The OCTAVIUS System is intended to collect beam data for patient plan verification of a treatment planning system (TPS) and under the aspect of machine QA for the following purposes:

IMRT patient plan verification
periodic QA procedures, e.e. constancy checks
beam data analysis according to international therapy dosimetry protocols
measurements after repair or replacement of major treatment unit components

Device Description

The OCTAVIUS System is comprised of a two-dimensional ion chamber based detector array, uniformly arranged as a matrix and a separate detector interface for data acquisition. The detector array can be placed either in a static cubic or octagonal phantom or in a linear rotational phantom. For the measurement of moving radiation sources (e.g. the rotating gantry of a LINAC), the rotational phantom rotates synchronously with the gantry. An inclinometer, fixed to the gantry, delivers the gantry angle values which are used to align the rotating detector to the gantry. The whole system is controlled with software for data display and processing.

AI/ML Overview

The provided text describes the OCTAVIUS System, a device for dosimetry measurements in radiotherapy, and its FDA 510(k) premarket notification. However, it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in a tabular format, nor does it detail a multi-reader multi-case (MRMC) comparative effectiveness study, ground truth establishment methods for training or test sets, or standalone algorithm performance.

Therefore, much of the requested information cannot be extracted directly from this document. Based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states, "The FDA has not published any performance standards for this product," meaning specific quantitative acceptance criteria set by the FDA are not provided in this document. The document primarily focuses on verifying that the device "fulfills the design specification and its intended use."

Acceptance Criteria (General)	Reported Device Performance (General)
Fulfills design specification	Demonstrated through software verification and validation testing.
Fulfills intended use	Demonstrated through software verification and validation testing.
Electrical safety compliance	Certified in compliance with IEC 61010-1:2010.
Electromagnetic compatibility (EMC) compliance	Certified in compliance with IEC 61326-1:2012 and 47 CFR Part 15 Subpart B.
Biocompatibility (for operator contact)	Biologically uncritical due to contact with uninjured skin and non-critical materials.

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

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text. The testing seems to be internal verification and validation of the device's functionality rather than a clinical study with patient data.

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

Not specified. The "ground truth" for this device appears to be its internal design specifications and the expected physical measurement outcomes, rather than expert-labeled data for an AI algorithm.

4. Adjudication method for the test set:

Not applicable as no expert-based ground truth establishment or adjudication method is described.

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, an MRMC comparative effectiveness study is not mentioned. The OCTAVIUS System is a dosimetry measurement device, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images.

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

The document implies that the device's software was tested in isolation ("software verification and validation testing results were conducted and submitted"). The device itself is a measurement system, and its "performance" is its ability to accurately collect beam data. It's not an AI algorithm in the traditional sense that operates autonomously on diagnostic data or has a "human-in-the-loop" for interpretation.

7. The type of ground truth used:

The implicit "ground truth" for the OCTAVIUS System's performance would be the physical reality of radiation dose distributions and the design specifications of the device for measuring these distributions accurately. The verification and validation process likely involved comparing the device's measurements against known or highly calibrated standards.

8. The sample size for the training set:

Not applicable. The OCTAVIUS System is a physical measurement device, not an AI system that undergoes "training" on a data set.

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

Not applicable for the same reason as above.

Summary

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PTW-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychlau GmbH Dr. Sandor-Csaba Ats Regulatory Affairs Manager Loerracher Str.7 Freiburg, 79115 BW GERMANY

October 20, 2017

Re: K160405

Trade/Device Name: OCTAVIUS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 29, 2017 Received: October 2, 2017

Dear Dr. Ats:

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 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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.

Robert Ochs

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160405

Device Name OCTAVIUS

Indications for Use (Describe)

The OCTA VIUS System is intended to collect beam data for patient plan verification of a treatment planning system (TPS) and under the aspect of machine QA for the following purposes:

IMRT patient plan verification
periodic QA procedures, e.g. constancy checks
beam data analysis according to international therapy dosimetry protocols
measurements after repair or replacement of major treatment unit components

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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OCTAVIUS System

510(k) premarket notification

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510(k) Summary

1.	Applicant:	PTW-Freiburg Physikalisch-Technische-WerkstaettenDr. Pychlau GmbH
2.	Address:	Loerracher Strasse 779115 FreiburgGermanywww.ptw.de
3.	Contact Person:	Dr. Sándor-Csaba ÁtsTel. +49 (0) 761 49055 896sandor.ats@ptw.de
4.	Preparation Date:	September 5, 2017
5.	Device Name:	OCTAVIUS
6.	Proprietary Name:	OCTAVIUS
7.	Common Name:	Dosimetric Quality Assurance for Patient Specific RadiationTreatment
8.	Classification:	Regulation number: 21 CFR 892.5050Name: Medical charged-particle radiation therapy system,Product Code: IYE
9.	Predicate Device:	Sun Nuclear's “MapCHECK2” and “ArcCHECK” (K131466)
10.	Device Description:	The OCTAVIUS System is comprised of a two-dimensional ionchamber based detector array, uniformly arranged as a matrixand a separate detector interface for data acquisition. The detectorarray can be placed either in a static cubic or octagonalphantom or in a linear rotational phantom. For the measure-ment of moving radiation sources (e.g. the rotating gantry of aLINAC), the rotational phantom rotates synchronously with thegantry. An inclinometer, fixed to the gantry, delivers the gantryangle values which are used to align the rotating detector to thegantry. The whole system is controlled with software for datadisplay and processing.
11.	Intended Use:	The PTW OCTAVIUS System is used for dosimetry measure-ments in the context of a radiotherapy system, e.g. a medicallinear accelerator (LINAC), electron or photon beams, a particletherapy system or a Cobalt-60 treatment machine. The deviceis intended for the measurement of dose distributions and thecomparison with the data as calculated by the treatment plan-ning system (patient plan verification) and/or for periodic qualityassurance procedures according to the QA plan of the respon-sible medical physicist (e.g. constancy checks).
12.	Indications:	The OCTAVIUS System is intended to collect beam data forpatient plan verification of a treatment planning system (TPS)and under the aspect of machine QA for the following purpos-es:– IMRT patient plan verification– periodic QA procedures, e.g. constancy checks– beam data analysis according to international therapy do-simetry protocols– measurements after repair or replacement of major treat-ment unit components
13.	Contraindications:	The OCTAVIUS System is for QA purposes and must not beused while a patient is present.It must not be used for Diagnostic Radiology.The resulting measurement data is for data verification of thepatient plan and must not be used to control the radiotherapydevice by importing the data into the therapy patient plan.
14.	Intended User:	The OCTAVIUS System must be used only by qualified per-sonnel, usually the medical physicists responsible for the radio-therapy system or an authorized person.
15.	Substantial equivalence	The characteristics of this device are similar to those of thepredicate devices identified on the comparison chart, which isprovided with the premarket notification submission. It is ouropinion that the OCTAVIUS does not have technological char-acteristics that raise additional types of questions related toterms of safety and effectiveness.
	Differences to the predicate devices:	OCTAVIUS provide ion chambers for radiation detection whilepredicate devices utilize semiconductor technology.Both methods are used since many years and provide equalperformance and accuracy.No additional safety issue is raised by using different detectortypes.
16.	Performance Data:	The FDA has not published any performance standards for thisproduct.
	Biocompatibility:	The device is used for pre-treatment quality assurance while nopatient is present. Since the contact of the operator with thedevice occurs only with uninjured skin and the surface of thedevice components contains no critical material, the contactwith the operator is biologically uncritical.
	Electrical & mechanicalsafety and electromagneticcompatibility (EMC):	Electrical safety and EMC testing were conducted by inde-pendent test laboratories. OCTAVIUS is certified as in compli-ance with IEC 61010-1:2010 (with no patient contact of theproduct the focus is directed to user safety) and IEC 61326-1:2012 (emission and immunity) / CISPR 11:2009+A1:2010(RF technology) and 47 CFR Part 15 Subpart B.

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OCTAVIUS System

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510(k) premarket notification

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OCTAVIUS System

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effectiveness.

Image /page/5/Picture/2 description: This document excerpt discusses software verification and validation testing, as well as bench and non-clinical testing. It mentions that software verification and validation testing results were conducted and submitted according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005). The document also states that verification and validation testing demonstrated that OCTAVIUS fulfills the design specification and its intended use. The document concludes that the PTW OCTAVIUS System is as safe and effective as the predicate device and that the application is as well or better.

to the use the device do not raised new questions of safety and

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.