(46 days)
iPlan RT FiberTracking's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic and other imaging sources including
- image preparation -
- image localization -
- image fusion -
- image segmentation -
- isocenter handling -
- plan review and approval
- fiber tracking -
where the result is used for stereotactic radiation treatment planning that is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.
Fiber Tracking:
iPlan RT FiberTracking's indication for use is to prepare and present patient and image data based on MRI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation and display of fiber bundles in a selected region of interest. The created treatment plans of iPlan TT FiberTracking can be used million in a scienced region of interest. The StainLAB medical devices such as BrainSCAN, iPlan RT Image, and iPlan RT Dose where this medical device is used for radiotherapy treatment planning.
iPlan RT FiberTracking is developed to enhance the functionality of Intuition Image software with the import and il lan in 11 Tiber Husking to do volupes (DTI). Additional to the basic functions of Intuition Image (viewing, drawing, planning of annuolen concernment of this application provides functions for the import and inflage fusion and attrootable racessing of the DTI data and the display of calculated fiber tracks.
This document provides a summary of the iPlan RT FiberTracking device and its substantial equivalence to a predicate device, rather than a detailed study proving its acceptance criteria. Therefore, I cannot fully complete all sections of your request based solely on the provided text.
However, I can extract the information that is present and highlight what is missing.
Here's a breakdown of the available and missing information regarding acceptance criteria and a study proving device performance:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a table of acceptance criteria or reported device performance metrics for the iPlan RT FiberTracking. It states that the device "has been verified and validated according to BrainLAB's procedures for product design and development," and "The trailer was found to be substantially equivalent with the predicate device iPlan! FiberTracking (K041703) and Intuition Image (K032511)." This indicates that the device met internal validation criteria and regulatory substantial equivalence, but specific performance metrics or their comparison against acceptance criteria are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the text.
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)
This information is not provided in the text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the text.
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
This information is not provided in the text. The document describes a "planning system" and "medical charged-particle radiation therapy system" that includes "fiber tracking." While fiber tracking involves advanced image processing, the text does not characterize it as an "AI" system in the modern sense or discuss human-in-the-loop performance studies with AI assistance. The focus is on the device's functionality and substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The text describes the iPlan RT FiberTracking as a system that "prepares and presents patient and image data" and is used for "calculation and display of fiber bundles." This suggests it's an algorithm-driven component. However, the document does not explicitly state that a standalone performance study was conducted or provide its results. The substantial equivalence claim implies that its performance is comparable to predicate devices, which would have undergone their own validation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the text.
8. The sample size for the training set
This information is not provided in the text. The device's description does not explicitly mention "training set" in the context of machine learning, as this document predates the widespread use of deep learning in medical devices. The development process emphasizes "verification and validation," which implies testing against established data, but not necessarily a distinct "training set" as understood today.
9. How the ground truth for the training set was established
This information is not provided in the text.
In summary:
The provided document is a 510(k) premarket notification summary focused on establishing substantial equivalence to existing predicate devices. It states that the device was "verified and validated according to BrainLAB's procedures for product design and development" to ensure its safety and effectiveness. However, it does not include the detailed study methodology, acceptance criteria, specific performance metrics, or patient data acquisition details that would typically be found in a clinical study report. The substantial equivalence argument itself serves as the regulatory "proof" that the device meets acceptance criteria by being similar to already-accepted devices.
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SEP 3 0 2005
K05 22
5 Po 11 Summary of etv and Effectiveness for iPlan RT FiberTracking
Manufacturer:
| Address: | BrainLAB AGAmmerthalstrasse 885551 HeimstettenGermanyPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33 |
|---|---|
| Contact Person: | Mr. Per Persson |
| Summary Date: | August 11, 2005 |
| Device Name: | |
| Trade name: | iPlan RT FiberTracking |
Common/Classification Name:
Planning System / Medical charged-particle radiation therapy system
Predicate Device: iPlan! FiberTracking (K041703). Intuition Image (K032511).
Device Classification Name: Medical charged-particle radiation therapy system Regulatory Class: Class II
Indications For Use:
iPlan RT FiberTracking's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic and other imaging sources including
- image preparation -
- image localization -
- image fusion -
- image segmentation -
- isocenter handling -
- plan review and approval
- fiber tracking -
where the result is used for stereotactic radiation treatment planning that is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.
Fiber Tracking:
iPlan RT FiberTracking's indication for use is to prepare and present patient and image data based on MRI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation and display of
{1}------------------------------------------------
fiber bundles in a selected region of interest. The created treatment plans of iPlan TT FiberTracking can be used million in a scienced region of interest. The StainLAB medical devices such as BrainSCAN, iPlan RT Image, and iPlan RT Dose where this medical device is used for radiotherapy treatment planning.
Device Description:
iPlan RT FiberTracking is developed to enhance the functionality of Intuition Image software with the import and il lan in 11 Tiber Husking to do volupes (DTI). Additional to the basic functions of Intuition Image (viewing, drawing, planning of annuolen concernment of this application provides functions for the import and inflage fusion and attrootable racessing of the DTI data and the display of calculated fiber tracks.
Substantial equivalence:
Substantial equivalioner.
iPlan RT FiberTracking has been verified and validated according to BrainLAB's procedures for product design in in 11 i be rrucking nad boon vermes the safety and effectiveness of the system. The information provided by and developmont. The railer was found to be substantially equivalent with the predicate device iPlan! FiberTracking (K041703) and Intuition Image (K032511).
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Mr. Rainer Birkenbach Executive Vice President BrainLAB AG Ammerthalstrasse 8 85551 Heimstetten Germany
SEP 3 0 2005
Re: K052220
Trade/Device Name: iPlan RT FiberTracking Regulation Number: 21 CFR 892.5050 Regulation Name: Medical chargedparticle radiation therapy system Regulatory Class: II Product Code: IYE, MUJ Dated: August 11, 2005 Received: August 15, 2005
Dear Mr. Birkenbach:
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 requirc 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 (Premarket Approval), 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.
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 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, 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:
| 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" (21 CFR 807.97). You may obtain 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) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon 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): | Kp52222 |
|---|---|
| --------------------------- | --------- |
Device Name:
iPlan RT FiberTracking
Indications For Use:
iPlan RT FiberTracking's indications for use is to prepare and present patient and image data based on CT, MR, Angiographic and other imaging sources including
- image preparation -
- image localization ﮯ
- image fusion -
- image seqmentation -
- isocenter handling -
- plan review and approval -
- fiber tracking
where the result is used for stereotactic radiation treatment planning that is intended for use in wholo the roban formal, computer planned, LINAC based radiation treatment of cranial, head and neck and extracranial lesions.
Fiber Tracking:
iPlan RT FiberTracking's indication for use is to prepare and present patient and image data based on MRI scanned with diffusion-weighted sequences. These diffusion images are used for the calculation mnt ooallify of fiber bundles in a selected region of interest. The created treatment plans of iPlan RT and display of can be used with other iPlan treatment plans and other BrainLAB medical devices such as BrainSCAN, iPlan RT Image, and iPlan RT Dose where this medical device is used for radiotherapy treatment planning.
(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
(Optional Format I-2-96)
Division of Reproductive, Abdom
§ 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.