AESCULAP ABSORBABLE CRANIOFIX

• K Number: K040080
• Device Name: AESCULAP ABSORBABLE CRANIOFIX
• Manufacturer: AESCULAP, INC.
• Date Cleared: 2004-03-31 ( 76 days)
• Product Code: GXR
• Regulation Number: 882.5250
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K031654 , K021408 , K002334

Intended Use

Aesculap's Absorbable CranioFix is intended for fixation of cranial bone flaps.

Device Description

Aesculap's Absorbable CranioFix consists of two absorbable discs connected by a suture loop.

AI/ML Overview

The provided document is a 510(k) summary for the Aesculap Absorbable CranioFix, a medical device for cranial bone flap fixation. This document is a regulatory submission, not a study report, and therefore does not contain the detailed information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical or technical study.

Here's a breakdown of why the requested information is not present in this document:

• Acceptance Criteria and Reported Device Performance (Table): This type of information is typically found in a detailed performance study report. The 510(k) summary declares the device's intended use and describes its components, but it doesn't provide quantifiable performance metrics or pre-defined acceptance criteria that would be used in a study to "prove" the device meets them.
• Sample size, data provenance (test set): Not applicable as no performance study is detailed.
• Number of experts and qualifications, adjudication method (test set): Not applicable as no performance study with expert review is detailed.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable as no such study is mentioned or summarized.
• Standalone (algorithm only) performance study: Not applicable as this is a medical device, not an AI algorithm.
• Type of ground truth used: Not applicable as no performance study is detailed.
• Sample size for the training set: Not applicable as this is a medical device, not an AI algorithm.
• How the ground truth for the training set was established: Not applicable as this is a medical device, not an AI algorithm.

What the document does provide is:

• Intended Use: Fixation of cranial bone flaps.
• Device Description: Two absorbable discs connected by a suture loop.
• Substantial Equivalence: The primary method for clearance, indicating the device is equivalent to existing, legally marketed devices (Synthes Resorbable Cranial Clamp, MacroPore CraniLoc NS). This means the device relies on the established safety and effectiveness of its predicates rather than new, independent performance studies against specific acceptance criteria.
• Regulatory Information: Product code, regulation number, device class, and review panel.

To find the kind of information requested, one would typically need to refer to detailed design control documents, validation reports, or clinical trial summaries, which are usually not included in the public 510(k) summary but are part of the full 510(k) submission reviewed by the FDA.

Regulation Number and Section

§ 882.5250 Burr hole cover.

(a)
Identification. A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.(b)
Classification. Class II (performance standards).