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The Endo SmartCap™ is intended to supply sterile water to series 10, 100 and 130 Olympus endoscopes when connected to a commercially available sterile water bottle.

The Endo SmartCap™ consists of two tubes, arranged coaxially, with a fitting on one end and a hottle cap adapter on the other. On one end, the tubes engage a coaxial fitting designed to replicate the fitting of the predicate device and how it engages with the receptacle on the Endoscope. The fitting is designed to receive air from the Endoscope and direct the flow through the annulus between the inner and outer tubes. The opposite end of the outer tube is connected to a bottle cap adapter by means of a compression fitting to form an airtight scal. The inner tube passes through the compression fitting and extends beyond the cap adapter. When assembled with a bottle of sterile water, the device allows air from the Endoscope to pressurize the bottle and motivate water out of the bottle through the inner tube. The inner tube terminates at the coaxial fitting where water is directed through a separate channel of the receptacle to feed the Endoscope. The Endo SmartCap™ is sold as a sterile, single patient use device. It will be individually packaged in a Chevron-style sterile barrier pouch with the product label affixed to the clear side of the package, or the label pre-printed on the Tyvek® side of the pouch.

The provided text describes the Endo SmartCap™, a sterile water bottle adapter for endoscopes, and its performance testing.

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

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

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

• Sample Size: The document does not specify an exact number of units or individual test runs. It mentions "a variety of pressure settings" for flow rate tests and testing with "sterile water bottles from the three largest sterile water manufacturers (Abbott, Baxter and McGaw)" for pressure tests.
• Data Provenance: The testing was "Bench Testing" performed by the applicant ("Endo SmartCap™ Company"). The provenance is internal company testing, likely prospective, as it was conducted specifically for this submission. The country of origin is implicitly the United States, given the company's address and the FDA submission context.

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 study is a bench test comparing the functional performance of the new device against a predicate device and engineering specifications. It does not involve human interpretation of medical images or clinical outcomes that would require expert adjudication to establish ground truth.

4. Adjudication method for the test set

This information is not applicable, as there was no expert review or adjudication process for this type of bench testing. The results were quantitative measurements (flow rate, pressure resistance).

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. This device is a sterile water bottle adapter, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance comparison was performed.

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

This is not applicable. The device is a mechanical accessory, not an algorithm. Bench testing was performed to evaluate its physical performance.

7. The type of ground truth used

The "ground truth" for this engineering bench testing was established by:

• Predicate device performance: The flow rate of the Endo SmartCap™ was compared directly to that of the Olympus MD-431 Water Container.
• Engineering specifications/known parameters: The pressure test used the maximum rated pressure of the Olympus Endoscope air pump (0.32 kg/cm² or 4.4 PSI) as a reference point for acceptable performance. The device needed to withstand at least this pressure.

8. The sample size for the training set

This is not applicable. This device is a physical product, not a machine learning model, so there is no training set in the AI sense.

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

This is not applicable as there is no training set.

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