(88 days)
Spinal needles are indicated for the injection of local anesthetics into a patient to provide regional anesthesia.
A spinal needle is an instrument used for the injection of local anesthetics into a patient to provide regional anesthesia. The needle consists of a luer hub, a stainless steel cannula, and a stainless steel stylete. The needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in our regional anesthesia trays. The spinal needles are provided in three styles; Lancet Point (Quincke), Pencil Point (Whitacre), and European Style (Sprotte). The introducer needle is a simple hypodermic needle, either 18g or 20g, to make the initial puncture through the skin to aid in the placement of the spinal needle.
The provided document is a 510(k) Summary for Spinal Anesthesia Needles. It describes the device, its intended use, technical characteristics, and non-clinical data. It does not present acceptance criteria or a study designed to prove the device meets specific acceptance criteria as would be typical for an AI/ML medical device.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through comparison testing of physical characteristics and performance attributes (like flow rate and penetration force). This is a regulatory pathway for traditional medical devices, not for AI/ML algorithms.
Therefore, for your request, I must state that the information you are asking for (acceptance criteria, specific study design, performance metrics, ground truth, expert involvement, MRMC studies, standalone performance, training set details) is not available in this document because it pertains to a different type of device evaluation (traditional medical device vs. AI/ML medical device).
The document's "study" is a comparison test, not a performance study against predefined acceptance criteria in the context of an AI/ML algorithm.
Here's a breakdown of why each specific point you asked for cannot be extracted from this document:
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A table of acceptance criteria and the reported device performance: This document does not establish explicit "acceptance criteria" for the device in the way an AI/ML device would, nor does it report performance against such criteria. Instead, it compares characteristics like "increased inside diameter" and "reduced outside diameter" to predicate devices, stating that the proposed device "compared well" and that the differences are "not significant."
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "comparison testing between the proposed device and the predicate devices" and "unisis needles tested." However, it does not specify sample sizes for this testing, nor does it provide details on data provenance (e.g., country of origin, retrospective or prospective nature of the test data).
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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): Since this is a physical medical device and not an AI/ML system, the concept of "ground truth" established by experts for a test set is not applicable in the way it would be for an AI/ML device. The "truth" here is based on physical measurements and mechanical performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical medical device comparison test.
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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 document is about spinal needles, not an AI system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" in this context would be the physical properties and performance characteristics of the needles themselves (e.g., measured flow rates, penetration force), rather than clinical outcomes or expert consensus on interpretations.
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The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.
§ 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).