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Indicated for use to cannulate and inject contrast media to obtain a cholangiogram of the biliary duct system. The contrast media is injected through the cannula and fluoroscopy or x-ray is performed to obtain the cholangiogram.

The DualFlex™ RX ERCP Cannula is a rapid exchange wire-guided catheter used to cannulate and for delivery of contrast media in the biliary duct.

The provided text describes a 510(k) summary for the Boston Scientific DualFlex™ RX ERCP Cannula, focusing on its substantial equivalence to a predicate device. This document is a premarket notification for a medical device and, as such, does not typically contain "acceptance criteria" and "device performance" in the sense of a clinical or AI-based study with quantifiable metrics like accuracy, sensitivity, or specificity. Instead, the "performance data" referred to here relates to engineering and functional testing to demonstrate that the new device meets its design specifications and is as safe and effective as the predicate device.

Therefore, many of the requested items (sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth) are not applicable or cannot be extracted from this type of regulatory submission. The device described is a physical medical instrument (a cannula), not a diagnostic algorithm or AI system.

Here's an attempt to answer the questions based only on the provided text, highlighting what is implicitly or explicitly stated and what is not applicable:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative manner (e.g., specific thresholds for flow rates, burst pressures, or imaging quality). Instead, the performance is demonstrated through "design control activities" and "physical comparison and functional testing" to support substantial equivalence.

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

Not applicable. This is a physical device subject to engineering and functional testing, not a study involving patient data in the typical sense of a test set for an AI algorithm. The performance data refers to device testing, not data from human subjects.

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 applicable. "Ground truth" in this context would refer to engineering specifications or validated test methods, not expert consensus on medical images or diagnoses.

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

Not applicable. Adjudication methods are used for resolving disagreements among human readers or experts in diagnostic studies, which is not relevant for this physical device's regulatory review.

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. MRMC studies are for evaluating diagnostic performance, often with AI, and this device is a physical medical instrument, not an AI or diagnostic tool that assists human readers.

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

Not applicable. This is a physical medical device (cannula), not an algorithm or AI system.

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

Not applicable in the context of diagnostic performance. For a physical device, "ground truth" implicitly refers to established engineering standards, material specifications, and validated functional performance tests (e.g., flow rate measurements, burst pressure tests, material compatibility), which are part of design control activities. The document states that "design control activities" and "physical comparison and functional testing" were used, but does not specify the exact nature of these tests or their 'ground truth' validation methods.

8. The sample size for the training set

Not applicable. There is no "training set" for this type of physical medical device.

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

Not applicable. There is no "training set" or "ground truth" establishment in this context.

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ERCP is a diagnostic procedure for suspected biliary tract obstruction such as strictures or stones. The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage. Patients with diagnosed biliary tract calculi or strictures can then be treated with an assortment of therapeutic modalities.

The ERCP cannula serves as the pathway by which contrast media is injected for the purpose of identifying the reason for blockage.

The provided text is a summary of safety and effectiveness for Endoscopic Retrograde Cholangiopancreatography (ERCP) cannulas. It discusses the procedure, contraindications, and manufacturing overview for this medical device.

However, the document does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample size, ground truth establishment, expert qualifications, or comparative effectiveness studies) as requested in your prompt.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The text focuses on the device's intended use, contraindications for the procedure itself, and manufacturing quality control, rather than performance evaluation data.

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