The Grossman Self-Retaining Low Profile Brain Retractor is a flexible multi segmented device. The device consists of a flexible multi segmented arm. interchangeable blades, and a clamping fixture to anchor the retractor arm in place. The flexible arm and the clamp fixture are constructed of Stainless Steel and Anodized Aluminum components. The retractor blades are constructed from Stainless Steel.

AI/ML Overview

I am sorry, but based on the provided document, I cannot answer your request. The document describes a medical device, the Grossman Self-Retaining Low Profile Brain Retractor, and its 510(k) summary for FDA clearance. It focuses on the device's description, classification, predicate devices, and substantial equivalence to those predicates.

Crucially, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.

The information provided confirms that the device is a Class II medical device, categorized as a self-retaining retractor for neurosurgery, and was granted 510(k) clearance based on its substantial equivalence to predicate devices (Budde®-Halo Retractor and Tew Cranial/Spinal Retractor). The FDA's letter (pages 2-3) reinforces this by stating that the clearance is based on substantial equivalence for the stated indications for use, not on a detailed performance study with specific acceptance criteria as you've requested.

Therefore, I cannot extract the requested table of acceptance criteria, study details, or ground truth information because this content is not present in the provided text.

Summary

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510(K) SUMMARY

Submitter: KLS-Martin, L.P. 11239-1 St. Johns Industrial Parkway South Jacksonville, FL 32246 Phone: 904-641-7746 Fax: 904-641-7378

Contact Person: Jennifer Damato Director RA/QA
Date of Summary: 10 January 2006

Classification

Device Description:

Device

Name and Number:

Regulatory Class:

Grossman Self-Retaining Low Profile Brain Retractor Device Name:

Trade Name: Grossman Self-Retaining Low Profile Brain Retractor

Common Name: Retractor, Self-Retaining

Retractor, Self-Retaining, For Neurosurgery (CFR 882.4800)

Predicate Devices: Budde®-Halo Retractor (K830332)

Tew Cranial/Spinal Retractor 1090 Model A (K960807)

K060097

The Grossman Self-Retaining Low Profile Brain Retractor is designed to retract soft tissue during neurosurgical procedures.

Description: The Grossman Self-Retaining Low Profile Brain Retractor is a flexible multi segmented device. The device consists of a flexible multi segmented arm. interchangeable blades, and a clamping fixture to anchor the retractor arm in place. The flexible arm and the clamp fixture are constructed of Stainless Steel and Anodized Aluminum components. The retractor blades are constructed from Stainless Steel.

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Technological Characteristics:

Similarities to Predicate

The Grossman Self-Retaining Low Profile Brain Retractor is similar in application to the Budde®-Halo Retractor (Halo Retractor Arm) (K830332) and the Tew Cranial/Spinal Retractor Model A1090 (Flexible Micro-Retractor Arm) (K960807).

Differences to Predicate

The Grossman Self-Retaining Low Profile Brain Retractor is a stand alone device that is independently mounted and does not rely on a complete system to be utilized.

Substantial Equivalence:

The Grossman Self-Retaining Low Profile Brain Retractor is substantially equivalent in design and application to the Budde®-Halo Retractor (Halo Arm) (K830332) and the Tew Retractor Cranial/Spinal Retractor Model A1090 (Flexible Micro-Retractor Arm) (K960807).

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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 consists of a stylized eagle with three stripes forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2006

KLS-Martin, L.P. c/o Ms. Jennifer Damato Director Regulatory Affairs and Quality Assurance 11239 St. Johns Industrial Parkway South Jacksonville, Florida 32246

Re: K060097

Trade/Device Name: Grossman Self-Retaining Low Profile Brain Retractor Regulation Number: 21 CFR 882.4800 Regulation Name: Self-retaining retractor for neurosurgery Regulatory Class: II Product Code: GZT Dated: January 10, 2006 Received: January 13, 2006

Dear Ms. Damato:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrobare) to regary the Medical Device Amendments, or to conimered prices that have been reclassified in accordance with the provisions of the Federal Food. Drug. devices mat have been require approval of a premarket approval application (PMA). and Costicule Act (71ct) that do novice, subject to the general controls provisions of the Act. The r ou may, merelore, mantes of the Act include requirements for annual registration, listing of general controls proficions 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 it may be subject to sach additional ventrol - Ling. Title 21, Parts 800 to 898. In addition, FDA ean of found in the overaling your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease of advised that I Driviseanse a vour device complies with other requirements of the Act that I DA has made a acturinmentations administered by other Federal agencies. You must of any I cuctar statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the Ace 3 requirements, 01); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Damato

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 & legally 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" (21 CFR Part 807.97). You may obtain 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) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Enclosure

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Indications for Use

510(k) Number (if known): ├ОЄ: ССУД 7

Grossman Self-Retaining Low Profile Brain Retractor Device Name:

Indications For Use:

The Grossman Self-Retaining Low Profile Brain Retractor is designed to retract soft tissue during neurosurgical procedures.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices	Page 1 of

" ! ! (k) Number_ Ko60097

Regulation Number and Section

§ 882.4800 Self-retaining retractor for neurosurgery.

(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).