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Progreat Lambda is intended for the infusion of contrast media, or embolic materials for hemostasis, into the peripheral vasculature, excluding the blood vessels belonging to the central circulatory system. Progreat Lambda is also indicated for drug infusion in intra-arterial therapy in the peripheral vasculature. Progreat Lambda should not be used in cerebral or coronary vessels.

Progreat Lambda is a single use, ethylene oxide sterilized device that is intended for the infusion of contrast media, or embolic materials for hemostasis, into the peripheral vasculature, excluding the blood vessels belonging to the central circulatory system. Progreat Lambda is also indicated for drug infusion in intra-arterial therapy in the peripheral vasculature. Progreat Lambda should not be used in cerebral or coronary vessels. The catheter consists of metal wire mesh reinforced multi-layer polymer tubing. The mesh is embedded in the catheter wall the entire length of the catheter with the exception of the distal tip section. This increases the flexibility, kink resistance, and pressure resistance of the catheter. The inner layer of the catheter is made of PTFE (polytetrafluoroethylene) to ensure smooth movement of devices such as the guide wire. The outer surface of the catheter is coated with a hydrophilic polymer with the exception of the proximal end that is 60cm from the catheter hub. The coating becomes lubricious when wet with saline solution or blood. The device is offered in effective lengths of 110, 130, 150, 165 and 175 cm.

Here's an analysis of the acceptance criteria and supporting studies for the "Progreat Lambda" device based on the provided FDA 510(k) summary:

The document does not contain information relevant to AI/ML or a multi-reader multi-case (MRMC) study. The device described is a microcatheter, a physical medical device, not a diagnostic software or AI/ML algorithm. Therefore, many of the requested categories like effect size of AI assistance, standalone algorithm performance, number of experts for ground truth, and training set information are not applicable to this submission.

The acceptance criteria and studies focus on the physical and biological performance of the catheter itself.

Acceptance Criteria and Reported Device Performance

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

The document states that "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life." However, it does not explicitly list the quantitative acceptance criteria for each test. It only lists the tests performed. Without the specific numerical thresholds for "acceptance criteria," a direct comparative table with reported performance cannot be fully constructed from this document.

Below is a table summarizing the types of performance tests conducted, implying that the device met the unstated acceptance criteria for each.

2. Sample size used for the test set and the data provenance

• Performance Testing: The document does not explicitly state the numerical sample size for each performance test. It mentions that tests were performed on "nonaged and accelerated aged samples," indicating multiple samples were used for each condition. The provenance of the data is internal to the manufacturer (Terumo Clinical Supply Co., Ltd., Japan). The tests are presumably prospective laboratory tests conducted on manufactured device units.
• Biocompatibility Testing: The specific numerical sample size is not provided, but it notes tests were conducted on "non-aged, sterile, whole device" and "accelerated-aged (3 years), sterile, whole device." These tests were also prospective laboratory tests.

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

Not applicable. This device is a physical medical device, not an AI/ML diagnostic. Ground truth as typically defined for AI/ML (e.g., expert consensus on medical images) does not apply. The "ground truth" for this device's performance is established by objective engineering and biocompatibility standards.

4. Adjudication method for the test set

Not applicable. This is not a diagnostic device requiring human reader adjudication. Performance is assessed against predefined engineering and biological criteria.

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. This is a physical medical device (microcatheter), not an AI/ML diagnostic system. Therefore, MRMC studies and AI assistance effect sizes are not relevant to this submission.

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

No. This is a physical medical device. The concept of an "algorithm only" performance is not applicable.

7. The type of ground truth used

The "ground truth" for evaluating this device's performance is based on established engineering standards and specifications (e.g., tensile strength, leak rates, dimensions, coating integrity), and biocompatibility standards (ISO 10993-1, pyrogenicity, hemolysis, cytotoxicity, etc.). These are objective, measurable criteria. For manufacturing and quality, the "ground truth" is adherence to design specifications and validated processes.

8. The sample size for the training set

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

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

Not applicable. (See #8).

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