GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00

• K Number: K060097
• Device Name: GROSSMAN SELF-RETAINING LOW PROFILE BRAIN RETRACTOR, MODEL 04-001-00
• Manufacturer: KLS-MARTIN L.P.
• Date Cleared: 2006-02-27 ( 45 days)
• Product Code: GZT
• Regulation Number: 882.4800
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K830332 , K960807

Intended Use

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

Device 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.

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.

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).