Nova Surface Applicator is indicated for and intended to be placed on the patient's skin to navigate an HDR radiation source during the treatment of various types of cancer using brachytherapy.

The device is for a single patient's use only and can be reused throughout the entirety of the treatment plan.

The device is designed by radiation therapy professionals using patient imaging data as input and must be verified and approved by the trained radiation therapy professional prior to use.

The device is restricted to sale by or on the order of a physician and is by prescription only.

Device Description

Adaptiv's Nova Surface applicator is a 3D printed patient-matched radiation therapy accessory that expands the application of brachytherapy by providing a patient-specific fit and catheter trajectory design.

Patient imaging data from the treatment planning system (TPS) are used as inputs to generate digital design of the surface brachytherapy applicator by 3D Brachy Software Application (K213438), previously developed by Adaptiv. The resulting output Stereolithography (STL) file is compatible with the third-party 3D printers.

Nova Surface applicator navigates a radiation source toward tumors located closely to or on the surface of the body (e.g. skin cancers). It fits the patient's anatomy by means of a patient-specific contact surface ensuring that optimal dose is delivered to a target surface of the body. It accommodates catheter tunnels which guide the HDR brachytherapy radiation source according to the patient-specific design input chosen by users.

A surface brachytherapy applicator device is 3D printed by Stereolithography (SLA) technology using methacrylic resin.

AI/ML Overview

It appears there might be a misunderstanding. The provided text is a 510(k) clearance letter and its associated summary for a medical device (Nova Surface Applicator). This document does not describe a study involving an AI algorithm or a multi-reader, multi-case (MRMC) comparative effectiveness study.

The device in question, the Nova Surface Applicator, is a 3D-printed accessory for brachytherapy that navigates a radiation source. The performance testing described is focused on the physical characteristics and accuracy of this manufactured device, not on the performance of a diagnostic AI algorithm.

Therefore, I cannot provide information on:

Table of acceptance criteria and reported device performance for an AI algorithm: The criteria listed are for physical properties and fit, not for diagnostic accuracy (e.g., sensitivity, specificity).
Sample size for test set and data provenance for an AI algorithm: There's no mention of a test set for an AI. The "worst-case samples" and "real patient datasets" refer to the physical testing of the applicator itself.
Number of experts and their qualifications for ground truth establishment for an AI algorithm.
Adjudication method for an AI algorithm test set.
MRMC comparative effectiveness study or effect size of AI assistance.
Standalone AI algorithm performance.
Ground truth type for an AI algorithm.
Sample size for the training set for an AI algorithm.
How ground truth for the training set for an AI algorithm was established.

The document describes non-clinical performance testing for a physical medical device. Here's what can be extracted about the device's acceptance criteria and testing:

Device: Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) - a 3D printed patient-matched radiation therapy accessory.

Purpose: To be placed on the patient's skin to navigate an HDR radiation source during the treatment of various types of cancer using brachytherapy.

Acceptance Criteria & Reported Device Performance (Based on Non-Clinical Tests):

Acceptance Criteria Category	Specific Criteria/Test Description	Reported Device Performance/Conclusion
Post-production verification (Physical Inspection & Functional Tests)	- Look, feel, surface quality: Ensure acceptable physical appearance and tactile properties.	Demonstrated conformance to requirements.
	- Inner structure consistency (mass consistency and dimensional fidelity): Verify that the internal structure of the 3D printed device is uniform and accurately reproduces the designed dimensions.	Demonstrated high printing accuracy of key functional features and functional key property (density of the material after printing) in conformance with performance requirements.
	- Functionality of catheter tunnel accessibility, orientation, inter-tunnel, and source-to-surface distances: Ensure that the tunnels for guiding the radiation source are correctly formed, accessible, oriented as designed, and maintain specified distances.	Demonstrated high printing accuracy of key functional features.
	- Labels legibility: Verify that all labels on the device are clear and readable.	Results not explicitly detailed for this point, but implied by overall positive conclusion.
	- Additional features functionality (dosimetry pockets and alignment guides): Ensure any other designed features perform as intended.	Results not explicitly detailed for this point, but implied by overall positive conclusion.
Simulated performance testing (Spatial Fidelity & Fit)	- Evaluation of spatial fidelity and fit of patient-specific devices: Virtuallý positioning a CT scan of the device with respect to a DICOM-RT structure representing the patient's anatomy to ensure accurate fit and spatial relationship. This ensures the "patient-specific contact surface" provides enough accuracy to fit the patient's anatomy.	Demonstrated high accuracy in terms of spatial fidelity, providing a precise fit of the device on the patient's anatomy and successful delivery of radiation to the treatment target tissues. The technological and validation methods used are considered applicable to ensure product quality during the production process. Performance testing results demonstrate substantial equivalence to the predicate device and are considered evidence of overall safety and effectiveness.
Material & Manufacturing Process	- SLA technology and material compatibility: Ensure that Stereolithography (SLA) technology and methacrylic resin are suitable for manufacturing and do not negatively impact safety and effectiveness.	All tests verified that the chosen manufacturing technology performed as intended and did not affect the overall safety and effectiveness of the device, and are beneficial compared to the previously used technology (FDM and PLA for predicate). SLA offers high accuracy/tolerance, smoother surface finish, and transparency.

Other Available Information from the Provided Text (NOT related to AI):

Sample size used for the test set: The document states "The batch of the tests has been performed on worst-case samples as well as on the final device real patient datasets." No specific number for "worst-case samples" or "real patient datasets" is provided.
Data provenance: Not explicitly stated for the "real patient datasets" (e.g., country of origin). The testing is described as non-clinical.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a physical device test, not a diagnostic accuracy study. The device design process mentions it's "designed by radiation therapy professionals using patient imaging data as input and must be verified and approved by the trained radiation therapy professional prior to use." This refers to clinical use and design, not the test itself.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted, as this is not an AI diagnostic device.
Standalone (i.e. algorithm only without human-in-the-loop performance): Not applicable, as this is a physical medical device, not an algorithm.
The type of ground truth used: For the physical device testing, the "ground truth" seems to be the designed specifications and the expected physical and functional performance of the applicator. For the simulated performance, the "ground truth" is the patient's anatomy as represented by the DICOM-RT structure.
The sample size for the training set: Not applicable; this device is manufactured from a design based on patient imaging data, not trained like a machine learning model.
How the ground truth for the training set was established: Not applicable. The device is designed based on patient-specific imaging data as input into the Adaptiv's 3D Brachy Software Application.

Summary

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August 30, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The seal is a stylized depiction of an eagle and a caduceus, while the FDA acronym and name are written in blue, with the word "Administration" appearing below the acronym and name.

Adaptiiv Medical Technologies, Inc. Olga Zhuk Quality and Regulatory Associate 1969 Upper Water Street, Suite 906 Halifax, NS B3J 3R7 Canada

Re: K241318

Trade/Device Name: Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: May 10, 2024 Received: May 10, 2024

Dear Olga Zhuk:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Loca Weidner

Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K241318

Device Name

Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)

Indications for Use (Describe)

Nova Surface Applicator is indicated for and intended to be placed on the patient's skin to navigate an HDR radiation source during the treatment of various types of cancer using brachytherapy.

The device is for a single patient's use only and can be reused throughout the entirety of the treatment plan.

The device is designed by radiation therapy professionals using patient imaging data as input and must be verified and approved by the trained radiation therapy professional prior to use.

The device is restricted to sale by or on the order of a physician and is by prescription only.

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

Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K241318

Contact Details

Applicant Name	Adaptiiv Medical Technologies, Inc.
Applicant Address	1969 Upper Water Street, Suite 906 Halifax NS B3J 3R7 Canada
Applicant Contact Telephone	902-442-9091
Applicant Contact	Olga Zhuk
Applicant Contact Email	olga.zhuk@adaptiiv.com
Device NameDevice Trade Name	Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)
Common Name	Medical charged-particle radiation therapy system
Classification Name	System, Planning, Radiation Therapy Treatment
Regulation Number	892.5050
Product Code	MUJ

Legally Marketed Predicate Devices

Predicate #	K213438
Predicate Trade Name	Patient-Matched 3D Printed Radiation Therapy Accessory
Product Code	MUJ

Device Description Summary

A surface brachytherapy applicator device is 3D printed by Stereolithography (SLA) technology using methacrylic resin.

Intended Use/Indications for Use

Nova Surface Applicator is indicated for and intended to be placed on the patient's skin to navigate an HDR radiation source during the treatment of various types of cancer using brachytherapy.

The device is for a single patient's use only and can be reused throughout the entirety of the treatment plan.

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The device is designed by radiation therapy professionals using data as input and must be verified and approved by the trained radiation therapy professional prior to use.

The device is restricted to sale by or on the order of a physician and is by prescription only.

Indications for Use Comparison

The referenced submission (K213438) includes both software components: stand-alone desktop applications, 3D Bolus and 3D Brachy, and corresponding patient-matched 3D printed radiation therapy accessories. The scope of current submission is limited to the brachytherapy accessory under a new Indications for Use statement. The Indications for Use statement has been updated to increase the clarity. It is merely a documentation update, no actual change in the substance or meaning in the intended uses of predicate devices has been implemented.

Technological Comparison

Nova Surface Applicator is manufactured using SLA technology with clear resin. Usage of SLA technology as well as clear resin for manufacturing of brachytherapy applicators increases the safety and effectiveness of the device compared to FDM technology and PLA material used for predicate device (K213438) manufacturing due to the following reasons:

High accuracy and tolerance of printing ensure proper fit of the patient anatomy as well as accurate delivery of radiation during the treatment.
Smoother surface finish improves overall comfort while using patient-specific devices intended to be placed on the skin surface.
The brachytherapy applicator is used as a navigator of radiation by integrating catheter tunnels in its design. The catheter that will guide a wire with radioactive material is inserted inside the applicator's the brachytherapy treatment session. The transparency of the final device printed with clear resin increases its usability and level of control during the catheter placement as well as fit of the device on the patient's anatomy.

As a part of the design change, a nonclinical assessment was performed to ensure SLA technology and material compatibility with device design in facilitating the 3D printing of brachytherapy accessories. All tests verified that the chosen manufacturing technology performed as intended and did not affect the overall safety and effectiveness of the device and are beneficial compared to the previously used technology.

Non-Clinical Tests Summary & Conclusions

Performance Testing conducted for the Nova Surface Applicator includes two testing approaches:

Post-production verification: a set of testing aimed to demonstrate that the device's functional features and properties directly affecting the device's performance, conform to the requirements defined in correspondence with the intended use. The batch of the tests has been performed on worst-case samples as well as on the final device real patient datasets - and included the following:

Look, feel, surface quality.
Inner structure consistency (mass consistency and dimensional fidelity).
The functionality of catheter tunnel accessibility, orientation, inter-tunnel, and source-to-surface distances).
Labels legibility.
. Additional features functionality (dosimetry pockets and alignment guides).

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Simulated performance testing: Evaluation of the spatial fidelity and fit of the patient-specific devices by virtually positioning a CT scan of the device with respect to a DICOM-RT structure that represents a faithful reproduction of a patient's anatomy at the time of scanning. This test is intended to ensure that a key functional feature - patientspecific contact surface, directly affecting intended device performs to user needs and performance requirements and provides enough accuracy to fit the patient's anatomy.

The results of both testing approaches demonstrated:

. High printing accuracy of the key functional features of functional key property (density of the material after printing) in conformance with performance requirements.
. High accuracy in terms of spatial fidelity providing a precise fit of the device on the patient's anatomy and delivery of the radiation to the treatment target tissues.
. The technological and validation methods used in the testing provide results and are considered applicable to ensure product quality during the production process.

Performance testing results demonstrate substantial equivalence to the predicate device (K213438) and are considered as evidence of the overall safety and effectiveness of the device, as compared to the predicate, for use in clinical conditions.

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.

Re: K241318

Indications for Use

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510(k) Summary - K241318

Contact Details

Legally Marketed Predicate Devices

Device Description Summary

Intended Use/Indications for Use

Indications for Use Comparison

Technological Comparison

Non-Clinical Tests Summary & Conclusions

§ 892.5050 Medical charged-particle radiation therapy system.

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