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The Elation™ Pulmonary Balloon Dilation Catheter is intended to be used to endoscopically dilate strictures of the trachea and bronchi.

The Pulmonary Balloon Catheters are multi-lumen catheters with a dilation balloon on the distal tip. The catheters have two extension legs with luer connectors on the proximal end. The catheter is designed to pass through the working channel of a bronchoscope and accept a 0.035 in (0.89 mm) X 260 cm guidewire lumen. Two redundant inflation lumens are used to inflate and deflate the dilation balloon.

The dilation balloon will be available in a 7.5F catheter with a length of 1.5 cm and in one additional balloon diameter of 4mm range that will be added to the current range from to 20 mm. Each balloon size will inflate to three different diameters for the specified inflation pressures. The balloon will be identifiable with both endoscopic and radiopague marker bands. A glow-in-the-dark tag that can be read in low light conditions is attached to the catheter shaft. The tag indicates diameter and corresponding pressure of the balloon.

The provided text is a 510(k) summary for the Elation™ Pulmonary Balloon Dilation Catheter. It outlines the device, its intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device. However, it does not contain a study that explicitly establishes acceptance criteria and then proves the device meets those criteria through a detailed performance study as would be seen in a clinical trial.

Instead, the document details a series of non-clinical, bench-top tests designed to show that the modified device (with a smaller balloon diameter and shorter length) performs equivalently to its predicate. The text states "All tests passed the predetermined acceptance criteria," but it does not list these specific criteria or provide detailed results from a study proving this. It also mentions a "design validation study... with porcine lungs to demonstrate the safety of dilation of smaller (6mm diameter or below) bronchi," but no specific data or acceptance criteria for this study are provided.

Therefore, many of the requested items cannot be fully answered from the provided text.

Here's an attempt to answer based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: Not specified for any of the non-clinical tests or the porcine lung study.
• Data Provenance: The tests are described as "non-clinical tests" and a "design validation study... with porcine lungs," indicating bench-top and ex-vivo (animal) testing rather than human clinical data. No country of origin for the data is specified, but the applicant address is in the United States. The data is retrospective in the sense that it was collected as part of the device development and submission process.

3. Number of Experts and Qualifications for Ground Truth of Test Set

• Not applicable as this was a non-clinical/pre-clinical study. Ground truth was established by device specifications and technical standards for the bench tests, and likely by veterinary observations/measurements for the porcine study.

4. Adjudication Method for Test Set

• Not applicable as this was a non-clinical/pre-clinical study. Results would have been measured against predetermined technical specifications.

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

• No, a MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter), not an AI diagnostic or assistive technology that would typically be evaluated with MRMC studies.

6. Standalone Performance Study

• The non-clinical tests listed (Balloon length, diameter, burst pressure, etc.) can be considered standalone performance evaluations of the device's physical properties. The design validation study in porcine lungs also falls into this category, evaluating the device's functional performance in a relevant biological model without human intervention as part of the primary outcome assessment.

7. Type of Ground Truth Used

• Non-clinical tests: Engineering specifications, material properties, and relevant industry standards.
• Porcine lung study: Direct observation, measurement, and potentially histological analysis of the porcine lung tissue post-dilation, guided by pre-defined safety endpoints.

8. Sample Size for Training Set

• Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI models. The design and manufacturing process would be informed by engineering principles, material science, and prior device knowledge.

9. How Ground Truth for Training Set was Established

• Not applicable (see #8).

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