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The LBI Catheter System is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system.

The Lumen Biomedical Inc. (LBI) Xtract™ Catheter System is a single-use, 0.014" guidewire compatible, temporary intravascular extraction and aspiration catheter system. It has a distal radiopaque tip marker, a varying stiffness shaft, a rapid exchange port, and a proximal luer-lock hub. The system consists of one (1) Catheter, one (1) Extension Tube with Stopcock, two (2) 30cc Aspiration Syringes, and one (1) 40um Strainer.

The provided text describes a 510(k) submission for the LBI Catheter System (also referred to as Xtract™ Catheter System) and mentions that in vitro bench, biocompatibility, and animal tests were conducted to demonstrate substantial equivalence to predicate devices. However, the document does not provide specific acceptance criteria or detailed results of a study that proves the device meets those criteria, especially in terms of clinical performance or effectiveness.

It primarily focuses on compliance with standards and the claim of substantial equivalence for safety and performance based on these types of tests, rather than clinical efficacy.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or clinical performance comparisons (like MRMC studies) is not available in the provided text.

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

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not specified. The document mentions in vitro bench tests and animal tests, but not the number of samples or animals used.
• Data provenance: The tests mentioned are in vitro (bench) and animal, implying a pre-clinical setting. Country of origin not specified, but the manufacturer is in Plymouth, MN, USA. The study type mentioned (bench, animal) indicates prospective testing specific to the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not specified. The tests mentioned are physical (bench) and animal, not reliant on expert review for ground truth in the way a clinical imaging study would be.

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

• Not applicable/Not specified. The tests mentioned are physical (bench) and animal, not involving human interpretation for adjudication.

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

• No MRMC comparative effectiveness study was done or mentioned. This device is a catheter system, not an AI diagnostic tool.

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

• Not applicable/Not specified. This is a medical device (catheter), not an algorithm.

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

• For the in vitro bench tests, ground truth would be based on engineering specifications, physical measurements, and performance standards outlined in ISO and ASTM documents.
• For the animal tests, ground truth would be based on physiological responses, tissue analysis, and direct observation of the device's performance within the animal model, observed against pre-defined success criteria for the procedure.
• No human clinical outcomes or pathology data are mentioned for establishing ground truth in this document.

8. The sample size for the training set

• Not applicable/Not specified. This is a medical device, not an AI model requiring a training set in the conventional sense.

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

• Not applicable/Not specified. As it's not an AI model, a training set and its ground truth are not relevant in this context.

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