The ACCUSYTE™ 3D Fiducial Markers are used to mark the location of a tumor cavity after the tumor has been removed. In addition, the Markers are indicated on situations where soft tissue needs to be marked for future medical procedure such as subsequent Radiation Therapy.

Device Description

The ACCUSYTE™ 3D Fiducial Marker is an implantable marker comprised of an absorbable suture (polylactic acid) component which absorbs completely in less than one year, and a permanent component, a Platinum or Gold Marker attached to the suture by a crimping operation similar to the operation use to attach the Stainless-Steel Needle. The ACCUSYTE™ 3D Fiducial Marker is provided Sterile for single use and is implantable.

AI/ML Overview

The provided text describes a 510(k) submission for the ACCUSYTE™ 3D Fiducial Marker, aiming to establish substantial equivalence to predicate devices. The study focuses on demonstrating the device's technical characteristics and performance, particularly its visualization compatibility and MRI safety. However, it does not contain the information needed to fully answer all aspects of your request, especially regarding specific acceptance criteria, detailed study designs for those criteria, or the role of AI.

Here's an analysis of the available information:

This document describes a medical device called the ACCUSYTE™ 3D Fiducial Marker. It is a K180027 510(k) Pre-market Notification from 2018 for a Medical Charged-Particle Radiation Therapy System, and thus the description below is limited purely to the device as presented in the document.

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state formal acceptance criteria with specific thresholds for visualization or other performance metrics. Instead, it describes performance data gathered to demonstrate the device's capabilities and substantial equivalence to predicate devices.

Performance Aspect	Reported Device Performance (ACCUSYTE™ 3D Fiducial Marker)
Visualization Clarity	- Bench tested for clarity of visualization using a phantom breasts model across computed tomography (CT), kilovoltage (KV), cone-beam CT (CBCT), and megavoltage (MV) linear accelerator imaging. - Radiographic Imaging 6-8 weeks after implantation. - Mammography imaging after 1-year post implantation. (No specific quantitative clarity metrics or acceptance thresholds are provided, only that it was "clear visualization.")
MRI Safety	MR Conditional: - Static magnetic field of 1.5-Tesla or 3-Tesla. - Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m). - Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg in the Normal Operating Mode. - Expected to produce a maximum temperature rise of ≤2°C after 15-minutes of continuous scanning at 3 Tesla.
MRI Image Artifact	- Image artifact not expected to extend more than 10-mm from the device when imaged with a gradient echo pulse sequence and a 3-Tesla MRI system.
Absorbable Suture Testing	Performed on the Absorbable Suture component (K130735): - Bacterial Endotoxin (USP Pharmacopeia <85>) - Pyrogenicity. - Biocompatibility (ISO-10993) - suture component - Implant. - Physical Testing - USP 30 <861, <871, and <881 - suture component. - Residual Strength and Absorption Rate studies as outlined in FDA's Class II Special Controls Guidance Document: Surgical Sutures.
Human Study (Safety)	No complications reported such as bleeding, pain, inflammation, or tissue reactions.

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

Test Set Description: The document refers to a "human study" where complications were assessed.
Sample Size: The sample size for the human study is not specified.
Data Provenance: The document does not specify the country of origin or whether the human study was retrospective or prospective. Given it references "implantation" and "6-8 weeks after implantation" and "1-year post implantation" within the context of a "human study" with no complications reported, it suggests a prospective, clinical observation.

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

This information is not provided in the document. The study primarily focuses on the physical properties and visibility of the marker, not diagnostic accuracy requiring expert interpretation of images relative to a ground truth. The "human study" mentioned is for safety, not for establishing ground truth for image interpretation.

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

This information is not provided as the type of study described (assessing physical visibility and safety) does not involve adjudication of diagnostic interpretations.

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

MRMC Study: An MRMC comparative effectiveness study was not done.
AI Improvement Effect Size: The document does not mention AI or any AI assistance in its evaluation. This is a medical device (fiducial marker), not an AI-powered diagnostic tool.

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

A standalone algorithm performance study was not done because the device is a physical fiducial marker, not a software algorithm.

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

For the visualization characteristics, the "ground truth" seems to be the physical presence and known location of the marker within the phantom or human subjects, allowing direct assessment of its visibility. For the safety aspects, the ground truth was the observed clinical outcomes/complications in the human study.

8. The sample size for the training set

This information is not applicable as the ACCUSYTE™ 3D Fiducial Marker is a physical device and not an AI model that requires a training set.

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

This information is not applicable as the ACCUSYTE™ 3D Fiducial Marker is a physical device and not an AI model that requires a training set.

Summary

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RADIATION PRODUCTS LLC

July 18, 2018

% Mr. Victor Pereira Principal VHP Consulting 7240 NW 63 Terrace PARKLAND FL 33067

Re: K180027

Trade/Device Name: ACCUSYTE 3D Fiducial Marker Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 3, 2018 Received: June 13, 2018

Dear Mr. Pereira:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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 comprehensive regulatory information about medical devices and radiation-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 (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D'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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

K 180027

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name ACCUSYTE 3D Fiducial Marker

Indications for Use (Describe)

The ACCUSYTE 3D Fiducial Markers are used to mark the location of a tumor cavity after the tumor has been removed.

In addition, the Markers are indicated on situations where soft tissue needs to future medical procedure such as subsequent Radiation Therapy.

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

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

Applicant: Surgical Radiation Products LLC

Date Prepared: April 29, 2018 (amended)

Contact Person: John D Corbitt MD

Radiation Products LLC 142 JFK Drive Lake Worth FL 33462 Phone: (561) 379-6210 Fax: (561) 439-9902 e-mail: jdcorbitt@aol.com

Trade Name: ACCUSYTE™ 3D Fiducial Marker

Common Name: Implantable Radiographic Marker Classification Name: Medical charged-particle radiation therapy system Classification Number: 892.5050 Device Classification: Class II Product Code: IYE Predicate Device: CIVCO Suture-Type Marker (K071614) Reference Devices: BioZorb Marker (K143484) Foosin WEGO-PGLA Absorbable Suture (K130735)

Substantially Equivalent to:

The ACCUSYTE™ 3D Fiducial Marker is substantially equivalent in intended use, principle of operation, and technological characteristics to the CIVCO Suture-Type Marker (K071614), to the BioZorb Marker (K143484), and to the Foosin WEGO-PGLA Absorbable Suture (K130735).

Description of the Device subject to Premarket Notification:

The ACCUSYTE™ 3D Fiducial Marker is provided Sterile for single use and is implantable.

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Indication for Use:

The ACCUSYTE™ 3D Fiducial Markers are used to mark the location of a tumor cavity after the tumor has been removed.

In addition, the Markers are indicated on situations where soft tissue needs to be marked for future medical procedure such as subsequent Radiation Therapy.

Technical Characteristics:

The ACUSYTE™ 3D Fiducial Marker has similar physical and technical characteristics to the predicative and reference devices, as illustrated in the table below:

TechnicalCharacteristic	Subject Device	PrimaryPredicate	ReferenceDevice	Reference Device
	ACCUSYTE™ 3DFiducial Marker	CIVCO Suture-Type Marker(K071614)	BioZorb Marker(K143484)	WEGO-PGLAAbsorbable Suture(K130735)
OverallTechnologicalCharacteristic	Radiographicallyvisiblepermanentmarker on anabsorbablesuture	Radiographicallyvisiblepermanentmarker on anabsorbablesuture	Radiographically visiblepermanentmarker elementin a bio-absorbablepolymer space	Suture-N/A
Principle ofOperation	Marker issecured ontumor cavityarea forradiographicvisualization oftumor site afterremoval	Marker ispositioned intotissue site forradiographicvisualization oftissue site	Marker ispositioned intotissue site forradiographicvisualization oftissue site	Suture holdsmarker in placeduring tissuehealing process
Absorptiontime for sutureand polymer	Less than 1 year(suture)	Unknown forsuture	Longer than 1year(Polymer)	Suture- Less than 1year
VisualizationCompatibility	ikV CT, 2DLinac- basedkilovoltage andmegavolt-age X-ray imagingsystems and kV	X-RayCT (presumed)	Mammography,Ultrasound, X-Ray, and CT	Suture-N/A

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	cone-beam CT.
Materials ofConstruction	Gold orPlatinum/Iridium Markercomponent,absorbablesuture(Glycolide-co-Lactide)	Gold Marker andabsorbablesuture	TitaniumMarkers andabsorbablepolymer(spacer)	Suture-Glycolide-co Lactide withStainless SteelNeedle
Overall DeviceLength	<0.5 cm(Marker)	<5cm (Marker)	2-5 cm (Marker)	Suture-45 cm
TypicalAnatomicTreatment Site	Soft tissuetumor cavity siteincluding breast	Breast	Soft tissueincluding breast	Suture- soft tissue
-Method ofMarkerDeployment	Surgicallyimplanted	Surgicallyimplanted	Manual, opensurgical	Suture- surgicalplacement
MarkerStability	Sutured in place	Sutured in place	Tissue retention	Suture retainsmarker in placethrough healingprocess
How Provided	Sterile for singleuse	Sterile single use	Sterile singleuse	Suture-SterileSingle Use
SterilizationMethod	ETOvalidated cyclewith SAL of 10-6	Unknown	Radiation	Suture- ETOvalidated cyclewith SAL of 10-6

Performance Data:

The Absorbable Suture component on the candidate device was tested as part of its 510 (k) submission (K130735) with the following tests:

Bacterial Endotoxin (USP Pharmacopeia <85>) - Pyrogenicity
Biocompatibility (ISO-10993) - suture component - Implant
Physical Testing - USP 30 <861, <871, and <881 - suture component
Residual Strength and Absorption Rate studies as outlined in FDA's Class II Special Controls Guidance Document: Surgical Sutures.

Performance data for the ACCUSYTE™ 3D Fiducial Marker device included:

. The Gold and Platinum/Iridium markers were bench tested for clarity of visualization using a phantom breasts model across computed tomography (CT), kilovoltage (KV), cone-beam CT (CBCT), and megavoltage (MV) linear accelerator imaging
Radiographic Imaging 6-8 weeks after implantation
Mammography imaging after 1-year post implantation

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MRI Safety:

The ACCUSYTE™ 3 D Fiducial Markers are considered "MR Conditional"

Non-clinical testing has demonstrated the ACCUSYTE™3D Fiducial Marker device is MR Conditional. A patient with this device can be safely scanned in an MR system meeting the following conditions:

Static magnetic field of 1.5-Tesla or 3-Tesla
Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m)
Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2- W/kg in the Normal Operating Mode
Under the scan conditions defined above, the Accusyte™ 3D Fiducial marker is expected to produce a maximum temperature rise of ≤2℃ after 15-minutes of continuous scanning at 3 Tesla
The image artifact caused by the Accusyte™ 3D Fiducial is not expected to extend more than 10-mm from this device when imaged with a gradient echo pulse sequence and a 3- Tesla MRI system.

The Accusyte™ 3D Fiducial and may be safely scanned with MRI under the conditions listed above. Scanning under different conditions may result in severe patient injury.

The ACCUSYTE™ 3D Fiducial Marker performance is equivalent to that of the predicate and reference devices in that it provides clear visualization of the tumor site, the candidate device secures the markers on soft tissue of the tumor cavity for a more accurate localization of the site, aiding in targeting the area for subsequent Radiation therapy and limiting exposure to adjacent tissue.

There were no complications reported from the candidate markers device during the human study, such as bleeding, pain, inflammation, or tissue reactions. Therefore; demonstrating that the candidate device is safe and effective for its intended use.

Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation, and overall technological characteristics, the ACCUSYTE™ 3D Fiducial Marker is determined by Radiation Products LLC to be substantially equivalent to the existing legally marketed predicate device CIVCO Suture Type Marker.

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.