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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 via 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 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 irrigation option for the user. All valves, with the exception of one version, are supplied non-sterile.

There are two irrigation devices 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 Irrigating Adaptor consists of a luer connection attached to a stainlesssteel tip. The Bioshield Irrigating Adaptor 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 devices are provided non-sterile.

This document describes the premarket notification (510(k)) for the BioShield Biopsy Valve, Irrigator, and Irrigating Adaptor. The focus of the provided text is primarily on the regulatory submission and does not detail a study proving device performance against acceptance criteria in the typical sense of a clinical or non-clinical performance study with detailed methodologies, sample sizes, or ground truth establishment.

Instead, the document states: "Based on the intended use, technological characteristics and non-clinical performance data, the subject device is shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use." This implies that the 'study' to prove the device meets acceptance criteria is primarily a non-clinical performance testing suite designed to demonstrate equivalence to a predicate device and compliance with material and functional safety standards.

Here's the information extracted and inferred:

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

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

The document does not explicitly state the sample sizes used for the leakage or biocompatibility testing. The data provenance is non-clinical, meaning it's likely conducted in a laboratory setting. There is no information regarding country of origin of the data or whether it was retrospective or prospective.

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 and not provided in the document. Ground truth as typically understood in AI/clinical studies (e.g., expert consensus on medical images or pathology reports) is not relevant for non-clinical performance tests like leakage or biocompatibility. These tests rely on predefined technical standards and measurements.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where expert disagreement on ground truth might occur. For non-clinical performance tests, results are usually objective measurements against established criteria.

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

No. This document describes a medical device (biopsy valve, irrigator, adaptor), not an AI/software device. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant.

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

No. This document describes a medical device, not an algorithm or AI.

7. The type of ground truth used

For the non-clinical performance testing:

• Leakage Testing: The ground truth is the absence of spraying or geyser-type leaks, which would be objectively observed during the test.
• Biocompatibility Testing: The ground truth is established by adherence to recognized biocompatibility standards (e.g., ISO 10993 series), which involve laboratory assays and tests to determine cytotoxicity, sensitization, irritation, and pyrogenicity. The 'Pass' result indicates compliance with these established biological safety criteria.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

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