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The Ancora-SB is an accessory to an endoscope. The Ancora-SB is intended for use with any standard endoscope that has an outer diameter of 9.0 - 9.4 mm and a working length of 1680 mm or greater. The Ancora-SB is intended for use with any standard flexible endoscopy balloon inflation unit with a set pressure of 5.4 kPa (+2.6 kPa, -1.8 kPa). The device is indicated to ensure complete positioning of an endoscope in the small intestine by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment.

The Ancora-SB is a single-use, close-fitting sleeve that slides freely over a currently marketed standard endoscope having an outer diameter of 9.0 – 9.4 mm and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the small intestine, by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment. The device is designed to be used with a Balloon Endoscopy System (BES) which includes a multi-channel endoscope, an endoscopy tower (light source, display monitor, recording equipment, etc.) and a balloon inflation unit (equipment that inflates or deflates by a push button control, inflation is to a stated maximum pressure and the pressure is maintained during active use when inflated).

The provided text is a 510(k) summary for the Ancora-SB device. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe an acceptance criteria table with reported device performance or a study demonstrating the device meets such criteria using human reader data. Therefore, many of the requested items cannot be extracted from this document as they pertain to clinical or human-in-the-loop performance studies, which are not detailed here.

However, I can extract information regarding non-clinical testing performed to establish safety and effectiveness for substantial equivalence.

Here's a summary of what can be extracted based on the provided document:

1. Table of acceptance criteria and the reported device performance:

The document does not provide a table of acceptance criteria linked to reported exact performance metrics for the device. It lists types of non-clinical tests that were performed to demonstrate safety and equivalence to the predicate device.

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

The document describes non-clinical bench testing and an animal study. For these types of studies, standard sample sizes for individual tests are typically used based on engineering principles and regulatory guidelines. The document does not specify these sample sizes. The data provenance is not mentioned beyond stating "GLP animal study" and "bench performance testing."

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

This is not applicable as the studies described are non-clinical (bench and animal) and do not involve expert interpretation or ground truth establishment in the context of clinical scenarios, human readers, or expert consensus.

4. Adjudication method for the test set:

Not applicable, as this refers to clinical studies with human readers, which are not detailed in this document.

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 MRMC comparative effectiveness study is mentioned. This document focuses on non-clinical testing for substantial equivalence. The device does not appear to be an AI-based diagnostic tool.

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

Not applicable, as the device is not an algorithm, but a physical accessory to an endoscope. Its performance is evaluated through bench and animal testing, not standalone algorithmic performance.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" would be established by the physical and mechanical properties being measured (e.g., dimensions, force, inflation time) as defined by engineering standards. For the animal study, the "ground truth" would be the observed physiological responses or effects in the animal model. Specific details on how this "ground truth" was established are not provided in the summary.

8. The sample size for the training set:

Not applicable, as this document does not describe an AI/ML device that requires a training set.

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

Not applicable, as this document does not describe an AI/ML device that requires a training set.

Summary of Non-Clinical Testing Performed (from Section: SUMMARY OF NON-CLINICAL TESTING):

The document states that the following non-clinical tests were performed to demonstrate safety and substantial equivalence:

• Biocompatibility testing: Per ISO 10993-1, -5, -10, and -23.
• Distribution testing: Per ASTM D4169-22.
• Shelf-life testing: Per ASTM F1980-21.
• Bench performance testing: Including:
  • Dimension inspection
  • Packaging inspection
  • Components and features inspection
  • Balloon compatibility and reliability
  • Overtube friction force and reliability
  • Balloon inflation time
  • Balloon anchor force
  • Joint strength
• GLP animal study.

Conclusion:

"The results of these tests indicate that the Ancora-SB is substantially equivalent to the predicate device."
"Based on the testing performed, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device."

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