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

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 end of 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.

This FDA 510(k) clearance document for the Gastric Alimetry System states that no new clinical studies were required for this submission. The submission relies on prior clearances and bench testing, as the modifications introduced were considered minimal and did not significantly impact safety or performance.

Therefore, the document does not contain the detailed information usually found in a study proving a device meets acceptance criteria, such as:

• A table of acceptance criteria and reported device performance (for a new study).
• Sample size used for a test set or data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness study details.
• Standalone algorithm performance.
• Type of ground truth used (for a new study).
• Training set sample size or how its ground truth was established.

Based only on the provided document, here's what can be inferred / what is explicitly stated:

The document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (Gastric Alimetry System, K223398) due to minor modifications.

Here's a breakdown of the requested information, referencing the document's content:

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

   • No specific acceptance criteria table for this submission's performance study is provided. The document states: "The modifications to the device since the prior clearances... were minimal and did not significantly impact the safety or performance of the device as reflected in the previously performed bench testing, the testing submitted in the prior 510(k) notice remains applicable."
   • The "Technological Characteristics / Substantial Equivalence" table (pages 5-6) compares the subject device to the predicate across various parameters (e.g., sampling frequency, number of channels, power source, software features). For almost all parameters, the "Subject Device" and "Primary Predicate Device" columns state identical characteristics, followed by "Same as the predicate." This implicitly means the performance characteristics are expected to be the same as the predicate and were deemed acceptable based on the predicate's clearance.
   • For "Symptom Outputs", the subject device adds visualizations without removing or altering existing outputs, and the addition of gut-brain wellbeing questions does not impact device performance.

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

   • Not applicable. No new clinical "test set" was used for this 510(k) submission. "No clinical studies were required."

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

   • Not applicable. No new clinical "test set" for which ground truth needed to be established for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. No new clinical "test set" for this submission.

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, an MRMC study was not done for this submission. The device (Gastric Alimetry System) is an electrogastrography (EGG) device intended to "record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders." It provides "myoelectrical signal data for manual analysis, together with computed data summaries and plots." It is not described as an "AI assistance" device for human readers in the context of interpretive diagnostic imaging.

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

   • Not explicitly stated for this submission. The device provides data for "manual analysis" by clinicians. The document focuses on the equivalence of the data acquisition and reporting features, not on a standalone diagnostic algorithm's performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable for this submission. No new clinical study was conducted where such ground truth would be established. The device is an EGG system, aiding in diagnosis by presenting myoelectrical activity data. The "ground truth" for its function would relate to how accurately it records and processes these physiological signals, which is addressed through technical and bench testing described in previous submissions, not a comparative diagnostic outcome study in this document.

8. The sample size for the training set:

   • Not applicable for this submission. This document describes minor modifications to an already cleared device and does not detail a new AI model with a training set. The "Minor Algorithm fixes" mentioned on page 5 suggests iterative improvements, but no new large-scale training is implied or detailed.

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

   • Not applicable. See point 8.

In summary, the provided document explicitly states, "No clinical studies were required," for this 510(k) clearance due to the minor nature of the changes. The acceptance criteria and performance proof are based on the prior clearance of the predicate device (K223398) and repeated bench testing for specific components (array electrical performance).

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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 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.

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.

Study Details:

1. A table of acceptance criteria and the reported device performance:
   (See table above)

2. 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.

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):
   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.

4. 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.

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, 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.

6. 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.

7. 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.

8. 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.

9. 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.

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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 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.

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

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.

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