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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 single-use BioShield biopsy valve is used to cover the biopsy/suction channel of gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation.

The BioShield Irrigator - extension tubing is intended to provide irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with the BioShield Irrigator.

The BioShield Irrigating Adaptor is intended to be used with the BioShield Biopsy Valve to provide access for irrigation.

The BioShield biopsy valve is a single-use disposable cap that is used to cover the biopsy/suction channel of endoscopes during endoscopic procedures and other procedures. It provides access to the endoscope's working channel, minimizes leakage of biomaterial and other fluids during insufflation and instrument exchange and allows for irrigation. The device consists of a valve body and a cap. The device is made from thermoplastic elastomer. There are a total of 10 versions of the BioShield biopsy valve. All 10 versions of the BioShield Biopsy valve are subject to the major change of removing the skirt that aided in maintaining insufflation in the predicate device and two of these 10 versions have had an irrigation line added. Seven versions of the biopsy valve that are compatible with Olympus and Fujinon endoscopes and three versions of the valve that are compatible with Pentax endoscopes. Also, of these 10 versions, there are two versions that have an irrigation line to provide another option to the user to irrigate. All valves, with the exception of one version, are supplied non-sterile.

There are two accessories provided with the BioShield biopsy valve. These devices were not previously cleared under the 510(k) process. Their product code is OCX. They are the BioShield Irrigator and the BioShield Irrigator Extension Tubing. The BioShield Irrigator consists of a luer connection attached to a stainless-steel tip. The Bioshield Irrigator is used for intraprocedural gastrointestinal endoscopic irrigation when attached to a luer-lock or slip-tip syringe directly through the BioShield biopsy valve. The BioShield Irrigator Extension Tubing is a 180 cm long piece of irrigation tubing that has connectors on both ends. The tubing can be connected to a BioShield Irrigator biopsy valve on one end and to an irrigation system (irrigation tubing connected to an irrigation source used with an auxiliary water pump) on the other end in order to provide hands-free foot pedal irrigation control. Both of these irrigation accessories are provided non-sterile.

Here's an analysis of the provided text, extracting the acceptance criteria and study details as requested. It's important to note that this document is a 510(k) summary for a medical device and therefore focuses on non-clinical performance testing (bench and simulated use), not clinical studies involving human patients or complex AI algorithms requiring ground truth establishment through expert consensus.

The document discusses devices related to gastrointestinal endoscopes (BioShield Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor). The testing described is primarily focused on the mechanical and fluid dynamic performance of these physical devices, not on diagnostic performance or interpretation of medical images.

Acceptance Criteria and Reported Device Performance

Study Details (Based on the provided text)

Given that this is a 510(k) summary for physical medical devices and not an AI/software device, many of the requested categories related to AI performance, human readers, and image interpretation are not applicable (N/A) to this document. The testing described is "Non-clinical performance testing" which "consisted of ... bench and simulated use testing."

1. Sample sized used for the test set and the data provenance:
* Sample Size: Not explicitly stated for each test, but the nature of bench and simulated use testing implies a sample size sufficient to demonstrate consistent performance across different models/versions of the device and against the predicate.
* Data Provenance: The document does not specify country of origin for the test data for these non-clinical tests. The tests are "bench and simulated use testing," implying laboratory-based evaluations rather than patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* N/A. Ground truth in the context of expert review for diagnostic/AI performance is not applicable here. The "ground truth" for these mechanical tests is based on measurable physical properties (e.g., force, flow rate, or visual observation of leakage/spraying) and comparison to a predicate device's established performance.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* N/A. Adjudication methods are typically used in clinical studies or AI performance evaluations involving subjective human assessment. For these mechanical/fluid dynamic tests, results are objective (Pass/Fail based on quantitative and qualitative criteria).

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:
* N/A. This applies to AI-assisted diagnostic tools, not to physical endoscope accessories.

5. Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* N/A. This applies to AI algorithms. The device itself is a physical accessory.

6. Type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Bench and Simulated Use Data / Objective Measurements / Predicate Device Performance. The ground truth for evaluating these devices is their ability to meet defined physical and functional criteria, often compared directly to a legally marketed predicate device's known performance characteristics (e.g., retention force = 3.2 lbs).

7. The sample size for the training set:
* N/A. No "training set" in the context of machine learning is applicable. Device development would involve iterative design and testing, but not a formally defined AI training set.

8. How the ground truth for the training set was established:
* N/A. As no AI training set is involved, this question is not applicable.

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