FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

I apologize, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Neo-Care Peritoneal Dialysis Administration Set) and an "Indications for Use Statement."

This document does not contain any information regarding acceptance criteria or a study that proves the device meets acceptance criteria. It is a regulatory communication stating that the device is substantially equivalent to a previously marketed device and can therefore be marketed.

Therefore, I cannot provide the requested information based on the input text. The questions you've asked (about sample size, ground truth, expert qualifications, etc.) are related to performance studies, which are not detailed in this regulatory document.

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K Number

K970997

Device Name

NEO-CARE LUMBER PUNCTURE KIT

Manufacturer

KLEIN-BAKER MEDICAL, INC.

Date Cleared

1997-05-22

(64 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

A single use, disposable, lumbar puncture kit for collection and sampling of spinal fluid from Neonatal patients.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the Neo-Care Lumbar Puncture Kit. It is not a study report or a summary of a study that establishes acceptance criteria and reports device performance against those criteria. Therefore, most of the requested information cannot be extracted from this document.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device's clearance is based on substantial equivalence to a predicate device, rather than a standalone study demonstrating performance against predefined acceptance criteria. The FDA reviews the provided information to ensure the new device is as safe and effective as a legally marketed predicate device.

Therefore, the following information cannot be provided based on the given text:

A table of acceptance criteria and the reported device performance
Sample sizes used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
Whether a standalone (algorithm only) performance study was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

The only piece of relevant information provided is the Indications for Use:

Indications for Use: A single use, disposable, lumbar puncture kit for collection and sampling of spinal fluid from Neonatal patients.