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 System 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 gastric myoelectrical data and movement artifacts using an array with recording electrodes on an adhesive patch. which is used for recording the myoelectrical data from the skin surface. An App is used to set up the device and capture patient-reported symptom data. A report is provided to the clinicians at the test which includes myoelectrical signal data for manual analysis, together with computed data summaries and plots. A Supplementary Report is also routinely available to clinicians that includes signal data from all 64 channels on the array.

In the modified Gastric Alimetry System, the following minor updates are introduced in order to provide additional data summaries within the Report:

Addition of four post-processing data summary metrics:
- Principal Gastric Frequency showing the frequency of myoelectrical activity o occurring within the gastric range
- 'BMI-Adjusted Amplitude' calculated amplitude for BMI up to the recommended O device limit (BMI <35)
- Gastric Alimetry Rhythm Index a calculated measure of the stability of the gastric о rhythm
- fed:fasted Amplitude Ratio a calculated ratio showing the change in the gastric o myoelectrical amplitude after a meal stimulus.
Addition of a 'Symptom Burden' tracking bar to the front page of the Report. This is a ● calculated average of the patient-reported symptom data already shown in the Report, and is provided as a summary next to the spectral plot as a convenience for clinicians.
Addition of data tables to the Supplementary Report. These provide hour by hour read ● outs of the symptom logs and summary metrics provided in the main Report, and are made available in Table form as a convenient reference for clinicians.
Some minor Report rearrangements, with the 'signal strength' and 'best 8 channel' plots . moved from the main Report to the Supplementary Report.

The four additional metrics are equivalent to other metrics widely applied in the EGG literature, and are included in the Reference Device, with only minor updates that address recognized inaccuracies that may affect performance.

AI/ML Overview

Based on the provided text, the Gastric Alimetry System is an electrogastrography (EGG) device. The performance data section focuses on demonstrating the substantial equivalence of four newly added data summary metrics to equivalent metrics in a Reference Device (Medtronic Polygram NET EGG System), rather than establishing new acceptance criteria for the entire device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria here aren't typical performance thresholds (like achieving a certain sensitivity or specificity for a diagnostic claim). Instead, the "acceptance criteria" for the newly added metrics in the modified Gastric Alimetry System appear to be demonstrating high correlation with equivalent metrics from a legally marketed Reference Device. The aim is to prove substantial equivalence, meaning these minor updates do not raise new questions of safety or effectiveness.

Acceptance Criteria Category	Specific Criteria (Implicit from Study Design)	Reported Device Performance and How it Meets Criteria
New Metrics' Equivalence	The four newly introduced data summary metrics (Principal Gastric Frequency, BMI-Adjusted Amplitude, Gastric Alimetry Rhythm Index, fed:fasted Amplitude Ratio) must show high correlation with their equivalent metrics in the Reference Device (Medtronic Polygram NET EGG System).	"In all four comparisons, high correlations were demonstrated (r>0.91; p<0.0001), confirming the substantial equivalence of all metrics." This explicitly states that the criteria of high correlation were met for all four new metrics.

Study Details:

A table of acceptance criteria and the reported device performance:
(See table above)
Sample size used for the test set and the data provenance:
- Sample Size: 86 subjects (43 patients with chronic nausea and vomiting syndromes, gastroparesis, and functional dyspepsia, and 43 healthy matched controls).
- Data Provenance: "post-market data from a study". The text does not specify the country of origin or if it was retrospective or prospective, beyond "post-market". It implies existing collected data.
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):
The text does not mention the use of experts to establish a "ground truth" for the test set in the context of this performance study. The study's purpose was to compare the new metrics to existing, approved metrics, not to validate diagnostic accuracy against a clinical ground truth. The "ground truth" in this comparative study context is the output of the Reference Device's equivalent metrics.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This study was a direct comparison of computational metrics between two systems (the modified device's metrics vs. the reference device's metrics), not a human-in-the-loop diagnostic study requiring expert adjudication.
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, an MRMC study was not done. The device (Gastric Alimetry System) is described as an EGG device that "provides additional data summaries within the Report" and "includes myoelectrical signal data for manual analysis, together with computed data summaries and plots." While it processes data, it isn't an AI-based diagnostic tool in the typical sense that would assist human readers in image interpretation or diagnosis. The study focused on the equivalence of the calculated metrics themselves, not on how they might improve human interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in a sense. The comparison was of the computational output of the new metrics from the Gastric Alimetry System directly against the computational output of the equivalent metrics from the Reference Device. This is an "algorithm only" comparison for these specific metrics. The device itself is not presented as a fully automated diagnostic algorithm but rather a system that aids diagnosis by providing data and summaries for manual analysis.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the purpose of this equivalence study was the output of the equivalent metrics from the accepted Reference Device (Medtronic Polygram NET EGG System). It was a comparative validation, not a validation against a clinical gold standard like pathology or long-term outcomes for diagnostic accuracy.
The sample size for the training set:
Not mentioned. The description of the performance data focuses solely on a "test set" or "comparison cohort" for demonstrating equivalence of the new metrics. Since the changes are described as "minor updates" to address "recognized inaccuracies" and the goal is "substantial equivalence" to a predicate, it's possible that the development of these metrics leveraged existing physiological knowledge and signal processing techniques rather than a large machine learning training set as might be seen for a novel AI algorithm.
How the ground truth for the training set was established:
Not applicable, as no training set or ground truth for a training set is discussed for these specific updates.

Summary

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April 27, 2023

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

Re: K223398

Trade/Device Name: Gastric Alimetry Regulation Number: 21 CFR§ 876.1735 Regulation Name: Electrogastrography System Regulatory Class: II Product Code: MYE Dated: March 27, 2023 Received: March 27, 2023

Dear Janice 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 Federal statutes and regulations administered by other Federal agencies.

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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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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 -S

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) K223398

Device Name Gastric Alimetry

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.

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: November 8, 2022

Name of Device and Name/Address of Sponsor

Trade Name: Gastric Alimetry

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 and Reference Devices

1. Trade Name: Gastric Alimetry (K213924) (primary predicate) Manufacturer: Alimetry Ltd.
1. Trade Name: Polygraf ID with POLYGRAM NET ElectroGastroGraphy Application Software (K014269) (reference device) 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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In the modified Gastric Alimetry System, the following minor updates are introduced in order to provide additional data summaries within the Report:

Addition of four post-processing data summary metrics:
- Principal Gastric Frequency showing the frequency of myoelectrical activity o occurring within the gastric range
- 'BMI-Adjusted Amplitude' calculated amplitude for BMI up to the recommended O device limit (BMI <35)
- Gastric Alimetry Rhythm Index a calculated measure of the stability of the gastric о rhythm
- fed:fasted Amplitude Ratio a calculated ratio showing the change in the gastric o myoelectrical amplitude after a meal stimulus.
Addition of a 'Symptom Burden' tracking bar to the front page of the Report. This is a ● calculated average of the patient-reported symptom data already shown in the Report, and is provided as a summary next to the spectral plot as a convenience for clinicians.
Addition of data tables to the Supplementary Report. These provide hour by hour read ● outs of the symptom logs and summary metrics provided in the main Report, and are made available in Table form as a convenient reference for clinicians.
Some minor Report rearrangements, with the 'signal strength' and 'best 8 channel' plots . moved from the main Report to the Supplementary Report.

Technological Characteristics / Substantial Equivalence

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

Item	Subject Device	Primary Predicate Device	Discussion
Device	Gastric Alimetry System	Gastric Alimetry System
Manufacturer / K#	Alimetry Ltd.	Alimetry Ltd. / K213924
Item	Subject Device	Primary Predicate Device	Discussion
Intended Use andindication for use	To record, store, view andprocess gastric myoelectricalactivity as an aid to thediagnosis of various gastricdisorders.	To record, store, view andprocess gastric myoelectricalactivity as an aid to thediagnosis of various gastricdisorders.	Same as the predicate.
User Population	Medical professionals to set upand use the systemPatients 18 years and olderSpecialist GI physicians	Medical professionals to set upand use the systemPatients 18 years and olderSpecialist GI physicians	Same as the predicate.
Accessories
Setup andCharging Dock	Gastric Alimetry Dock forcharging and user convenience	Gastric Alimetry Dock forcharging and user convenience	Same as the predicate.
Electrodes	Disposable; same componentsas ECG electrodes.Peel-and-stick patch.	Disposable; same componentsas ECG electrodes.Peel-and-stick patch.	Same as the predicate.
Technological Characteristics
SamplingFrequency	4 Hz	4 Hz	Same as the predicate.
Low FrequencyRange	DC	DC	Same as the predicate.
High frequencyrange	2 Hz	2 Hz	Same as the predicate.
Number ofchannels	64 (+2 reference)	64 (+2 reference)	Same as the predicate.
Electrode torecorder interface	Reader located on the Array anddirectly connected to it.	Reader located on the Array anddirectly connected to it.	Same as the predicate.
Screen	Dedicated tablet for systemoperation	Dedicated tablet for systemoperation	Same as the predicate.
Motion Sensor	Accelerometer	Accelerometer	Same as the predicate.
Data Storage	On data acquisition device andcloud server	On data acquisition device andcloud server	Same as the predicate.
Weight of deviceon patient	225 grams – Reader and Array	225 grams – Reader and Array	Same as the predicate.
ltem	Subject Device	Primary Predicate Device	Discussion
Power Source	Battery powered	Battery powered	Same as the predicate.
Software	Setup (including clinical data),device control, data acquisitionsoftware and system checks viaApp running on a tablet.	Setup (including clinical data),device control, data acquisitionsoftware and system checks viaApp running on a tablet.	Same as the predicate.
Patient SymptomLogging	Available on App interface.Presented as plot with times.	Available on App interface.Presented as plot with times.	Same as the predicate.
Skin Preparation	Yes. Shave, measure, skin prepwith abrasive conductive gelAdditional array templatemarking step for convenience.	Yes. Shave, measure, skin prepwith abrasive conductive gelAdditional array templatemarking step for convenience.	Same as the predicate.
Sterilization	Electrodes are disposable, non-sterile.Reader and Dock arereprocessed, not suppliedsterile. Cleaning and disinfectioninstructions using wipesprovided.	Electrodes are disposable, non-sterile.Reader and Dock arereprocessed, not suppliedsterile. Cleaning and disinfectioninstructions using wipesprovided.	Same as the predicate.
Safety Features
System Checks	Impedance monitor andconnectivity check displayedprior to recordings.	Impedance monitor andconnectivity check displayedprior to recordings.	Same as the predicate.
Instructions toPatient	Yes. User instructs patient tolimit movement, talking andsleeping.Additional step of displayingthese instructions to patient viaApp as an added safetymeasure.	Yes. User instructs patient tolimit movement, talking andsleeping.Additional step of displayingthese instructions to patient viaApp as an added safetymeasure.	Same as the predicate.
Reporting Features
Visualization ofmyoelectricalwaveforms	Yes, all channels.	Yes, all channels.	Same as the predicate.
AutomatedSpectral Analysis	Yes, by Fourier-transform	Yes, by Fourier-transform	Same as the predicate.
Item	Subject Device	Primary Predicate Device	Discussion
ArtifactEvaluation	By manual identification of noisein waveforms and with referenceto motion sensor.Additionally provides automatednoise detection for convenience.	By manual identification of noisein waveforms and with referenceto motion sensor.Additionally provides automatednoise detection for convenience.	Same as the predicate.
DominantFrequency andAmplitude ofMyoelectricalActivity	Yes, data tables, andvisualization by spectral graphsand myoelectrical waveforms.	Yes, data tables, andvisualization by spectral graphsand myoelectrical waveforms.	Same as the predicate.
OtherMyoelectricalParameters	Measures of % time infrequency ranges, changes insignal power over time, andcross-channel coupling (wavepropagation across thestomach) are available by visualinspection of spectral maps andwaveforms.Additionally processes theseoutputs as tables forconvenience.	Measures of % time infrequency ranges, changes insignal power over time, andcross-channel coupling (wavepropagation across thestomach) are available by visualinspection of spectral maps andwaveforms.No additional processing ofthese metrics.	Equivalent. Same plotsavailable for visualinspection as thepredicate. Additionalspectral metric outputsequivalent totechnologicalreference.See substantialequivalencediscussion.
SymptomOutputs	Yes. Arranged in time plots forconvenience.	Yes. Arranged in time plots forconvenience	Same as the predicate.
Technical /recording qualityoutputs	Yes. Impedance, motion.Additionally shows Arrayposition and spatial distributionof amplitude for userconvenience.	Yes. Impedance, motion.Additionally shows Arrayposition and spatial distributionof amplitude for userconvenience.	Same as the predicate.
Standards with which the Device Complies
Electrodes	ANSI/AAMI EC12:2000 –compliance with relevantrequirements.	ANSI/AAMI EC12:2000 –compliance with relevantrequirements.	Same as the predicate.
Medical ElectricalEquipment	IEC 60601-1	IEC 60601-1	Same as the predicate.
ElectromagneticCompatibility	IEC 60601-1-2	IEC 60601-1-2	Same as the predicate.

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Performance Data

The four data summary metrics included in the modified Gastric Alimetry System are technically equivalent to those used in the Reference Device (Medtronic Polygram NET EGG

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System). Minor technical updates were made to the four metrics to address issues that have been recognized to affect the performance of these metrics in the vears since the Reference Device was approved. Therefore, additional performance testing was conducted to confirm that substantial equivalence was maintained as compared to the Reference Device.

These analyses were performed using post-market data from a study of 86 subjects, being 43 patients with chronic nausea and vomiting syndromes, gastroparesis, and functional dyspepsia, and 43 healthy matched controls. Each of the four metrics included in the modified Gastric Alimetry System were subjected to direct comparison with the equivalent Reference Device metrics, using this comparison cohort. In all four comparisons, high correlations were demonstrated (r>0.91; p<0.0001), confirming the substantial equivalence of all metrics.

Substantial Equivalence

The modified Gastric Alimetry System has the same intended uses and the same indications, technological characteristics, and principles of operation as its predicate device, the Gastric Alimetry System. The minor technological differences between the Gastric Alimetry and its predicate devices do not raise different questions of safety or effectiveness. In addition, performance testing based on post-market data analysis in patients with various gastric disorders and matched controls showed that the four additional metrics in the modified Gastric Alimetry System remained highly correlated to their equivalent metrics in the Reference Device after minor updates to correct recognized performance issues. Therefore the modified Gastric Alimetry System is shown to be substantially equivalent.

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.