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The QXT catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

The QXT catheter is designed to aspirate or extract soft thrombus from arterial vasculature. It has a dual-lumen design-an extraction lumen that allows for the removal of thrombus by aspiration and a rapid-exchange guidewire lumen that accommodates ≤0.014" diameter guidewires. A Y-adapter is bonded to the catheter's proximal end that facilitates the attachment of syringes and extension lines, and there is a self-sealing straight valve bonded to one port of the Y-adapter. The purpose of the straight valve is to provide a means of inserting and removing a stiffening mandrel, that is supplied with the device, while maintaining hemostasis during use. The catheter's outer diameter is a maximum of approximately 0.063" and its working length is approximately 137cm. The catheter is compatible with ≥6F guide catheters. There is a single radiopaque marker located near the distal tip, and the catheter's shaft has non-radiopaque positioning marks printed at approximately 95cm and 105cm proximal to the distal tip. Each device is supplied with a stiffening mandrel that is placed through the self-sealing straight valve, a 30mL VakLok syringe, and a 6 inch extension line that has a one-way stopcock. The QXT catheter is provided sterile and intended for single use.

The provided document is a 510(k) summary for the QXT Extraction Catheter, submitted to the FDA. It does not include acceptance criteria or the details of a study designed to prove the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of device characteristics and the results of bench testing for design verification.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria based on the provided document. The document explicitly states: "No QXT catheter clinical evaluations were conducted." and focuses on "Bench testing was conducted on the QXT catheter and included an assessment of the device's physical properties and its ability to achieve its intended use."

The sections below highlight what would be provided if the document contained the requested information, but given the limitation, I can only state that such information is absent.

Acceptance Criteria and Device Performance:

The document does not provide a table of acceptance criteria and reported device performance directly related to proving the device meets specific performance thresholds in a clinical or structured performance study beyond general bench testing.

Study Details (Based on available information, which is limited to bench testing, not a formal study with acceptance criteria):

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

   • The document implies that multiple units of the QXT catheter were used for each bench test listed. However, specific sample sizes (e.g., "n=X" for each test) are not provided.
   • Data provenance: Not explicitly stated, but assumed to be from internal laboratory testing given it's a 510(k) submission, likely conducted in the US (where Vascular Solutions, Inc. is located). The testing is prospective for the device's design verification.

2. 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. Ground truth, in the context of an expert evaluation or clinical outcome, is not established for this submission as "No QXT catheter clinical evaluations were conducted." The bench tests assess physical properties and performance against engineering specifications or established test methods, not against expert-derived ground truth.

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

   • Not applicable. No expert adjudication process is described as there were no clinical evaluations or multi-reader studies.

4. 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. A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a medical catheter, not an AI-powered diagnostic or assistive technology.

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

   • Not applicable. This device is a physical medical instrument, not an algorithm.

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

   • For the bench tests, the "ground truth" or reference standard would be the pre-defined engineering specifications, industry standards, or established test methods for device performance (e.g., bond strength, kink resistance, thrombus extraction efficiency under controlled conditions). It is not derived from expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • Not applicable. This is a medical device, not an AI/ML algorithm that requires a training set.

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

   • Not applicable. This is a medical device, not an AI/ML algorithm.

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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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