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The LMI Irrigation Catheter is intended for intra-operative procedures requiring irrigation in either arterial or venous blood vessels.

The catheter consists of a stainless steel wire reinforced silicone tube that is end formed to create a rounded leading nose. The proximal end of the catheter consists of a female luer connector and a strain relief that are bonded to the silicone shaft. The distal end of the catheter has four side ports as well as central lumens that provide openings for irrigating fluid. The "DEVICE" is packaged in an ElO breathable tray for protection and then sealed in an EtO breathable pouch. It is E.O sterilized and non-pyrogenic. The "DEVICE" is for Single Use Only and is used only By or On the Order of a Physician.

The provided text is a 510(k) summary for a medical device (Lucas Medical, Inc.'s LMI Irrigation Catheter) seeking clearance from the FDA in 1997. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than extensive clinical studies or performance criteria in the way a modern AI/ML device submission would.

Therefore, the document does not contain the kind of information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. These elements are typically found in submissions for novel devices or those with more complex functional claims, especially those involving AI/ML.

Here's a breakdown of why each requested point cannot be answered from the provided text:

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

   • Reason not available: This document is a 510(k) submission from 1997 for a medical catheter. The concept of "acceptance criteria" and "reported device performance" in the context of quantifiable metrics, as would be expected for an AI/ML device, is not applicable here. The goal of this submission is to demonstrate "substantial equivalence" to existing, legally marketed devices. Performance is generally assumed to be similar to the predicate based on design and material similarities, rather than statistical performance metrics.

2. Sample sizes used for the test set and the data provenance:

   • Reason not available: No test set or sample size data is mentioned. The submission relies on comparing the device's design, materials, and intended use to existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Reason not available: No "ground truth" establishment or expert review of a test set is discussed. This is not a study design where expert consensus or other forms of ground truth would be established for evaluating a device's diagnostic or predictive performance.

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

   • Reason not available: No adjudication method is mentioned as there is no test set or study requiring such a method.

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:

   • Reason not available: This device is an irrigation catheter, not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study or any assessment of human reader improvement with AI assistance is entirely irrelevant to this submission.

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

   • Reason not available: This is a physical medical device (catheter), not an algorithm. Standalone algorithm performance is not applicable.

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

   • Reason not available: No ground truth in the context of an evaluative study is mentioned or implied.

8. The sample size for the training set:

   • Reason not available: This is a physical device, not an AI/ML model. There is no concept of a "training set" for an irrigation catheter.

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

   • Reason not available: As there is no training set, there is no ground truth for it.

In summary, the provided documentation is for a 1997 medical device (catheter) 510(k) submission, which focuses on demonstrating substantial equivalence rather than presenting extensive performance study data typical of modern AI/ML device evaluations.

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