(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.
§ 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.