The VHA Radiotherapy Bolus product is a device that will be placed on the skin of a patient as a radiotherapy accessory intended to help control the radiation dose received by the patient. VHA Radiotherapy Boluses are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. The VHA Radiotherapy Bolus product must be verified and approved by the radiation therapy professional prior to use on a patient. The VHA Radiotherapy Bolus is intended for patients of all ages receiving radiotherapy treatment.

VHA Radiotherapy Bolus was evaluated using 6 MV photons and 9MeV electrons but has not been assessed for use with protons or at orthovoltage X-rays.

Device Description

Boluses are used in external beam radiation therapy (EBRT) to change the depth of the radiation dose delivered, thereby overcoming the skin-sparing effect. Using clinical treatment planning software (TPS) and clinical expertise, a radiotherapy clinician designs the bolus to conform with the patient anatomy. The bolus is produced using additive manufacturing in a soft elastomeric material to conform to the patient's skin. The bolus is placed on the patient and verified for fit and acceptance to the clinical treatment plan prior to initiating treatment.

AI/ML Overview

The provided text (P0-P6) is a 510(k) Premarket Notification from the FDA regarding the "VHA Radiotherapy Bolus" device. It primarily focuses on demonstrating substantial equivalence to a predicate device (VSP Bolus, K214093) rather than detailing a specific study proving the device meets acceptance criteria through algorithm performance. The device described is a patient-specific physical bolus created through 3D printing for radiotherapy, not an AI/ML algorithm.

Therefore, many of the requested details, such as sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and how ground truth was established for training data, are not applicable to this document because the submitted device is a physical medical device, not a software algorithm requiring such clinical study designs.

However, I can extract information related to the acceptance criteria and performance testing that was conducted for this physical device.

Here's the analysis based on the provided text:

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

The document does not provide a quantitative table of acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity) for the device itself. Instead, it states that the device's performance was evaluated through "Simulated use testing" and that "All acceptance criteria for performance testing were met." The nature of these acceptance criteria appears to be qualitative or based on successful functionality within the simulated environment.

Criteria Category	Acceptance Criteria (Stated)	Reported Device Performance
Performance Testing	Demonstrated safety based on current industry standards. Functionality in simulated use.	"Simulated use testing was completed for clinically relevant cases using both electron and photon radiation therapy. All acceptance criteria for performance testing were met." "The VHA Radiotherapy Bolus was deemed fit for clinical use by radiation therapy professionals."
Biocompatibility	Compliance with ISO 10993-1, ISO 10993-5, and ISO 10993-10 standards. Biocompatible for intact skin contact.	"All acceptance criteria for biocompatibility were met and the testing adequately addresses biocompatibility for the output devices and their intended use." Data leveraged from predicate device due to identical materials and manufacturing.

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

Sample Size for Test Set: Not specified. The document mentions "clinically relevant cases" for simulated use testing but does not provide a number or details about these cases.
Data Provenance: Not applicable in the traditional sense for an AI/ML model's test set. The "testing" refers to physical performance and biocompatibility of the 3D-printed bolus.

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

Not explicitly stated or applicable for a physical device. The device is "designed by radiation therapy professionals" and "must be verified and approved by the radiation therapy professional prior to use on a patient." The "ground truth" for its performance would implicitly be its ability to correctly modify dose distribution per a treatment plan, which is verified by radiation therapy professionals.

4. Adjudication method for the test set

Not applicable as it's not a study involving human readers or AI output adjudication. The verification is done by a "radiation therapy professional" for the physical bolus.

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. This is not an AI/ML device. Therefore, no MRMC comparative effectiveness study was conducted or is relevant.

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. Its function is to be placed on a patient.

7. The type of ground truth used

The "ground truth" for this device's performance is its ability to accurately alter the radiation dose distribution as intended by the radiation therapy professional's treatment plan. This is verified indirectly through "simulated use testing" and the requirement for verification by a "radiation therapy professional" via a CT scan prior to first treatment. It's not a 'ground truth' in the context of diagnostic imaging outcomes (e.g., pathology, clinical outcomes).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set and associated ground truth establishment.

Summary

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November 4, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.

VHA Dean % Laura Gilmour Principal Consultant LG Strategies, LLC 3903 S. Congress Ave #3930 AUSTIN TX 78704

Re: K222639

Trade/Device Name: VHA Radiotherapy Bolus Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: Class II Product Code: IXI Dated: August 31, 2022 Received: September 1, 2022

Dear Laura Gilmour:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Lora D.
Weidner -S
Digitally signed by
Lora D. Weidner -S
Date: 2022.11.04
15:35:42 -04'00'

for Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222639

Device Name VHA Radiotherapy Bolus

Indications for Use (Describe)

VHA Radiotherapy Bolus was evaluated using 6 MV photons and 9MeV electrons but has not been assessed for use with protons or at orthovoltage X-rays.

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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5. 510(k) Summary

5.1 Applicant/Submitter

Company Name	VHA DEAN
Company Street Address	810 Vermont Avenue, NW
City	Washington
State	DC
Country	United States
Zip Code	20420
5.2 Contact Person
Full Name	Beth Ripley, MD, PhD
Job Title	Deputy Chief
Email	beth.ripley@va.gov
5.3 Correspondent Information
Full Name	Laura Gilmour
Job Title	Principal Consultant, Advanced Manufacturingand Regulatory Strategy
Phone	901-258-3629
Email	laura.gilmour@va.gov
5.4 Date of Preparation
Date of Preparation	October 25, 2022

5.5 Device Information

Table 5.1 Device Information

Trade Name	VHA Radiotherapy Bolus
Common or Usual Name	Patient specific radiotherapy bolus
Classification Name	Radiation therapy beam-shaping block
Classification Regulation	892.5710
Regulatory Class	Class II
Product Code	IXI

K222639

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5.6 Predicate Device(s)

Table 5.2 Predicate Device(s)

Predicate Type	510(k) Number	Device Name	Manufacturer
Primary Device	K214093	VSP Bolus	3D Systems
Reference Device	K091911	Bolus Compensator	.decimal

The predicate devices have not been subject to a design-related recall.

5.7 Device Description

5.8 Intended Use/Indications for Use

VHA Radiotherapy Bolus was evaluated using 6 MV photons and 9MeV electrons but has not been assessed for use with protons or at orthovoltage X-rays.

5.9 Comparison of Technological Characteristics with Predicate

VHA DEAN believes that the VHA Radiotherapy Bolus is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has the same intended use and technological characteristics to the device cleared in K214093. Technological characteristics include identical manufacturing method, material, patient population and use environment as K214093. The reference device (K091911) and the subject device have the same input parameters. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicate (K214093).

A comparison of the technical characteristics between VHA Radiotherapy Bolus and the predicate device is provided in the following Comparison Table:

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Specification/Characteristic	Subject Device	Primary Predicate Device
	VHA Radiotherapy BolusVHA DEANK222639	VSP® Bolus3D Systems, Inc.K214093
Indications for Use	The VHA Radiotherapy Bolus product is adevice that will be placed on the skin of a patientas a radiotherapy accessory intended to helpcontrol the radiation dose received by thepatient. VHA Radiotherapy Boluses are designedby radiation therapy professionals for a uniquepatient and are intended to modify the shape of abeam from a radiation therapy source. The VHARadiotherapy Bolus product must be verified andapproved by the radiation therapy professionalprior to use on a patient. The VHA RadiotherapyBolus is intended for patients of all agesreceiving radiotherapy treatment.VHA Radiotherapy Bolus was evaluated using 6MV photons and 9MeV electrons but has notbeen assessed for use with protons or atorthovoltage X-rays	The 3D Systems VSP® Bolus product is adevice that will be placed on the skin of a patientas a radiotherapy accessory intended to helpcontrol the radiation dose received by thepatient. VSP Bolus is generated using input fromradiation therapy professionals and medicalimaging data to produce a bolus that is specificto the patient being treated. The VSP Bolusproduct is verified and approved by the radiationtherapy professional prior to use on the patient,and is intended for patients of all ages receivingradiotherapy treatment.VSP Bolus was evaluated using 6 MV photonsbut has not been assessed for use with protons,electrons, or at orthovoltage X-rays.
Device InputParameters	1. DICOM2. The device is designed by the radiationtherapy professional.	1. DICOM2. Radiotherapy professional input (i.e.thickness, anatomical location)
DeviceManufacturingMethod	Additive Manufacturing (3D Printing)	Additive Manufacturing (3D Printing)
Device Material	VisiJet® M2E-BK70	VisiJet® M2E-BK70
Patient ContactMaterial Standards	Biocompatible for intact skin contact	Biocompatible for intact skin contact
Device ClinicalAcceptance	Each VHA Radiotherapy Bolus must be verifiedand approved by the radiation therapyprofessional through a CT scan prior to the firsttreatment fraction.	Each VSP® Bolus must be verified andapproved by the radiation therapy professionalthrough a CT scan prior to the first treatmentfraction.
Patient Population	Cancer patients requiring external beamradiotherapy.	Cancer patients requiring external beamradiotherapy.
Patient PopulationAnatomical Sites	Various	Various
Use Environment	Radiotherapy Clinic	Radiotherapy Clinic
DevicePerformance	Clinically oriented validation test cases werewritten and executed. The VHA RadiotherapyBolus was deemed fit for clinical use byradiation therapy professionals.	Clinically oriented validation test cases werewritten and executed. VSP Bolus was deemed fitfor clinical use by radiation therapyprofessionals.

Table 5.3 Technical Characteristics Comparison Table

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5.10 Summary of Non-Clinical Testing

The following tests were performed to demonstrate safety based on current industry standards:

5.10.1 Performance Testing

Simulated use testing was completed for clinically relevant cases using both electron and photon radiation therapy. All acceptance criteria for performance testing were met.

5.10.2 Biocompatibility Testing

The VHA Radiotherapy Bolus has identical indications for use, identical material and manufacturing method, and an identical worst-case configuration and post processing conditions to the predicate device. Therefore, the subject device leveraged data on hand. All acceptance criteria for biocompatibility were met and the testing adequality addresses biocompatibility for the output devices and their intended use. Biocompatibility testing was in compliance to ISO 10993-1 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process, ISO 10993-5 Biological evaluation of medical devices—Part 5: Tests for In Vitro cytotoxicity, and ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.

5.11 Clinical Testing

No clinical data were provided in order to demonstrate substantial equivalence.

5.12 Conclusion

Based on the testing performed, including performance testing and biocompatibility testing, it can be concluded that the subject device does not raise any new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the VHA Radiotherapy Bolus are assessed to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.5710 Radiation therapy beam-shaping block.

(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.