yes	same
External data acquisitiondevice	Yes	Yes	same
External amplifier	Yes	No	Better
Use of a external StripChart Recorder	Yes	No1	BetterMakes the system simpler.
Measurement setup	On HW devices	By use of protocol	Better
		settings in SW.	Ensures initially same settingevery time
Visualize signals in timedomain.	Yes	Yes	same
Running SpectrumAnalysis	Yes	Yes	same
Gain	100	1, 10, 1002	same
High-Freq.	0.25 Hz	0.25Hz	same
Low Freq.	0.016 Hz	DC,0.0083Hz;0.016Hz;0.030Hz	Better
Offset	0	High Pass filter3	Same result
SW high pass filter	NO	Yes	Better.No need for 5 minutes periodto "settle down". The recor-ding can begin immediately
Number of channels	1	1 to 4	Better.Gives the ability to analyzethe channel with the mostsignificant data
Motion sensor	Yes	Yes	Same
Indications for use	To be used to recordelectrogastro-grams,as a component of acomprehensive clini-cal evaluation in pa-tients with symptomsconsistent with ga-strointestinal motilitydisorders	Record, store view andanalyze gastric myoe-lectrical activity as anaid in the diagnosis ofgastrointestinal motilitydisorders	Same
Intended populations	Infants, pediatrics toadults	Adults	Less
Sterilization	Accessories are notsupplied sterile,manufacturer labelsthe accessories withcleaning instructions	Electrodes are dispo-sable. Cables are notsupplied sterile, manu-facturer labels the ac-cessories with cleaninginstructions	Same
Biocompatibility	The sensors are theonly part that comesinto contact with thepatients	Same	Same

I The raw data is presented on the screen formatted as a strip chart. The hole recording or part's of it can be printed or included in the report.

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510(k) Notification Electrogastrography (EGG) System

7. Assessment of non-clinical performance data for equivalence:

Verifications results show that the enhanced system performs as its predicate system.

² The Digital resolution is as following: Gain 1 -> 1.12 µV ; Gain 10 -> 0.112 µV; Gain 100 -> 0.0112µV

3 The Polygraf ID handles signals in the range of f +- 2.5 V. The DC offset is removed by use of a software high pass filter.

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KC14269
PAGE 4 OF 4

510(k) Notification Electrogastrography (EGG) System

8. Assessment of clinical performance data for equivalence: Clinical trials are not performed. This new system does not raise any new safety or performance issues.

9. Biocompatability:

Not applicable

10. Sterilization:

Not applicable

11. Standards and Guidances:

The Polygraf ID conforms to the following voluntary and mandatory standards:

EN 60601-1, Medical equipment .
EN 60601-1-1, Electrical Safety ●
EN 60601-1-2, Electro magnetic Compatibility ●
CAN/CSA 22.2 No. 601.1 - M90

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20:350

NOV 21 2002

Re: K014269

Mr. Toni Kennet Jørgensen Regulatory Affairs Specialist Medtronic Functional Diagnostics A/S Tonsbakken 16-18 DK-2740 Skovlunde DENMARK

Trade/Device Name: Polygraf ID with POLYGRAM NET™ ElectroGastroGraphy (ECG) Application Software Regulation Number: 21 CFR 8876.1735 Regulation Name: Electrogastrography system Regulatory Class: II Product Code: 78 MYE Dated: August 20, 2002 Received: August 23, 2002

Dear Mr. Jørgensen:

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, 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 (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 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 this 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" (21 CFR Part 807.97). 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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510(k) Number (if known): K014269

Device Name: ElectroGastroGraphy (EGG) Application Software

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Ingram

(Optional Format 3-10-98)

Prescription Use

Regulation Number and Section

§ 876.1735 Electrogastrography system.

(a)
Identification. An electrogastrography system (EGG) is a device used to measure gastric myoelectrical activity as an aid in the diagnosis of gastric motility disorders. The device system includes the external recorder, amplifier, skin electrodes, strip chart, cables, analytical software, and other accessories.(b)
Classification. Class II (Special Controls). The special controls are as follows:(1) The sale, distribution and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter.
(2) The labeling must include specific instructions:
(i) To describe proper patient set-up prior to the start of the test, including the proper placement of electrodes;
(ii) To describe how background data should be gathered and used to eliminate artifact in the data signal;
(iii) To describe the test protocol (including the measurement of baseline data) that may be followed to obtain the EGG signal; and
(iv) To explain how data results may be interpreted.
(3) The device design should ensure that the EGG signal is distinguishable from background noise that may interfere with the true gastric myoelectric signal.
(4) Data should be collected to demonstrate that the device has adequate precision and the EGG signal is reproducible and is interpretable.