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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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