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.

Device Description

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.

AI/ML Overview

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.

Summary

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APR - 7 1997

K970287

II. 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90

B. Braun Medical, Inc January 15, 1997 824 Twelfth Avenue Bethlehem, PA 18018 (610) 691-5400

CONTACT: Mark S. Alsberge, Regulatory Affairs Manager

PRODUCT NAME: Lumbar Puncture Kit

TRADE NAME: Lumbar Puncture Kit

CLASSIFICATION NAME: General Hospital Class II, 80 FMJ, Spinal Fluid Manometer 21 CFR 880.2500

SUBSTANTIAL EQUIVALENCE TO:

510 (k) number	Name	Applicant
K932569	Pencil Point SpinalNeedle and Tray	B. Braun of America
K920305	Pharmaseal Clear HubSpinal Needle	Baxter HealthcareCorporation

DEVICE DESCRIPTION:

The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.

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MATERIAL :

The Lumbar Puncture Kit contains components that have already been reviewed and cleared by the FDA for their intended use.

SUBSTANTIAL EQUIVALENCE:

The Lumbar Puncture Kit is equivalent in components and intended use to the Pencil Point Spinal Tray currently marketed by B. Braun Medical (formerly B. Braun of America). It is also equivalent to the Lumbar Puncture Kit manufactured by Baxter. There are no new issues of safety or effectiveness raised by the Lumbar Puncture Kit.

SAFETY AND EFFECTIVENESS:

All finished products are tested and must meet all required release specifications before distribution. 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.

.. . . . . . . . .

Regulation Number and Section

§ 880.2500 Spinal fluid manometer.

(a)
Identification. A spinal fluid manometer is a device used to measure spinal fluid pressure. The device uses a hollow needle, which is inserted into the spinal column fluid space, to connect the spinal fluid to a graduated column so that the pressure can be measured by reading the height of the fluid.(b)
Classification. Class II (performance standards).