(329 days)
The PolygrafID with POLYGRAM NET™ ElectroGastroGraphy Application is intended to record, store, process and view gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.
The system is a stationary electrogastrography system for use in the evaluation of gastrointestinal motility disorders. The system measures the myoelectrical activity of the gastrum using sensors situated on the skin. The parameters measured are presented on a computer screen during the capture and are also stored for later display, review, analysis and reporting.
Here's an analysis of the provided text regarding the EGG system's acceptance criteria and study data:
This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device for a new Electrogastrography (EGG) system. It does not contain detailed information about specific acceptance criteria, a dedicated study proving performance against those criteria, or the typical AI/ML study components you've requested.
The document is a US FDA 510(k) Notification, which aims to show that a new device is "substantially equivalent" to a legally marketed predicate device. This process often relies on comparisons of technical specifications, intended use, and safety/performance characteristics rather than new clinical trials with defined acceptance criteria and statistical endpoints, especially for low-risk devices.
Therefore, many of your requested points cannot be directly answered from the provided text.
Here's a breakdown of what can be extracted and where information is missing:
Electrogastrography (EGG) System - Acceptance Criteria and Study Information
Note: This 510(k) submission primarily establishes substantial equivalence to a predicate device. It does not describe a standalone clinical performance study with predefined acceptance criteria as would be typical for a novel AI/ML device or a device requiring new clinical validation. The "acceptance criteria" here implicitly refer to the device performing comparably to the predicate and meeting general safety and electrical standards.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k), explicit acceptance criteria are not stated in a quantitative performance table. Instead, the "performance" is implicitly deemed acceptable if the device is substantially equivalent to the predicate and adheres to relevant standards.
| Feature/Specification | Predicate Device (3CPM EGG Machine K984637) | New Device (Polygram NET EGG Application) | Comparison/Explanation | Implied "Acceptance" |
|---|---|---|---|---|
| PC Based | Yes | Yes | Same | Comparable functionality |
| External Data Acq. Device | Yes | Yes | Same | Comparable functionality |
| External Amplifier | Yes | No | Better (implied) | Improved design, maintains functionality |
| Use of External Strip Chart Recorder | Yes | No¹ | Better, simpler system | Improved design, maintains functionality |
| Measurement Setup | On HW devices | By use of protocol settings in SW | Better, ensures initial same setting every time | Improved workflow, maintains accuracy |
| Visualize Signals in Time Domain | Yes | Yes | Same | Comparable functionality |
| Running Spectrum Analysis | Yes | Yes | Same | Comparable functionality |
| Gain | 100 | 1, 10, 100² | Same (range extended) | Comparable/Better, maintains signal quality |
| High-Freq. | 0.25 Hz | 0.25Hz | Same | Comparable signal filtering |
| Low Freq. | 0.016 Hz | DC, 0.0083Hz, 0.016Hz, 0.030Hz | Better (more options) | Comparable/Better, maintains signal quality |
| Offset Handling | 0 | High Pass filter³ | Same result | Comparable signal processing |
| SW high pass filter | NO | Yes | Better, recording can begin immediately | Improved efficiency, maintains signal quality |
| Number of Channels | 1 | 1 to 4 | Better, ability to analyze most significant data | Improved diagnostic utility |
| Motion Sensor | Yes | Yes | Same | Comparable functionality |
| Indications for Use | "To be used to record electrogastrog-rams, as a component of a comprehensive clinical evaluation in patients with symptoms consistent with gastrointestinal motility disorders" | "Record, store view and analyze gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders" | Same | Substantially equivalent clinical utility |
| Intended Populations | Infants, pediatrics to adults | Adults | Less | More restricted, but still substantial equivalence for adults |
| Sterilization | Accessories not sterile, cleaning instructions | Electrodes disposable, cables not sterile, cleaning instructions | Same | Substantially equivalent infection control |
| Biocompatibility | Sensors only part in contact | Same | Same | Substantially equivalent patient safety |
| Digital Resolution | Not specified | Gain 1: 1.12 µV; Gain 10: 0.112 µV; Gain 100: 0.0112 µV | NA | Explicitly stated, implies sufficient precision. |
| Signal Range | Not specified | +/- 2.5 V | NA | Explicitly stated, implies sufficient range. |
Key Implication: The "acceptance criteria" are generally met by demonstrating that the device functions correctly, adheres to electrical safety standards (EN 60601-1, etc.), and provides equivalent or improved data capture and processing capabilities compared to the predicate device for its intended use.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document states, "Clinical trials are not performed." It implies that performance was assessed through engineering verifications and comparisons to the predicate device's specifications and functionality rather than a clinical "test set" with patient data.
- Data Provenance: Not applicable, as formal clinical test data, in the sense of patient studies, were not conducted for this 510(k).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No clinical test set requiring expert ground truth establishment is described.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.
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
- MRMC Study: No. This device is an EGG system, not an AI-based interpretation tool for human readers.
- Effect Size of AI: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of an AI algorithm. The device measures and processes physiological signals. Its performance is related to the accuracy and reliability of these measurements and processing, which are verified through engineering tests and comparison to the predicate, not in an "algorithm-only" performance study.
7. The type of ground truth used
- Type of Ground Truth: For the device itself, the "ground truth" for verification would primarily be:
- Engineering Specifications: Ensuring hardware and software perform according to design (e.g., gain settings, frequency filtering, digital resolution).
- Predicate Device Performance: The predicate device (3CPM EGG Machine) serves as the benchmark for "truth" in terms of clinical utility and output characteristics.
- Regulatory Standards: Compliance with electrical safety and EMC standards (EN 60601-1, etc.) acts as a form of "ground truth" for safety.
- "Verifications results show that the enhanced system performs as its predicate system." This statement implies the predicate's established performance is the de facto ground truth.
8. The sample size for the training set
- Sample Size: Not applicable. This is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable. This is not an AI/ML device.
In summary: The provided 510(k) document is for an Electrogastrography (EGG) system seeking substantial equivalence to a predicate. It relies on non-clinical performance data (engineering verifications, adherence to standards, and feature comparison to the predicate) to demonstrate equivalence rather than a clinical trial with predefined acceptance criteria against new patient data. Therefore, most of the questions related to AI/ML device validation are not applicable.
§ 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.