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The Endo SmartCap™ is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

The Endo SmartCap™ supplies sterile water and either air or CO2 to an endoscope during endoscopic procedures when connected to a sterile water source and an air or CO2 source. Two tubes are arranged coaxially; air or CO2 supplied through the outer tube pressurizes the sterile water container, forcing water up through the inner tube and to the endoscope. The proximal end of the tube set includes a bottle cap for attachment to a user-provided sterile water container; the Endo SmartCap™ is compatible with all major brands of sterile water containers. The proximal end of the tube set terminates in a tube weight which keeps the tip of the tubing submerged. A pinch clip prevents water from dripping from the tube's distal end when the device is detached from the endoscope. The distal end of the tube set terminates in a connector which mates with the corresponding brand of endoscope; Endo SmartCap™ models are available for all major brands of endoscopes. The device is provided sterile (EtO). The device is fabricated from metals, plastics, and elastomers. The Endo SmartCap™ is intended for 24 hour multi-patient use and should be discarded daily. No portion of the device comes in direct contact with patients.

The provided text is a 510(k) Premarket Notification for the "Endo SmartCap™" device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/ML device meets specific performance criteria. The document describes a medical device accessory, not an AI/ML system.

Therefore, many of the requested details about acceptance criteria for AI/ML performance, study design, sample sizes for test/training sets, expert involvement, and ground truth establishment cannot be found in this document because the device is a physical accessory (Endoscope and Accessories), not an AI/ML software.

However, I can extract the information related to the device's functional performance testing.

Here's what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance (for functional testing):

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

• Sample Size: Not explicitly stated as a number of devices/tests, but implies multiple production samples for the flow rate test ("average mean flow of the 100551-production sample").
• Data Provenance: The document does not specify the country of origin of the data. The tests conducted are functional performance tests of the device itself, not data-driven performance. The tests are retrospective in the sense that they were conducted for the 510(k) submission.

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 device is a physical accessory undergoing functional engineering tests (flow rate, backflow prevention), not an AI/ML algorithm requiring expert interpretation of medical images or data for ground truth. The "ground truth" here is the objective measurement of physical properties.

4. Adjudication method for the test set:

• Not applicable for functional engineering tests. The results are objective measurements against predefined engineering 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:

• Not applicable. This device is a physical medical accessory, not an AI/ML system for diagnostic assistance. No human reader studies with or without AI were conducted or are relevant.

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

• Not applicable. This is not an algorithm. The reported tests are for the standalone physical device's functional performance.

7. The type of ground truth used:

• For flow rate and backflow prevention tests, the "ground truth" is established by engineering specifications and direct physical measurement. For example, for flow rate, it would involve direct measurement of water/gas volume over time. For backflow, it's the observation of whether water backflows into the insufflator.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set.

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

• Not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth for a training set.

In summary, this document is for a traditional medical device accessory (Endo SmartCap™) seeking 510(k) clearance based on substantial equivalence. The "study that proves the device meets the acceptance criteria" in this context refers to engineering performance testing rather than the clinical validation or AI algorithm performance studies typically associated with the detailed questions provided.

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The Endo SmartCap™ is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

Not Found

This document does not contain the detailed information necessary to complete the request regarding acceptance criteria and a study proving a device meets them. The provided text is a 510(k) clearance letter and summary for the "Endo SmartCap™," which primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance study results or acceptance criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set, data provenance, or details about the ground truth establishment for a test set.
• Information about expert involvement for ground truth, adjudication methods, or MRMC studies.
• Results from a standalone algorithm performance study.
• Sample size for a training set or ground truth establishment for a training set.

The document primarily states the intended use of the device and its regulatory classification. It lists predicate devices but does not delve into their performance or comparison in detail.

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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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