A cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the biopsy procedure.

Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.

Device Description

The Trident® HD Specimen Radiography System is a self-contained, direct digital imaging system for imaging surgical and biopsy specimens. The Trident® HD system includes the following major components: an image display monitor, touch-screen control display, and an imaging cabinet.

The system is self-contained. Shielding is incorporated within the cabinet chamber system design, eliminating the need for separate shielding. The unit is mounted on casters to allow for easy transportation.

Dedicated specimen radiography systems are intended for use in the following environments:

The surgical suite
The stereotactic biopsy suite
The pathology lab

Specimen radiography units are utilized to confirm removal of the intended tissue, or site marker in surgical and core biopsy specimens from various anatomical regions. By generating a high-resolution X-ray of the specimen, the presence of a lesion or calcification in the extracted sample can be confirmed by the user reviewing the digital image.

AI/ML Overview

The provided document is a 510(k) summary for the Hologic Trident HD Specimen Radiography System. It describes the device's technical specifications and a comparison to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets these criteria in the context of clinical performance or diagnostic accuracy.

The "Summary of Testing" section explicitly states: "No clinical studies have been performed. Substantial equivalence has been demonstrated by nonclinical testing." The testing mentioned focuses on system design control verification, validation tests, compliance with engineering standards (IEC 61010), and bench testing (functional and usability).

Therefore, based solely on the provided text, I cannot fulfill the request for:

A table of acceptance criteria and the reported device performance: No acceptance criteria related to diagnostic performance are stated, nor are any diagnostic performance results reported.
Sample size used for the test set and the data provenance: No clinical test set was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth was established for a test set.
Adjudication method for the test set: Not applicable.
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, as this is a specimen radiography system, not an AI-assisted diagnostic device, and no clinical studies were performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): No clinical ground truth was used.
The sample size for the training set: Not applicable, as no training set for a clinical algorithm is mentioned.
How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device (Trident Specimen Radiography System, K111508) based on engineering, performance, and safety rather than clinical efficacy or diagnostic accuracy. The key message for demonstrating substantial equivalence is that the new device has the same intended use, general configuration, principles of operation, and operating parameters, with minor changes that do not raise new questions of safety or effectiveness.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 10, 2019

Hologic, Inc. % Meghan Wakeford Regulatory Affairs Specialist 36 Apple Ridge Road DANBURY CT 06810

Re: K182727

Trade/Device Name: Trident HD Specimen Radiography System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: MWP Dated: December 11, 2018 Received: December 13, 2018

Dear Ms. Wakeford:

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

{1}------------------------------------------------

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 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 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,

Hse 2. Nils

for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

Device Name

Trident HD Specimen Radiography System

Indications for Use (Describe)

Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Traditional 510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92

Date Prepared:	December 11, 2018
Manufacturer:	Hologic, Inc.36 Apple Ridge RoadDanbury, CT 06810 USA
Establishment Registration #:	1220984
Contact Person:	Meghan WakefordRegulatory Affairs SpecialistP: 203.702.7819
Identification of the Device:
Proprietary/Trade Name:	Trident® HD Specimen Radiography System
Classification Name:	Cabinet X-Ray System
Regulatory Number:	21 CFR 892.1680
Product Code:	MWP
Device Class:	Class II
Review Panel:	Radiology
Identification of the Legally Marketed Predicate Device:

Trade Name:	Trident® Specimen Radiography System
Classification Name:	Cabinet X-Ray System
Regulatory Number:	21 CFR 892.1680
Product Code:	MWP
Device Class:	Class II
Review Panel:	Radiology
Submitter/510(k) Holder:	Hologic, Inc.
Clearance:	K111508 (cleared August 19, 2011)

Device Description:

Dedicated specimen radiography systems are intended for use in the following environments:

. The surgical suite
The stereotactic biopsy suite
The pathology lab ●

{4}------------------------------------------------

Indications for Use:

Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the time the patient needs to be under examination.

Standards:

UL 61010-1:2012 Safety Requirements for Electrical Equipment for Measurement, Control, ● and Laboratory Use; Part 1: General Requirements
IEC 61010-1:2010 Safety Requirements for Electrical Equipment for Measurement, Control, ● and Laboratory Use, Part 1: General Requirements
IEC 61010-2-091:2012 Safety Requirements for Electrical Equipment for Measurement, ● Control. and Laboratory Use, Part 2-091: Particular Requirements for Cabinet X-ray Systems
EN 61326-1:2013 Electrical Equipment for Measurement, Control, and Laboratory Use EMC ● Requirements, General Requirements
EN 55011 and CISPR 11 (Class A) Industrial, Scientific and Medical (ISM) Radio-Frequency ● Equipment - Electromagnetic Disturbance Characteristics - Limits and Methods of Measurement
ISO 14971: 2012 – Medical devices – Application of Risk Management to Medical Devices

FDA Guidance Documents:

"Applying Human Factors and Usability Engineering to Medical Devices," issued on February 3. ● 2016
. "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices," issued on September 1, 2016
. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued on May 11, 2005
"Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software," ● issued on January 14, 2005
"Radio Frequency Wireless Technology in Medical Devices," issued on August 14, 2013 ●
. "Off-the-Shelf Software Use in Medical Devices," issued on September 9, 1999

Comparison with Predicate Device:

The Trident® HD System and its predicate device, the Trident® Specimen Radiography System, have the same intended use, general configuration, principles of operation, and operating parameters.

{5}------------------------------------------------

Substantial Equivalence:

	Trident® SpecimenRadiography System	Trident® HD SpecimenRadiography System
	Predicate (K111508)	Proposed	Comparison
Indications for Use	A cabinet X-ray systemused to provide digitalX-ray images of surgicaland core biopsyspecimens from variousanatomical regions inorder to allow rapidverification that thecorrect tissue has beenexcised during thebiopsy procedure.	A cabinet X-ray systemused to provide digital X-ray images of surgicaland core biopsyspecimens from variousanatomical regions inorder to allow rapidverification that thecorrect tissue has beenexcised during the biopsyprocedure.	Same
	Doing the verification inthe same room as theprocedure or nearbyimproves workflow, thusreducing the time thepatient needs to be underexamination.	Doing the verification inthe same room as theprocedure or nearbyimproves workflow, thusreducing the time thepatient needs to be underexamination.
Level of Concern	Moderate	Moderate	Same
Method of Use	Cabinet X-ray systemused for imaging smallto medium biopsy andsurgical specimens	Cabinet X-ray systemused for imaging small tolarge biopsy and surgicalspecimens	Expanded specimensize capabilities withlarger detector
Mechanism ofAction	Sample verification:obtain correct margins,specimen of interest, etc.	Sample verification:obtain correct margins,specimen of interest, etc.	Same
Physical
Construction	Shielded cabinet onmoveable cart	Fully integrated systemwith movable basecasters	Similar; redesigned forease of use andtransportation
Size (W x D x H)(in.)	26.5 x 37.5 x 68.3	24 x 26 x 66.5	Similar; reducedfootprint for ease of useand transportation
Weight (lb.)	275325 with UPS	278 (with MFD)291 (with HDT)	Similar; minor weightchanges due to designchange
Digital Image Receptor
DetectorTechnology	TFT-based directcapture technology	TFT-based direct capturetechnology	Same
X-ray AbsorptionMaterial	Amorphous selenium	Amorphous selenium	Same
Active ImagingArea Size	12 cm x 14 cm	12 cm x 14 cm (MFD)20 cm x 20 cm (HDT)	Trident® HD isavailable with two
			detectors for variety inimage size andpreference
Digital Detector	Detector used onpredicate, K111508, wasapproved for use withthe Selenia FFDMsystem, in P010025.	MFD used on the AffirmProne Biopsy System,cleared under K153486.HDT used on the SeleniaDimensions systems,approved inP010025/S013 andP080003.	Both the predicate andthe proposed devicesuse detectorscleared/approved foruse with Hologic digitalmammography andbiopsy systems.
Pixel Size	70 μm pixels	70 μm pixels	Same
Limiting SpatialResolution	7.1 lp/mm	7.1 lp/mm	Same
Output Image	14-bit image data	14-bit image data	Same
ImageEnhancement	Enhanced visualizationadjustment for imagesharpness	Enhanced visualizationadjustment for imagesharpness	Same
Acquisition Workstation
Display Monitor	2.3 MP color LCDdisplay	2 MP High luminescencediagnostic monitor	Similar
Operating System	Windows 7	Windows 10	Similar; both thepredicate and proposeddevices use WindowsOS
DICOM Services	Worklist, print, storage	Worklist, print, storage,query retrieve	Similar; increasedDICOM capabilitiesthrough ability to pullpriors
User Interface	Keyboard, mouse	Integrated touch screen,track pad	Improved for ease ofuse
X-ray Source
Energy Range	20-35 kV	20-50 kV	Expanded upper rangeto support largerdetector and imagingarea
Anode Type	Tungsten	Tungsten	Same
Tube Current	1 mA	1 mA	Same
Exposure	Up to 10 mAs	Up to 20 mAs	Increase to supportthicker specimensamples
Focal Spot Size	50 μm	50 μm	Same
Filtration	125 μm beryllium	200 μm beryllium	Larger target angle;larger image area
Exposure Modes
Manual	User selects kV andmAs	User selects kV and mAs	Same
Auto	System determinesoptimum kV and mAs	System determinesoptimum kV and mAs	Same
System Performance
Time to Preview	< 20 seconds	< 20 seconds	Same
Cycle Time	30 Seconds	< 60 seconds	Increased cycle time tosupport thickerspecimen samples
Cabinet
Safety Features	Door interlock, keyswitch, fully shielded	Door interlock, passcodekey, fully shielded	Similar
Indicators	Power, door open, ready,X-ray ON	Power, door open, ready,X-ray ON	Same
Magnification	Specimen tray positionsat 1.5x and 2.0x, auto-sensed	Specimen tray positionsat 1.5x and 2.0x, auto-sensed	Same

{6}------------------------------------------------

{7}------------------------------------------------

Summary of Testing:

The Trident® HD system successfully performed system design control verification and validation tests, which are summarized in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005) based on a moderate level of concern.

The Trident® HD system complies with IEC 61010 standards, as performed by the third-party test house, UL. No clinical studies have been performed. Substantial equivalence has been demonstrated by nonclinical testing. Additional bench testing, including functional testing and usability testing, was also performed on the Trident® HD system. The comparative and other performance testing showed that the overall system demonstrated equivalent performance and equivalent safety and effectiveness as the predicate Trident® Specimen Radiography System (K111508).

Conclusion:

Based on the information submitted in this premarket notification, The Trident® HD system is substantially equivalent to the Trident® system (K111508). The design, operation, basic construction and materials used are substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.