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The LMI Carotid Endarterectomy Shunt Catheter is intended for use during a carotid endarterectomy procedure to provide temporary carotid artery bypass (blood flow) for cerebral circulation.

The LMI Carotid Endarterectory Shunt Catheter consists of a multi-lumen, straight or tapered silicone tube with or without stainless steel wire reinforcement with one or more silicone balloons formed at either or both ends. Additional silicone tubes are attached at the approximate center and at approximately 90 degrees of the main tube for communicaton with the main central lumen as well as the smaller lumen used to inflate the balloons that are located on either or both ends. The proximal ends of the balloon inflation tubes are fitted with a female luer connector and may on some models incorporate a strain relief that is bonded to the silicone shaft. The proximal communicating tube is also fitted with a female luer connector and models incorporate a strain relief that is bonded to the silicone shaft. Stopcocks are attached to the female her connecting tubes. The ends of the main nulti-lumen tube are end formed to create a soft leading edge. The main multi-lumen tube may also be tapered in certain models to enchance blood tlow.

I am sorry, but the provided text from the 510(k) notification for the LMI Carotid Endarterectomy Shunt does not contain the detailed information required to fill out all the sections of your request. This document is a summary of the device for regulatory clearance, not a clinical study report.

Specifically, the text does not contain information about:

• Acceptance criteria and reported device performance in a table format. It states the device is "substantially equivalent" to predicate devices, but doesn't provide specific performance metrics or acceptance criteria that were met through a study.
• Sample size used for the test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers with/without AI assistance. (This is not applicable as it's a medical device, not an AI/software device).
• Whether a standalone (algorithm only) performance study was done. (Not applicable as it's a physical medical device).
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

The document discusses the device's description, intended use, principle of operation, and its substantial equivalence to other legally marketed devices based on materials, construction, sterilization, and indicated use. The FDA letter confirms the substantial equivalence finding, allowing the device to be marketed.

To provide the information you're looking for, you would typically need a clinical study report or a more detailed technical file for the device, which would include performance data and the methodology of any testing conducted. This 510(k) summary focuses on regulatory clearance based on equivalence rather than detailed performance study results.

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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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The LMI Thrombectomy Catheter is intended for use in venous thrombectomy procedures for intra-operative removal of venous thrombus formations from veins.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the LMI Thrombectomy Catheter. It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance, specific studies, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.

The letter is a regulatory approval document confirming market readiness based on substantial equivalence, not a detailed report of technical performance studies. Therefore, I cannot provide the requested information from the given text.

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The device is intended for intra-operative short term use in the biliary tree to aid in the removal of ductal stones and debris.

The catheter consists of a single lumen stainless steel wire reinforced silicone lube that is end formed to create a rounded leading nose. A silicone balloon is bonded to the cather at the end form. The proximal end of the catheter consists of a female luer connector and a strain relief that are bonded to the silicone shaft. The "DEVICE" is packaged in an ErO breathable tray for protection and then sealed in an ErO breathable pouch. It is EtO sterilized and non-pyrogenic. The "DEVICE" is for Single Use Only By or On the Order of a Physician.

This 510(k) premarket notification describes a medical device, the LMI Biliary Catheter, which is a physical device used in a surgical procedure. Therefore, the questions related to AI/algorithm performance, ground truth, training/test sets, and expert review are not applicable in this context. These questions are typically relevant for AI/ML-based diagnostic or prognostic devices.

However, I can extract information related to the acceptance criteria and how the device meets them based on the provided text.

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

Based on the provided text, the primary "acceptance criterion" for this 510(k) submission is Substantial Equivalence to a legally marketed predicate device. The performance is therefore demonstrated by showing that the new device is "the same" as the predicate device in key aspects.

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

Not applicable. This is a physical medical device submission, not an AI/ML-based device relying on a test set of data. The "testing" involves demonstrating manufacturing quality, material compatibility, and adherence to design specifications to show substantial equivalence.

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. Ground truth for an AI/ML model is not relevant to this physical device submission.

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

Not applicable.

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

Not applicable. This is not an AI-assisted diagnostic or prognostic device.

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

Not applicable. This is a physical medical device.

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

Not applicable.

8. The sample size for the training set

Not applicable. This is not an AI/ML-based device.

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

Not applicable.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device