(86 days)
The intended use of the ProLong Centinuous Nerve Block set is for prolonged regional anesthesia and analgesia via blockade of peripheral nerves.
Not Found
The provided document is an FDA 510(k) clearance letter for the "ProLong Continuous Nerve Block Set." This type of document declares a device substantially equivalent to a predicate device and permits its marketing. It does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a clinical study report or a 510(k) summary, which is a separate document.
Therefore,Based on the provided FDA 510(k) clearance letter:
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1. A table of acceptance criteria and the reported device performance: This information is not available in the provided document. The letter states the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is considered acceptable based on the predicate's established safety and effectiveness. However, specific acceptance criteria and performance metrics are not detailed here.
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2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not available in the provided document.
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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 available in the provided document.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not available in the provided document.
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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 information is not available in the provided document. The device is a medical instrument (nerve block set), not an AI-powered diagnostic or assistive tool, so an MRMC study related to AI assistance would not be applicable.
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6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not available in the provided document. As noted above, the device is an instrument, not an algorithm.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not available in the provided document. Given the nature of a nerve block set, ground truth would likely relate to the device's ability to deliver nerve blocks successfully and safely, assessed through clinical outcomes or direct observation, but specifics are not provided.
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8. The sample size for the training set: This information is not available in the provided document. If a training set were relevant (e.g., for an AI device), its details would typically be in a separate technical study summary.
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9. How the ground truth for the training set was established: This information is not available in the provided document.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).