(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.
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Image /page/0/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'GE' intertwined within a circular shape. The letters and the circle are in black, with some white highlights to give a sense of depth and dimension to the design. The overall design is simple, yet recognizable as the brand identity of General Electric.
GE Medical Sys
General Electric Com P O Box 414 Milwaukee, WI 53201
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
- Submitter Larry A. Kroger, Ph.D. Senior Regulatory Program Manager Telephone: (262) 544-3894, FAX: (262) 544-3863 Date Prepared: August 22, 2001
PRODUCT IDENTIFICATION
| Name: | Advanced Lung Analysis-1 |
|---|---|
| Classification Name: | Accessory to Computed Tomography System |
| Classification Number: | 892.1750 |
| Manufacturer : | General Electric Medical Systems283, rue de la Miniere78533 Buc Cedex, FRANCE |
| Distributor: | General Electric Medical Systems, Milwaukee, WI |
Marketed Devices Advanced Lung Analysis is substantially equivalent to the device listed below:
| Model: | Tissue Volume |
|---|---|
| Manufacturer: | General Electric Medical Systems, Milwaukee, WI |
| 510(k) #: | K963345 |
Device Description:
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.
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Indications for Use:
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.
Comparison with Predicate:
ALA-1 is an image analysis software package that allows extraction of a suspicious lesion/nodule area found in a series of CT images from the surrounding lung tissue. The tool is laid out to give volumetric estimation of a lesion or nodule size over time. The functional features of this package are substantially equivalent to that of the following device:
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|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------.11 100 100 000 000 0 0 0 0 1 8 0 1 1 00 1 0 0 1 0 0 1 1 1 000 1 00 1 1 1 1 0000000 00 0 1 1 1 1 0000000 00 0 1 1 | ANTIQUE AND AND A---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. |
Adverse Effects on Health :
The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:
- · Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
- · Adherence to industry and international standards.
Conclusions:
ALA-1 does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the ALA-1 to be equivalent to those of Tissue Volume (K963345).
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
General Electric Medical Systems % Mr. Wolfram Gmelin TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K013381
OCT 2 6 2001
Trade/Device Name: Advanced Lung Analysis-1 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: October 8, 2001 Received: October 12, 2001
Dear Mr. Gmelin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdor Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Advanced Lung Analysis (ALA-I)
Indications for Use
Advanced Lung Analysis (ALA-I) is intended to provide an optimized non-invasive application to Advanced Lung Analysis (ALA-i) is ifiended to promotes, lesions etc.) from a set of computed measure abhormalities in the lung (lor examply, the Advantage Windows Workstation The software allows measurement of volume over time using a consistent (K913770). (K913770). The Somware allows theasurement of estimation of the volume doubling time.
standardized measurement protocol, thus providing and they and thus, natient standardized measurement protocol, thus providing an ostinator of the road. So and thus, patient management care decision process.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801-109)
OR Over-The-Counter Use_
Nancy C brogdon
Division Sign (Off)
Division: Reproductive Abdominal,
and Radiological Devices
510(k) Number K013381
§ 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.