The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.

Device Description

The Gastric Alimetry is an electrogastrography (EGG) device, used for non-invasively measuring the myoelectrical activity of the stomach at the surface of the abdomen. The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.

The device is used to acquire and digitize the myoelectrical data and movement artifacts through an array with recording electrodes on an adhesive patch which is used for recording the myoelectrical data from the skin surface. An App used to set up the device and capture patient-reported symptom data.

A report is provided to the clinicians at the end of the test which displays myoelectrical data.

AI/ML Overview

The provided text describes the Gastric Alimetry System, an electrogastrography (EGG) device. However, it does not explicitly state specific acceptance criteria (e.g., a specific sensitivity or specificity threshold) for the device's performance. Instead, it concludes that the device's performance is "equivalent" or "comparable" to a predicate device and manual marking of artifacts.

Therefore, the table below will reflect the comparison to the predicate device where performance is discussed, rather than predefined acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Derived from comparison to predicate/manual)	Reported Device Performance
Gastric Myoelectrical Frequency Detection (vs. Predicate)	Detection and measurement of gastric myoelectrical frequency across pre-prandial and postprandial periods in an equivalent manner to the predicate device.	The Gastric Alimetry System detects and measures gastric myoelectrical frequency across pre-prandial and postprandial periods in an equivalent manner to the predicate device within a cohort of patients with various gastric disorders.
Automated Artifact Detection (vs. Manual Marking)	Automated artifact detection algorithm to be comparable to manual marking by clinicians.	The automated artifact detection algorithm is comparable to manual marking.

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

Sample Size (for Gastric Myoelectrical Frequency Detection Study): 25 patients.
Data Provenance: Prospective clinical study. The country of origin of the data is not specified.

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

For Gastric Myoelectrical Frequency Detection: The study was a "simultaneous head-to-head comparison to the predicate," meaning the predicate device itself served as a pseudo-ground truth for comparison, rather than an independent expert panel.
For Automated Artifact Detection: Ground truth was established by "manual marking of artifacts by clinicians." The number of clinicians and their specific qualifications are not specified in the provided text.

4. Adjudication method for the test set:

The text does not specify an adjudication method like 2+1 or 3+1. For the gastric myoelectrical frequency detection, it was a head-to-head comparison to the predicate. For artifact detection, it was compared against "manual marking by clinicians," implying those clinicians' markings were the reference, without detailing an adjudication process.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers and AI assistance is not described in the provided text. The studies mentioned focus on the standalone performance of the device or its algorithms against a predicate or manual marking.

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

Yes, the performance studies described are essentially standalone evaluations:
- The head-to-head comparison with the predicate device evaluates the device's ability to measure gastric myoelectrical frequency.
- The evaluation of the artifact detection algorithm compares its automated output against manual markings.

7. The type of ground truth used:

For Gastric Myoelectrical Frequency Detection: The performance of the predicate device (Polygraf ID with POLYGRAM NET ElectroGastroGraphy Application Software) was used as the reference point for comparison.
For Automated Artifact Detection: "Manual marking of artifacts by clinicians" was used as the ground truth.

8. The sample size for the training set:

The document does not provide details about a training set or its sample size. The clinical studies described are presented as evaluations of the device's performance, implying they might be test or validation sets.

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

As no information on a specific training set or its ground truth establishment is provided, this cannot be answered from the given text.

Summary

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June 3, 2022

Alimetry Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19115

Re: K213924

Trade/Device Name: Gastric Alimetry System Regulation Number: 21 CFR 876.1735 Regulation Name: Electrogastrography system Regulatory Class: Class II Product Code: MYE Dated: December 15, 2021 Received: December 15, 2021

Dear Ms. Hogan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213924

Device Name Gastric Alimetry System

Indications for Use (Describe)

The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY Alimetry's Gastric Alimetry

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Alimetry Ltd.

Phone: +64 27 609 1886 Facsimile: -Contact Person: Yaara Yarmut, Chief Regulatory Officer. Date Prepared: December 15, 2021

Name of Device and Name/Address of Sponsor

Gastric Alimetry Trade name:

Manufacturer: Alimetry

Address: 70 Symonds St. Grafton Auckland 1010 New Zealand
Common name: Gastric Alimetry System

Classification Name:

Electrogastrography system, 21 CFR 876.1735, Product code: MYE

Class II

Predicate Devices

Trade Name: Polygraf ID with POLYGRAM NET ElectroGastroGraphy Application Software (K014269) Manufacturer: Medtronic A/S

Intended Use / Indications for Use

The Gastric Alimetry is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.

Device Description

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A report is provided to the clinicians at the end of the test which displays myoelectrical data.

Technological Characteristics / Substantial Equivalence

The Gastric Alimetry device has the same intended use, and substantially similar indications for use and technological characteristics as the cleared predicate. Both devices are intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.

	Gastric Alimetry	Medtronic Polygram NET Electrogastrography (EGG) System (K014269)
Intended Use and indication for use	To record, store, view and process gastric myoelectrical activity as an aid to the diagnosis of various gastric disorders.	To record, store, process and view gastric myoelectrical activity as an aid to the diagnosis of gastrointestinal motility disorders
Electrodes	Disposable; Peel-and-stick patch.	Disposable; Placed individually.
Sampling Frequency	4 Hz	1Hz
Low Frequency Range	DC	DC
High frequency range	2 Hz	0.5 Hz
Number of channels	8 displayed 64 (+2 reference)	4 (+2 reference)
Electrode to recorder interface	Reader located on the Array and directly connected to it.	Electrodes connected to recorder with cables.
Screen	Dedicated tablet for system operation	Connected to a desktop computer for system operation
Motion Sensor	Accelerometer	Accelerometer
Power Source	Battery powered	Connected to the mains power supply
Patient Symptom Logging	Available on App interface.	Available on desktop interface.

Performance Data

Testing was performed to verify device specifications and confirm the safety and performance of the device. In all instances, the Gastric Alimetry functioned as intended. Testing comprised:

. Biocompatibility testing addressing cytotoxicity, sensitization, and skin irritation in accordance with ISO 10993

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Cleaning and disinfection validation of reusable components
. Package validation
Shelf life validation
. Software verification and validation
Electromagnetic compatibility in accordance with IEC 60601-1-2:2014 4th edition and FCC 47 CFR Part 15 subpart C 2021.
Electrical safety in accordance with IEC 60601-1:2005 + A1:2012
. Human factors evaluation by medical professional to address placement of the array and comprehension of the report

A prospective clinical study was undertaken on a total of 25 patients aged 18 and over with various qastric disorders. This was a simultaneous head-to-head comparison to the predicate to evaluate the mean of the frequency of the raw data recorded from the predicate electrode channels vs identically positioned channels recorded simultaneously with the Gastric Alimetry System. The results demonstrate that the Gastric Alimetry System detects and measures gastric myoelectrical frequency across pre-prandial and postprandial periods in an equivalent manner to the predicate device within a cohort of patients with various gastric disorders who form the target population for the device in clinical practice. Minimal adverse events were observed, with all reported events being minor and transient and predominantly related to irritation at the site of the electrodes.

Additional clinical study data was used to evaluate the sensitivity and specificity of the artifact detection algorithm against manual marking of artifacts by clinicians. These data demonstrated that the automated artifact detection algorithm is comparable to manual marking.

Substantial Equivalence

The Gastric Alimetry has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Gastric Alimetry and its predicate devices do not raise different questions of safety or effectiveness. Performance data demonstrate that the Gastric Alimetry is as safe and effective as the Polygraf ID with Electrogastrography System. Thus, the Gastric Alimetry is substantially equivalent to the predicate.

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.