Search Results

The Lumbar Puncture Kit is designed to collect samples of cerebralspinal fluid (CSF) from a patient while undergoing a lumbar puncture procedure. This device is also designed to attach a manometer to measure intracranial pressure (ICP), detect blood in CSF, inject dyes and gasses into the spine for radiologic studies, and to administer drugs or anesthesia between the third and fourth lumbar vertebrae in adult or pediatric patients.

In accordance with section 510 (k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the Lumbar Puncture Kit. The Lumbar Puncture Kit is designed to collect samples of cerebralspinal fluid (CSF) from a patient while undergoing a lumbar puncture procedure. This device is also designed to attach a manometer to measure intracranial pressure (ICP), detect blood in CSF, inject dyes and gasses into the spine for radiologic studies, and to administer drugs or anesthesia between the third and fourth lumbar vertebrae in adult or pediatric patients.

This document is a 510(k) summary for a medical device (Lumbar Puncture Kit). It's focused on demonstrating substantial equivalence to previously cleared devices for regulatory approval, not on presenting a study with acceptance criteria for device performance as would be expected for an AI/software as a medical device (SaMD) product.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided text. This type of information is typically found in clinical validation studies for AI/SaMD, which is not what this document is.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided. This document does not describe specific performance-based acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or reported device performance in those terms. It focuses on physical and visual testing as part of manufacturing release.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided. No "test set" in the context of an AI/SaMD performance study is mentioned. The testing described refers to manufacturing quality control, not a clinical performance evaluation.

3. 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)

• Cannot be provided. No ground truth establishment by experts is described, as this is not an AI/SaMD performance study.

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

• Cannot be provided. No adjudication method is mentioned.

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

• Cannot be provided. No MRMC study is mentioned. This document is for a physical medical device, not an AI-assisted diagnostic tool.

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

• Cannot be provided. No standalone algorithm performance is mentioned, as this is not an AI/SaMD.

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

• Cannot be provided. No ground truth in the context of a clinical performance study is mentioned. The "testing" refers to meeting product design specifications for material properties and manufacturing.

8. The sample size for the training set

• Cannot be provided. No "training set" is mentioned. This is a non-AI physical device.

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

• Cannot be provided. No "training set" or its ground truth establishment is mentioned.

Summary derived from the provided text regarding "acceptance criteria" (though not in the AI/SaMD sense) and how it's met:

The document states that "All finished products are tested and must meet all required release specifications before distribution."

Acceptance Criteria (as described for manufacturing release):

• Meeting "required release specifications"
• Conformance to "product design specifications"

Reported Device Performance / How Criteria are Met:

• "The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product)."
• "The physical testing is defined by Quality Control Test Procedure documents."
• "These tests are established testing procedures and parameters which conform to the product design specifications."
• "The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP's."

In essence, the "acceptance criteria" are the internal quality control and design specifications, and the "study" is the routine manufacturing testing and product release procedures, ensuring the device meets its established physical and visual standards. The document emphasizes substantial equivalence to predicate devices and adherence to GMPs.

Ask a specific question about this device

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.

Ask a specific question about this device