Search Results

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 indicated for patients 12 years and older.

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 the Alimetry Reader connected to a single use Gastric Alimetry Array which includes electrodes on an adhesive patch used for recording the myoelectrical data from the skin surface. The Gastric Alimetry App runs on an iPad mini and is used to set up the device and capture patient-reported symptom data. The Gastric Alimetry Report is provided to the clinicians at the end of the test and 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. The Alimetry Cloud acts as a secure website portal for physicians to access Gastric Alimetry Reports. The Gastric Alimetry Dock (Accessory) is used to guide alignment of the Array and Reader during the setup procedure and charge the Reader.

The Gastric Alimetry System is non-invasive and used in healthcare facilities.

The provided text is a 510(k) Summary for the Gastric Alimetry system. It details modifications made to an already cleared device (K232925, Gastric Alimetry) and argues for substantial equivalence. The summary emphasizes that the changes are minor and do not significantly impact the safety or performance of the device.

Here's an analysis of the acceptance criteria and study information, based only on the provided text. It's important to note that this document is a summary and therefore may not contain all the detailed information of the full 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria or reported device performance in the typical format of a standalone clinical study. Instead, it asserts substantial equivalence to a predicate device (K232925) based on the minimal nature of the modifications and the applicability of previously performed bench testing.

The device's intended use and indications for use are considered the primary "performance" criteria for comparison to the predicate.

• Updating Amplitude plot to BMI-adjusted Amplitude plot.
• Updating spectral analysis section to include normative ranges.
• Updating the Gut-Brain Wellbeing survey responses presentation and adding a total score.
  These updates are stated to "not impact the performance or safety of the device." |
  | Safety Features: Biocompatibility, software, system checks, skin preparation, instructions to patient, sterilization. | Same as the predicate. |
  | Compliance with Standards: ANSI/AAMI EC12:2000, IEC 60601-1, IEC 60601-1-2. | Same as the predicate. |

2. Sample Size for Test Set and Data Provenance:

The document explicitly states: "The modifications to the device since the prior clearances, namely additional Symptom Summary panel, Symptom Correlation Analysis panel, additional Gut-Brain Wellbeing questions, and an update to the Reader's enclosure, were minimal and did not significantly impact the safety or performance of the device as reflected in the previously performed bench testing submitted in the prior 510(k) notice remains applicable."

This implies that no new test set (clinical data) was used or required for this specific 510(k) submission (K240946) due to the nature of the modifications. The submission relies on the existing performance data of the predicate device (K232925).

Therefore, specific sample size, country of origin, or retrospective/prospective nature for a new test set are not provided in this document. The decision is based on asserting that the changes do not warrant new clinical performance data.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable for this submission. As stated above, no new clinical test set was presented or required to demonstrate performance for these minor modifications. The modifications relate to presentation of existing data (BMI-adjusted amplitude, normative ranges, survey presentation) and an expanded age indication supported by a systematic review of literature and real-world data, rather than a new performance claim verified by expert interpretation of new cases.

4. Adjudication Method for Test Set:

Not applicable for this submission, as no new clinical test set was presented.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done for this submission. The provided text does not mention any comparative effectiveness study, with or without AI assistance, or any effect size of human reader improvement. The focus of this 510(k) is on the safety and performance of the device as a diagnostic aid, specifically justifying minor changes and an expanded age indication based on existing data and prior clearance.

6. Standalone (Algorithm Only) Performance:

The document describes the device as a "diagnostic aid" that records, stores, views, and processes data for clinicians to analyze. It mentions "manual analysis" alongside "computed data summaries and plots." This suggests that the device's outputs are intended for interpretation by a clinician, rather than providing a definitive automated diagnosis (standalone performance).

The "modifications to the report" include "normative reference intervals" and "BMI-Adjusted Amplitude plot," which are tools to aid clinician interpretation, not to replace it with a standalone algorithmic decision.

7. Type of Ground Truth Used:

For the justification of the expanded age indication (12 years and older), the document states: "Systematic review of the extensive general medical literature, together with real-world and structured research evaluations specific to the Gastric Alimetry System, show comparable device performance in adolescents with no new questions of safety and efficacy."

This suggests that the "ground truth" for affirming comparable performance in the adolescent population was based on:

• Systematic review of general medical literature: Implies accepted medical knowledge and established diagnostic criteria.
• Real-world and structured research evaluations specific to the Gastric Alimetry System: This would likely involve data from previous deployments or studies, where clinical outcomes or established diagnostic methods would serve as ground truth for evaluating the device's measurements. However, no specifics are provided in this summary.

For the changes to reporting features (BMI-adjusted amplitude, normative ranges, Gut-Brain Wellbeing survey), the ground truth is implicitly related to accepted physiological measurements and clinical utility in presenting information to clinicians.

8. Sample Size for Training Set:

The document does not provide details of a training set sample size for this specific submission because it's focused on modifications to an already cleared device. Any training data would have been part of the original K232925 submission.

9. How Ground Truth for Training Set was Established:

Not specified in the provided text, as this submission focuses on modifications to an existing device rather than initial development and training. This information would refer to the predicate device's initial development.

Ask a specific question about this device

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).

Ask a specific question about this device

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

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.

Ask a specific question about this device

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.

Ask a specific question about this device