(267 days)
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:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile Strength | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Torque Strength | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Torqueability | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Tip Flexibility | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Coating Integrity | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Catheter Compatibility | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Visual Inspection | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Corrosion Resistance | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Kink Resistance | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Radio Detectability | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Dimensional Verification | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Coating Integrity / Acute Particulate Characterization | Met all acceptance criteria and performed similarly to predicate/reference devices. |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity, USP Rabbit Pyrogen, Hemolysis, Partial Thromboplastin Time, In Vivo Thrombogenicity, Sc5b-9 Complement Activation) | Performed to assess biocompatibility. (Implied to have met criteria, as stated in the overall conclusion). |
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.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.