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The STANDARD BOUGIE SB38 is indicated for use in conjunction with the Titan SGS stapler in vertical sleeve gastrectomy 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 Standard Bougie Hand Pump (SBHP) is an accessory to the current Standard Bougie (SB38). The SBHP is provided to enable insufflation of the stomach to enable controlled rearrangement of the gastric folds/rugae of the stomach or to perform leak testing during gastric and bariatric procedures.

This document is a 510(k) premarket notification for a medical device called the "Standard Bougie, 38 Fr. and Hand Pump" (K212728). The purpose of the submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Here's the breakdown of the 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" and "reported device performance" in the typical sense of quantitative benchmarks for a novel diagnostic or treatment device. Instead, the submission for this Class II surgical accessory focuses on demonstrating substantial equivalence to a predicate device by comparing their technological characteristics and performing verification and validation activities.

The "acceptance criteria" are implicitly met if the device demonstrates equivalent performance and safety to the predicate device and introduces no new safety concerns. The "reported device performance" is demonstrated through nonclinical testing to ensure the added hand pump accessory does not negatively impact the device's original functions (suction, drainage, irrigation, insufflation, sizing) and maintains its safety profile.

Here's a summary derived from the "Overview of Substantial Equivalence" table and the "Performance Data" section:

• Transit and 1 year Accelerated Aging
• Performance Testing post Transit and 1 year Accelerated Aging
• Pressure Decay Testing
• Insufflation Testing
• Reliability Testing |
  | Safety and Effectiveness (As safe and effective as predicate) | The nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device. The addition of the Standard Bougie Hand Pump does not raise any new types of questions. |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes nonclinical performance data (bench testing) for the accessory component (Standard Bougie Hand Pump) and confirms the existing data for the main device (Standard Bougie SB38) remains applicable.

• Sample Size for Test Set: Not explicitly stated in terms of patient numbers, as this is a nonclinical study. The "test set" refers to the devices or accessories subjected to the specified engineering tests (Transit and 1 yr Accelerated Aging, Performance Testing, Pressure Decay, Insufflation, Reliability Testing). The number of units tested per test is not detailed.
• Data Provenance: This is a submission for a medical device by Standard Bariatrics, Inc. located in Cincinnati, OH. The data would originate from internal company testing and validation activities. The document does not specify if any of the testing was conducted outside the U.S.
• Retrospective or Prospective: Not applicable as this is nonclinical (bench) testing of a medical device accessory, not a clinical study involving patients or patient data.

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)

This section is not applicable as the document describes nonclinical (bench) testing of a surgical accessory, not a diagnostic device that requires expert interpretation for establishing ground truth (e.g., radiologist for imaging, pathologist for tissue samples). The "ground truth" here is defined by engineering specifications, risk assessments, and established testing methodologies.

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

This is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, especially those involving human readers interpreting data where consensus is needed to establish ground truth. The tests described are objective engineering tests.

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

This is not applicable. A multi-reader multi-case (MRMC) comparative effectiveness study is relevant for diagnostic devices, particularly those involving Artificial Intelligence (AI) assistance for human interpretation. The Standard Bougie and Hand Pump is a surgical accessory, not an AI-powered diagnostic tool.

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

This is not applicable. This question refers to the performance of an AI algorithm independent of human input. The device is a physical surgical tool with a mechanical accessory, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device, in the context of its nonclinical performance evaluation, is based on:

• Engineering specifications and design requirements: The device's ability to meet its functional requirements (e.g., insufflation pressure, reliability, transit resistance, aging effects) as defined by its design.
• Risk assessment: The demonstration that the device (especially the new accessory) does not introduce unacceptable risks.
• Comparison to predicate device: The fundamental "ground truth" for a 510(k) submission is that the device is substantially equivalent to a legally marketed predicate device, meaning it performs as safely and effectively.

8. The sample size for the training set

This is not applicable. A "training set" refers to data used to train machine learning models. This document describes the regulatory submission for a physical medical device, not an AI/ML product.

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

This is not applicable for the same reason as above (not an AI/ML product).

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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.

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The STANDARD BOUGIE® is indicated for use in conjunction with the STANDARD CLAMP® in vertical sleeve gastrectomy procedures for the application of suction, stomach decompression, drainage of gastric fluids, irrigation and to serve as a sizing guide.

The Standard Bougie is a single patient use, non-sterile device which consists of an 80 cm long, 18 French 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 contents, and allow for irrigation 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 is a 510(k) summary for the Standard Bougie device. It describes the device, its intended use, and its comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system.

The "Performance Data" section (VII) lists several types of verification and testing, such as "Drainage Flow Rate Verification," "Balloon Strength Verification," and "Device Usability." These tests are likely related to the physical and functional performance of the bougie itself, not to an AI system's diagnostic accuracy or a human-AI team's effectiveness.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets them from the provided text. The document describes a medical device (a bougie) used in bariatric surgery, not an AI or imaging diagnostic device.

To answer your request, I would need a different document that details the development, validation, and performance studies of an AI-powered medical device.

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