(29 days)
The Arrow StimuCath™ continuous nerve block set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
The StimuCath™ continuous nerve block device is an anesthesia conduction catheter that is electrically conductive. Using peripheral nerve stimulation, the user can locate specific nerves or nerve plexuses for continuous nerve block anesthesia or analgesia.
The provided text is a 510(k) Summary for a medical device (StimuCath™ continuous nerve block set) seeking market clearance, not an AI/ML device study. Therefore, the information requested in the prompt, which is typically found in studies evaluating AI/ML device performance, is not present in the provided document.
The document describes the device, its intended use, technological characteristics, and performance tests conducted to demonstrate substantial equivalence to predicate devices. However, these tests are traditional engineering and biocompatibility tests, not studies on the statistical performance of an AI model concerning a specific medical task.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance in the context of AI/ML metrics (e.g., sensitivity, specificity, AUC).
- Sample sizes for a test set for AI/ML evaluation.
- Data provenance (country of origin, retrospective/prospective) for AI/ML data.
- Number of experts or their qualifications for establishing ground truth for AI/ML.
- Adjudication method for an AI/ML test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes for AI assistance.
- Standalone (algorithm only) performance for an AI/ML model.
- Type of ground truth (e.g., expert consensus, pathology, outcomes data) used for AI/ML.
- Sample size for a training set for AI/ML.
- How ground truth for the training set was established for AI/ML.
The "Performance tests" section lists engineering and biological tests demonstrating the device's physical and material properties, rather than diagnostic or prognostic performance evaluated by AI. These include:
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Flow rate
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Leak test (positive pressure)
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Holding strength of SnapLock™ adapter to catheter
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Snap force of SnapLock™
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Biocompatibility tests
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Power and current density calculations
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Bond strength
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Dielectric tests
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Peel back tests
The conclusion states that "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices." This refers to its physical and functional safety and efficacy, not the performance of an AI algorithm.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).