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This product is intended to direct a catheter to the desired anatomical vasculature (excluding coronary and cerebral vessels).

The CROSSLOOP is steerable guide wire with a maximum diameter of 0.018 inches (0.46 mm) and available in various lengths of 200 cm, 235 cm and 300 cm. The CROSSLOOP consists of a stainless-steel (SUS) core wire with a Pt-Ni alloy coil, soldered with Au-Sn solder. The distal tip is loop-structured. The coil is radiopaque to achieve visibility and can be made to bend easily to accommodate vessel tortuosity. A silicone and hydrophilic coating are applied to the distal portion of the guide wire. A hydrophobic coating (PTFE) is applied to proximal portion. The purpose of these surface coatings is to provide lubricity when the guide wire is passed through percutaneous catheters.

The provided text describes a 510(k) premarket notification for a medical device called "CROSSLOOP," a catheter guide wire. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval Application).

Therefore, the information you're asking for, such as "acceptance criteria and the study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established," are not directly applicable or available in this document.

This 510(k) summary focuses on non-clinical testing/performance data and biocompatibility to demonstrate that the device is substantially equivalent to existing cleared devices, not that it independently proves clinical efficacy or diagnostic accuracy (as would be the case for an AI-powered diagnostic device, for example).

Here's how to address your points based on the provided text:

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

The document states: "The in vitro bench tests demonstrated the CROSSLOOP met all acceptance criteria and performed similarly to the predicate and reference devices." However, it does not provide a table specifying the precise acceptance criteria or quantitative performance results for each test. It only lists the types of non-clinical tests performed:

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

• Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: The tests are "in vitro bench tests" and "biocompatibility" tests. The manufacturer is ASAHI INTECC CO., LTD. whose global headquarters and R&D center are in Japan. The specific country where the testing was performed is not explicitly stated, but it's likely linked to the manufacturer's R&D facilities. These are laboratory tests, not clinical data, so terms like "retrospective" or "prospective" don't apply in the common clinical sense.

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 to this type of device and submission. "Ground truth" established by experts (like radiologists for imaging devices) is relevant for AI/ML-powered diagnostic tools or clinical studies, neither of which are described here. The "ground truth" for the non-clinical tests would be the established engineering and materials science standards and specifications.

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

This is not applicable. Adjudication methods are typically used in clinical trials involving human observation or interpretation, especially with imaging reads. For bench testing, results are typically quantitative measurements compared against predefined engineering 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

This is not applicable. An MRMC study is designed for AI-assisted diagnostic devices to assess the impact of AI on human reader performance. The "CROSSLOOP" is a physical medical device (catheter guide wire), not an AI/ML software tool.

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

This is not applicable. This question refers to the performance of an AI algorithm in isolation. The CROSSLOOP is a physical medical device.

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

For a physical device like a guide wire, the "ground truth" for non-clinical testing refers to pre-defined engineering specifications, material properties, and performance standards (e.g., tensile strength required to withstand certain forces, flexibility within a specified range, biocompatibility per ISO standards). This is not derived from expert consensus on clinical cases, pathology, or outcomes data, but rather from material science and mechanical engineering principles.

8. The sample size for the training set

This is not applicable. "Training set" refers to data used to train AI/ML models. This device is not an AI/ML product.

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

This is not applicable for the same reason as point 8.

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This product is intended to direct a catheter to the desired anatomical vasculature (excluding coronary and cerebral vessels) during diagnostic or interventional procedures.

The CROSSLEAD 0.018inch is steerable guide wire with a maximum diameter of 0.46mm (0.018inches) and available in various lengths of 100 cm, 200 cm, 235 cm and 300 cm. The quide wire consists of a hybrid nitinol (Ni-Ti) and stainlesssteel (SUS) core wire with a stainless steel inner coil, a stainless steel and Platinum-Nickel (Pt-Ni) outer coil. The coil is radiopaque to achieve visibility and can be made to bend easily to accommodate vessel tortuosity. A hydrophilic and polyurethane coating are applied to the distal portion of the guide wire. A hydrophobic coating (PTFE) is applied to proximal portion. The purpose of these surface coatings is to provide lubricity when the guide wire is passed through percutaneous catheters.

The provided text is a 510(k) Premarket Notification from the FDA regarding the "CROSSLEAD 0.018inch" guide wire. This document primarily focuses on establishing substantial equivalence to predicate devices through non-clinical bench testing and biocompatibility assessments. It does not contain information about a study involving human-in-the-loop performance, expert ground truth establishment for a test set, or a multi-reader multi-case (MRMC) comparative effectiveness study, which are typically associated with the evaluation of artificial intelligence (AI) or software-based medical devices.

Therefore, I cannot fulfill your request for information related to:

• A table of acceptance criteria and reported device performance in the context of an AI/software study. The document lists non-clinical tests and states they met acceptance criteria, but these are for the physical device, not an AI.
• Sample size used for a test set (in the context of an AI study).
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for a test set.
• MRMC comparative effectiveness study or related effect sizes.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document discusses the physical characteristics and performance of a medical guide wire, not a software or AI device that would require such studies. The "non-clinical testing/performance data" section refers to bench tests for the physical guide wire's properties (e.g., tensile strength, torqueability, coating integrity, biocompatibility), not an algorithm's performance on a dataset.

In summary, the provided text does not describe the kind of study you are asking about, which typically pertains to the evaluation of AI/software in medical devices.

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This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. Do not use the guide wire in neurovascular.

The CROSSLEAD 0.014inch is steerable guide wire with a maximum diameter of 0.014inch (0.36mm) and available in various lengths of 100cm, 200cm, 235cm and 300cm. This quide wire consists of a hybrid nitinol (Ni-Ti) and stainless-steel (SUS) core wire with a stainless-steel inner coil and Platinum-Nickel (Pt-Ni) outer coil. The coil is radiopaque to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion. The basic structure, construction and materials of the CROSSLEAD 0.014inch are similar to those of previously described in the predicate ASAHI Gladius (K150445/K163426) and references; CROSSLEAD Penetration (K230377), MINAMO (K190176) and Astato XS40 (K153443/K163426).

All sizes are available with a straight and a pre-shaped design.

This document is a 510(k) Premarket Notification for a medical device (CROSSLEAD 0.014inch guide wire) and does not describe a study involving an AI/Machine Learning enabled device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and performance studies for such devices, including details on test sets, expert ground truth, MRMC studies, or training sets.

The document discusses non-clinical bench testing to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not an AI algorithm.

Therefore, I cannot fulfill the request as the provided text does not contain information related to AI/ML device testing and acceptance criteria.

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