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510(k) Data Aggregation
(90 days)
The EndoFLIP® system is an endoscopically placed device indicated for use in patients fitted with a gastric band. The device is intended to estimate the size of the stoma produced by the gastric band in a clinical setting.
The EndoFLIP® comprises a measuring system and a single use catheter to assist in measuring the stoma. In practice, the EndoFLIP® balloon catheter is attached to a syringe, pre-filled with a diluted saline solution, which is inserted into the syringe pump on the front of the EndoFLIP® system. The deflated balloon is inserted alongside an endoscope and introduced across the gastric band under direct visualization. Where available, fluoroscopy may be used to guide the catheter since the measurement electrodes are clearly visible in the image field. Once the balloon has been correctly located, it is then inflated with the diluted saline solution to a user programmed volume. The display shows the changes in the estimated stoma diameter as the gastric band is filled. The system also allows snapshots to be taken and compared to the real-time images.
Here's a breakdown of the acceptance criteria and study information for the EndoFLIP® System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Range/Resolution/Accuracy) | Reported Device Performance (same as criteria as no deviation indicated) |
|---|---|---|
| Estimated Balloon Diameter (Dest) | ||
| Range | 5 to 25 mm | 5 to 25 mm |
| Resolution | 0.1 mm | 0.1 mm |
| Accuracy | ± 1 mm rounded to nearest integer at 95% confidence | ± 1 mm rounded to nearest integer at 95% confidence |
| Balloon Pressure | ||
| Range | -10 to 100 mmHg | -10 to 100 mmHg |
| Resolution | 0.1 mmHg | 0.1 mmHg |
| Accuracy | ± 1 mmHg at 95% confidence | ± 1 mmHg at 95% confidence |
| Balloon Volume | ||
| Range | 0 to 50 mL | 0 to 50 mL |
| Resolution | 1 mL | 1 mL |
| Accuracy | ± 5 mL | ± 5 mL |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information on the sample size used for a test set, nor does it specify data provenance (country of origin, retrospective/prospective). The performance acceptance criteria are presented as specifications of the device itself, likely derived from internal validation rather than a clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention any experts used to establish ground truth for a test set or their qualifications. The performance specifications appear to be technical measurements of the device's accuracy in measuring physical parameters (diameter, pressure, volume) rather than interpreting clinical images or patient outcomes.
4. Adjudication Method for the Test Set
Since no clinical test set or expert ground truthing is described, an adjudication method for a test set is not applicable and not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or performed according to this 510(k) summary. The device focuses on measuring physical parameters rather than assisting human readers in diagnostic tasks.
6. Standalone (Algorithm Only) Performance Study
The provided text details the performance of the "EndoFLIP® system" as a whole, including its components (measuring system and catheter). The performance specifications for estimated balloon diameter, pressure, and volume are presented as the device's standalone capabilities. Therefore, a standalone performance was done for the reported specifications. However, this is for the device as a whole, rather than a distinct "algorithm only" component usually associated with AI devices.
7. Type of Ground Truth Used
The "ground truth" for the reported performance metrics (diameter, pressure, volume) would be physical measurements calibrated against known standards. For example, the accuracy of diameter measurement would be validated against objects of known diameters, and pressure/volume against calibrated sensors. The document does not explicitly state the methodology for establishing this ground truth, but it is implied by the nature of the measurements.
8. Sample Size for the Training Set
The 510(k) summary does not mention a "training set" or its sample size. The EndoFLIP® System is a physical measurement device, not a machine learning or AI-driven system that typically requires a training set for algorithm development.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned or applicable, the method for establishing its ground truth is not applicable and not provided.
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