The Integrated Conical Collimator Verification and Interlock system (ICVI) is an accessory device indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery and precision Radiotherapy on intra-cranial and extra cranial lesions or tumors.

Device Description

Integrated Conical Collimator Verification and Interlock system (ICVI) is a secondary collimation system. It also has a security feature that verifies the correct selection of a conical collimator and prevents the radiation treatment device from commencing irradiation when the selected conical collimator is out of conformance with the treatment plan.

Integrated Conical Collimator Verification and Interlock system (ICVI) consists of a collimator mount that attaches to the accessory plate (Slot 2) of the linear accelerator, conical collimators that insert into the mount and are capable of being read electronically by the mount, and a locking ring that locks the conical collimator to the mount.

AI/ML Overview

The provided document is a 510(k) summary for the Integrated Conical Collimator Verification and Interlock system (ICVI). It describes the device, its intended use, and compares it to a predicate device. However, it does not contain a detailed study that proves the device meets specific acceptance criteria in the manner one would expect for an AI/CADe device.

Instead, the summary focuses on demonstrating substantial equivalence to a predicate device and outlines general performance testing. The "acceptance criteria" presented are primarily a comparison of characteristics between the subject device and the predicate device for demonstrating substantial equivalence, rather than quantitative performance metrics from a formal study.

Therefore, many of the requested elements (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance metrics, training set details) are not available in this document because the described "testing" is not a clinical study to quantify performance against specific efficacy or diagnostic accuracy metrics. It's a verification and validation process against engineering specifications and regulatory requirements for a physical accessory device.

Here's an attempt to answer the questions based on the provided text, highlighting what is available and what is missing:

Acceptance Criteria and Device Performance

A table of "acceptance criteria" in the traditional sense of performance metrics (e.g., sensitivity, specificity, AUC) is not provided. Instead, the document presents a comparison of characteristics between the subject device (ICVI) and the predicate device (SNT Linac Accessories, K971893) to establish substantial equivalence. The "Acceptance Criteria" column below will represent these comparative characteristics, and "Reported Device Performance" will indicate how the ICVI meets or exceeds the predicate.

Acceptance Criteria (Characteristic)	Predicate Device Information	Reported Device Performance (ICVI Information)
Intended Use	The SNT Linac Accessories are indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The accessories include a secondary collimation system, components to mount a patient in a stereotactic headring to a linear accelerator's treatment couch, and components to position the patient relative to the isocenter of a linear accelerator in conjunction with a laser alignment system.	The Integrated Conical Collimator Verification and Interlock system is intended for use with a Linear Accelerator to perform Stereotactic Radiosurgery or precision Radiotherapy on intra-cranial and extra cranial lesions or tumors that require a conical collimator to shape the radiation beam. (Yes - Broader anatomical sites and precision radiotherapy)
Indications for Use	The SNT Linac Accessories are indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery or Radiotherapy on cranial lesions. The accessories include a secondary collimation system, components to mount a patient in a stereotactic headring to a linear accelerator's treatment couch, and components to position the patient relative to the isocenter of a linear accelerator in conjunction with a laser alignment system.	The Integrated Conical Collimator Verification and Interlock system is an accessory device indicated for use with a Linear Accelerator to perform Stereotactic Radiosurgery and precision Radiotherapy on intra-cranial and extra cranial lesions or tumors. (Yes - Broader anatomical sites and precision radiotherapy for benign or malignant lesions)
Duration of Use	The patient would usually receive a series of treatments with a linear accelerator.	The patient would usually receive a series of treatments with a linear accelerator. (Yes - Equivalent)
Collimator mount	Yes	Yes (Yes - Equivalent)
Collimators	Yes, comes with collimators	Yes, comes with collimators (Yes - Equivalent)
Design Dimensions (Mount)	Not published	476 x 350 x 100 mm without the conical collimator; 476 x 350 x 180 mm with the conical collimator. (Yes - Comparable, and dimensions provided for subject device)
Design Dimensions (Conical S)	118 mm base diameter; 73 mm conical collimator diameter; 14 mm length	118 mm base diameter; 73 mm conical collimator diameter; 14 mm length. (Yes - Equivalent)
Design Material (Mount)	Not published	Aluminum, Stainless Steel, Brass, Copper, PCB, Cabling. (Yes - Materials specified, assumed comparable in function)
Design Material (Conical S)	Tungsten & Aluminum	Tungsten & Aluminum. (Yes - Equivalent)
Anatomical Sites	Cranial lesions	Intra-cranial and extra-cranial lesions or tumors, benign or malignant. (Yes - Broader)
Mount & conical collimators electronically verifiable	No	Yes (Yes - Superior, an added safety feature)
Provides verification that the correct conical collimator has been selected for patient treatment based on the patient's treatment plan.	No	Yes (Yes - Superior, an added safety feature and core function of the ICVI)
Patient Contact	None	None (Yes - Equivalent)
Biocompatibility	N/A no patient contact	N/A no patient contact (Yes - Equivalent)

The document states: "Results of verification and validation testing showed conformance to applicable requirement specifications and assured hazard safeguards functioned properly." This is a general statement of compliance, not a detailed report of quantitative performance against specific acceptance criteria.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable/Not Provided. The document describes "verification and validation testing" but does not refer to a clinical "test set" in the context of diagnostic or efficacy studies. The testing would have involved physical devices and perhaps simulated use cases for mechanical and electronic functionality, but no patient data is mentioned.
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):
- Not Applicable/Not Provided. This is a hardware accessory device with safety interlocks. The "ground truth" would be engineering specifications and functional correctness, verified through engineering tests rather than expert consensus on medical images or diagnoses.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Provided. Not relevant for this type of device and testing.
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/Not Provided. This device is a physical accessory for a linear accelerator with an interlock system. It is not an AI/CADe device, and no MRMC study would be relevant or expected for its regulatory submission.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable/Not Provided. This is a physical device, not an algorithm. The "standalone" performance would be its functional verification (e.g., does the interlock activate when it should, does it accurately read the collimator). The document states: "Testing was performed to demonstrate - That the device functions correctly with the specified Linear Accelerators. - That the device meets mechanical specifications. - Usability was assessed to the requirements of IEC 62366:2007." These are standalone functional tests.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Specifications and Functional Requirements. The ground truth for this device's "acceptance" is its adherence to mechanical specifications, proper electronic verification of collimator selection, and reliable activation of safety interlocks as designed. This is not derived from patient outcomes or expert medical interpretation but from engineering design and validation.
The sample size for the training set:
- Not Applicable/Not Provided. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established:
- Not Applicable/Not Provided. As it's not an AI/ML device, no training set or its associated ground truth establishment method is relevant.

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence of the ICVI system to a predicate device, as required for a Class II medical device. The "study" described is verification and validation testing to ensure the device meets its engineering specifications, functions correctly, and provides the intended safety features (electronic verification and interlock). It is not a clinical study to assess diagnostic accuracy or treatment efficacy, and therefore, the detailed metrics and methodologies typical for AI/CADe clinical studies are not present. The primary "acceptance criteria" are the functional equivalence or superiority to the predicate device in terms of features, intended use, and safety mechanisms.

Summary

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K 123788

JAN 1 5 2013

510(k) Summary SUMMARY OF SAFETY AND EFFECTIVENESS

Integrated Conical Collimator Verification and Interlock system (ICVI)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

Submitted by:

Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304

Phone: 650-424-6320 Fax: 650-842-5040

Contact Person: Peter J. Coronado, Director, Regulatory Affairs

Date summary prepared: December 7, 2012

Trade Name: Integrated Conical Collimator Verification and Interlock system (ICVI)

Common Name: Integrated Conical Collimator Verification and Interlock system (ICVI)

Classification Name: Medical charged-particle radiation therapy system 21 CFR 892.5050, Class II Product Code: IYE

Predicate Devices: SNT Linac Accessories, K971893

Device Description:

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Indications for Use:

Intended Use:

The Integrated Conical Collimator Verification and Interlock system is intended for use with a Linear Accelerator to perform Stereotactic Radiosurgery or precision Radiotherapy on intracranial and extra cranial lesions or turnors that require a conical collimator to shape the radiation beam.

Characteristic	Predicate Device	Subject Device	Equivalent
	SNT Linac Accessories, K971893	Integrated Conical CollimatorVerification and Interlocksystem (ICVI)	or Better?
Intended Use	The SNT Linac Accessories areindicated for use with a LinearAccelerator to perform StereotacticRadiosurgery or Radiotherapy oncranial lesions. The accessoriesinclude a secondary collimationsystem, components to mount apatient in a stereotactic headring toa linear accelerator's treatmentcouch, and components to positionthe patient relative to the isocenterof a linear accelerator inconjunction with a laser alignmentsystem	The Integrated ConicalCollimator Verification andInterlock system is intendedfor use with a LinearAccelerator to performStereotactic Radiosurgery orprecision Radiotherapy onintra-cranial and extra craniallesions or tumors that requirea conical collimator to shapethe radiation beam.	Yes
Indications forUse	The SNT Linac Accessories areindicated for use with a LinearAccelerator to perform StereotacticRadiosurgery or Radiotherapy oncranial lesions. The accessoriesinclude a secondary collimationsystem, components to mount apatient in a stereotactic headring toa linear accelerator's treatmentcouch, and components to positionthe patient relative to the isocenterof a linear accelerator inconjunction with a laser alignment system	The Integrated ConicalCollimator Verification andInterlock system is anaccessory device indicated foruse with a Linear Acceleratorto perform StereotacticRadiosurgery and precisionRadiotherapy on intra-cranialand extra cranial lesions ortumors.	Yes
	system
Duration of Use	The patient would usually receive aseries of treatments with a linearaccelerator.	The patient would usuallyreceive a series of treatmentswith a linear accelerator.	Yes
Collimatormount	Yes	Yes	Yes
Collimators	Yes, comes with collimators	Yes, comes with collimators	Yes
DesignDimensions	MountNot published	Mount476 x 350 x 100 mm withoutthe conical collimator476 x 350 x 180 mm with theconical collimator	Yes
DesignDimensions	Conical Collimators118 mm base diameter73 mm conical collimatordiameter14 mm length	Conical Collimators118 mm base diameter73 mm conical collimatordiameter14 mm length	Yes
Design Material	MountNot published	MountAluminum, Stainless Steel,Brass, Copper, PCB, Cabling	Yes
	Conical CollimatorsTungsten & Aluminum	Conical CollimatorsTungsten & Aluminum
AnatomicalSites	Cranial lesions	Intra-cranial and extra-craniallesions or tumors, benign ormalignant	Yes
Mount &conicalcollimatorselectronicallyverifiable	No	Yes	Yes
Providesverification thatthe correctconicalcollimator hasbeen selected forpatient treatmentbased on thepatient's	No	Yes	Yes
treatment plan.
Patient Contact	None	None	Yes
Biocompatibility	N/A no patient contact	N/A no patient contact	Yes

Technological Characteristics:

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Summary of Performance Testing:

Testing was performed to demonstrate

That the device functions correctly with the specified Linear Accelerators .
. That the device meets mechanical specifications
Usability was assessed to the requirements of IEC 62366:2007 .

Results of verification and validation testing showed conformance to applicable requirement specifications and assured hazard safeguards functioned properly.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 15, 2013

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

Re: K123788

Trade/Device Name: Integrated Conical Collimator Verification and Interlock System (ICVI)

Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: December 7, 2012 Received: December 10, 2012

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

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Page 2-Mr. Coronado

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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. O'Hara

Janine M. Morris 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): K123788

Device Name: Integrated Conical Collimator Verification and Interlock System (ICVI)

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K123788 510(k) =======================================================================================================================================================================

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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.