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.

Device Description

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.

AI/ML Overview

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.

Summary

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DEC 0 5 2001

K013112

510(k) Summary of Safety and Effectiveness Computerized Medical Systems Premarket Notification FOCAL CT Simulation (FOCAL SIM)

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
Date Summary Prepared:	September, 2001
Device Trade Name:	FOCAL Workstation
Device Common Name:	Accessory to Radiation Treatment Planning System
Device Classification:	System, Simulation, Radiation Therapy per21CFR892.5840
Substantial Equivalence:	Picker International Acqsim Simulator/Localizer -K923851GE Advantage Sim - K951830ADAC Advantage Sim - K993923

Device Description: (See Section 7 of this submittal for a more detailed Device Description). The FOCAL Workstation was initially cleared for marketing under K981535. (At that time, the device was referred to as the FOCUS Pilot Contouring Workstation. However, by the time the Premarket Notification was cleared, the CMS Marketing Department had selected another trade name.)

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

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510(k) Summary of Safety and Effectiveness Computerized Medical Systems Premarket Notification FOCAL CT Simulation (FOCAL SIM) Page 2 of 3

Workstation was designed to work with our FOCUS Radiation Treatment Planning (RTP) W orkstation was designed to work while of the same of the most recently under System willer was intraily ordains repically performed by the Radiation Oncologist, is K002147. The task of contouring, typediation therapy planning and requires a minimum of the most thing consuming task in rad to free up the higher powered UNIX-based RTP Computer Capaonity. It was our goal goal calculation-intensive activities of treatment Workstation for performing the ing to a remote device. This remote device was a prailing by moving the contourning to a common Microsoft products (Windows 95, Fersonal Computer fouded with the FOCAL contouring software running on that While was 20, While 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 first ferease of FOCAL Ease". The second release enhanced the users ability to the trade hame of 'I OCAL Lase ' - I vision of 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 treatment planning perfermed vans as well as Dose Volume Histograms (DVH's) and abinty to view isodose assations (DRR's). This was given the name "FOCAL Vue" Dighany Roconsalation at a remote capability to view and compare alternate treatment plans and select the one which best satisfied her/his prescription.

All of these development efforts were performed per the CMS software development An of these de relopment of the Premarket Notification clearance. This included inhouse validation testing to assure clinical efficacy and safety.

The subject of this Premarket Notification is the addition of the ability to perform CTV The subject of this Promation, a feature we call "FOCAL Sim". This addition simulation off the contouring of patient targets or viewing of treatment planning results into a more active role in the treatment planning process. For a description of the CT simulation process, refer to Section 7 of this submittal.

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510(k) Summary of Safety and Effectiveness Computerized Medical Systems Premarket Notification FOCAL CT Simulation (FOCAL SIM) Page 3 of 3

Device Intended Use: The FOCAL Workstation will continue to be used for patient contouring and viewing of treatment plan outputs. With this new software it will also be econtring and for the mations and forward this information to the RTP System for dose calculation.

Summary of Technological Characteristics Compared to Predicate Devices: The CT Simulation capability described in this 510(k) will be a software module "added-on" to the existing FOCAL Workstation previously cleared under K981535 in April, 1999. The FOCAL System with CT Simulation capability incorporates no technological characteristics not currently in the predicate CT Simulation devices.

The FOCAL System supports the most popular CT Scanners as well as the three most common linear accelerators (Varian, Siemens and Philips/Elekta).

Summary of Clinical Testing: Clinical testing was not performed as part of the development of this feature. Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness. This software merely takes some of the tasks previously performed on the RTP System and allows them to be performed on the FOCAL Workstation.

Summary of Non-Clinical Testing: The testing performed by CMS and our results can be found in Section 9 of this submittal.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

DEC 0 5 2001

Mr. Michael A. Parsons Director, Quality Assurance and Regulatory Affairs Computerized Medical Systems, Inc. TM 1145 Corporate Lake Drive ST. LOUIS MO 63132

Re: K013112

Trade/Device Name: FOCAL CT Simulation (CT Sim) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II

Product Code: 90 MUJ Dated: September 14, 2001 Received: September 18, 2001

Dear Mr. Parsons:

We have reviewed your Section 510(k) premarket notification of intent to market the device w one review 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 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 this 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" (21 CFR Part 807.97). 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: K013112

Device Name: FOCAL Workstation with CT Simulation Capability

Indication for use: The FOCAL workstation software is a computer software package intended to be used as an accessory to a radiation treatment planning system.

Concurrence of the Center for Devices and Radiological Health, Office of Device Evaluation (ODE)

Prescription Use

✓

OR per 21 CFR 801.109

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

Dave Brion

(Division Sign Off)
Division of Reprodustila, Abdominal,
and Radioteland Daviess K013112
510(k) Number...

Regulation Number and Section

§ 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.