(89 days)
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.
| Acceptance Criteria (Derived from Substantial Equivalence Claim) | Reported Device Performance (as stated for the modified device) |
|---|---|
| Intended Use: To record, store, view and process gastric myoelectrical activity as an aid to the diagnosis of various gastric disorders. | Same as the predicate. |
| Indications for Use: Patients 12 years and older (modified from predicate) | Indicated for patients 12 years and older. (Previous predicate was 18 years and older). This difference "does not raise different questions of safety or effectiveness." |
| Technological Characteristics: Similar to predicate (e.g., hardware, sampling frequency, number of channels, reporting features) with minor modifications. | Modifications include: |
- 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.
§ 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.