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The Pure-Vu EVS System is intended to connect to standard or slim colonoscopes to help facilitate intra-procedural cleansing of the GI tract by irrigating or cleaning 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 doctors' offices.

The Pure-Vu EVS System enables cleaning of the GI tract during endoscopy using a standard or slim colonoscope with a length of 1630mm - 1710mm and an outer diameter range of 11.7mm - 13.2mm or gastroscope with a length of 950 – 1030mm and an outer diameter of 9.2 - 10mm The EVS Flex Channel , which fits alongside the endoscope and is connected to an external Workstation, generates fluid and gas to break up debris The debris & fluids are removed through the suction channel of the EVS Flex Channel into an external waste container/bag.

The Pure-Vu EVS System consists of the following main components:
Disposable device which includes a Flex Channel section and an Umbilical Section (US) - The EVS Flex Channel fits alongside the endoscope 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 debris 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 fluid and matter from the GI tract. 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 modifications to the Pure-Vu EVS System and its substantial equivalence to predicate devices, but it does not contain the specific acceptance criteria or a study proving the device meets those criteria, nor any of the detailed information requested.

The document is a 510(k) summary for the Pure-Vu EVS System, a device intended for intra-procedural GI tract cleansing during endoscopy. It focuses on demonstrating substantial equivalence to previously cleared devices (Pure-Vu System K220007 and K210981) due to design changes.

Here's an analysis of the provided information against your requested points:

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

• Not found. The document includes tables comparing the technological characteristics of the subject device with its predicate, such as dimensions, flow rates, and materials. However, it does not present specific acceptance criteria (e.g., minimum pressure tolerance, maximum steering angle impact) with corresponding reported performance values against those criteria. It states that "Design verification and validation testing concluded that the design changes have no impact on the Pure-Vu System performance," but does not provide the specifics of that performance or the criteria used to judge it.

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

• Sample size: For "System Validation Testing," it states "Validation testing for the entire Pure Vu EVS system (WS and disposable devices) was performed with 6 physicians." This is the only mention of human-involved testing with a specific number.
• Data provenance: Not specified.

3. 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 found. There is no mention of establishing ground truth or the qualifications of the 6 physicians involved in the validation testing. Their role is described as performing "Validation testing," not establishing ground truth.

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

• Not found. No adjudication method is described.

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 found. This is not an AI-powered device, and no MRMC study or comparative effectiveness study involving human readers or AI assistance is mentioned. The device is a physical system for irrigation and cleaning.

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

• N/A. The device is a mechanical/electro-mechanical system, not an algorithm, so this concept does not apply.

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

• Not found. The document does not describe the establishment or type of ground truth for any evaluation.

8. The sample size for the training set

• N/A. As this is not an AI/machine learning device, there is no concept of a "training set."

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

• N/A. As there is no training set, this is not applicable.

In summary, the provided document outlines the technical specifications, modifications, and verification/validation testing conducted for the Pure-Vu EVS System to demonstrate its substantial equivalence to previously cleared devices. It details various engineering tests (environmental conditioning, dimensions, head pull, steering, pressure, bond strength, software verification) and mentions system validation with 6 physicians. However, it does not provide the kind of detailed clinical study data, acceptance criteria, or ground truth information typically associated with performance evaluation against specific clinical endpoints or for AI/software-as-a-medical-device.

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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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