(139 days)
Atlas-Based Autosegmentation is a standalone software application that produces estimates of anatomy boundary contours needed for the creation of a radiotherapy treatment plan.
Contouring of radiation therapy targets and surrounding anatomical structures (also known as image segmentation) is a critical part of radiation treatment planning that can be extremely time consuming. Atlas-Based Autosegmentation (ABAS) is a software application that automates the contouring process using atlas-based autosegmentation. This method uses an already-segmented image set (atlas) to segment a set of new, user-input images using deformable registration algorithms. The contours ABAS generates are not usable for treatment as-is; they must be exported to a treatment planning system for editing. However, Atlas-based Autosegmentation provides a good starting point from which minimal editing is required, enabling the clinician to create a high quality treatment plan more efficiently.
Here's a summary of the acceptance criteria and study information for the Atlas-Based Autosegmentation (ABAS) device, based on the provided text:
Important Note: The provided document is a 510(k) summary, which often focuses on demonstrating substantial equivalence rather than detailed clinical performance studies. As such, information regarding specific quantitative acceptance criteria or detailed clinical trial results is limited. The document explicitly states: "Clinical trials were not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Clinically oriented validation test cases were written and executed in-house by CMS customer support personnel. ABAS was deemed fit for clinical use."
Therefore, many of the requested sections below will reflect the absence of such clinical studies.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Verification | ABAS successfully passed verification testing as documented in the "ABAS Verification Test Report." This testing ensured the system operates as designed. |
| Clinical Suitability | "Clinically oriented validation test cases were written and executed in-house by CMS customer support personnel. ABAS was deemed fit for clinical use." |
| Substantial Equivalence | Found substantially equivalent by the FDA to predicate devices (BrainLAB iPlan RT Dose (K053584), Pinnacle3 (K041577), IKOEngelo (K061006)). |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. The text mentions "clinically oriented validation test cases" but does not quantify the number of cases.
- Data Provenance: The document does not specify the country of origin of the data. The "clinically oriented validation test cases" were executed "in-house by CMS customer support personnel," implying they were likely internal or simulated datasets, not from external clinical sites. The data was retrospective as clinical trials were not performed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The phrase "clinically oriented validation test cases" suggests some form of clinical relevance, but the method and personnel for establishing ground truth are not described.
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Adjudication method for the test set:
- Not specified. Given the testing was "in-house by CMS customer support personnel" and clinical trials were not performed, a formal adjudication process akin to clinical studies is unlikely to have occurred.
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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:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical trials were not performed as part of the development of this product." The device's primary function is described as providing an "initial contouring function" that requires further editing by clinicians in a treatment planning system. Therefore, a study on human reader improvement with AI assistance (i.e., human-in-the-loop performance) was not presented.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense, standalone performance was assessed through non-clinical verification and internal "clinically oriented validation test cases." The device is described as a "standalone software application that produces estimates of anatomy boundary contours." The "Summary of Non-Clinical Testing" indicates "Verification tests were written and executed to ensure that the system is working as designed," and the "clinically oriented validation test cases" were used to deem ABAS "fit for clinical use." However, quantitative metrics of accuracy, precision, etc., for this standalone performance against a defined ground truth, are not provided in this summary. It's also important to note the disclaimer that "The contours ABAS generates are not usable for treatment as-is; they must be exported to a treatment planning system for editing."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For the "clinically oriented validation test cases," the nature of the ground truth is not detailed beyond "already-segmented image set (atlas)" being used in the process. It's reasonable to infer that the "atlas" itself serves as a form of expert-derived ground truth for the autosegmentation process.
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The sample size for the training set:
- Not specified. The device uses an "atlas-based autosegmentation" method, which implies a training set or an "atlas" library. However, the size or composition of this atlas is not mentioned. It states that users can "expand its library of atlases," suggesting a flexible and potentially user-managed training-like data source.
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How the ground truth for the training set was established:
- The document implies that the ground truth for the model's operation is derived from "already-segmented image set (atlas)." How these initial atlas segmentations were created (e.g., by experts, manually) is not detailed in this summary.
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1080799
AUG - 7 2008
510(k) Summary of Safety & Efficacy Atlas-Based Autosegmentation 510(k)
Submitter Name: Computerized Medical Systems, Inc. Submitter Address: 1145 Corporate Lake Drive St. Louis, MO 63132-1716 Submitter Phone: 314 993 0003 Submitter Fax: 314 993 0075 Contact Person: Kathryn Stinson - Regulatory Affairs Associate Date Summary Prepared: Device Trade Name: Atlas-Based Autosegmentation Device Common Name: Autosegmentation Software Device Classification: System, Simulation, Radiation Therapy per 21CFR892.5840 Substantial Equivalence: BrainLAB iPlan RT Dose (K053584) Pinnacle3 (K041577); IKOEngelo (K061006);
Level of Concern & Rationale*: Major
*Per FDA document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005.
4b of Table 1, "Does the Software Device control the delivery of potentially harmful energy that could result in death or serious injury, such as radiation treatment systems ... " Atlas-Based Autosegmentation (abbreviated "ABAS") does not directly control the linear accelerator that delivers the radiation. Once completed, contours are sent to a treatment planning system where dose is calculated and contours are adjusted. reviewed, approved by qualified clinicians and subject to quality assurance practices before treatment actually takes place. There is no automatic link between the ABAS software and the linear accelerator. ABAS is not a full treatment planning system and performs only an initial contouring function. However, because previous guidance has held that radiation treatment planning systems are devices of major concern, and because we believe ABAS falls under the larger category of software programs associated with treatment planning, we have assumed a "major" level of concern for the purposes of this submission.
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Device Description: Contouring of radiation therapy targets and surrounding anatomical structures (also known as image segmentation) is a critical part of radiation treatment planning that can be extremely time consuming. Atlas-Based Autosegmentation (ABAS) is a software application that automates the contouring process using atlas-based autosegmentation. This method uses an already-segmented image set (atlas) to segment a set of new, user-input images using deformable registration algorithms. The contours ABAS generates are not usable for treatment as-is; they must be exported to a treatment planning system for editing. However, Atlas-based Autosegmentation provides a good starting point from which minimal editing is required, enabling the clinician to create a high quality treatment plan more efficiently.
Device Intended Use: Atlas-Based Autosegmentation is a standalone software application that produces estimates of anatomy boundary contours needed for the creation of a radiotherapy treatment plan.
Summary of Technological Characteristics Compared to Predicate Devices: ABAS is unique compared to substantially equivalent products in that it performs only autosegmentation. BrainLAB's iPlan RT Dose and Phillips/ADAC's Pinnacle are fully functioning treatment planning systems that include autosegmentation, contour editing, dose calculation and plan review. IKOEngelo allows the user to edit contours in addition to providing autosegmentation capability. ABAS's sole function is to automatically generate estimated contours generated are not clinically usable as-is, and ABAS does not offer the tools necessary to edit them. The user must export the segmented image sets to a treatment planning system for contour editing, dose calculation, plan review and other necessary treatment planning activities.
ABAS uses an altas-based approach to autosegmentation. like iPlan and IKOEngelo, and allows the user to expand its library of atlases just as Pinnacle3 allows the user to save new models and templates. Like all of the predicate devices, ABAS uses deformable registration and communicates with other treatment planning applications using DICOM.
A detailed comparison can be found in section 12 of this submittal.
Summary of Clinical Testing: Clinical trials were not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Clinically oriented validation test cases were written and executed in-house by CMS customer support personnel. ABAS was deemed fit for clinical use.
Summary of Non-Clinical Testing: Verification tests were written and executed to ensure that the system is working as designed. Pass/fail requirements and results of this testing can be found in the ABAS Verification Test Report, which is included in section 18 of this submittal. ABAS successfully passed verification testing.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 2008
Ms. Kathryn Stinson Regulatory Affairs Associate Computerized Mcdical Systems, Inc. 1145 Corporate Lake Drive ST. LOUIS MO 63132
Re: K080799
Trade/Device Name: Atlas-Based Autosegmentation Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN and MUJ Dated: July 18, 2008 Received: July 20, 2008
Dear Ms. Stinson:
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 such 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.
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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. Youngers of Your of t 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 100-1050.
This letter will allow you to begin marketing your device as described in your Section 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, pervoits 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliari) produce of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRF s Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reportion (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may othing other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-241 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/industry/support/indox.2011 or
Sincerely yours,
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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Statement of Indication for Use Atlas-Based Autosegmentation 510(k)
Atlas-Based Autosegmentation is a standalone software application that produces estimates of anatomy boundary contours needed for the creation of a radiotherapy treatment plan.
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Concurrence of the Center for Devices and Radiological Health, Office of Device Evaluation (ODE)
Prescription Use
OR per 21 CFR 801.109
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Atlas-Based Autosegmentation 510(k) Computerized Medical Systems, Inc.
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§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.