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The Pure-Vu EVS System is intended to connect to standard and slim colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the irrigation the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.

It is for use only by trained medical personnel located in hospitals, clinics and doctor offices.

The Pure-Vu EVS System enables colon cleaning during colonoscopy using a standard or slim colonoscope with a length of 1630mm – 1710mm and an outer diameter range of 11.7mm – 13.7mm. The Oversleeve, which fits over the colonoscope and is connected to an external Workstation, generates fluid and gas to break up feces. The fecal matter & fluids are removed through the suction channel of the Oversleeve into an external waste container.
The Pure-Vu EVS System consists of the following main components:
Oversleeve (OS) and Umbilical Section (US) - The disposable Oversleeve is mounted on Standard or Slim commercially available colonoscopes to allow a physician to cleanse the GI tract and is connected to the external Workstation via a disposable US.
Workstation (WS) – The Workstation [WS] is reusable and supplies an irrigation mixture of water or saline and gas, and evacuates fecal material and fluids. The Workstation includes the following components:
A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the GI tract, and suction of fluids and feces from the colon.
Irrigation Bag/Bottle (saline or water) which is connected to the irrigation line.
Waste Containers for collecting the GI content & fluids that are suctioned from the GI tract through the suction lines.
Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device.
Outlet Module that includes pumps to evacuate fluid and matter from the GI tract.
A foot pedal activates the cleansing, suction and purging functions, and enables switching between cleansing modes used by the physician.

The provided text describes the Pure-Vu EVS System, its indications for use, technological characteristics, and a comparison to its predicate device. It also briefly mentions performance data. However, the document does not contain specific acceptance criteria, detailed study results, or information regarding sample sizes for training/test sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance.

Therefore, based only on the provided text, I cannot complete the requested table and answer all questions definitively.

Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance

Detailed Study Information (Not available in the provided text):

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

   • Not specified in the provided text. The document only mentions "Validation testing for the WS and disposable device was performed with 4 physicians." This appears to refer to human factors or usability testing rather than a clinical performance study with a test set of patient data.

2. 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):

   • Not specified in the provided text.

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

   • Not specified in the provided text.

4. 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/Not specified. This device is for intra-procedural cleaning during colonoscopy, not an AI-powered diagnostic imaging device requiring reader studies in this context. The document describes a physical medical device (Pure-Vu EVS System) for colon cleaning, not an AI algorithm.

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

   • Not applicable/Not specified. As above, this is a physical medical device, not an AI algorithm. Its performance is intrinsically "human-in-the-loop" as it assists a physician during a colonoscopy.

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

   • Not explicitly stated in the provided text. The performance data section focuses on engineering verification and validation testing (e.g., pressure, flow rates, dimensional compliance, biocompatibility, software compliance) rather than a clinical ground truth for a diagnostic claim. The clinical outcome (effective colon cleaning) is assumed to be evaluated during the "Validation testing for the WS and disposable device was performed with 4 physicians," but the specific metrics and how "ground truth" for cleaning effectiveness were established are not detailed here.

7. The sample size for the training set:

   • Not applicable/Not specified. There is no mention of a "training set" as this is a physical medical device, not an AI model requiring machine learning training.

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

   • Not applicable/Not specified. See point 7.

In summary, the provided document is a 510(k) summary for a physical medical device. It covers the technical performance verification and validation to demonstrate substantial equivalence to a predicate device. It does not contain the detailed clinical study information typically found for AI/ML-based devices regarding diagnostic performance, ground truth, reader studies, and sample sizes for algorithmic evaluation. The "performance data" section focuses on engineering tests (e.g., environmental, mechanical, flow, pressure, software validation) and a mention of "validation testing for the WS and disposable device was performed with 4 physicians" which likely refers to human factors or usability rather than an effectiveness study using a "test set" of patient data for an algorithm.

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