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The BAROnova Access Sheath Kit is used in conjunction with an endoscope for procedures requiring multiple insertions of the endoscope into the upper gastrointestinal tract, with or without instruments through the instrument chamel of the endoscope.

The BAROnova Access Sheath Kit is used in conjunction with the TransPyloric Shuttle Delivery Device to facilitate insertion and positioning of the device during TPS delivery and deployment.

The Access Sheath Kit is NOT indicated for foreign body removal or instrument use alongside the endoscope.

The BAROnova Access Sheath Kit includes the following products:

• BAROnova Access Sheath (with obturator)
• Endoscope (Seal) Cap
• Insufflation Syringe

The BAROnova Access Sheath consists of a clean, non-sterile mated Obturator/Access Sheath Assembly. The Access Sheath is composed of thinwalled tubing, a handle and a distal cuff and balloon with an atraumatic tip. The Obturator is made of flexible tubing with an atraumatic tip. The Seal Cap consists of a non-sterile, plastic cap for use with standard endoscopes. A 10cc syringe is also provided with the Access Sheath Kit to enable balloon inflation and deflation.

This document is a 510(k) summary statement for the BAROnova Access Sheath Kit. It's a regulatory submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device. This type of document generally focuses on comparing the new device to existing ones and providing non-clinical performance data (e.g., bench testing) to support safety and effectiveness, rather than detailed clinical study data with acceptance criteria for device performance in a clinical setting.

Therefore, much of the requested information about clinical acceptance criteria, sample sizes, expert ground truth, adjudication methods, and human reader studies is not available in this document. This submission emphasizes technological equivalence and non-clinical performance.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and reported device performance:

Based on the provided text, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum leakage rate) for design verification tests are not explicitly stated in this summary. The document broadly states that the device "meet all requirements."

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

• Sample Size for Test Set: Not specified for any of the non-clinical tests.
• Data Provenance: The tests are non-clinical (bench testing, simulated use, animal study) and were conducted by BAROnova, Inc. (the manufacturer). The country of origin for the data generation is not explicitly stated but would likely be the location of the manufacturing and testing facilities. It is inherently "retrospective" in the sense that the tests were performed to validate the device's design before submission.

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

• Not applicable/Not specified. For non-clinical tests (dimensional, mechanical, etc.), "ground truth" is typically established by engineering specifications and objective measurements, not expert consensus in the clinical sense. For the animal study, the assessment would be made by veterinary or medical professionals participating in the study, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set:

• Not applicable/Not specified. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies with human assessors to resolve discrepancies in diagnoses or interpretations. Non-clinical tests usually involve objective measurements against predefined specifications.

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:

• No. This document describes a medical device (an access sheath kit), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

• No. As noted above, this is a physical medical device, not a standalone algorithm.

7. The type of ground truth used:

• For non-clinical tests (e.g., dimensional, mechanical, balloon integrity, shaft wall integrity, seal cap functionality), the "ground truth" is typically engineering specifications, design requirements, and quantifiable measurements. Deviations from these specifications are considered failures.
• For the simulated use and animal studies, "ground truth" would relate to the observed functional performance, safety, and any adverse events or complications during the simulated or animal procedures, assessed against expected outcomes and safety profiles.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not a machine learning algorithm that requires a "training set."

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

• Not Applicable. No training set was used.

Summary of what is present:

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:

• Identical Indications for Use.
• Identical Technological Characteristics (design, materials, construction) to the predicate BAROnova Access Sheath, and the included Seal Cap and Syringe being standard components.
• Non-clinical testing: This included dimensional, mechanical, balloon integrity, shaft wall integrity, seal cap functionality, simulated use, animal, and biocompatibility studies. The outcome of these tests was that the devices "met all requirements" and were found to be safe and effective for their intended use.

This 510(k) submission is a device-specific regulatory filing for a physical medical product, not a software or AI-driven product, which explains the absence of information related to clinical studies, expert adjudication, or AI performance metrics.

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