Search Results

The ROVO Mechanical Thrombectomy Device is indicated for the removal and thrombi from vessels in the peripheral vasculature.

The ROVO Mechanical Thrombectomy Device is indicated for the removal of soft emboli and thrombi from vessels in the peripheral vasculature. It consists of a ROVO Driver, a ROVO Locking Aspiration Syringe, and a ROVO Catheter. The ROVO Driver handpiece was designed to work with an off-the-shelf catheter manufactured by Merit Medical Systems, Inc (K121051 and K132409) and an off-the-shelf locking aspiration syringe (K163597) also manufactured by Merit Medical Systems, Inc. Both the catheter and syringe are private labeled with the ROVO system name.

The ROVO Catheter is maneuvered under fluoroscopic observation to the location of the target thromboemboli utilizing the surgeon's preferred vascular access procedure. Once in the desired location, the ROVO Driver handpiece with the ROVO Locking Syringe is attached to the catheter. Squeezing of the handpiece rotates the distal tip of the ROVO Driver. This rotation ensures the thromboemboli is loosened and the catheter tip is fully exposed to the vessel to completely capture and aspirate the thromboemboli. Rotation does not happen when the trigger is released. Aspiration of the emboli/thrombi happens upon release of the Locking Syringe, independent of the catheter rotation. During aspiration, the surgeon can continue to pull the trigger and move the catheter as needed to capture the target thromboemboli.

The provided text describes a medical device called the ROVO Mechanical Thrombectomy Device and its 510(k) clearance. However, it does not include information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of AI/ML or diagnostic accuracy, as your specific questions imply (e.g., effect size of human readers with AI, standalone algorithm performance, ground truth establishment for test/training sets).

This document focuses on the substantial equivalence of a physical medical device (mechanical thrombectomy device) to existing predicate devices, primarily through non-clinical performance data and a comparison of technological characteristics. Clinical testing was explicitly stated as not necessary for the determination of substantial equivalence in this context.

Therefore, many of your requested details regarding AI/ML device performance and testing methodology cannot be extracted from this document.

Here's what can be answered based on the provided text:

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

The document lists various non-clinical tests performed on the device components but does not provide specific acceptance criteria or quantitative performance results for these tests. It only states that these tests were "evaluated for" or "completed by Merit Medical Systems".

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

This information is not provided. The document focuses on non-clinical engineering and biological tests, not data from human subjects or retrospective/prospective studies.

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)

This information is not applicable and not provided. "Ground truth" in the context of expert consensus or pathology is relevant for diagnostic or AI/ML-driven devices, which this is not.

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

This information is not applicable and not provided for the same reasons as above.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done, as explicitly stated: "Clinical testing was not necessary for the determination of substantial equivalence." This device is a mechanical thrombectomy device, not an AI-assisted diagnostic tool.

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

This is not an AI/ML or algorithm-based device, so a standalone algorithm performance study was not conducted.

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

No "ground truth" of this nature was established, as the device's substantial equivalence was determined through non-clinical performance testing and comparison to predicate devices, not through diagnostic accuracy studies.

8. The sample size for the training set

This information is not applicable and not provided, as this is not an AI/ML device.

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

This information is not applicable and not provided, as this is not an AI/ML device.

Ask a specific question about this device

"Intended for the intravascular introductional devices into the peripheral, including pulmonary, vasculature."

Lumax® Guiding Catheters are conduits introduced, either singly or as a coaxial pair, into a vein or artery and tracked over a wire guide to the site of a vascular lesion where interventional devices can be delivered through the guiding catheter's internal lumen for treatment. The Lumax® Guiding Catheters may include either a single guiding catheter or a coaxial catheter pair (composed of an outer guiding catheter and an inner coaxial catheter). The single guiding catheters are available in a 7.0 French outer diameter in lengths of 80 or 90 cm. They are manufactured with a multilayered braided nylon shaft, bonded Luer hub, and radiopaque tip. The guiding catheters are designed with a multipurpose (MPA) distal curve configuration. The coaxial catheter pair comprises an outer guiding catheter matched to an inner coaxial catheter. The guiding catheter component is available in an outer diameter of 8.0 French and a length of 80 cm. The inner coaxial catheter is manufactured from radiopaque braided nylon tubing and has an outer diameter of 6.0 French and a length of 100 cm. For lubricity, the distal 40 cm of the inner catheter is treated with hydrophilic coating. The Lumax® Guiding Catheters are supplied as packaged, sterile devices, intended for single-patient use.

The provided text describes the Lumax® Guiding Catheters and their acceptance criteria through various performance tests. However, it does not include a study that proves the device meets acceptance criteria for an AI/CADe device, as this device is a physical medical catheter, not a software or AI-based diagnostic tool.

Therefore, many of the requested categories for AI/CADe studies will not be applicable or present in this document.

Here's the information extracted from the document regarding the acceptance criteria and performance of the Lumax® Guiding Catheters:

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

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

This information is not provided in the document. The document describes laboratory performance testing, not a clinical trial with a "test set" and "data provenance" in the context of an AI/CADe study.

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)

This information is not applicable and not provided. The testing described is performance testing of a physical device against engineering and safety standards, not an evaluation requiring expert interpretation of results to establish ground truth.

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

This is not applicable and not provided.

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

This is not applicable and not provided, as this is a medical device (catheter) and not an AI or CADe system.

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

This is not applicable and not provided, as this is a medical device (catheter) and not an AI or CADe system.

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

The "ground truth" for this device's performance testing is based on established engineering standards (e.g., ISO, BS EN ISO) and pre-determined acceptance criteria for physical and mechanical properties, as well as biocompatibility.

8. The sample size for the training set

This is not applicable and not provided. This document describes the performance testing of a manufactured medical device, not the training of an AI model.

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

This is not applicable and not provided. There is no concept of a "training set" or "ground truth" establishment for training in the context of this device's regulatory submission.

Ask a specific question about this device