The intended use of the PRIMUS and ONCOR Avant-Garde linear accelerator systems is to deliver x-ray radiation for the therapeutic treatment of cancer.

The SIMTEC IM-MAXX, software application is an optional software accessory to these devices and is indicated where a specific method of treatment delivery, commercially marketed as Fast Intensity Modulated Radiation Therapy (FIMRT), is prescribed by a licensed medical oncologist.

The SIMTEC IM-MAXX 2 software option is intended to further enhance the speed of delivery of the Fast Intensity Modulated Radiation Therapy (FIMRT) treatment delivery technique. The indications for use of this accessory has remained unchanged as a result of the modification.

Device Description

The SIMTEC IM-MAXX 2 Option (also called IM-MAXX 2) is to be used in conjunction with Siemens PRIMUS and ONCOR Avant-Garde Linear Accelerators and its accessories and provides a method of delivering Fast Intensity Modulated Radiation Therapy (FIMRT) by modifications and a modification of the serial communication and jaw movements of the Multi-Leaf Collimator between treatment delivery.

The SIMTEC IM-MAXX 2 software incorporates no new technological characteristics not currently in the predicate SIMTEC IM-MAXX (FIMRT) option.

The SIMTEC IM-MAXX 2 software consists of:

(1) The original SIMTEC IM-MAXX technology, also referred to as Automatic Field Sequencing (AFS), where the software architecture and design had not been modified. The serial communication consists of the Siemens proprietary communication interfaces based on a Gbit Ethernet. In accordance to the desired delivery speed of the FIMRT treatment delivery technique, the Serial Communication had been modified in these areas:
- a. DMIP -- The serial communication path between the planning systems and the control console based on the proprietary DMIP (Delivery Machine Interface Protocol).
- b. MLCIP -- The serial communication path between the control console and the 82 Leaf MLC based on the proprietary MLCIP (MLC Interface Protocol).
(2) The DMIP and MLCIP serial communications design specifications has been used in the previously cleared ONCOR Avant-Garde with COHERENCE workspace (K031764) Linear Accelerator systems.
(3) Setup and delivery of the SIMTEC IM-MAXX 2 (FIMRT) (treatment option) in the COHERENCE™ Therapist workspace or the PRIMEVIEW 3i workspace has been the same as for the original SIMTEC IM-MAXX option. The only Record and Verify (V & R) systems have been the previously cleared i.e. COHERENCE Therapist workspace as part of the ONCOR Avant-Garde (K031764) and the PRIMEVIEW (aka Treatstation, K972275). The current to existing V & R has undergone minor, evolutionary changes to the original V & R and has remained unchanged in their intended use.
(4) Fast Intensity Modulation Therapy (FIMRT) is a component of the PRIMEVIEW3i (for PRIMUS Systems) record and verify interface. See Figure 1 Block Diagram, Tab 4.
(5) The safety and control mechanism of system interlocks to stop treatment when the SIMTEC IM-MAXX 2 remains unchanged as for the original. Only one minor addition, an interest message has been added.

AI/ML Overview

The provided text is a 510(k) summary for the SIMTEC IM-MAXX 2 Option, a software accessory for linear accelerators used in radiation therapy. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, many of the requested items (e.g., specific acceptance criteria, sample sizes for test/training sets, ground truth establishment methods, expert qualifications, adjudication methods, MRMC study details, and standalone performance) are not explicitly present in the provided document. The 510(k) process for this type of device typically relies on demonstrating that the new device does not introduce new technological characteristics or safety risks compared to existing, legally marketed predicate devices, rather than new clinical effectiveness studies.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices (K993425 PRIMUS Linear Accelerator and K031764 ONCOR Avant-Garde with COHERENCE Workspaces) by stating that the SIMTEC IM-MAXX 2 Option:

"incorporates no new technological characteristics not currently in the predicate SIMTEC IM-MAXX (FIMRT) option."
"does not introduce any new potential safety risks, has the same intended use, similar technical characteristics and is substantially equivalent to the predicate devices."
"is intended to further enhance the speed of delivery of the Fast Intensity Modulated Radiation Therapy (FIMRT) treatment delivery technique."

The "reported device performance" is implicitly that it functions equivalently to the predicate devices, but with enhanced speed for FIMRT delivery. No quantitative metrics for this enhancement are provided in this summary.

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

This information is not provided in the document. As a software accessory claiming substantial equivalence based on no new technological characteristics and same intended use, a formal "test set" in the context of clinical performance evaluation (like for diagnostic AI) is not detailed. The evaluation described refers to internal verification and validation of the software.

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

This information is not provided. Given the nature of a 510(k) for a software accessory that enhances speed of a pre-existing treatment delivery technique, the "ground truth" would likely be established through engineering and software validation against design specifications, rather than a clinical expert-driven process to establish a diagnostic "gold standard."

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study is not mentioned or suggested by the document. This type of study is typically performed for diagnostic devices where human reader performance is compared with and without AI assistance in interpreting medical images. The SIMTEC IM-MAXX 2 is a treatment delivery system accessory, not a diagnostic imaging interpretation tool.

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

The document describes the SIMTEC IM-MAXX 2 as a "software application" and an "optional software accessory." The "testing" mentioned includes "code review, verification of requirements and validation of user needs," which indicates standalone testing of the software's functionality. However, specific performance metrics for this standalone performance (e.g., speed increase quantified) are not detailed in this summary. The device's function is "with human-in-the-loop" as it operates in conjunction with linear accelerators and is prescribed by a medical oncologist.

7. The Type of Ground Truth Used

The "ground truth" in this context would be the successful and accurate delivery of the planned radiation therapy, consistent with established quality and safety standards for such devices. This is established through a combination of:

Design specifications and user requirements: The software must perform as designed.
Verification and validation testing: Ensuring the software's functionality, safety, and compatibility with the hardware and existing treatment planning/record & verify systems.
Risk analysis: Identifying and mitigating potential hazards.

It is not based on expert consensus for diagnosis, pathology, or outcomes data in the way a diagnostic AI would be.

8. The Sample Size for the Training Set

This information is not provided. This device is a software accessory for a radiation therapy system, not a machine learning model that learns from a large "training set" of patient data in the typical sense. Its development would involve software engineering principles rather than AI model training datasets.

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

This information is not provided. As mentioned above, the concept of a "training set" and "ground truth" for it, as typically applied to machine learning or AI models, does not directly apply to the information presented for this software accessory. The "ground truth" for its development would be adherence to engineering specifications, safety standards, and validated functionality.

Summary

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SEP 2 2 2005

K052315

Tab 1 510(k) Summary

Submitter:	Siemens Medical Solutions USA, Inc.Oncology Care Systems4040 Nelson AvenueConcord, CA 94520
Contact:	Christine DunbarSenior Regulatory Affairs Specialist
Phone:	(925) 602-8139
Fax:	(925) 602-8008
Email:	christine.dunbar@siemens.com

Establishment Registration Number 2910081
Proprietary Name:	SIMTEC IM-MAXX 2 Option
Common Name:	(Accessory To) - Accelerator, Linear, Medical
Classification:	892.5050
Product Code:	IYE
	CD 8-23-05

Substantial Equivalence Claimed To:

K993425 PRIMUS Linear Accelerator, cleared on Nov. 26, 1999. .
K031764 ONCOR Avant-Garde with COHERENCE Workspaces, cleared on Sept 5, 2003 .

Historical Information and Device Description:

The radiation therapy treatment technique known as "Intensity Modulation Radiation Therapy" or "IMRT" The ladiation therapy treathern toonline as the fractionated irradiation of patients in the conventional 2D has to ongine in a troutined applied to controlled conformal (3D) step and shoot or arcradiation therapy.

The Automatic Field Sequencing method is trade-named SIMTEC® (Sequential Intensity Modulated The Addinatic Field Ocquonomy mother 16 transm (K882729) product. A faster version of this rechnology, trade named SIMTEC IM-MAXX® (internal name is East IMRT) was introduced in the PRIMUS™ (K993425) product, which is the predicate for this submission. The IM-MAXX treatment delivery technique is a Static IMRT, also known as "step and shoot" method where nothing moves (MLC leaves or technique is a a Giallo mill s on. This static treatment method has remained unchanged from the IMRT gainly) when the Boun is on This State Risital Mevatron product and later in the PRIMUS and ONCOR products.

The SIMTEC IM-MAXX 2 Option (also called IM-MAXX 2) is to be used in conjunction with Siemens THE SIM LO IM MAXX Z Option (also ballod its accessories and provides a method of delivering Fast radian the application bytions and a modification of the serial communication and jaw movements of the Multi-Leaf Collimator between treatment delivery.

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Summary of Technological Characteristics Compared to Predicate Devices:

The SIMTEC IM-MAXX 2 software incorporates no new technological characteristics not currently in the predicate SIMTEC IM-MAXX (FIMRT) option.

The SIMTEC IM-MAXX 2 software consists of:

(1) The original SIMTEC IM-MAXX technology, also referred to as Automatic Field Sequencing (AFS), I he original Silvi EC IM-MAXX technology, also toronodied. The serial communication consists of the software alchillecture and design had not boon weeks Serial Protocol developed by Siemens propretary comminication intenaces based on a Ghivery speed of the FIMRT treatment In accordance to the Arel Esize examinication has been modified in these areas:
- very technique, the Senal Communication had Boom modified the planning systems and the control
- control
  b. MLCIP -- The serial communication path between the control console and the 82 Leaf MLCIP = The senal communication patil betwoon the proprietary MLCIP (MLC Interface Protocol).
(2) The DMIP and MLCIP serial communications design specifications has been used in the previously
(2) The DMIP and MLCIP serial communications and Committee Coursely of Coun i he Divil" and MCGr Senateonined.com/ dosign-of-Schildland-Garde with COHERENCE workspace (K031764) Linear Accelerator systems
(KUST704) Lifear Accelerator Uyclomo
(3) Setup and delivery of the SIMTEC IM-MAXX 2 (FIMRT) (reatment option) in the Setup and delivery of the SiMTEC IM-MAXX & (1 mirr) (road.nortes) in the same as for
COHERENCE™ Therapist workspace or the PRIMEVIEW 3i works been been COHEHENGE = "Therapist workspace of the Philips hand Record (V & R) systems have been the original Silvi EC INFMAXA option: The Tonly orkspace as part of the ONCOR Avant-Garde proviously cleared f.e. COTIENCE Therepor workepad as par current PRIMEVEW 3i product
(K031764) and the PRIMEVIEW (aka Treatstation, K972275). The current to exisinal V. R (KU31764) and the FrhinLViLW (aka Troduction) Rev LEF S) - The Minor, evolutionary changes to the original V & R has a 5 ro(k) non mining justice remained unchanged in their intended use.
Fast Intensity Modulation Therapy (1 Mirr) It Sament of the PRIMEVIEW3i (for PRIMUS Systems) record and verify interface. See Figure 1 Block Diagram, Tab 4.
(5) The safety and control mechanism of system interlocks to stop treatment when the SIMTEC IM-The safety and control mechanism of System inchooks to etop trounny in one minor addition. MAXX 2 remains unchanged as for the onlyind. Only interest message has been added.

See the Modified Device Description, Tab 4 and Comparison Table, Tab 5, for the descriptions of these modifications.

General Safety and Effectiveness Concerns:

Labeling: The device labeling contains instructions for use and any necessary caution and/or warings, to Labeling: The device labeling contains instructions for societing i.e. User Manual, remains provide for the sale and enective use of the oction. The oxio.net as a service the series and has been retification update in the form of a User Release Note will be provided to the user.

Risk Management: Risk management has been assured by use of Risk Analysis, which is used to identify Hisk Management. Hisk management has book about a controlled or mitigated in part or in combination by several means:

by a means of design of the application ●
- eans of design of the application
  including the refinement of the product requirements and customer requirements o
by software means, .
- including best-practice development, adherence to software configuration control and ಂ defect management.
by documentation means, .

Image /page/1/Picture/20 description: The image shows the number 000004. The numbers are in a simple, bold font. The numbers are all the same size and are evenly spaced. The image is a simple black and white image.

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user instructions including device description, use instructions, warnings and/or cautions as o necessary.
necessary.
by means of testing, including, but not limited to, code review, verification of requirements and . by means of testing, including, a see of the intended use of the device.
validation of user needs and the michdod ass of the safe and effective use of the device. .

Design Control:

The Project Development Procedure (GPA02) contains a provision for tailoring smaller projects utilizing a
rmanian and contraction (DCC) at any at which contains soctions for The Project Development Procedure (GPAG2) collians a proviect planning for design Design Change Specification (DS) document which contains section for proposition testing, reporting testing, reporting testing, reporting testing, reporting testing, reportin control, doolyn reviews. Refer to Tab 12.

Intended Use:

The intended use of the PRIMUS and ONCOR Avant-Garde linear accelerator systems is to The intended abo of the therapeutic treatment of cancer.

The SIMTEC IM-MAXX 2, software application is an optional software accessory to these devices The SIMTEC IM-MAXX Z, Soliware applications of treatment of the states of the states as Fast and is Indicated Where a spon Therapy (FIMRT), is desired.

Conclusion:

In conclusion, Siemens is of the opinion that the SIMTEC IM-MAXX 2 option does not introduced In conclusion, Slemens is of the opinion that the ended use, similar technical characteristics and is
any new potential safety risks, has the same intended use, similar secur any new polential salety histo, has the same international the predicate devices.

0000005

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a circular seal or logo. The seal contains the symbol of the U.S. Department of Health & Human Services in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Public Health Service

Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2005

Ms. Christine Dunbar Senior Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. Oncology Care Systems 4040 Nelson Avenue CONCORD CA 94520

Re: K052315

Trade/Device Name: SIMTEC IM-MAXX 2 Option Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LNH Dated: August 23, 2005 Received: August 25, 2005

Dear Ms. Dunbar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 (Premarket Approval), it may be subject to such 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 requirements of the Act of any 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 Section 510(k) premarket notification. The FDA finding of substantial equivalence of your deviews to legal/y 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:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Actrons (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/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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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TAB 3

510(k) Number (if known):

Device Name: SIMTEC IM-MAXX 2 Option

Indications for Use:

The intended use of the PRIMUS and ONCOR Avant-Garde linear accelerator systems is to deliver x-ray radiation for the therapeutic treatment of cancer.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use_

000007

David A. Layson

(Division Sign-Off) Division of Reproductive and Radiological Devices 510(k) Number ...

CONFIDENTIAL

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.