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An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

The BD Spinal needle consists of a non-lubricated stainless steel cannula attached to the needle hub using an insert molding process. When appropriate for the procedure, this needle includes a stylet. This stylet consists of nonlubricated stainless steel. The stainless steel stylet is attached to the stylet handle using an insert molding process. The needle assembly is protected with a polypropylene shield. The Spinal needle is packaged appropriately for either sterile or non-sterile, single use, purposes.

The provided document is a 510(k) summary for a medical device (BD Spinal Needle) seeking substantial equivalence to a predicate device. It is a regulatory submission, not a study report that details acceptance criteria and performance data for a new device's efficacy or safety. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and comparative effectiveness studies is not present in this document.

The document discusses the substantial equivalence of the BD Spinal Needle to existing predicate devices based on identical technological characteristics and intended use. This type of submission relies on the established safety and effectiveness of the predicate, rather than conducting new clinical performance studies for the new device itself.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample size for test set: Not applicable and not provided. This submission relies on demonstrating substantial equivalence to a predicate device, not on a new performance study with a test set of data.
• Data provenance: Not applicable. No new data from a test set is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable and not provided. No ground truth for a test set was established as part of this submission. The regulatory review process involves FDA experts evaluating the submission for substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable and not provided. No test set requiring adjudication was used.

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:

• No MRMC or AI-related study was done. This device is a physical medical instrument (spinal needle), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. The "ground truth" in this context refers to the established safety and effectiveness of the predicate device, which is assumed by the FDA for substantial equivalence evaluations. No new ground truth needed to be established for the submitted device's performance.

8. The sample size for the training set:

• Not applicable and not provided. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable and not provided. No training set was used.

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