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The intended use of FOCUS RTP System is to provide radiation treatment planning capability, for both external beam and brachytherapy sources, to satisfy the prescription of a Radiation Oncologist. The resultant treatment plan is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel. Operation of the system is identical to FOCUS systems cleared under previous Premarket Notifications with the exception the user can now select a third type of external beam particle for therapy (protons) in addition to the earlier two particles (electrons and photons)..

The FOCUS Radiation Treatment Planning System accepts a) patient diagnostic imaging data from CT and MR scans, or from films, and b) "source" dosimetry data, typically from a linear accelerator. The system then permits the user to display and define (contour) a) the target volume to be treated and b) critical structures which must not receive above a certain level of radiation, on these diagnostic images. Based on the prescribed dose, the user, typically a Dosimetrist or Medical Physicist, can then create multiple treatment scenarios involving the type, number, position(s) and energy of radiation beams and the use of treatment aids between the source of radiation and the patient (wedges, blocks, ports, etc.). The FOCUS system then produces a display of radiation dose distribution within the patient, indicating not only doses to the target volume but to surrounding tissue and structures. The "best" plan satisfying the prescription is then selected, one which maximizes dose to the target volume while minimizing dose to surrounding healthy volume. The parameters of the plan are output in hard-copy format for later reference and for placement in the patient file. Previously, for situations where external beam therapy was to be used, either Electron and/or Photon radiation beams could be selected.. These were delivered by a linear accelerator whose output characteristics are input to the treatment planning system prior to beginning planning. This Premarket Notification addresses the addition of a third type of radiation beam -Proton. The algorithm for calculating dose was provided by the Massachusetts General Hospital (MGH), based on their years of experience at the Harvard Cyclotron Lab. In addition to providing the algorithm, MGH also worked with CMS in its implementation. Software developers at MGH were trained on the CMS software development process to permit them to create code directly for use in FOCUS. As the final step, MGH provided the verification testing to assure the algorithm had been implemented correctly, measuring calculated dose against measures. A FOCUS RTP System with proton planning capability is now in clinical use at the Northeast Proton Therapy Center.

The provided text describes the K020027 FOCUS Radiation Treatment Planning System with Proton Planning Capability. It details the device's function, its new proton planning feature, and the non-clinical testing performed.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated in terms of a specific number of cases or plans. The text refers to "Algorithm test cases" without detailing their quantity.
• Data Provenance: The testing was a "non-clinical" study. The algorithm was developed based on "years of experience at the Harvard Cyclotron Lab" at Massachusetts General Hospital (MGH). The verification testing involved measuring "calculated dose against measures," implying an experimental setup or phantom measurements rather than patient data. The study, "Validation of the CMS Proton Treatment Planning System for Treatments In Large Field Beam Line at the Harvard Cyclotron Laboratory (HCL)," suggests a laboratory-based, prospective evaluation of the algorithm's performance against physical measurements or highly controlled simulated scenarios.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not explicitly stated. However, the algorithm itself was provided by the Massachusetts General Hospital (MGH), implying the expertise of their staff at the Harvard Cyclotron Lab (HCL). MGH also performed the verification testing.
• Qualifications of Experts: The text states the algorithm was based on "years of experience at the Harvard Cyclotron Lab." This implies the involvement of highly experienced medical physicists and other specialists familiar with proton therapy dose calculation. "Skip Rosenthal of MGH" authored the validation document, indicating his expertise in this area.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not described. The validation appears to be a direct comparison of calculated dose values to measured dose values, rather than an expert consensus process.

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, an MRMC comparative effectiveness study was not done. The device is a radiation treatment planning system algorithm, not a diagnostic AI intended to assist human readers in interpreting images or making a diagnosis. Its function is to calculate dose distributions based on user input for treatment planning. The study focused on the accuracy of the dose calculation algorithm itself.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: Yes, in essence, the "non-clinical testing" described is a standalone performance study. The "Algorithm test cases were written and executed to assure the system is calculating dose correctly for proton treatment plans." This focused solely on the algorithm's output (calculated dose) compared to a reference (measured dose), without evaluating user interaction or clinical outcomes in humans. The current device is meant to be used by "Dosimetrist or Medical Physicist" where they would evaluate, modify and approve the plans. However, the specific testing described in the summary is of the algorithm's accuracy in isolation.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was measured dose values. The text explicitly states "measuring calculated dose against measures" in the verification testing. This indicates that the algorithm's computed dose distributions were compared against physical measurements obtained from a phantom or experimental setup at the Harvard Cyclotron Laboratory.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not explicitly stated. The algorithm itself was provided by MGH, based on their "years of experience at the Harvard Cyclotron Lab." This implies that it was developed and implicitly "trained" or refined over a long period from extensive data and knowledge accumulated at HCL, but there's no defined "training set" in the context of supervised machine learning with a specific sample size.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: The ground truth for the underlying algorithm's development (or its "training" in a broader sense) was established through extensive experience and data collection at the Harvard Cyclotron Lab (HCL) over many years. This would likely involve:
  • Clinical experience and outcomes: Understanding how protons interact with tissue and the effects of different dose distributions.
  • Physics measurements: Extensive experimental data on proton beam characteristics, interactions, and dose deposition in phantoms and biological samples.
  • Computational modeling and simulations: Development and validation of physics models used in dose calculation.
    The algorithm provided by MGH represents the culmination of this accumulated knowledge and empirical validation.

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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.

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