(132 days)
The EndoFLIP® EF-620 catheter is indicated for use as an adjunct to a bougie for measuring the size of a gastric sleeve created during bariatric surgery. It is suitable for diameter measurements for 22 to 60 French sleeves.
The EF-620 catheter is to be used only with the EndoFlip System.
The EndoFLIP® comprises a measuring system and a single use catheter to assist in measuring the gastric sleeve. 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 into the stomach by an anesthesiologist with placement being confirmed by the surgeon under direct laparoscopic visualization. One the balloon has been correctly located, it is then inflated with the diluted saline solution to user programmed volume. The display estimates the gastric sleeve diameter at sixteen points along the balloon. The system also allows snapshots to be taken and compared to real-time images.
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 Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Estimated balloon diameter (Dest) at 16 points in the balloon, displayed in numeric and graphical form. | Yes, the device provides this functionality. |
| Range: 7 to 20 mm | Range: 7 to 20 mm (Matches acceptance criteria) |
| Resolution: 0.1 mm | Resolution: 0.1 mm (Matches acceptance criteria) |
| Accuracy: ± 1 mm (at 95% confidence) rounded to nearest integer | Accuracy: ± 1 mm (at 95% confidence) rounded to nearest integer (Matches acceptance criteria) |
Study Details
The provided document describes a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive clinical or standalone performance study in the way one might evaluate a new AI algorithm.
1. Sample sized used for the test set and the data provenance:
- The document states, "We performed the appropriate bench testing to demonstrate that the new catheter in combination with the EndoFLIP® controller performs within the specifications of the predicate catheter with the EndoFLIP® controller."
- The exact sample size for the "bench testing" is not directly specified in the document.
- Data provenance is not specified. The testing appears to be internal bench testing, likely conducted in a lab environment.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device measures physical dimensions using a specific electromechanical system. The "ground truth" for its accuracy would likely be established using calibrated physical measurement tools (e.g., precise calipers, micrometers, or reference gauges) in a laboratory setting, not expert human readers. There is no mention of human experts being involved in establishing ground truth for the diameter measurements.
3. Adjudication method for the test set:
- Not applicable. As the "ground truth" is established by physical measurement tools, there is no need for expert adjudication.
4. 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 such study was conducted or reported. The EndoFLIP® system is a measurement device that provides data; it does not involve AI assistance for human readers in interpreting images or making diagnoses.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- While the device itself is a "standalone" system in terms of performing its measurement function, the "performance" section refers to the system's ability to accurately measure diameter, which is its core function. There isn't an "algorithm only" component that would perform a task typically done by a human, making this question less applicable in the context of this specific device's function. The stated accuracy reflects its standalone measurement capability.
6. The type of ground truth used:
- The ground truth for the diameter measurements would be based on calibrated physical measurements (e.g., using precision measurement tools) of known diameters against which the device's readings are compared.
7. The sample size for the training set:
- Not applicable. The EndoFLIP® system, as described, is an electromechanical measurement device. It does not utilize machine learning or AI that would require a "training set" in the conventional sense. Its function is based on established physical principles and calibrated components.
8. How the ground truth for the training set was established:
- Not applicable. As no training set for a machine learning model is involved, this question is not relevant.
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).