(138 days)
ViSiGi® LUX is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing quide.
VISIGi® LUX is a non-sterile, single patient use device for use in gastric and bariatric surgery. It is used to apply suction, decompress the stomach, drain gastric fluids, irrigate and to serve as a sizing guide. The design is derived from the predicate by addition of battery-powered LED lights. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end includes a slide valve, integral suction regulator and a battery case. The non-rechargeable batteries power up an array of LEDs enclosed within the distal end of the tube. The purpose of the LED lights is to aid visualization of the tube by tissue transillumination during insertion and surgery under laparoscopic vision. The device is inserted by an anesthesiologist under supervision of the surgeon. The added lights do not change the intended use and are not required for the surgery to proceed safely.
The provided text describes the 510(k) premarket notification for the ViSiGi LUX device. However, it does not contain information about acceptance criteria, device performance against specific metrics, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for an AI/algorithm-driven device.
The document focuses on demonstrating substantial equivalence of a physical medical device (a gastrointestinal tube with added LED lights) to a predicate device. The tests mentioned are for physical and electrical safety, biocompatibility, and functional performance (suction, drainage, irrigation) of the tube itself.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as it relates to AI or algorithmic performance against specific metrics, as this information is not present in the provided text.
Specifically:
- 1. A table of acceptance criteria and the reported device performance: Not available for an AI/algorithm. The document lists general tests like "Suction Testing," "Drainage Testing," etc., and states "Passing these tests demonstrates substantial equivalence." It doesn't define quantitative acceptance criteria or specific performance numbers for these tests.
- 2. Sample sized used for the test set and the data provenance: Not applicable in the context of an AI/algorithm for this device. The tests mentioned are laboratory bench tests on physical devices.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as this is a physical device submission, not an AI/imaging algorithm.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable, as this device does not involve human readers or AI assistance in image interpretation.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for an AI/algorithm. Ground truth for a physical device typically refers to engineering specifications and performance benchmarks.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
The device, ViSiGi LUX, is a gastrointestinal tube with an added LED light subassembly. Its primary function is mechanical (suction, drainage, irrigation, sizing guide). The LED lights are for visualization, not for generating or processing diagnostic data that would typically involve AI or complex algorithmic performance evaluation metrics as requested in the prompt.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.