The Planmed Clarity 2D and Planmed Clarity S mammography units acquire digital 2D mammographic images. The Planmed Clarity 2D/S systems are intended to be used for screening and diagnosis of breast cancer. The Clarity 2D/S systems may also be used for additional diagnostic workup of the breast.

Device Description

The Planmed Clarity 2D and Clarity S are Full Field Digital Mammography (FFDM) systems for generating mammographic x-ray images that can be used for screening and diagnosis of breast cancer. Planmed Clarity 2D and Clarity S utilize an amorphous silicon based digital image receptor to capture images. The receptor directly converts the incoming X-ray photons to digital image data.

The workflow with Clarity 2D is controlled by the side displays/touch panels and the workflow of Clarity S is controlled from the acquisition workstation and Clarity Manager acquisition and communications software. The patient information is entered manually or received from the hospital, radiology, or mammography information systems (HIS, RIS, or MIS. respectively), as a format of modality worklist. Subsequently, the images are acquired. processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Planmed Clarity 2D and Clarity S device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria/Metric	Reported Device Performance (Subject Device)
System Performance	Sensitometric Response	Responds linearly to radiation exposure
	Spatial Resolution (MTF)	Performs similarly to predicate
	Noise Analysis	Slightly better noise performance
	SNR	Slightly higher
	CNR	Slightly higher
	Dynamic Range	Higher DQE than predicate
	Repeated Exposures	Ghost tolerance similar
	AEC Performance (Organ Dose)	1.23 mGy (for 40mm PMMA, W/Ag beam)
	Patient Radiation Dose	Within generally acceptable limits
	RMI Phantom Scores	Similar for all attributes
	CDMAM Test	Passes
Image Quality	Acceptable for Mammographic Usage	All images rated good or excellent by MQSA radiologists

Study Information

2. Sample Size and Data Provenance for Test Set:

Sample Size: 6 patients
Data Provenance: One site in Bulgaria. The cases selected also included diagnostic mammograms (spot and/or magnification images) in addition to routine screening images (BI-RADS score 1 or 2).
Retrospective/Prospective: The text does not explicitly state if the study was retrospective or prospective. Given that "6 patients participated to routine breast cancer screening" and images were then selected for evaluation, it suggests a prospective acquisition for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

Number of Experts: Two
Qualifications: MQSA qualified experienced US radiologists.

4. Adjudication Method for Test Set:

Method: The two MQSA qualified experienced US radiologists reviewed the images independently. There is no mention of a formal adjudication process (like 2+1 or 3+1) if their independent ratings differed. The statement "All images were rated good or excellent" suggests they either agreed or the individual assessments were sufficient.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Was it done?: No, a formal MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not performed as described in the provided text. The study focused on physician perception of image quality from the new device rather than reader performance with AI.

6. Standalone (Algorithm Only) Performance Study:

Was it done?: No, a standalone algorithm-only performance study was not described. The evaluation focused on the overall system's image quality as reviewed by human experts.

7. Type of Ground Truth Used (Test Set):

Type: The ground truth for the clinical image evaluation was based on expert consensus/review by two MQSA qualified experienced US radiologists, who rated the images as "good or excellent" for mammographic usage. The images themselves were selected based on BI-RADS scores 1 or 2 (indicating negative or benign findings), and some diagnostic mammograms.

8. Sample Size for Training Set:

The provided text does not mention a training set or any machine learning/AI components requiring a training set. The descriptions relate to the hardware and software of a digital mammography system and its image quality validation.

9. How Ground Truth for Training Set was Established:

Not applicable, as no training set for a machine learning model is mentioned.

Summary

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October 23, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Planmed Oy % Lars Moring Regulatory Affairs Manager Sorvaajankatu 7 Helsinki. 00880 FINLAND

Re: K192317

Trade/Device Name: Planmed Clarity 2D and Clarity S Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: Class II Product Code: MUE Dated: September 22, 2020 Received: September 25, 2020

Dear Lars Moring:

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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K192317

Device Name

Planmed Clarity 2D and Clarity S

Indications for Use (Describe)

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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510(k) Summary

(updated version 3.) K192317

I. SUBMITTER

Manufacturer

Planmed Oy Sorvaajankatu 7 FI-00880 Helsinki, Finland Phone: +358 20 7795 300 Fax: +358 20 7795 396 Contact person: Lars Moring

U.S. designated agent

Planmed USA Inc. 100 North Gary Avenue, Suite A Roselle, IL 60172 Phone: (630) 894 2200 Fax: (630) 894 4271 Contact person : Brett Hines

Date Prepared: October 23, 2020

II. DEVICE

Name of Device:	Planmed Clarity 2D and Clarity S
Common or Usual Name:	Full Field Digital Mammography (FFDM) System
Classification Name:	Full Field Digital Mammography (FFDM) System(21 CFR 892.1715)
Regulatory Class:	II
Product Code:	MUE

III. PREDICATE DEVICE

Planmed Clarity Full Field Digital Mammography X-ray System, K163328 This predicate system has not been subject to a design-related recall. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

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V. INDICATIONS FOR USE

The Planmed Clarity 2D and S mammography units acquire digital 2D mammographic images. Both systems are intended to be used for screening and diagnosis of breast cancer. The Clarity 2D and S systems may also be used for additional diagnostic workup of the breast.

The Indications for Use (IFU) statement are the same for both subject and predicate systems.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

General

Both predicate and subject devices are using the same basic operating principles and are technically very similar. The Clarity 2D system is similar to the predicate Clarity. The 2D system can be technically upgraded to a DBT system in the field (not for the US market). The Clarity S system is a value system derived from Clarity and it cannot be upgraded to DBT. The dual touchscreen user interfaces of Clarity and Clarity 2D are omitted from Clarity S. X-ray generation and control are identical in both systems. The compression system and AEC technology are the same.

Integrated detector

The digital full field flat panel detector is a new version of the Clarity detector. The new detector has essentially identical imaging characteristics and signal processing as the predicate device. Quality assurance with pixel defect acceptance criteria comparison is similar. Pixel matrixes are identical, pixel width 83 um. ADC bit depth is 16 bit for the subject system vs. 14 bit for the predicate system. Software interface to communicate with the detector has not been changed.

X-ray unit

Dimensions of the units are similar.

X-rav tube

Units use the same X-ray tube.

X-ray generator

Units use the same X-ray generator.

X-rav anti-scatter grid

Same grid is used on both systems.

Software

The Clarity Manager workstation software was changed to run on Windows 10 instead of Windows 7 of the predicate system. The software of the system has been improved to include encrypted DICOM communication. Imaging sequence has been made shorter by improving the software interface with the detector and with some optimization of the x-ray generator timing. The software has been adapted for the higher dynamic range of the new detector version (from 14 bit to 16 bit). Also some new hardware version related changes of the user interfaces have been made. A detailed software description document is included with this submission along with a comprehensive description of changes between software versions of the predicate device to the subject device.

Risks

Cyber security risks and their mitigations have been addressed more closely and comprehensively with the latest software release for the subject systems. New hazards in comparison to predicate device have been identified and addressed.

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Table 1: Comparison of device specifications

Device	Planmed Clarity 2D	Planmed Clarity S	Planmed Clarity
	Subject device	Subject device	Predicate device
General comparison
Description	Full Field DigitalMammography system	Full Field DigitalMammography system	Full Field DigitalMammography system
System configuration	X-ray stand andWorkstation PC	X-ray stand andWorkstation PC	X-ray stand andWorkstation PC
Application software	Clarity Manager 2.3 onWindows 10	Clarity Manager 2.3 onWindows 10	Clarity Manager 1.3 onWindows 7
User interfaces	Touch screen userinterface side displays onboth sides of x-ray stand	No side displays on x-raystand, user interfaceincluded in workstationPC display	Touch screen userinterface side displayson both sides of x-raystand
'Side access' featurefor easier patientpositioning	yes, standard	not available	yes, standard
Control switches	additional C-arm controlswitches, compressionfine adjustment	no additional switches	additional C-arm controlswitches, compressionfine adjustment
Upgradeability	DBT with s2D (not in US)stereotactic device (notin US) optional	not upgradeable to 3Dnot upgradeable withstereotactic device	DBT with s2D (not in US)stereotactic device (notin US) optional

Detector comparison
Detector type	Varex Paxscan 3024MX	Varex Paxscan 3024MX	Varex Paxscan 3024M
Detector technology	Amorphous silicon (a-Si)with Csl:TI scintillatorTFT array	Amorphous silicon (a-Si)with Csl:TI scintillatorTFT array	Amorphous silicon (a-Si)with Csl:TI scintillatorTFT array
Pixel matrix	2816x3584	2816x3584	2816x3584
Size of active area	23.1x29.1cm	23.1x29.1cm	23.1x29.1cm
Pixel size	83 μm	83 μm	83 μm
ADC bit depth	16 bit	16 bit	14 bit
Pixel fill factor	0.52	0.52	0.70
Readout time	236 ms	236 ms	495 ms

(all other imaging effecting specifications are substantially equal for all these systems)

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

Since the subject systems are almost identical to the predicate device, no new patient contacting mechanical parts have been added to the subject system. Hence no new biocompatibility testing was necessary. Thus, there is no risk or concern to the patient's safety from contact with the materials of construction of this new mammography unit. Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Planmed Clarity mammography system. The system complies with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-28, IEC

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60601-2-45, ISO 10993-1 for safety, and IEC 60601-1-2 for EMC. The only electrical difference is the flat panel detector type which has been separately emc tested by TÜV Rheinland (please see attached emc testing report in VOL17.)

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.

Physical laboratory testing

The performance of the system was tested according to Class II Special Controls Guidance Document: Full-Field Digital Mammography System Document issued on: March 27, 2012.

Summary of physical laboratory testing (bench testing) results:

1. Sensitometric response: Both detectors respond linearly to radiation exposure
Spatial resolution: Both systems perform similar in terms of MTF since the detector 2. scintillator material or thickness are the same and detector element pixel size is the same.
1. Noise analysis: The subject device has slightly better noise performance. Also SNR and CNR are slightly higher.
1. Dynamic range: The subject device produces higher DQE than the predicate system.
1. Repeated exposures: Ghost tolerance was similar.
1. Automatic Exposure Control (AEC) performance: With automatic filtration change the organ and entrance doses are well within generally accepted levels. With a 40 mm PMMA phantom corresponding to an average breast thickness and glandularity, organ dose was measured 1.23 mGy with W/Ag beam quality.
1. Phantom test: RMI phantom scores for all attributes are similar for subject and predicate devices. CDMAM test passes with both systems.
1. Patient radiation dose: With varving phantom thickness and varying adiposity and glandularity factors, both systems achieve radiation dose levels well within generally acceptable limits.
1. Breast compression system: Powered compression pressure test results are similar.

Clinical image evaluation

Clinical image evaluation was performed with the subject Clarity 2D system. Purpose was to determine if the image quality were judged to be of sufficiently acceptable quality for mammographic usage when reviewed by MQSA qualified experienced radiologists. The images were taken in one site in Bulgaria where 6 patients participated to routine breast cancer screening. Images assigned BI-RADS score 1 or 2 were selected for the evaluation. Some cases also included diagnostic mammograms, i.e. spot and/or magnification images. The images were then reviewed by two MQSA qualified experienced US radiologists independently. All images were rated good or excellent and thus the overall image quality was acceptable for all cases and image types.

VIII. CONCLUSIONS

The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the Planmed Clarity 2D and S full field digital mammography systems perform as intended in the specified use conditions. The clinical image evaluation also shows that the devices equipped with the new detector version perform comparably to the predicate device that is currently marketed for the same intended use.

Regulation Number and Section

§ 892.1715 Full-field digital mammography system.

(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.