(28 days)
The On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks.
The On-Board Imager device has been modified to include the already cleared CBCT (cone-beam CT) option for the Acuity simulator (K033339) so that cone-beam CT image acquisition will be available in the treatment room. This will allow users to acquire cone-beam CT images of the patient while they are on the treatment couch in the treatment room. The users can then compare the locations of soft-tissue anatomy seen in reference CT scans with the locations of the same soft-tissue anatomy in the cone-beam CT images. The reference CT images can come from multiple sources including conventional CT scanners, the Acuity simulator or previous cone-beam CT scans acquired using the On-Board Imager.
This 510(k) summary and associated FDA letter for the Varian Medical Systems' On-Board Imager Device (K042720) does not contain details about specific acceptance criteria, a study proving performance against those criteria, or the methodology for such a study.
The document states that the device has been modified to include the already cleared CBCT (cone-beam CT) option for the Acuity simulator (K033339). The basis for clearance is substantial equivalence to existing predicate devices (Varian Medical Systems' On Board Imager, K040192, and the Acuity simulator's CBCT option, K033339). This means the FDA determined the new device is as safe and effective as a legally marketed device and does not require new efficacy studies.
Therefore, I cannot provide the requested table and detailed study information. However, I can infer some aspects based on the nature of 510(k) submissions for substantial equivalence.
Here's an explanation of what can and cannot be provided from the given text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria or a performance study. Its clearance is based on substantial equivalence to predicate devices, implying that its performance is expected to be similar or identical to the cleared predicate devices, which would have had their own validation data.
2. Sample size used for the test set and the data provenance
- Cannot be provided. No test set or performance study data is described. The clearance is based on comparison to predicate devices, not new clinical or performance data for this specific iteration.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot be provided. No test set or related ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication process is described.
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. This document predates widespread AI in medical imaging devices and does not describe any MRMC studies or AI components. The device is for "verification of correct patient position" using imaging, not for interpretation tasks typically associated with MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This is not a standalone algorithm submission. It is a physical imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. No ground truth establishment method is described as no performance study is detailed.
8. The sample size for the training set
- Cannot be provided. This document discusses a hardware modification being cleared via substantial equivalence, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable as there is no mention of a training set for a machine learning model.
In summary: The provided 510(k) documentation focuses on the technological characteristics and intended use of a modified medical device, asserting its substantial equivalence to previously cleared devices. It does not include primary performance data or study details for this specific submission, which is typical for substantial equivalence clearances of device modifications.
§ 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.