The iGUIDE 2.1 System is a powered radiation therapy support assembly which provides patient positioning control prior to radiotherapy treatment. iGUIDE 2.1 System consists of the iGUIDE workstation with software, a tracking system, reference frame, calibration tool, isolation transformer, KVM Extender and monitors for the workstation and terminal.

The iGUIDE software controls the combined working of the HexaPOD evo RT System components and provides status detection via the software GUI to the user. The HexaPOD evo RT System consists of iGUIDE and the HexaPOD evo RT Couchtop, a robotic patient-positioning platform with six degrees of freedom, which is cleared under K072898.

AI/ML Overview

This document is a 510(k) summary for the iGUIDE 2.1 system, a medical device for patient positioning in radiotherapy. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (iGUIDE System, K072079).

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from predicate device K072079)	Reported Device Performance (iGUIDE 2.1 System)
Accuracy of 3D Tracking System: Not explicitly stated as "acceptance criteria," but for comparison, the predicate had a reported accuracy of 0.35mm.	Accuracy of 3D Tracking System: 0.35mm
Accuracy of total system (Treatment table + tracking system): < 0.5 mm (translation), < 0.25° (rotation)	Accuracy of total system (Treatment table + tracking system): <1mm; C195: <0,5mm

Note: The document explicitly states that "physical parameters characterize the system (e.g. accuracy) and give information about substantial equivalence." While not phrased as strict "acceptance criteria" in the format of a clinical trial, these accuracy metrics are the performance benchmarks against which the new device is compared to its predicate.

2. Sample size used for the test set and the data provenance

The document states, "The Performance Testing is based on Benchmark Testing only." There is no mention of a sample size in terms of patient data or clinical cases. The testing appears to be based on engineering benchmarks, not human subject data. Therefore, there is no data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The testing described is "Benchmark Testing" focusing on physical parameters like accuracy, not on expert-interpreted results or clinical ground truth.

4. Adjudication method for the test set

Not applicable, as the testing described focuses on measurable physical parameters and doesn't involve subjective interpretation that would require an adjudication method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The iGUIDE 2.1 system is a patient positioning device, not a diagnostic AI system that assists human readers in interpreting medical images.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The entire performance assessment for the iGUIDE 2.1 system described in this document appears to be focused on its standalone technical performance (accuracy of positioning) through "Benchmark Testing." There is no discussion of human-in-the-loop performance studies.

7. The type of ground truth used

The "ground truth" for the performance testing appears to be measured physical parameters (accuracy), established through calibrated measurement techniques in "Benchmark Testing."

8. The sample size for the training set

Not applicable. The iGUIDE 2.1 system is described as a "powered radiation therapy support assembly" with software control for positioning. It is not an AI/ML model that would typically have a "training set" of data in the context of learning or inference. The software "controls the combined working of the HexaPOD evo RT System components."

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set or AI/ML model training.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 4, 2015

Medical Intelligence Medizintechnik GmbH % Mr. Michael Wolff Regulatory Affairs Manager Robert-Bosch-Strasse 8 Schwabmunchen, 86830 GERMANY

Re: K143485

Trade/Device Name: iGUIDE 2.1 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: November 4, 2014 Received: December 8, 2014

Dear Mr. Wolff:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No.0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K143485

Device Name
iGUIDE 2.1

Indications for Use (Describe)

The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.

Type of Use (Select one or both, as applicable)
ZJ Prescription Use (Part 21 CFR 801 Subpart D)	D Over-The-Counter Use (21 CFR 801 Subpart C)
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Traditional 510(k) 510(k) Summary

iGUIDE 2.1

iGUIDE 2.1- 510(k) Summary

1.	Applicant	Medical Intelligence Medizintechnik GmbH
2.	Address	Robert-Bosch-Straße 8
		86830 Schwabmünchen
		Germany
3.	Contact Person	Michael Wolff, +49 (0) 8232 9692 701
4.	Preparation Date	December 2nd, 2014
5.	Device Submitted	iGUIDE® 2.1 System
6.	Proprietary Name	iGUIDE® 2.1 System
7.	Common Name	iGUIDE® 2.1
8.	Classification Name	Accelerator, Linear, Medical (21 CFR 892.5050, Product CodeIYE)
9.	SubstantialEquivalence	The iGUIDE® 2.1 is substantially equivalent to the followingcurrently marketed device:iGUIDE® System (K072079)iGUIDE® 2.1 is an advancement of the iGuide® System and hassimilar technological characteristics as the predicate device.
Device Description		The iGUIDE 2.1 System is a powered radiation therapy supportassembly which provides patient positioning control prior toradiotherapy treatment. iGUIDE 2.1 System consists of theiGUIDE workstation with software, a tracking system, referenceframe, calibration tool, isolation transformer, KVM Extender andmonitors for the workstation and terminal.The iGUIDE software controls the combined working of theHexaPOD evo RT System components and provides statusdetection via the software GUI to the user. The HexaPOD evo RTSystem consists of iGUIDE and the HexaPOD evo RT Couchtop, arobotic patient-positioning platform with six degrees of freedom,which is cleared under K072898.
10.	Indications for Use	The intended use of the device is to control accurate patient

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Traditional 510(k) 510(k) Summary

iGUIDE 2.1

positioning with assistance of a 3D Tracking System in a radiotherapy environment.

1. Summary of Product

Changes

o Compatibility with the Brainlab ExacTrac® V6.1 system
- Control of the Elekta Precise Treatment Table .
- Enhanced usability and elimination of use errors through: .
  - Automatic receipt of patient data o
  - Use of Remote Automatic Table Movement interface; o manual prepositioning function is no longer supported
  - Automated data transfer from XVI to iGUIDE & o Sentinel to iGUIDE
1. Summary of iGUIDE® 2.1 is similar to the predicate device in terms of:

Similarities

Intended use .
product components ●
. technological characteristics (regarding design, material, energy source)

13. Comparison with predicate device

Manufacturer	Medical IntelligenceMedizintechnik GmbH	Medical IntelligenceMedizintechnik GmbH
Device Name	iGUIDE 2.1 System	iGUIDE System
PreMarket NotificationNumber	Proposed	K072079
Indications for Use	The intended use of the device isto control accurate patientpositioning with assistance of a3D Tracking System in aradiotherapy environment.	The intended use of the device isto control accurate patientpositioning with assistance of a3D Tracking System in aradiotherapy environment.
Components	Software Tracking System Workstation Monitor KVM Extender Isolation Transformer Reference Frame Calibration Tool	Software Tracking System Workstation Monitor KVM Extender Isolation Transformer Reference Frame Calibration Tool
Protection Class	IB	IB

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Traditional 510(k) 510(k) Summary

iGUIDE 2.1

Manufacturer	Medical IntelligenceMedizintechnik GmbH	Medical IntelligenceMedizintechnik GmbH
Device Name	iGUIDE 2.1 System	iGUIDE System
Software SafetyClassification	C(Major Level of Concern)	C(Major Level of Concern)
Hardware Platform	Part of the HexaPOD evo RTSystem - consisting of HexaPODevo Couchtop (K072898) andiGUIDE components (see below)	Part of the HexaPOD RT System -consisting of HexaPOD Couchtop(K071870) and iGUIDEcomponents (see below)
Position control by 3Dtracking System	yes	yes
HexaPOD evo RT CouchTop as treatment couch	yes	yes
Movement Control	yes	yes
Table Movement	Remote Automatic TableMovement	Manual prepositioning function
Accuracy of 3D TrackingSystem	0.35mm	0.35mm
Accuracy of total system(Treatment table +tracking system)	<1mm;C195: <0,5mm	< 0.5 mm (translation)< 0.25° (rotation)
Receiving patient data	Automatic data transfer to iGUIDE	Manual data transfer to iGUIDE
Sending patient data	Automated data transfer fromiGUIDE	Manual data transfer from iGUIDE
Enable switches	Interrupts directly the power of the moving component In control room and treatment room	Interrupts directly the power of the moving component In control room and treatment room
Interlock connection toLinac	Overrides the enable switchcontrol	Overrides the enable switchcontrol

14. Summary of Performance Testing

The Performance Testing is based on Benchmark Testing only.

Rationale: As the iGUIDE 2.1 is a positioning device which does not perform any treatment on its own but helps to position and re-position the patient, only physical parameters characterize the system (e.g. accuracy) and give information about substantial equivalence of the modified system compared to the predicate (unmodified) system which was cleared under K072079.
The results of the verification and validation and bench testing demonstrate that the iGUIDE 2.1 System with the extended compatibility and improved usability satisfies the intended use as described above and supports the claim of substantial equivalence.

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.