(78 days)
The FOCAL workstation software is a computer software package intended to be used as an accessory to a radiation treatment planning system.
FOCAL Sim is intended to permit CT simulation to be performed on the FOCAL workstation. The CT scan is read into the radiation treatment planning system and then sent to the FOCAL workstation. On FOCAL, the user is able to identify patient isocenters, place treatment beams and identify beam modifiers (blocks, wedges, etc.). This information is then passed back to the radiation treatment planning system for storage and documentation of the resultant treatment plan and calculation of patient dose based on this information. The resultant plan is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel.
The FOCAL Workstation was initially cleared for marketing under K981535. The initial release of the product had, as its intended use, the remote contouring of patient outlines, structures and tumors as part of radiation therapy planning. The FOCAL Workstation was designed to work with our FOCUS Radiation Treatment Planning (RTP) System. The task of contouring, typically performed by the Radiation Oncologist, is the most time consuming task in radiation therapy planning and requires a minimum of the most recently cleared FOCUS RTP Computer Capacity. It was our goal to free up the higher powered UNIX-based RTP Workstation for performing the calculation-intensive activities of treatment planning by moving the contouring to a remote device. This remote device was a Personal Computer loaded with the FOCAL contouring software running on that PC. While contouring was complete, the information was returned to the RTP System to continue the treatment planning process.
The first release of FOCAL contained only manual contouring capability and was given the trade name of "FOCAL Ease". The second release enhanced the users ability to view CT and MR images as well as providing an autosegmentation capability. This added functionality was given the trade name "FOCAL Fusion".
A later release of FOCAL software provided the capability to view the results of treatment planning performed earlier on the FOCUS RTP System. This included the ability to view isodose contours as well as Dose Volume Histograms (DVH's) and Digitally Reconstructed Radiations (DRR's). This was given the name "FOCAL Vue". This provided the Radiation Oncologist with a remote capability to view and compare alternate treatment plans and select the one which best satisfied her/his prescription.
The subject of this Premarket Notification is the addition of the ability to perform CTV simulation, a feature we call "FOCAL Sim". This addition moves the FOCAL Workstation from merely contouring of patient targets or viewing of treatment planning results into a more active role in the treatment planning process.
The provided document is a 510(k) Summary of Safety and Effectiveness for the FOCAL CT Simulation (FOCAL SIM) device. It describes the device, its intended use, and a comparison to predicate devices. However, it explicitly states that clinical testing was not performed as part of the development of this feature, and that non-clinical testing results can be found in Section 9 of the submittal (which is not provided in the extracted text).
Therefore, based solely on the provided text, I cannot answer most of your questions as the requested information is absent.
Here's what can be extracted based on your questions, with the understanding that key information regarding acceptance criteria and performance data from a study is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text.
- Reported Device Performance: Not explicitly stated or measured in the provided text's "Summary of Clinical Testing" or "Summary of Non-Clinical Testing."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. Clinical testing was explicitly not performed.
- Data Provenance: Not applicable. No clinical data was used for testing purposes.
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)
- Not applicable. No clinical testing was performed, thus no ground truth was established by experts for a test set in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical testing was performed.
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
- MRMC Study: No. The document states, "Clinical testing was not performed as part of the development of this feature." The device is a "CT Simulation" software module, not explicitly described as an AI-assisted diagnostic tool as you might find in an MRMC study context.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that the "FOCAL Sim" module allows "CT simulation to be performed on the FOCAL workstation" and that the user "is able to identify patient isocenters, place treatment beams and identify beam modifiers," suggesting a human-in-the-loop system. However, no specific "standalone" performance study is mentioned in the provided text.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical testing was performed. The device's "substantial equivalence" was based on comparison to predicate devices and non-clinical testing (details of which are not in the provided text).
8. The sample size for the training set
- Not applicable. The document does not describe the use of machine learning or AI models that would typically require a training set. The "FOCAL Sim" is described as a software module that "merely takes some of the tasks previously performed on the RTP System and allows them to be performed on the FOCAL Workstation."
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned.
In summary, based only on the provided text, the 510(k) summary explicitly states that clinical testing was not performed for the FOCAL CT Simulation (FOCAL SIM) feature. The regulatory approval was based on demonstrating "substantial equivalence" to predicate devices and non-clinical testing (details of which are not included in this extract). Therefore, the detailed information about acceptance criteria, performance data, sample sizes, ground truth establishment, and specific study types (like MRMC or standalone) is not present in the provided document.
§ 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.