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The TeleMed Systems 3-Lumen Occlusion Balloon Catheter is indicated for use in fluoroscopic examination of and removal of stones from the bile duct.

The 3-Lumen Occlusion Balloon consists of a compliant polymer balloon mounted on a plastic shaft. The shaft has 3 internal lumens, each of which terminates in a proximal connector and connection tube. The lumens are used for balloon inflation, guidewire passage and distal fluid injection.

1. Acceptance Criteria and Reported Device Performance:

The provided document describes a Special 510(k) for a device modification, focusing on proving substantial equivalence to a predicate device rather than setting new performance acceptance criteria for a novel device. Therefore, explicit, quantifiable acceptance criteria with corresponding reported performance values like sensitivity, specificity, or accuracy are not present as they would be for an AI/ML diagnostic.

Instead, the "acceptance criteria" are implied to be adherence to design specifications and demonstration that the modified device is as safe and effective as the predicate device. The "reported device performance" is the successful completion of Design Verification and Validation (V&V) testing.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not explicitly stated. The document refers to "Design Verification and Validation testing" but does not detail the number of units or data points used in this testing.
• Data Provenance: Not specified. Given the nature of a medical device modification (Occlusion Balloon Catheter), the V&V testing would likely involve bench testing, simulated use, and potentially pre-clinical animal studies, but the origin (e.g., country) of any data used is not mentioned. It is implicitly prospective testing as it's part of design validation for a new modification.

3. Number of Experts and Qualifications:

Not applicable. This is a medical device submission for an occlusion balloon catheter, which does not involve interpretation of medical images or data by human experts for ground truth establishment in the way AI/ML diagnostic devices do.

4. Adjudication Method:

Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. See point 3. This device is a physical medical instrument, not a diagnostic AI/ML algorithm.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. See point 3. This is not an algorithm but a physical device.

7. Type of Ground Truth Used:

The "ground truth" for this device is derived from engineering specifications, material properties, mechanical testing results, and functional performance benchmarks against the predicate device. For example, balloon inflation pressures, lumen patency, material strength, and sterilization efficacy would be assessed against predefined criteria. It is based on objective, measurable physical properties and functional outcomes rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The "training" here refers to the design and manufacturing process, where iterations and physical testing lead to the final design.

9. How Ground Truth for Training Set was Established:

Not applicable. As this is not an AI/ML device, there is no "training set." The design and manufacturing processes are guided by regulatory standards, engineering principles, internal quality management systems (e.g., 21 CFR 820.30 Design Control), and the performance characteristics of the predicate device. Ground truth for these processes is established through engineering design reviews, risk analysis, material specification, and rigorous physical testing of prototypes and production samples.

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