The Surface Applicator Set is intended for treatment of small skin tumours or other superficial disease (such as keloid formations) with HDR Brachytherapy.

Device Description

The Surface Applicator Set is an applicator for Brachytherapy. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Surface Applicator Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or superiority through extensive clinical trials. As such, the information you've requested regarding detailed acceptance criteria, study methodologies, expert qualifications, and specific performance metrics often associated with AI/ML device evaluations or new clinical indications is not explicitly available in this document.

Here's an analysis based on the provided text, addressing your points where possible, and noting when information is absent:

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

The document states: "Bench testing was performed to evaluate the suitability of the applicator sets repeated use for up to 500 times and 100 cleaning cycles. Non-clinical testing showed the test articles met the pre-defined acceptance criteria, thereby demonstrating that the device performs as intended."

This indicates that acceptance criteria were pre-defined, but the actual numerical values or specific performance metrics are not provided in the summary. For example, it might have involved acceptable levels of wear, deformation, or structural integrity after repeated use/cleaning, but these details are not disclosed.

Acceptance Criteria (Not explicitly stated in detail)	Reported Device Performance (Summary)
Suitability for repeated use up to 500 times	Met pre-defined acceptance criteria, performs as intended
Suitability for 100 cleaning cycles	Met pre-defined acceptance criteria, performs as intended

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Bench testing." For bench testing of physical devices, the "sample size" typically refers to the number of units tested. This specific number is not provided. The data provenance would be a laboratory setting, not patient data, so "country of origin" or "retrospective/prospective" are not applicable in the usual sense for clinical data.

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)

This information is not applicable and therefore not provided. Since this is a physical medical device (applicator) for brachytherapy and the testing was "bench testing" focusing on mechanical and material integrity (repeated use, cleaning cycles), there is no "ground truth" established by medical experts in the way it would be for an AI diagnostic device. The acceptance criteria would likely be engineering specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided. Adjudication methods are typically used for establishing ground truth in clinical studies involving interpretation of medical images or patient outcomes, which is not what was performed here.

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

This information is not applicable and therefore not provided. The device is a physical applicator, not an AI or imaging device that involves human readers or AI assistance. No MRMC study was conducted.

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

This information is not applicable and therefore not provided. This device is a physical applicator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As explained in point 3, the concept of "ground truth" as typically discussed for diagnostic or AI devices is not applicable to the bench testing of this physical applicator. The "ground truth" here would be the engineering specifications and performance requirements derived from the device's intended use and design, verified through controlled laboratory testing.

8. The sample size for the training set

This is not applicable and therefore not provided. The device is a physical product, not a software algorithm that requires a training set.

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

This is not applicable and therefore not provided. As above, there is no training set for this physical device.

In summary: The provided document is for a 510(k) premarket notification for a physical medical device (a brachytherapy applicator). The regulatory pathway focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing. Consequently, the detailed clinical study information, expert ground truth establishment, and AI-related metrics you've inquired about are generally not part of such submissions and are therefore not present in this document. The "performance data" section explicitly states "No clinical tests have been included in this pre-market submission."

Summary

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

February 28, 2017

Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Varian Oncology Systems Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304

Re: K162018

Trade/Device Name: Surface Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: February 9, 2017 Received: February 10, 2017

Dear Mr. Coronado:

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 O'Hara

For

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) K162018

Device Name Surface Applicator Set

Indications for Use (Describe)

The Surface Applicator Set is intended for treatment of small skin tumours or other superficial disease (such as keloid formations) with HDR Brachytherapy.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 www.varian.com

Premarket Notification [510(k)] Summary

Surface Applicator Set

The following information is provided following the format of 21 CFR 807.92(c).

Submitter's Name:	Varian Medical Systems, Inc.3100 Hansen Way E-110Palo Alto, CA 94304
	Contact Name: Peter J. Coronado
	Phone: 650.424.6320
	Fax: 650.646.9200
	Date: February 9, 2017
Proprietary Name:	Surface Applicator Set
Classification Name:	Remote controlled radionuclide applicator system21 CFR 892.5700, Class IIProduct Code: JAQ
Common/UsualName:	Remote controlled radionuclide applicator system
Predicate Devices:	Surface Applicator Set with Leipzig-style Cone (K123815)
Device Description:	The Surface Applicator Set is an applicator for Brachytherapy. Brachytherapy is a form ofradiotherapy using Gamma rays from a radioactive source placed at locations close to orwithin a tumor or other treatment area to a predefined treatment plan. The treatmentplan defines the positions and times for the source to ensure the correct dose for thetreatment area. The applicator acts to guide the radioactive source to the correctlocation or locations for treatment.
Intended UseStatement	The Surface Applicator Set is intended for treatment of small skin tumours or othersuperficial disease (such as keloid formations) with HDR Brachytherapy.
Indications for UseStatement	The Surface Applicator Set is intended for treatment of small skin tumours or othersuperficial disease (such as keloid formations) with HDR Brachytherapy.

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Technological Characteristics:

FEATURE AND/ORSPECIFICATION OFNEW/MODIFIED DEVICE	SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE(K123815)	MODIFIED DEVICE –SURFACE APPLICATOR SET
Compatible Afterloader	GammaMedplus Series	GammaMedplus Series
Intended Use	The Surface Applicator Set with Leipzig-style cone-GM11010080is indicated for treatment of small skintumours or other superficial disease(such as keloid formations) with HDRbrachytherapy.	The Surface Applicator Setis intended for treatment of small skintumours or other superficial disease(such as keloid formations) with HDRBrachytherapy.
Indications for Use	The Surface Applicator Set with Leipzig-style cone-GM11010080is indicated for treatment of small skintumours or other superficial disease(such as keloid formations) with HDRbrachytherapy.	The Surface Applicator Setis intended for treatment of small skintumours or other superficial disease(such as keloid formations) with HDRBrachytherapy.
Design/Component list	Shielding for tubus with a vertical sourceentrance:• Ø 10-25 mm and Ø 30-45 mmwith fixationSurface cone inset set:• Ø30, 35, 40 mm roundSterilization Plug GM11009960 andLeak Stop Button GM11003810	Shielding for the cone with avertical source entrance:• Ø 10-25 mm and Ø 30-45 mmwith fixationSurface cone inset set:• Ø15, 20, 25, 30, 35, 40 mmround• Ø 30 x 20 mm and Ø 45 x 25mm ovalCleaning Caps (K152018)
Materials	• Surface cone inset:Tungsten/hard PVC• Leipzig Style Cone: Tungsten/Stainless Steel	• Surface cone inset: Tungsten/hardPVC• Shielding for cones with fixation:Tungsten/Stainless steel
Packing	Individual	Individual
Sterility	Delivered in non-sterile condition.	Delivered in non-sterile condition.
Sterilization method	Device is not sterilized.	Device is not sterilized.
Repeated Use	500 times	500 times
Cleaning cycles	100	100
Biocompatibility	N/A. The use of a sterile plastic envelopeor surgical foil is required to prevent anyparts of the applicator from having bodycontact	N/A. The use of a sterile plasticenvelope or surgical foil is required toprevent any parts of the applicator fromhaving body contact
Anatomical sites	Skin	Skin
Compatible with CT orMR	No	No
Where used	Brachytherapy treatment room	Brachytherapy treatment room

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Performance Data:

Bench testing was performed to evaluate the suitability of the applicator sets repeated use for up to 500 times and 100 cleaning cycles. Non-clinical testing showed the test articles met the pre-defined acceptance criteria, thereby demonstrating that the device performs as intended.

Clinical Tests No clinical tests have been included in this pre-market submission

Conclusions

The non-clinical data support the safety of the device and the bench testing demonstrates that the Surface Applicator Set performs as intended. Varian therefore considers Surface Applicator Set to be safe and effective and to perform at least as well as the predicate device.

Regulation Number and Section

N/A