CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM

• K Number: K132044
• Device Name: CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM
• Manufacturer: NEOS SURGERY S.L.
• Date Cleared: 2013-09-30 ( 90 days)
• Product Code: GXR
• Regulation Number: 882.5250
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K101235

Intended Use

The Cranial LOOP Cranial Bone Fixation Systems: Cranial LOOP, Cranial LOOP L and Cranial LOOP XL, are long-term implantable devices indicated for post-craniotomy bone flap fixation.

In cranial bone fixation procedures, the Cranial LOOP (FC050000) and Cranial LOOP L (FC050100) are for use within the calvarial gap while the Cranial LOOP XL (FC050200) is to be used for covering a standard 14 mm cranial burr hole only.

Device Description

The Cranial LOOP. Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull, without any specific surgical instrument for its handling or implantation. It is provided sterile, for single use. This submission includes a line extension for the Cranial LOOP L and Cranial LOOP XL which have new device dimensions and design features that reduce lateral movement after implantation.

Cranial LOOP and Cranial LOOP L are applied in the craniotomy gap. It can fix cranial thicknesses ranging from 1.5 mm to 24 mm and gaps ranging between 1.7 mm and those made using a craniotome standard cranial router. Cranial LOOP XL is applied in a burr hole made using a standard drill 14 mm. They can fix cranial thicknesses ranging from 4 mm to 24 mm.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the "Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System." However, the supplied document does not describe a study involving an AI or algorithm-based device that requires acceptance criteria, a test set, expert ground truth, MRMC studies, or training sets as requested in the prompt.

The document pertains to a physical medical device (a burr hole cover) and details its mechanical, functional, and biomechanical testing to demonstrate substantial equivalence to a predicate device for regulatory clearance. It clearly states: "Clinical data was not required in support of this submission."

Therefore, I cannot provide the information requested in the prompt's numbered list because the provided text does not contain any data related to an AI or algorithm-based device study.

The document mainly covers:

• Device Description: What the Cranial LOOP system is.
• Predicate Device: Its comparison to a previously cleared device (K101235).
• Nonclinical Testing: Various physical tests performed on the device to assess its functionality and performance (e.g., breaking strength, cadaveric tests, biomechanical strength, accelerated aging, dimensional tests, packaging integrity).
• Substantial Equivalence Discussion: How the new device is similar to the predicate device in terms of intended use, operating principle, design, materials, manufacturing, and sterilization processes.

To directly answer the prompt based on the absence of the requested information in the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not presented in a formal table with specific numerical acceptance criteria and reported performance values for an AI/algorithm. The document lists "Tests" (e.g., Functional verification, Cadaveric test, Biomechanical tests) but does not provide quantitative acceptance criteria or detailed numerical results for each test. Instead, it refers to the outcome generally as "Mechanical and various performance testing confirms the Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System performs as intended and is substantially equivalent to the predicate device."
2. Sample sizes used for the test set and the data provenance: Not applicable to an AI test set. For the physical device testing:
   • Functional verification: Implied that individual units were tested, but specific sample sizes are not explicitly stated (e.g., "A load was applied").
   • Cadaveric test: "Three different craniotomies were tested." (Provenance: not specified, presumably in a lab setting).
   • Accelerated aging test: "5 samples" for 'Blister seal strength', 'Leak integrity', 'Sterility', 'Tensile strength'.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering and performance testing against defined specifications, not expert consensus on data like images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is not an AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, "ground truth" refers to engineering specifications, physical properties, and performance against those specifications (e.g., "breaking strength," "adaptation to different cranium curvatures," "strength to bone flap compression"), assessed through standardized, non-clinical mechanical and biological testing.
8. The sample size for the training set: Not applicable. There is no training set for a physical implantable device.
9. How the ground truth for the training set was established: Not applicable.

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).