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The product (Finecross™ MG) is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

FINECROSS MG consists of a catheter shaft, a hub and an anti-kink protector. The catheter shaft has reinforcing braided mesh, thus achieving the high shaft strength and anti-kink characteristics. The shaft has gradual hardness change from the proximal to the distal portion. This is achieved by joining outer layers of material with different hardness. By using polytetrafluoroethylene (PTFE) as the inner layer, high inner face mobility has been achieved. The outer surface of the catheter is coated with a hydrophilic polymer, therefore, it demonstrates a high lubricity upon moistening.

The provided text describes a 510(k) premarket notification for the FINECROSS™ MG Coronary Micro-Guide catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics typically associated with AI/software as a medical device (SaMD) clearances.

Therefore, many of the requested elements for an AI/SaMD study, such as sample size for test and training sets, expert qualifications, and adjudication methods, are not applicable or explicitly mentioned in this document. The device is a physical medical instrument, not an AI algorithm.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a physical medical device, specific "acceptance criteria" and "device performance" in the context of an AI algorithm's metrics (e.g., sensitivity, specificity) are not present. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various specifications and bench testing.

• Outer diameter (distal end): 1.8Fr (0.60mm)
• Outer diameter (proximal end): 2.6Fr (0.870mm)
• Inner diameter: 0.018" (0.45mm) to 0.0221" (0.55mm)
• Radiopaque markers: 1 |
  | Expiration Dating | 2 years. |

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

Not applicable for this type of device. The "test set" in this context would refer to physical prototypes undergoing bench testing, not a dataset for an AI algorithm. The document states "bench testing" was performed, but does not specify sample sizes or data provenance for these physical tests.

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

Not applicable. "Ground truth" in the context of AI refers to expert-labeled data. For a physical device, testing is typically against engineering specifications and predicate device performance, not expert-established ground truth in the AI sense.

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

Not applicable. This is a method for resolving discrepancies in expert labeling for AI ground truth.

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 device is a physical catheter, not an AI or software assistant for human readers. Therefore, an MRMC study related to AI assistance would not be performed for this product.

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

Not applicable. This is not an AI algorithm.

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

For this physical device, the "ground truth" would be established by engineering specifications, validated test methods, and direct comparison to the performance characteristics of the legally marketed predicate devices, rather than expert consensus on medical images or pathology.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. There is no training set for this physical device.

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CES MassTRANSIT Infusion Catheters are indicated for the selective infusion of various diagnostic, therapeutic and embolic agents into the peripheral, coronary and neurovasculatures.

The MassTRANSIT is a single lumen catheter designed to access small, tortuous vasculature for the delivery of diagnostic, embolic and therapeutic agents. The shaft tapers from 3.0F proximal to 2.8F distally. The catheter has a hydrophilic coating to provide lubrication for navigation of vessels. The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices.

The provided text describes a 510(k) premarket notification for the CES MassTRANSIT Infusion Catheter, focusing on its substantial equivalence to predicate devices rather than specific performance studies with acceptance criteria for device accuracy or effectiveness.

Therefore, many of the requested elements for describing "the acceptance criteria and the study that proves the device meets the acceptance criteria" are not explicitly available in the provided document. This document is a regulatory submission for premarket clearance based on substantial equivalence, not a clinical study report.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

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

• Acceptance Criteria: The document mentions "acceptance criteria stipulated in the test protocols" for biocompatibility. For the overall device, the primary "acceptance criterion" for this 510(k) submission is substantial equivalence to predicate devices.
• Reported Device Performance: The document states:
  • "All appropriate biocompatibility tests have been performed according to the FDA modified matrix of ISO-10993 (Blue Book Memorandum G95-1). The catheters demonstrated compatibility with biological tissue by meeting the acceptance criteria stipulated in the test protocols."
  • "The CES MassTRANSIT Infusion Catheter is similar in its basic design, construction, indication for use and performance characteristics to the predicate devices."

Table (based on available information):

Missing Information (not detailed in this 510(k) Summary):

The document does not provide specific numerical performance metrics (e.g., accuracy, sensitivity, specificity, resolution, throughput, etc.) with corresponding acceptance criteria usually associated with studies designed to prove performance for a novel device. As a 510(k) claiming substantial equivalence, such detailed performance studies with quantifiable acceptance criteria are often not required if the device is sufficiently similar to existing legally marketed devices.

Regarding your specific questions (2-9):

Since this is a 510(k) submission focused on substantial equivalence rather than a de novo clinical or performance study for a novel device, the following points are largely not applicable or not extractable from the provided text:

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as there are no detailed performance studies on a "test set" described for this device. Biocompatibility tests were performed, but details on sample size or data provenance for these are not provided in this summary.
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" in the context of device performance studies (like for diagnostic AI) is not relevant here.
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 device is an infusion catheter, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this regulatory submission is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable.

In summary:

The document serves as a regulatory notification for a medical device (infusion catheter) achieving market clearance through the 510(k) pathway by demonstrating substantial equivalence to already approved predicate devices. It relies on a comparison to existing devices and performance of standard biocompatibility tests, rather than presenting a novel clinical study with detailed performance metrics and acceptance criteria as might be seen for entirely new device types, especially in areas like diagnostics or AI.

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