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The Outback LTD Re-Entry Catheter is intended to facilitate placement and positioning of guidewires and catheters within the peripheral vasculature. The Outback LTD Re-Entry Catheter is not intended for use in the coronary or cerebral vasculature.

The Outback LTD Re-Entry Catheter is a sterile (via Ethylene Oxide sterilization) device and is intended for single use only.

Here's an analysis of the provided text regarding the Outback LTD Re-Entry Catheter, focusing on acceptance criteria and study details:

Overall Assessment:

The provided document (K083814) is a 510(k) summary for a medical device – a re-entry catheter. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. As such, much of the requested information (like specific acceptance criteria values, sample sizes for test/training, expert details, MRMC studies, standalone performance, and ground truth types) is not present in the provided text. The submission relies solely on non-clinical in-vitro bench testing for its substantial equivalence claim, not clinical studies.

Description of Acceptance Criteria and Study to Prove Device Meets Them

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific quantitative acceptance criteria or detailed performance data are not explicitly stated. The submission's "Summary of Substantial Equivalence" indicates:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document only mentions "non-clinical in-vitro bench testing" data was collected. No specific number of tests/samples is provided.
• Data Provenance: The data is from non-clinical in-vitro bench testing. The country of origin is not explicitly stated, but the manufacturer (Cordis Corporation) is a Johnson & Johnson Company, likely based in the US (given the regulatory submission to FDA). The data is not clinical (i.e., not from human subjects) and would be considered experimental/bench data, not retrospective or prospective in the clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable / Not Specified. For non-clinical bench testing focused on device functionality and substantial equivalence, "ground truth" as established by medical experts (like radiologists for image analysis) is generally not relevant. The "ground truth" would be the measured physical properties or performance of the device against engineering specifications. The document does not mention any expert involvement in establishing ground truth for the bench tests.

4. Adjudication Method for the Test Set

• Not Applicable / Not Specified. Since the testing is described as non-clinical in-vitro bench testing, an adjudication method (like 2+1, 3+1, etc., typically used for reconciling expert opinions in clinical ground truth establishment) is not described or implied.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is a type of clinical comparative effectiveness study involving human readers' performance with and without AI assistance. The provided document explicitly states that substantial equivalence was demonstrated via "non-clinical in-vitro bench testing," indicating no clinical human-reader studies were conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This device is a physical medical catheter, not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant. The substantial equivalence was based on the physical device's performance in bench tests.

7. The Type of Ground Truth Used

• Not explicitly stated in terms of "ground truth" for clinical data. For the non-clinical in-vitro bench testing, the "ground truth" would be implicitly defined by the engineering specifications and performance characteristics expected of such a catheter, and the performance observed in the predicate device (K043534). This would typically involve physical measurements, material properties, and functional tests (e.g., re-entry success rates in a simulated vessel model, guidewire trackability, etc.). The document does not detail these specific "ground truths."

8. The Sample Size for the Training Set

• Not Applicable / Not Specified. As this is a physical medical device and not an AI/ML algorithm, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. Again, no training set for an algorithm exists for this device.

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