(88 days)
The HANNIBAL™ steerable guide wires are designed to reach and cross stenotic lesions prior to the insertion on a coronary balloon dilatation catheter. Schneider steerable stont support guide wires are also designed to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilatation catheter with mounted expandable stent, or of a stent delivery device. Any use other than that intended is not recommended.
The HANNIBAL " Guidewire is a 0.014" guidewire manufactured in lengths of 185-315 cm. The guidewire is made of stainless steel, HIHE coated proximal shatt, which tapers down to a flexible distal tip. The tip area consists of a radiopaque tungsten spring coll. which is attached to the distal flexible shaft port and soldered to the proximal taper of the shaft. The dietal part of the coil is very flexible and shapeable.
This 510(k) summary for the HANNIBAL™ Guidewire (K970494) does not provide information about acceptance criteria or a study proving the device meets them in the AI/machine learning context you're asking about. This document is from 1997 and predates the widespread use of AI in medical devices and the establishment of regulatory frameworks for evaluating AI-based devices.
Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and performance testing relevant to traditional medical devices like guidewires.
Here's why your requested information cannot be found in this document, and how it relates to the information provided:
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A table of acceptance criteria and the reported device performance: This document does not present acceptance criteria in the form of metrics like sensitivity, specificity, or AUC, which are common for AI/ML devices. Instead, it mentions "comparative performance testing" for characteristics like "bond strength, tip flexibility, coating adhesion, torque and compatibility with interventional devices." The "reported device performance" is summarized by the statement: "The results of all testing indicated that the HANNIBAL™ guidewire is equivalent to the ACS Hi-Torque Extra S'port™ guidewire and is, therefore, safe for the intended use." Specific quantitative values for these performance metrics are not given, nor are explicit acceptance thresholds.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document refers to physical device testing, not a dataset for an AI model.
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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 AI sense is not relevant here. The "truth" for this device would be its physical conformance to specifications and its performance in mechanical and material tests.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 is for a physical guidewire, not an AI diagnostic or assistance tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a guidewire, "ground truth" relates to its material properties and mechanical performance meeting engineering specifications and safety standards. This is typically established through laboratory testing.
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The sample size for the training set: Not applicable. There is no AI model being trained.
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How the ground truth for the training set was established: Not applicable.
In summary: The provided document is for a traditional medical device (a guidewire) and focuses on demonstrating its substantial equivalence to existing devices through standard engineering and biocompatibility testing. It does not involve any AI/ML components, and therefore, the acceptance criteria and study details requested for an AI device are not present.
§ 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.