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K Number
K140369
Device Name
MEDLINE NEURO SPONGE
Manufacturer
MEDLINE INDUSTRIES, INC.
Date Cleared
2014-09-26

(224 days)

Product Code
HBA
Regulation Number
882.4700
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The device is intended to be used by trained physicians in neurosurgical procedures to protect nervous tissue, absorb fluids and stop bleeding.

Device Description

Not Found

AI/ML Overview

This looks like a 510(k) clearance letter from the FDA for a medical device called "Medline Neuro Sponge". This document is an approval letter, not a scientific study report or clinical trial summary.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and performance studies.

Here's why and what kind of information is present:

  • 510(k) Clearance: This is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically relies on demonstrating equivalence to an existing device, rather than proving novel performance against specific acceptance criteria through a new study.
  • Content of this Document:
    • It confirms that the FDA has reviewed the 510(k) premarket notification (K140369) for the "Medline Neuro Sponge".
    • It states that the device is "substantially equivalent" to legally marketed predicate devices.
    • It outlines the regulatory classification (Class II, Product Code: HBA) and regulation number (21 CFR 882.4700 - Neurosurgical Paddle).
    • It lists the general controls provisions of the Act that apply to the device.
    • It includes the "Indications for Use" for the device, which state it is "intended to be used by trained physicians in neurosurgical procedures to protect nervous tissue, absorb fluids and stop bleeding."

To answer your prompt, you would need a different type of document, such as:

  • A clinical study report.
  • A summary of safety and effectiveness data (such as an SSED for a PMA device, though this is a 510(k)).
  • A scientific publication describing the device's performance.

Since none of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, training set details) is present in this FDA clearance letter, I cannot populate your table or answer your specific questions based on this input.

§ 882.4700 Neurosurgical paddie.

(a) A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.
(b)
Classification. Class II (performance standards).