(86 days)
I-Beam is a self-contained mobile patient positioning system that uses real time ultrasound images of patient target organs or tumors while the patient is positioned on the couch of the linear accelerator to confirm the location of these patient target organs or tumors prior to delivery of external beam radiation therapy.
The I-Beam Patient Positioning System provides a method for a hospital/clinic to accurately position a patient prior to delivery of external beam radiation therapy each day such that the patient tumor volume on the day of therapy coincides with the tumor volume from the treatment plan. Patient positioning may be necessary because of day-to-day movement of the soft tissue target within the patient. Closer alignment assures proper tumor coverage and a minimum of dose to healthy tissue and structures surrounding the target.
I-Beam achieves this alignment by having a camera provide a signal to I-Beam. The camera is attached to an ultrasound transducer body by use of a custom "clamshell" in an orientation that points the camera in a direction 180 degrees from the plane of the transducer output. As the transducer ultrasound system (not part of I-Beam) images the patient target, the camera is looking up at a targeting grid located on the shadow tray of the linear accelerator. Using pattern recognition techniques, the I-Beam system is able to determine the position of the isocenter of the target volume relative to the isocenter of the linear accelerator. The user then superimposes the ultrasound tumor volume data obtained from this scan on that from the original treatment plan data input to I-Beam earlier. This treatment plan is based on a CT study set, and the user aligns the two tumor volumes by "moving" one relative to the other. I-Beam senses this relative movement of the ultrasound tumor volume to that from the treatment plan and converts that into a three axis "translation" figure which gives the operator the amount and direction the patient must be moved in each axis to achieve alignment with the treatment plan and thus the linear accelerator. Correct re-positioning of the patient is verified by performing a second ultrasound scan of the patient and overlaying that with the original CT-based treatment plan tumor volume information. The translation figures will advise the user of any remaining misalignment should there have been a misinterpretation of the translation date and/or patient positioning.
The provided documentation for the I-Beam Patient Positioning System (K032100) does not contain specific acceptance criteria or a study detailing device performance against such criteria. The submission states that "Actual testing in a clinic was not performed as part of the development" and "Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness of the device."
Instead, the submission relies on "Non-Clinical Testing" which involved:
- Verification and validation test cases: These were "written and executed to assure the system is correctly measuring patient tumor volume shift as well as outputting correct patient 'translation' to achieve alignment of planned versus actual patient tumor volume."
- Verification of correct operation: This included the "optical alignment target and the camera and the ability of I-Beam to convert this information into clinically correct patient repositioning information."
Given the information provided, it is impossible to create the table or answer most of the questions as the details simply aren't present in the document. The document describes the device's function and how it was designed to achieve its purpose but does not provide quantitative performance metrics or a formal study report.
Here's a breakdown of what can be said based on the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in quantitative terms. The text mentions ensuring "correctly measuring patient tumor volume shift" and "outputting correct patient 'translation'" and "clinically correct patient repositioning information." These are qualitative goals, not quantifiable acceptance criteria.
- Reported Device Performance: No quantitative performance metrics are provided. The document confirms that non-clinical testing was performed to "assure the system is correctly measuring" and "outputting correct" information, but no specific values or ranges are given.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "both verification and validation test cases were written and executed."
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The ground truth method itself is not explicitly defined in terms of expert involvement for the test set.
4. Adjudication method for the test set:
- Not specified.
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:
- No, an MRMC study was not done. The document explicitly states, "Actual testing in a clinic was not performed." This device is a patient positioning system, not an AI diagnostic tool involving human readers in the traditional sense of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The non-clinical testing appears to have evaluated the algorithm's performance in terms of its ability to measure shift and output translation. However, it's not a "standalone" performance evaluation in the context of typical AI device submissions without any human involvement, as the system provides "translation figures" for an "operator" to move the patient. The verification process described involves the system converting information into "clinically correct patient repositioning information," implying an assessment of its output for clinical use. No quantitative performance metrics are provided for this.
7. The type of ground truth used:
- The ground truth for the non-clinical testing was implied to be established against the "planned versus actual patient tumor volume" and the ability to convert information into "clinically correct patient repositioning information." This suggests a comparison against known or computed correct values within the simulated or test environment, rather than expert consensus, pathology, or direct outcomes data from real patients.
8. The sample size for the training set:
- Not applicable as this is a patient positioning system, and the description does not indicate the use of a "training set" in the context of machine learning model development.
9. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided 510(k) summary for the I-Beam Patient Positioning System focuses on demonstrating substantial equivalence to predicate devices and describes the non-clinical verification and validation activities conducted. However, it does not include the detailed quantitative acceptance criteria or performance study results that would typically be found for a device requiring such data, especially in the context of AI/ML-driven devices. The submission clearly states clinical testing was not performed or deemed necessary for this particular device and its 2003 submission context.
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Image /page/0/Picture/0 description: The image shows a handwritten note with the text "K032100" at the top. Below this, the words "Page 1 of 3" are written in cursive. The writing appears to be in black ink on a white background, and the overall quality of the image suggests it may be a scan or photocopy of an original document.
OCT = 2 2003
510(k) Summary of Safety and Effectiveness I-Beam Patient Positioning System
| Submitter Name: | Computerized Medical Systems, Inc. |
|---|---|
| Submitter Address: | 1145 Corporate Lake DriveSt. Louis, MO 63132-1716 |
| Submitter Phone: | 314 993 0003 |
| Submitter Fax: | 314 993 0075 |
| Contact Person: | Michael A. Parsons - Director - Quality Assuranceand Regulatory Affairs orKathryn Stinson - Regulatory Affairs Associate |
| Date Summary Prepared: | July 2003 |
| Device Trade Name: | I-Beam |
| Device Common Name: | Patient Positioning System |
| Device Classification: | System, Simulator, Radiation Therapy per21CFR892.5840 |
| Substantial Equivalence: | NOMOS BAT Ultrasound Localization andPositioning System (K981424)Brainlab ExacTrac 2.0 Ultrasound LocalizationSystem (K003285) |
Device Description: The I-Beam Patient Positioning System provides a method for a hospital/clinic to accurately position a patient prior to delivery of external beam radiation therapy each day such that the patient tumor volume on the day of therapy coincides with the tumor volume from the treatment plan. Patient positioning may be necessary because of day-to-day movement of the soft tissue target within the patient. Closer alignment assures proper tumor coverage and a minimum of dose to healthy tissue and structures surrounding the target.
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Image /page/1/Picture/0 description: The image shows a handwritten note with the text "K032100 Page 2 of 3". The handwriting is somewhat messy, and the text is slightly slanted. The note appears to be a page number from a larger document.
510(k) Summary of Safety and Effectiveness I-Beam Patient Positioning System Page 2 of 3
I-Beam achieves this alignment by having a camera provide a signal to I-Beam. The camera is attached to an ultrasound transducer body by use of a custom "clamshell" in an orientation that points the camera in a direction 180 degrees from the plane of the transducer output. As the transducer ultrasound system (not part of I-Beam) images the patient target, the camera is looking up at a targeting grid located on the shadow tray of the linear accelerator. Using pattern recognition techniques, the I-Beam system is able to determine the position of the isocenter of the target volume relative to the isocenter of the linear accelerator. The user then superimposes the ultrasound tumor volume data obtained from this scan on that from the original treatment plan data input to I-Beam earlier. This treatment plan is based on a CT study set, and the user aligns the two tumor volumes by "moving" one relative to the other. I-Beam senses this relative movement of the ultrasound tumor volume to that from the treatment plan and converts that into a three axis "translation" figure which gives the operator the amount and direction the patient must be moved in each axis to achieve alignment with the treatment plan and thus the linear accelerator. Correct re-positioning of the patient is verified by performing a second ultrasound scan of the patient and overlaying that with the original CT-based treatment plan tumor volume information. The translation figures will advise the user of any remaining misalignment should there have been a misinterpretation of the translation date and/or patient positioning.
Device Intended Use: I-Beam is a self-contained mobile patient positioning system that uses real time ultrasound images of patient target organs or tumors while the patient is positioned on the couch of the linear accelerator to confirm the location of these patient target organs or tumors prior to delivery of external beam radiation therapy.
Summary of Technological Characteristics Compared to Predicate Devices: The predicate devices can both use ultrasound imaging of the target volume on the day of treatment to determine the amount of target movement relative to the original treatment plan data and provide the user feedback on correct patient positioning for that day's therapy.
ExacTrac outputs the automatic couch movement in three dimensions necessary to reposition the tumor volume. BAT has an interface to the treatment couch to determine when the necessary patient movement to achieve alignment has been performed. I-Beam outputs the direction and amount of patient movement to achieve alignment onto the system display and this is verified during a second patient scan after repositioning.
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K02/100
Page 3 of 3
510(k) Summary of Safety and Effectiveness I-Beam Patient Positioning System Page 3 of 3
Summary of Clinical Testing: Actual testing in a clinic was not performed as part of the development of this feature. Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness of the device.
Summary of Non-Clinical Testing: Both verification and validation test cases were written and executed to assure the system is correctly measuring patient tumor volume shift as well as outputting correct patient "translation" to achieve alignment of planned versus actual patient tumor volume. This testing also verified correct operation of the optical alignment target and the camera and the ability of I-Beam to convert this information into clinically correct patient repositioning information.
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Image /page/3/Picture/1 description: The image shows a black and white logo. The logo features a stylized bird in flight, with three curved lines representing its wings and body. The bird is facing to the right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2003
Ms. Kathryn Stinson Regulatory Affairs Associate Computerized Medical Systems, Inc. 1145 Corporate Lake Drive, Suite 100 ST. LOUIS MO 63132
Re: K032100
Trade/Device Name: I-Beam Patient Positioning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II
Product Code: 90 IYE Dated: July 7, 2003 Received: July 8, 2003
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 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 the 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" (21CFR Part 807.97) you may obtain. 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. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indication for Use
510(k) Number: K032100
Device Name: I-Beam Patient Positioning System
Indication for use: I-Beam is a self-contained mobile patient positioning system that uses real time ultrasound images of patient target organs or tumors while the patient is positioned on the couch of the linear accelerator to confirm the location of these patient target organs or tumors prior to delivery of external beam radiation therapy.
Concurrence of the Center for Devices and Radiological Health, Office of Device Evaluation (ODE)
Prescription Use
OR
per 21 CFR 801.109
(Division Sign-Off) Division of Reproductive, Abdominal, Over the Counter Use _
and Radiological Devices 100 510(k) Number _
Computerized Medical Systems Inc. - 1-Beam Patient Positioning System - Indications For Use
§ 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.