The NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System is intended for use by a qualified clinician in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in intraparenchymal applications.

Device Description

The NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System consists of a single-use parenchymal probe for the real-time measurement of cerebral blood flow (CBF) and intracranial pressure (ICP) and a monitor for the display and storage of these measured variables and the computation and display of derived variables.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring System". This document focuses on the substantial equivalence of the modified device to a previously cleared device (K050720) and outlines the system's functionalities and compliance with various FDA and AAMI guidelines and standards for medical device software and safety.

However, the document does NOT contain information regarding:

Specific acceptance criteria (e.g., target accuracy, sensitivity, specificity values).
Any study that provides performance data against such acceptance criteria.
Details on sample sizes for test sets, data provenance, number/qualifications of experts, or adjudication methods for ground truth establishment.
Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
The type of ground truth used for performance claims.
Training set sample size or how ground truth was established for a training set.

The document primarily focuses on verification and validation (V&V) testing of the system's operations and software to confirm that the product's functional specifications met the defined requirements. It states that "The result of software testing indicates the System Requirements Specifications and System Functional Specifications have been fully met and that the NeuroSensor System is safe for use...". This is a statement of successful system verification, not a clinical performance validation against specific disease detection or measurement accuracy targets.

Therefore, I cannot populate the requested table or address most of the questions because the necessary clinical performance data and study details are not present in the provided text.

Based on the provided text, here's what can be stated:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document. (No quantitative performance metrics like accuracy, sensitivity, specificity, or specific measurement tolerances are provided.)	The software testing indicates that "System Requirements Specifications and System Functional Specifications have been fully met" and that the "NeuroSensor System is safe for use as a cerebral blood flow and intracranial pressure monitoring system".

2. Sample size used for the test set and the data provenance

Sample size for test set: Not specified. The document mentions "system testing" and "software testing" but provides no details on the number of cases or patients involved in assessing performance.
Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. The document describes system and software testing, not clinical performance validation against expert-established ground truth for disease or condition assessment.

4. Adjudication method for the test set

Not applicable/Not specified.

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. This device is a monitoring system that measures physiological parameters. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data for a diagnostic task. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's function as described.

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

The document implies that the system's functionality (data integrity, display, storage, mechanical/electrical functionality, instructional content) was tested, which could be considered a form of standalone system testing. However, this is not a "standalone algorithm performance" in the context of diagnostic AI where an algorithm makes a decision independently. It's validation of the device's operational capabilities.

7. The type of ground truth used

Not specified in terms of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for the testing described appears to be the "System Requirements Specifications and System Functional Specifications" themselves, meaning the system was tested to ensure it performed according to its design specifications (e.g., displaying data correctly, storing data, mechanical function).

8. The sample size for the training set

Not applicable/Not specified. This device is a physiological monitoring system, not a machine learning model that requires a training set in the conventional sense of AI development for diagnostic tasks.

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

Not applicable/Not specified, as this device does not appear to use a training set in the context of machine learning.

Summary

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510(k) SUMMARY

Submitter's Name and Address:

Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536 609-275-0500 (Telephone) 609-275-9445 (Fax)

Contact Person and Telephone Number:

Jon Caparotta, RAC Director Requlatory Affairs Integra LifeSciences Corporation 609-936-2495

Date Summary was Prepared: July 24, 2007

Name of the Device:

Trade Name:	NeuroSensor® Cerebral Blood Flow and IntracranialPressure Monitoring System
Common Name:	Neurological Diagnostic Device
Classification Name:	Intracranial Pressure Monitoring Device,21 CFR 882.1620, Product Code GWM
Classification Panel:	Neurology Device Panel

Substantial Equivalence:

The modified NeuroSensor® Cerebral Biood Flow and Intracranial Pressure Monitoring System is substantially equivalent in function and intended use to the NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System previously cleared under 510(k) K050720 on 5/11/05.

Testing was performed by Integra NeuroSciences, San Diego, CA, Integra NeuroSciences, Andover,UK and GemSoft, Inc in accordance with Integra established test protocols utilizing the following guidelines and standards:

. FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005
FDA Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf . Software Use in Medical Devices, September 9, 1999
. General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002
AAMI TIR32:2004, Medical Device Software Risk Management .
IEC 601.1, General Requirements for Safety Medical Electrical Equipment (in . process and to be completed prior to market release)

The result of software testing indicates the System Requirements Specifications and System Functional Specifications have been fully met and that the NeuroSensor System

AUG -6 2007

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K071505

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is safe for use as a cerebral blood flow and intracranial pressure monitoring system in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in intraparenchymal applications.

System testing was performed in accordance with established protocols to confirm the NeuroSensor System requirements as outlined in the product's functional specification met the product's defined requirements. These tests included verification and validation of the following System operations:

Screen Administrative Functions
를 Data Integrity, Display and Storage
. Mechanical and Electrical Functionality
트 Instructional and Informational Content

Device Description:

Indications for Use:

Technological Characteristics:

The NeuroSensor® System consists of a single-use probe and introducer for the continuous real-time measurement of Cerebral Blood Flow (CBF) and Intracranial Pressure (ICP), and a monitor for the display and storage of these measured parameters and the computation and display of derived parameters.

Two transducers are located at the tip of the probe. The CBF transducer consists of two optical fibers and functions by the principles of laser doppler flowmetry. The ICP sensor is a MEMS (Micro-Electro Mechanical System) silicon strain gauge. The probe is designed for use with the NeuroSensor® Model NS-100 monitor. A "cranial bolt" introducer is included with each probe. The cranial bolt is inserted in a twist drill hole in the skull. The probe is inserted into brain and is held in position by the cranial bolt.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 2007

Integra Lifesciences Corporation % Mr. Jon Caparotta Director Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K071505

Trade/Device Name: NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial pressure monitoring device Regulatory Class: II Product Code: GWM Dated: July 19, 2007 Received: July 20, 2007

Dear Mr. Caparotta:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Mr. Jon Caparotta

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10gally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon othnia other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .

Sincerely yours,
Mark N. Milbersen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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7/505

INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name: NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System

Indications for Use:

NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System, is intended for use by a qualified clinician in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in intraparenchymal applications.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use (Part 21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Melkerson

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

Regulation Number and Section

§ 882.1620 Intracranial pressure monitoring device.

(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).