Search Results

The SPROTTE® STANDARD (LUER/ NRFit®) lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection/ withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography.

The subject device, the SPROTTE® STANDARD (LUER/ NRFit®) anaesthesia conduction needle is a single-use anaesthesia conducting intended for administer anesthetic agent to the spinal space.

The SPROTTE® cannulas are equipped with a stylet as well as optional with an Introducer. It is available with a LUER respectively with a NRFit® hub. The LUER is either a standard hub, a magnifying hub or a 2.G hub. The cannula tube is straight. The distal connection of the hub is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6.

This document, an FDA 510(k) clearance letter and associated summary, pertains to a lumbar puncture needle – a physical medical device. The information provided heavily details the material composition, dimensions, and manufacturing processes (including sterilization and packaging) of the needle, and compares these characteristics to previously cleared predicate and reference devices.

Crucially, this document does NOT describe the acceptance criteria and study that proves a software algorithm or AI/ML device meets those criteria. It is about a physical medical device, not a digital health product that uses algorithms to process data or make predictions.

Therefore, I cannot extract the information required by your prompt, as it is designed for a different type of medical device (software/AI/ML).

To directly answer your numbered points based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not applicable for an AI/ML device. The document lists performance testing against physical standards (ISO 7864, ISO 9626, ISO 80369-6, ISO 80369-7) for the needle's physical properties (e.g., cleanliness, dimensions, bond strength, fluid/air leakage, stress cracking), with all sections reported as "Passed."
• 2. Sample sizes used for the test set and the data provenance: Not applicable for an AI/ML device. For the physical device, testing appears to be based on compliance with ISO standards, implying a certain number of units were tested to demonstrate conformity. Data provenance specific to an AI/ML context (e.g., country of origin, retrospective/prospective) is not present.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI/ML device. This document does not describe a process of establishing "ground truth" by experts reviewing medical images or data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for an AI/ML device.
• 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: Not applicable for an AI/ML device. This type of study is for evaluating AI assistance to human interpretation, which is not relevant for a physical needle.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for an AI/ML device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI/ML device. The "ground truth" for a physical needle's performance is its adherence to mechanical, material, and sterility standards.
• 8. The sample size for the training set: Not applicable for an AI/ML device. There is no AI model being trained.
• 9. How the ground truth for the training set was established: Not applicable for an AI/ML device.

In summary: The provided text describes the regulatory clearance for a traditional, physical medical device (a lumbar puncture needle) based on its material properties, manufacturing processes, and adherence to established physical performance standards. It does not contain any information relevant to the testing and validation of an AI/ML-based medical device.

Ask a specific question about this device