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The SIMS Lumbar Puncture (LP) Kit is indicated for sampling of Cerebrospinal Fluid (CSF) and the measurement of CSF pressure as indicated in standard textbooks.

The SIMS LP Kits are intended to be used when Lumbar Puncture is performed to obtain a CSF specimen for diagnostic study when possible CNS infection is suspected, such as sepsis and/or meningitis. The procedure can also be used to measure intracranial pressure which can result from infection, tumor, hemorthage or edema. This technique is also used to lower intracranial pressure by CSF drainage. CSF pressure is measured prior to CSF sampling using a manometer.

The SIMS Lumbar Puncture (LP) Kit is available in adult or pediatric configurations. The kit includes the preparatory and procedural components to perform Lumbar Puncture. A manometer may be included with the kit, depending upon the kit selected.

The SIMS LP Kits with a manometer are used to measure cerebrospinal fluid pressure in centimeters of water (cm of H2O). The manometer consists of two calibrated sections of tubing with a connector welded to the upper portion of the tubing.

Lumbar puncture is performed with standard prep and procedural componentry, similar to those used in spinal anesthesia kits, with the addition of a two part manometer, a 3-way stopcock and 5 inches of small bore extension tubing for the measurement of intracranial CSF pressure.

This document, a 510(k) summary for the SIMS Lumbar Puncture (LP) Kit, explicitly states:

"There were no nonclinical or clinical tests performed with these kits."

Therefore, based on the provided text, there is no study described that proves the device meets specific acceptance criteria.

Consequently, I cannot provide information for the following points as no such data is present in the document:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are provided.
2. Sample sized used for the test set and the data provenance: No test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth established from experts for a test set.
4. Adjudication method for the test set: No test set means no adjudication method.
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 study was performed, and this device is not an AI-based system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone performance study was done for an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth established.
8. The sample size for the training set: No training set was used.
9. How the ground truth for the training set was established: No training set means no ground truth establishment for it.

The document does offer a "SUMMARY OF PERFORMANCE DATA" for the manometer component stating: "Performance testing of the proposed kits show the SIMS manometer performed equal to or better than the predicate manometer from Abbott, both for the range in accuracy and for the average variance in accuracy." However, it does not detail the methodology, sample size, specific acceptance criteria, or raw performance data for this comparison. It only states a general outcome of comparison with a predicate device.

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