(14 days)
Advanced Lung Analysis (ALA-1) is intended to provide an optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lessons etc.) form a set of computed Tomography (CT) images. The analysis is performed on the Advantage Windows Workstation (K913770). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. This may aid the physician in characterization of suspicious nodules and thus, patient management care decision process.
Advanced Lung Analysis-1 (ALA-1) is an image analysis software package that provides support to the medical professional in assessing abnormalities such as lesions and nodules and changes in their growth over time. This software allows volumetric estimation of a lesion or nodule size over time. It contains productivity tools such as the book marking tool to keep a record of previously found nodules/lesions, the comparator tool to allow 'synchromized' comparison of nodule/lesion over time, database of all the nodules/lesions detected and enhanced speed and efficiency of the review process.
The provided document (K013381 - Advanced Lung Analysis-1) describes the device and its intended use, but it does not contain any data from a study demonstrating specific acceptance criteria or device performance measurements, nor does it detail acceptance criteria themselves.
The document states that ALA-1 "performs as well as devices currently on the market" and that "GE considers features of the ALA-1 to be equivalent to those of Tissue Volume (K963345)". This suggests a claim of substantial equivalence based on functional similarity rather than a detailed performance study with specific acceptance criteria.
Therefore, many of the requested details cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria or report specific performance metrics from a study (e.g., accuracy, sensitivity, specificity, or volume measurement deviation). It only states that the device is "substantially equivalent" to a predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not mention any specific test set, sample size, or data provenance for a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot be provided. The document does not describe the establishment of a ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No adjudication method is described as there's no mention of a test set with expert review.
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
- Cannot be provided. The document does not describe any MRMC comparative effectiveness study or any study where human readers' performance with and without AI assistance was evaluated.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. There is no mention of a standalone performance study. The description of the device ("provides support to the medical professional") implies a human-in-the-loop context, but no study details are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. As no performance study with a defined ground truth is mentioned, the type of ground truth is not specified.
8. The sample size for the training set
- Cannot be provided. There is no information regarding a training set or its sample size.
9. How the ground truth for the training set was established
- Cannot be provided. As there is no information about a training set, how its ground truth was established is also not mentioned.
Summary from the document:
The product, Advanced Lung Analysis-1 (ALA-1), is an image analysis software package for Computed Tomography (CT) images. Its purpose is to assist medical professionals in assessing lung abnormalities like lesions and nodules, tracking their changes over time, and estimating volume doubling time. It includes productivity tools for bookmarking, synchronized comparison, and database management. The FDA granted 510(k) clearance based on its substantial equivalence to the predicate device, "Tissue Volume" (K963345), manufactured by General Electric Medical Systems. The clearance letter confirms that ALA-1 can be marketed subject to general controls, as it does not pose new safety risks and performs comparably to existing devices. However, no specific performance metrics or study details (like sample sizes, ground truth methodology, or expert qualifications) are provided in this summary.
§ 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.