Search Results

The Endolumik Gastric Calibration Tube is indicated for use in gastric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids,irrigation, to test for leaks, to provide visualization of the tube position, and to serve as a sizing guide. The tube is also indicated for use in esophageal surgical procedures as an esophageal bougie and to provide visualization of the tube position.

The Endolumik Fluorescence Guided Gastric Calibration Tube is a flexible gastric tube for use in esophageal, gastric, and bariatric surgery. It may be used for the following: the application of suction, stomach decompression, drainage of gastric fluids, irrigation, to test for leaks, to provide visualization of the tube position, and to serve as a sizing and measurement guide. The tube is also indicated for use in esophageal surgical procedures as an esophageal bougie and to provide visualization of the tube position.
The Endolumik Gastric Calibration Tube is a non-sterile, single patient use device. The tube is 80 cm long and is available in 2 different diameters: 36 and 40 French. It has a rounded tip and small side holes at the distal end. The proximal end includes a handle with an integral suctionregulator. An additional squeeze bulb with pressure gauge may be attached to the end of the

The provided text describes a 510(k) premarket notification for a medical device called the "Endolumik Gastric Calibration Tube M Series." It focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information on acceptance criteria and a study proving those criteria are met for the device's primary function of gastric calibration.

However, the document does list several non-clinical tests that were performed to evaluate the substantial equivalence of the new device (M Series) to the predicate device. These tests primarily relate to electrical safety and electromagnetic compatibility standards, suggesting that the acceptance criteria for these aspects were met by passing the listed standards.

Here's a breakdown of the information that can be extracted or inferred, and what is missing:

Information Present or Inferable:

• Acceptance Criteria and Reported Device Performance:

  • Acceptance Criteria (Inferred): The device (Endolumik Gastric Calibration Tube M Series) must pass the requirements of the following international standards:
    • IEC 60601-2
    • IEC 60601-2 Section 5 (Likely refers to a specific section or part of IEC 60601-2)
    • IEC 60601-1
    • IEC 60601-2-18
    • IEC 62471
  • Reported Device Performance: "All tests passed." This indicates that the device met the requirements of the listed standards.

• Type of Ground Truth Used: Not applicable for the electrical safety and electromagnetic compatibility tests listed. These are objective engineering standard tests.

Missing Information:

The document does not provide information for most of the requested categories because it's a 510(k) summary focused on substantial equivalence to a predicate device, rather than a detailed clinical or performance study of the device's functional efficacy in gastric calibration. Specifically, the following are not mentioned:

• Sample size used for the test set and the data provenance: Not applicable for the engineering tests listed. There's no "test set" of clinical cases.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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: Not applicable. This device is a physical gastric calibration tube, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary Table of Available Information:

Ask a specific question about this device

The Endolumik Fluorescence Guided Gastric Callbration Tube (FG Bougie) is indicated for use in gastric and bariatric surgical procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation, to test for leaks, to provide visualization of the tube position, and to serve as a sizing and measurement guide.

The Endolumik Fluorescence Guided Gastric Calibration Tube is a flexible gastric tube for use in gastric and bariatric surgery. It may be used for the following: the application of suction, stomach decompression, drainage of gastric fluids, irrigation, to test for leaks, to provide visualization of the tube position, and to serve as a sizing and measurement guide.

The Endolumik Gastric Calibration Tube is a non-sterile, single patient use device. The tube is 80 cm long and is available in 2 different diameters: 36 and 40 French. It has a rounded tip and small side holes at the distal end. The proximal end includes a handle with an integral suction regulator. An additional squeeze bulb with pressure gauge may be attached to the end of the regulator.

The Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) is a flexible gastric tube for use in gastric and bariatric surgery. The device is intended for suction, stomach decompression, drainage of gastric fluids, irrigation, to test for leaks, to provide visualization of the tube position, and to serve as a sizing and measurement guide.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Visigi 3D) through various non-clinical tests. The "acceptance criteria" implicitly are that the device performs comparably to the predicate or meets established safety standards.

2. Sample size used for the test set and the data provenance:

The document describes non-clinical bench testing, not a clinical study on human subjects with a "test set" as typically understood in AI/ML performance evaluation. Therefore, there is no information about sample size for a test set of data or its provenance (country of origin, retrospective/prospective). The "samples" would refer to the number of devices or components tested in the various non-clinical evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable. The device underwent non-clinical testing rather than expert-adjudicated performance evaluation based on clinical cases. The "ground truth" for these tests would be the established scientific and engineering principles and the performance of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There was no clinical test set requiring adjudication of findings.

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. The device is a physical medical instrument (gastric calibration tube), not an AI/ML diagnostic or assistive device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests was established by:

• Compliance with recognized international and national standards: e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical and EMC safety, IEC 62471 for light safety, ASTM D4169 for packaging.
• Bench test results demonstrating functional equivalence to the predicate device for aspects like suction, drainage, irrigation, leak testing, and mechanical integrity.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. There is no training set for this device.

Ask a specific question about this device