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The Flexible Spinal Needle is intended for the administration of anesthetic agents to provide regional anesthesia.

The Flexible Spinal Needle consists of a coated flexible stainless steel cannula with a molded plastic hub. A stylet is also provided with the device which consists of a stainless steel cannula and a molded plastic hub. The Flexible Spinal Needle will be provided as a sterile, single use, disposable device and will be available in a variety of lengths and gauges.

This document is a 510(k) summary and FDA clearance letter for a Flexible Spinal Needle. It describes the device and its intended use, and compares it to predicate devices. However, the document does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

• Type of device: This is a medical device (a spinal needle), not a software or AI-driven diagnostic device. The questions about "algorithm only without human-in-the loop performance," "effect size of how much human readers improve with AI," and "sample size for the training set" are specific to AI/ML or diagnostic software and are not applicable to a physical medical instrument like this.
• Study Design: The document states "Bench Testing performed on the Flexible Spinal Needle to compare performance characteristics to the predicate device(s) confirmed that the performance of the Flexible Spinal Needle is similar to the predicate device(s)." This is a very high-level summary and doesn't provide the specifics requested in your prompt.

Therefore, most of the requested information cannot be extracted from the provided text.

Information that can be inferred or stated as not available:

1. Table of acceptance criteria and reported device performance: Not provided. The document generally states "performance... is similar to the predicate device(s)," but no specific criteria or performance metrics are listed.
2. Sample size used for the test set and data provenance:
   • Sample size: Not specified. "Bench Testing" is mentioned.
   • Data provenance: Not specified. Assumed to be lab/bench test data, not patient data in the typical sense requested by "country of origin" or "retrospective/prospective."
3. Number of experts and qualifications: Not applicable/Provided. Bench testing doesn't typically involve human experts in this context.
4. Adjudication method: Not applicable/Provided.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not conducted/applicable as this is not an AI/ML diagnostic system.
6. Standalone (algorithm only) performance: Not applicable. This is a physical device.
7. Type of ground truth used: Not explicitly stated for bench testing, but likely derived from engineering specifications and predicate device performance standards.
8. Sample size for the training set: Not applicable. There is no "training set" for a physical device undergoing bench testing for 510(k) clearance in this manner.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a 510(k) clearance for a physical medical device (spinal needle) based on substantial equivalence to predicate devices through bench testing. It does not provide the detailed study design, acceptance criteria, or performance metrics typically found in documentation for AI/ML or diagnostic software evaluations, as implied by most of your detailed questions.

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