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The catherer is designed to provide vital diagnostic information. It is indicated for: Accessing the cystic duct and injecting radiopaque medium during Laparoscopic Cholecystomy procedures.

This Cholangiographic Balloon Catheter is furnished in four French two lumen size, with a radiopaque band proximal to the balloon

The provided text is a 510(k) summary for a Cholangiography Balloon Catheter (K974336). It claims substantial equivalence to a predicate device (K935403), the J-LLoyd Medical, Inc. Wedge Pressure Catheter.

Based on the provided information, the submission describes the device and its intended use, but it does not contain details about specific acceptance criteria or an analytical study proving the device meets those criteria. Instead, it relies on the substantial equivalence argument, stating that the new device is "basically the same" as the predicate device with the addition of a radiopaque band, and that "performance data such as mechanical strength tests remain the same as with the Predicate Device."

Therefore, I cannot populate the requested table and study details directly from the provided text. The document indicates that the device's acceptable performance is presumed based on its similarity to a previously approved device.

Here's a breakdown of why the specific information requested is not present:

Missing Information and Why:

• Acceptance Criteria Table and Reported Device Performance: This critical information is absent. The submission hinges on the new device being substantially equivalent to the predicate, implying that the predicate's performance is the benchmark. However, no specific performance metrics (e.g., burst pressure, flow rates, flexibility) for either the new or predicate device are listed, nor are the acceptance limits for these criteria.
• Sample Size for Test Set and Data Provenance: No dedicated test set or study is described for the new device. The document states that "performance data such as mechanical strength tests remain the same as with the Predicate Device," suggesting reliance on the predicate's testing.
• Number of Experts, Qualifications, Adjudication Method: These are relevant for studies involving human interpretation or subjective assessment. Since no such study is described for the Cholangiography Balloon Catheter, this information is not applicable or provided.
• MRMC Comparative Effectiveness Study: There is no mention of a comparative effectiveness study, especially one involving human readers with or without AI assistance, as AI is not a component of this medical device.
• Standalone Performance Study: No standalone (algorithm-only) performance is applicable as this is a physical medical device, not a software algorithm.
• Type of Ground Truth Used: This is also not applicable for the type of device and submission. Performance is typically assessed through engineering tests (e.g., material strength, functionality) rather than ground truth established by expert consensus or pathology in this context.
• Sample Size for Training Set & How Ground Truth was Established for Training Set: These are not applicable for this type of device submission. Training sets and ground truth are concepts usually tied to machine learning algorithms.

Summary of available information related to performance justification:

The justification for acceptance appears to be based on the following:

• Substantial Equivalence: The key argument is that the Cholangiography Balloon Catheter is substantially equivalent to the J-LLoyd Medical, Inc. Wedge Pressure Catheter (K935403).
• Minimal Design Change: The only physical difference is "the addition of Stainless Steel band" (radiopaque band).
• Shared Materials and Design: The new device uses "the same materials, the same basic design and the same methods of assembly" as the predicate.
• Presumed Performance: The document explicitly states: "The performance data such as mechanical strength tests remain the same as with the Predicate Device." This implies that the new device is expected to perform identically due to its fundamental similarity and that the predicate's established performance is sufficient.
• Biological, Chemical, and Sterilization: These specifications also "remain the same as the Predicate Device."

In conclusion, while the submission aims to demonstrate acceptable device performance for regulatory approval, it does so by arguing substantial equivalence rather than presenting detailed experimental data from a new study specific to the Cholangiography Balloon Catheter.

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