AUTOBONE2

• K Number: K061625
• Device Name: AUTOBONE2
• Manufacturer: GE HEALTHCARE
• Date Cleared: 2006-06-26 ( 14 days)
• Product Code: JAK
• Regulation Number: 892.1750
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: K031871

Intended Use

The AutoBone 2 option is a software package that is intended to facilitate segmentation of bonv structures and calcifications from abdominal and extremity CT Angiography data.

Device Description

AutoBone 2 is an optional software extension of the Volume Viewer application for Advantage Workstation. This software can be used in order to facilitate visualization of vessel features and assist in segmentation of bony and calcified structures

AI/ML Overview

The provided text is a 510(k) summary for the GE Healthcare AutoBone 2 device. It describes the device, its intended use, and its substantial equivalence to a predicate device ("AutoBone", K031871). However, this document does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria.

Missing Information:

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on similar intended use and technology. It explicitly states: "AutoBone 2 does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the AutoBone 2 to be equivalent to AutoBone." This implies that explicit new performance studies with detailed acceptance criteria were not required or provided for this 510(k) submission, as the device is considered equivalent to a previously cleared product.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, sample sizes, ground truth establishment, or clinical study details, as this information is not present in the provided document.

To summarize, with respect to your request:

1. A table of acceptance criteria and the reported device performance: Not available in the document.
2. Sample size used for the test set and the data provenance: Not available in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in the document.
4. Adjudication method: Not available in the document.
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 available in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in the document (the device is an "optional software extension" to an existing application, implying it assists, rather than replaces, a human).
7. The type of ground truth used: Not available in the document.
8. The sample size for the training set: Not available in the document.
9. How the ground truth for the training set was established: Not available in the document.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.