Search Results

The STANDARD BOUGIE™ SB38 is indicated for use in conjunction with the Titan SGS ™ stapler in vertical sleve gastrectorny pouch creation for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and insufflation, and to serve as a sizing guide.

The Standard Bougie SB38 is a single patient use, non-sterile device which consists of an 80 cm long, 38 French (38 Fr) diameter tube with a luer connector at the proximal end of the tube has multiple holes and a rounded end. At the distal end is a balloon that can be inflated with water or saline to be used as a sizing guide. The device is used to decompress the stomach, remove stomach contents, and allow for irrigation and insufflation via the distal holes. The balloon is inflated and deflated as desired by connecting a syringe to the luer connector at the proximal end and injecting water into the balloon. The tube and balloon serve as a sizing guide.

The provided text describes the regulatory clearance of the "Standard Bougie, SB38" device and outlines its characteristics and comparison to a predicate device, along with a list of performance tests conducted. However, it does not provide detailed acceptance criteria or the specific results of those performance tests. The document states that "Standard Bougie SB38 performance testing has been submitted in this 510(k)", and then lists the types of tests. It concludes that "The conclusion drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device." but does not present the data itself.

Therefore, for aspects requiring specific numerical data, sample sizes, expert qualifications, or details of a study (like an MRMC study or standalone performance), the information is not available in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document only lists the types of performance tests conducted. It doesn't specify the acceptance criteria for each test or the quantitative results achieved by the device against those criteria.

2. Sample Size Used for the Test Set and Data Provenance

Not available in the provided text. The document lists performance tests but does not specify the sample sizes used for these tests or the provenance of any data (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable/available. The performance tests mentioned (Drainage Flow Rate Verification, Balloon Strength Verification, Balloon Size Verification, Balloon Firmness Verification, Tensile Strength Verification, Reliability Testing) appear to be engineering/mechanical tests rather than studies involving expert assessment of medical outcomes or images. Therefore, the concept of "ground truth established by experts" as typically seen in AI/diagnostic device studies does not apply here.

4. Adjudication Method for the Test Set

Not applicable/available. As the tests are engineering/mechanical in nature, an adjudication method (like 2+1, 3+1) is not typically used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The provided text does not mention an MRMC comparative effectiveness study. The device is a "bougie," which is a physical medical instrument used as a sizing guide and for other functions during surgery, not a diagnostic imaging or AI device that would typically undergo an MRMC study.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical medical instrument, not an algorithm or AI system. Therefore, a "standalone algorithm performance" study is not relevant.

7. Type of Ground Truth Used

Not explicitly stated, but implied as engineering/physical measurements. For the listed performance tests (e.g., strength, size, flow rate), the ground truth would be based on precise physical measurements and engineering specifications, not expert consensus, pathology, or outcomes data in the typical sense of a diagnostic study.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for a physical device, this question is not relevant.

Ask a specific question about this device