(22 days)
The Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.
The Pinnacle® Destination® Peripheral Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Peripheral Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip.
The provided text describes a 510(k) premarket notification for a medical device, specifically the Pinnacle® Destination® Peripheral Guiding Sheath. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the context of an AI/algorithm-driven device. The details requested are typically associated with performance evaluations of AI algorithms, particularly those seeking de novo clearance or 510(k) clearance for AI-based functions.
Here's why the requested information is absent and what the document does provide:
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Acceptance criteria and reported device performance (Table 1): The document outlines specifications for the device (Sheath Size, Nominal ID/OD, Length, Hydrophilic Coating, Distal Shape), which are analogous to acceptance criteria in terms of physical attributes. However, it does not present a table of performance acceptance criteria (e.g., sensitivity, specificity, or specific functional benchmarks in a clinical context) with corresponding reported performance for a new AI function. It states, "The performance of the Pinnacle® Destination® Peripheral Guiding Sheath is substantially equivalent to the performance of the unmodified Peripheral Guiding Sheath. The equivalence was shown through bench and vessel model testing." This indicates the performance was compared to the predicate, not measured against novel, AI-specific acceptance criteria.
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Sample size for the test set and data provenance: Not applicable. This device is a manual medical instrument, not an AI/algorithm. Performance was assessed through bench and vessel model testing, not clinical data sets with "test sets" in the AI sense.
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Number of experts used to establish ground truth for the test set and their qualifications: Not applicable. Ground truth as typically defined for AI models (e.g., expert consensus on image labels) is not relevant for this physical device's evaluation.
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Adjudication method for the test set: Not applicable.
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Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This study design is used for evaluating human reader performance with and without AI assistance. This device is a physical guiding sheath; it doesn't "assist" human readers with interpretation.
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Standalone (algorithm-only) performance: Not applicable. There is no algorithm.
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Type of ground truth used: For the physical characteristics, the ground truth would be engineering specifications and measurements. For the "performance" described as "substantially equivalent," the ground truth is the established performance of the predicate device.
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Sample size for the training set: Not applicable. This is not an AI/ML device that requires training data.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device (a guiding sheath) to an existing predicate device, primarily through bench and vessel model testing. It does not involve any artificial intelligence or machine learning component, and thus, the specific questions related to AI algorithm performance evaluation are not addressed in this document.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).