Search Results

The ASAHI Corsair Armet is intended to provide support to facilitate the placement of guide wires in the peripheral vasculature, and can be used to exchange one guide wire for another.

The ASAHI Corsair Armet is also intended to assist in the delivery of contrast media into the peripheral vasculature.

This device should not be used in coronary vasculature or neuro vasculature.

The ASAHI Corsair Armet consists of a distal tip, a shaft tube that is inserted into vasculature, a protector, and a connector for catheter control and infusion of contrast media. The device has a hydrophilic coating on the outer surface of distal tip and the shaft tube to provide a smooth transition in blood vessels. The distal tip of the Corsair Armet has a tapered shape. PTFE is applied to the inner lumen of the catheter for the purposes of a smooth transition and exchange of guidewires.

This document is a 510(k) summary for the ASAHI Corsair Armet. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific clinical acceptance criteria in a human study. Therefore, much of the requested information (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable or provided in this type of regulatory submission.

However, I can extract the acceptance criteria and the summary of non-clinical performance data provided.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

A series of non-clinical laboratory bench tests were performed on the ASAHI Corsair Armet. These tests were designed to evaluate the physical and mechanical properties of the device against predefined acceptance criteria for each test parameter.

Missing Information (Not provided in this 510(k) Summary):

2. Sample size used for the test set and the data provenance: This document does not detail the specific sample size (number of devices tested) for each bench test, nor does it refer to human "test sets" or data provenance in terms of country of origin or retrospective/prospective nature, as this is pre-market non-clinical testing.
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 this context is based on engineering specifications and performance standards for medical devices, not expert human interpretation of clinical data.
4. Adjudication method for the test set: Not applicable. The results are objective measurements from bench tests against defined specifications.
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 a percutaneous catheter, not an AI-powered diagnostic or assistive technology for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used: For the non-clinical tests, the "ground truth" or reference was established by pre-defined engineering and performance specifications and standards relevant to percutaneous catheters.
8. The sample size for the training set: Not applicable. This is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

Summary from the Document:

The ASAHI Corsair Armet underwent non-clinical laboratory testing, which included evaluating its appearance/dimensions, corrosion resistance, force at break, liquid leakage under pressure, air leakage, leak and damage under high static pressure, radio-detectability, torque transmission, slide durability, kink resistance, and torque durability.

The document states: "The in vitro bench tests demonstrated that the ASAHI Corsair Armet met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrate that the device functions as intended, and is substantially equivalent to the predicate devices."

Ask a specific question about this device

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.

Ask a specific question about this device