The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.

Device Description

The Head Frame provides rigid immobilization of a patient's skull by attaching a rigid halo (head frame) to the patient through four invasive contact points (called screws or pins) which penetrate the patient's skin and contact the bone of the skull. The head frame is secured to either the CT table or the treatment table via a bracket which is included in the system. This ensures the patient cannot easily move during imaging or treatment. This level of immobilization is generally used for stereotactic radiosurgery.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically seen for AI/ML-enabled devices. This document is a 510(k) premarket notification for a Varian Head Frame, which is a physical medical device used for patient immobilization during radiation therapy.

Therefore, many of the requested categories in the prompt, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (algorithm only without human-in-the-loop performance)," and information about training/test set sample sizes for algorithms, are not applicable to this submission.

The document discusses performance testing in terms of conformance to requirements specifications, hazard safeguards, and cleaning/sterilization validation. It also explicitly states: "Clinical Tests No clinical tests have been included in this pre-market submission".

Here's an attempt to fill in the requested information based on the provided text, indicating where information is not applicable or not found:

Acceptance Criteria and Study Details for Varian Head Frame (K180586)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What the device aims to achieve)	Reported Device Performance (How the device met the criteria)
Rigid immobilization of a patient's skull.	Device provides rigid immobilization by attaching a rigid halo to the patient through four invasive contact points.
Securement to CT or treatment table.	Head frame secured to either the CT table or the treatment table via a bracket.
Prevention of patient movement during imaging or treatment.	Ensures the patient cannot easily move during imaging or treatment.
Compatibility with CT scanners.	"CT compatible."
Effective cleaning processes for reuse.	Validated outlined cleaning procedures for Head Frame and Posts.
Effective sterilization processes for reuse.	Validated outlined sterilization procedures for Cranial pins, Head Frame, and Posts.
Durability for reprocessing.	Head Frame ring can be reprocessed up to 60 cycles; posts up to 286 cycles.
Conformance to applicable requirements specifications.	"Results of verification and validation testing showed conformance to applicable requirements specifications."
Assured hazard safeguards function properly.	"Assured hazard safeguards functioned properly."

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

Not Applicable. This is a physical device, not an AI/ML algorithm that uses a "test set" of data in the common sense. Performance was assessed through engineering verification and validation testing, including cleaning, sterilization, and reprocessing studies, not on patient data test sets.

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

Not Applicable. Ground truth in the context of expert review for medical image analysis is not relevant here. The ground truth for performance was established through engineering tests measuring physical properties, durability, and effectiveness of cleaning/sterilization protocols.

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

Not Applicable. Not relevant for the type of testing performed for this physical device.

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

Not Applicable. This device is a physical head frame, not an AI assistance tool for human readers. No MRMC study was performed.

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

Not Applicable. This is a physical device, not an algorithm.

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

The ground truth for this device's performance was established through:
- Engineering specifications and standards: The device's physical properties, materials, and mechanical functions were verified against established performance requirements.
- Laboratory testing: Specifically for cleaning, sterilization, and reprocessing, where established protocols and efficacy metrics (e.g., microbial reduction, material degradation) would serve as the ground truth.

8. The sample size for the training set

Not Applicable. This is a physical device; there is no "training set" in the context of machine learning.

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

Not Applicable.

Summary of Non-Clinical Testing Performed:

The submission highlights "verification and validation testing" demonstrating conformance to requirements and proper function of hazard safeguards. It also specifically mentions:

Cleaning, sterilization, and reprocessing testing which validated procedures.
Demonstrating that the Head Frame ring can be reprocessed up to 60 cycles and posts up to 286 cycles.

The document explicitly states "No clinical tests have been included in this pre-market submission." Therefore, the "study" proving the device meets criteria is a collection of non-clinical, engineering, and laboratory-based verification and validation tests against established performance specifications and recognized standards (listed in the document such as IEC 62366, ISO 10993, AAMI standards).

Summary

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April 2, 2018

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Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304

Re: K180586

Trade/Device Name: Varian Head Frame Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 2, 2018 Received: March 5, 2018

Dear Mr. Coronado:

We have reviewed vour 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.

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(1-800-638-2041 or 301-796-7100).

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone

Sincerely,

Michael D. 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)

K180586

Device Name Varian Head Frame

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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

varian

Varian Head Frame

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 94304Contact Name: Peter J. CoronadoPhone: 650.424.6320Fax: 650.646.9200Date: March 2, 2018
Name of the Device:Trade/ ProprietaryNames:	Varian Head Frame
Classification Name:	Medical charged-particle radiation therapy system21 CFR 892.5050, Class IIProduct Code: IYE
Common/UsualName:	Head Frame
Predicate Device:	Varian Head Frame K142560
Device Description:	The Head Frame provides rigid immobilization of a patient's skull by attaching a rigid halo(head frame) to the patient through four invasive contact points (called screws or pins)which penetrate the patient's skin and contact the bone of the skull. The head frame issecured to either the CT table or the treatment table via a bracket which is included inthe system. This ensures the patient cannot easily move during imaging or treatment.This level of immobilization is generally used for stereotactic radiosurgery.
Intended UseStatement	The Varian Head Frame is for use with a charged particle accelerator to performimmobilization of the treatment target for stereotactic radiosurgery or radiotherapytreatments on cranial lesions, tumors and conditions where radiation treatment isindicated.
Indications for UseStatement	The Varian Head Frame System is for use with a computed tomography scanner toperform imaging for treatment planning and a charged particle accelerator to performimmobilization of the treatment target for stereotactic radiosurgery or radiotherapytreatments on cranial lesions, tumors and conditions where radiation treatment isindicated

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Technological Characteristics:

Summary of Performance Testing

Results of verification and validation testing showed conformance to applicable requirements specifications and that the assured hazard safeguards functioned properly. Cleaning, sterilization and reprocessing testing validated the outlined procedures and demonstrated the Head Frame ring can be reprocessed up to 60 cycles and the posts can be reprocessed up to 286 cycles.

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

Standards conformance

The Varian Head Frame conforms with the following standards.

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IEC 62366:2007 ANSI/AAMI/ISO 10993-1:2009 ANSI/AAMI/ISO 10993-5:2009 AMSI/AAMI/ISO 10993-10:2010 AMSI/AAMI/ISO 10993-11:2010 AAMI TIR12 AAMI TIR30:2011

ANSI/AAMI ST81 ANSI/AAMI ST79 ANSI/AAMI ST35 AAMI TIR34 ASTM E2314-03 ISO 17664 ANSI/AAMI/ISO 17665-1

Conclusions

Based on the verification, validation and non-clinical cleaning and sterilization testing, the Varian Head Frame is as safe and effective and performs at least as well as the predicate device.

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.

FEATURE AND/OR SPECIFICATION	VARIAN HEAD FRAME	VARIAN HEAD FRAME
OF NEW/MODIFIED DEVICE
	(v1.0) K142560	(v2.0)
Indications for use	The Varian Head Frame System is for	The Varian Head Frame System is for
	use with a computed tomography	use with a computed tomography
	scanner to perform imaging for	scanner to perform imaging for
	treatment planning and a charged	treatment planning and a charged
	particle accelerator to perform	particle accelerator to perform
	immobilization of the treatment	immobilization of the treatment
	target for stereotactic radiosurgery or	target for stereotactic radiosurgery or
	radiotherapy treatments on cranial	radiotherapy treatments on cranial
	lesions, tumors and conditions where	lesions, tumors and conditions where
	radiation treatment is indicated.	radiation treatment is indicated.
Intended Use	The Varian Head Frame is for use with	The Varian Head Frame is for use with
	a charged particle accelerator to	a charged particle accelerator to
	perform immobilization of the	perform immobilization of the
	treatment target for stereotactic	treatment target for stereotactic
	radiosurgery or radiotherapy	radiosurgery or radiotherapy
	treatments on cranial lesions, tumors	treatments on cranial lesions, tumors
	and conditions where radiation	and conditions where radiation
	treatment is indicated.	treatment is indicated.
Head Frame Ring	Nickel-plated anodized aluminum	Nickel-plated anodized aluminum
Posts	Material: Delrin	Material: PEEK
CT	CT compatible	CT compatible
Sterilization:	Cleaning for the Head Frame and	Cleaning and Autoclave Sterilization
	Posts	for the Cranial pins, Head Frame and
	Autoclave Sterilization for the CranialPins only	Posts