PeekMed is a software system designed to help surgeons' specialists carry out the pre-operative planning in a prompt and efficient manner for several surgical procedures, based on their patients' imaging studies.

The software imports diagnostics imaging studies such as x-rays, CT or magnetic resonance image (MRI). The import process can retrieve files from a CD ROM, a local folder or the PACS. In parallel, there is a database of digital representations related to prosthetic materials supplied by their producing companies.

PeekMed allows health professional to digitally perform the surgical planning without adding any additional steps to that process. This software system requires no imaging study acquisition specification (no protocol). Experience in usage and a clinical assessment are necessary for a proper use of the software.

Device Description

PeekMed is a standalone software application that helps specialist doctors and surgeons to perform the pre-surgical planning for different procedures in a fast and effective way, based on the imaging studies of the patients.

PeekMed is a 3D pre-operative planning software for surgery. This software system allows surgeons to plan a surgery procedure simulating various environments, from hybrid (2D/3D) to 3D or 2D environments.

The software imports diagnostic imaging studies such as X-rays, Computed Tomography (CT) or Magnetic Resonance Image (MRI). The import process can retrieve files from a local folder or the Picture Archiving and Communications System (PACS) of the hospital/health center. In parallel, there is a database containing digital representations related to prosthetic materials supplied by their respective manufacturers. This offers the possibility of inserting templates of the materials to be used in the surgery in addition to the measurements, making a complete overview of the surgery.

In the case of a 3D or hybrid environment, the surgeon can resort to 3D model generated from a previous imaging study on the patient and 3D digital representations of the prosthetic material to be used during surgery, i.e. screws, fixation plates or full prosthesis, deriving from several producing companies.

AI/ML Overview

The PeekMed device is a software system designed for pre-operative planning in various surgical procedures, based on patient imaging studies.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the validation activities and states that "Acceptance criteria were achieved for all tests." However, it does not explicitly list the quantitative acceptance criteria for each specific performance metric. Instead, it describes the type of validation performed and the goals of that validation.

Based on the information provided, we can infer the following:

Acceptance Criteria (Implied)	Reported Device Performance
Software Functionality: All specified software functions operate as intended.	"Verification testing consisted of specific software functionalities testing and system level testing. Acceptance criteria, defined in the product requirements, were met for each verification test and are described in JIRA." This indicates that key functionalities, such as importing images, digital templating, measurement tools (ruler, angle), and 2D/3D planning environments, were tested and met their predefined criteria.
Measurement Accuracy and Repeatability: Lengths and angles measured by the software accurately and repeatedly match real dimensions.	"To reassure that the lengths and angles measured with the internal functions of 'ruler' and 'angle' of the PeekMed software effectively and repeatedly match the real dimensions, validation consists the measuring of images of three implantable medical devices (prosthesis), CE marked and with strictly defined dimensions. Validation phase ensures that all product requirements have been fulfilled, meets the end-users needs, and ensure the safety and proper performance of the device."
Fulfillment of Product Requirements: All defined product requirements are met.	"Validation phase ensures that all product requirements have been fulfilled..."
End-User Needs: The software meets the needs of end-users (surgeons).	"...meets the end-users needs..." and "Also, satisfaction questionnaires were made to assess the usability of the PeekMed software when comparing with others in the market, and also to make sure that the device operates as intended during the design stage."
Safety and Proper Performance: The device operates safely and performs properly.	"...and ensure the safety and proper performance of the device."
Usability: The software is usable for its intended purpose.	"Also, satisfaction questionnaires were made to assess the usability of the PeekMed software when comparing with others in the market..."
Effectiveness of 3D and Hybrid Planning (compared to 2D only): The new 3D and hybrid planning features do not raise new safety or effectiveness concerns.	The "Significant Differences" section of the "Comparison of Characteristics" table states: "In more to 2D, PeekMed can offer a 3D pre-surgical planning or a hybrid 2D/3D environment in addition to isolated 2D and 3D. PeekMed has been tested and validated for 3D and hybrid planning." And for the additional feature of allowing intersection of models: "The additional feature from PeekMed of allowing the intersection of the models has been tested and validated and does not raise different questions of safety or effectiveness."
Support for diversified Orthopedic Subspecialties: The procedures not common to both PeekMed and the predicate have been tested and validated.	The "Significant Differences" table notes: "The procedures that are not common to both devices have been tested and validated through PeekMed development. It does not raise different questions of safety or effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" with a particular sample size in the context of a clinical study for performance evaluation. Instead, the validation involved:

Internal validation: "measuring of images of three implantable medical devices (prosthesis), CE marked and with strictly defined dimensions." This sample size (n=3) is for validating measurement accuracy.
External validation/Follow-up: "continuous follow-up from the Marketing and Sales team, follow-up on events registered in the platform mixpanel and user/customer surveys."
Usability questionnaires: Sample size is not specified but implies a group of users.

Data Provenance: The document does not explicitly state the country of origin for the data used in validation. It mentions "images of three implantable medical devices (prosthesis), CE marked," which are likely standardized devices rather than patient data. The overall development and submission are from Portugal. The nature of the validation implies retrospective testing on the selected images and prospective feedback (user/customer surveys, event follow-up).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document states that validation was "performed internally prior to the release to the market by qualified personnel (personnel with background in anatomy and biomedical field)". It does not specify a number of experts who established ground truth for the test set (the three implantable devices). For these devices, the "strictly defined dimensions" act as the inherent ground truth, meaning no external expert adjudication was needed to establish it.

For overall clinical assessment and user feedback, it mentions "surgeons' specialists" as the intended users and that "Experience in usage and a clinical assessment are necessary for a proper use of the software," implying that the feedback and assessment come from qualified medical professionals, but a specific number and detailed qualifications (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set

For the measurement validation using the three implantable devices, no adjudication method (like 2+1 or 3+1) is indicated because the "strictly defined dimensions" of the CE-marked prostheses served as the objective ground truth. The software's measurements were compared against these known dimensions.

For broader validation including user satisfaction and functionality, adjudication methods are not typically applicable in the same way as for diagnostic accuracy studies.

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

No MRMC comparative effectiveness study is explicitly mentioned in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device (TraumaCad version 2.0) based on similar indications for use, technological characteristics, and performance testing, rather than a comparative effectiveness study showing improvement with AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

The device is described as "a software system designed to help surgeons' specialists carry out the pre-operative planning." It "allows health professional to digitally perform the surgical planning," and "human intervention for image interpretation" is explicitly listed as "Yes." This indicates that the device is an aid to a human professional and not intended for standalone use without a human in the loop for interpretation and decision-making. Therefore, a standalone (algorithm only) performance study as typically understood for diagnostic AI is not explicitly described or claimed. The validation focuses on the tools it provides to the surgeon.

7. Type of Ground Truth Used

For the core measurement accuracy validation: Known physical dimensions of CE-marked implantable medical devices (prostheses).
For overall functionality and user experience: Implied expert consensus/feedback from qualified personnel with anatomy/biomedical background during internal validation, and feedback from surgeons via satisfaction questionnaires and follow-up.
For comparing to predicate: The predicate device's established performance records.

8. Sample Size for the Training Set

The document does not describe the use of machine learning or AI models in a way that would require a distinct "training set" for an algorithm. It is presented as a software tool for pre-operative planning. Therefore, a training set size is not applicable or provided.

9. How the Ground Truth for the Training Set Was Established

Since no training set for an AI/ML algorithm is mentioned, this point is not applicable. The device is a "Picture Archiving And Communications System" with image processing capabilities facilitating human planning, rather than an autonomous diagnostic AI.

Summary

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October 25, 2018

Peek Health, S.A. % Rachel Paul Senior Consultant, QA&RA Emergo Europe Consulting Prinsessegracht 20 THE HAGUE, 2514 AP NETHERLANDS

Re: K182464

Trade/Device Name: PeekMed Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: September 6, 2018 Received: September 10, 2018

Dear Rachel Paul:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,

Image /page/1/Picture/5 description: The image shows the name Michael D. O'hara -S in a large font. Below the name is the text "Digitally signed by Michael D. O'hara -S". The image also contains the text "DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300 226759, cn=Michael D. O'hara -S Date: 2018.10.25 13:24:17-04'00'".

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

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Indications for Use

510(k) Number (if known) K182464

Device Name PeekMed

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

DEVICE NAME

K_182464

1. Submission Sponsor

Peek Health, S.A.

Praça Conde de Agrolongo, nº123

4700-312

Braga

Portugal

Sara Silva

Chief Quality Officer (CQO)

2. Submission Correspondent

Emergo Europe Consulting

Prinsessegracht 20

The Hague

2514 AP

The Netherlands

Rachel Paul

Senior Consultant, QA & RA

Email: LST.AUS.Projectmanagement@ul.com

3. Date Prepared

September 6, 2018

4. Device Identification

Trade/Proprietary Name: PeekMed

Common/Usual Name: Pre-operative planning software

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Classification Name:	Picture Archiving and Communications System (PACS)
Regulation Number:	892.2050
Product Code:	LLZ, System, Image Processing, Radiological
Device Class:	Class II
Classification Panel:	Radiology

5. Legally Marketed Predicate Device(s)

510(K) No.	K073714
Clearance date	03/19/2008
Device Name	TraumaCad version 2.0
Manufacturer	Orthocrat, Ltd

6. Indications for Use Statement

PeekMed allows health professional to digitally perform the surgical planning without adding any additional steps to that process. This software system requires no imaging study acquisition (no protocol). Experience in usage and a clinical assessment are necessary for a proper use of the software.

7. Device Description

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8. Substantial Equivalence Discussion

The following table compares PeekMed to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

Manufacturer	510(K) Submitter	Predicate	Significant Differences
	Peek Health, S.A.	Orthocrat, Ltd
Device Trade Name	PeekMed	TraumaCad version 2.0
510(k) Number	N/A	K140434	N/A
Product Code	LLZ	LLZ	N/A
RegulationNumber	21 CFR 892.2050	21 CFR 892.2050	N/A
Regulation Name	System, ImageProcessing, Radiological	System, Image Processing,Radiological	N/A
Intended for use	PeekMed is a pre-operative planningsoftware for surgery.	TraumaCad is a pre-operative planningsoftware for surgery.	N/A
Indications for use	PeekMed is a softwaresystem designed to helpsurgeons' specialistscarry out the pre-operative planning in aprompt and efficientmanner for severalsurgical procedures,based on their patients'imaging studies.The software importsdiagnostics imagingstudies such as x-rays, CT	The TraumaCAD programis indicated for assistinghealthcare professionalsin preoperative planningof orthopedic surgery. Thedevice allows foroverlaying of prosthesistemplates on radiologicalimages and includes toolsfor performingmeasurements on theimage and for positioningthe template. Clinical	In more to 2D, PeekMed can offer a 3D pre-surgical planning or a hybrid 2D/3D environment in addition to isolated 2D and 3D. PeekMed has been tested and validated for 3D and hybrid planning.
Manufacturer	510(K) Submitter	Predicate	Significant Differences
	Peek Health, S.A.	Orthocrat, Ltd
Device TradeName	PeekMed	TraumaCad version 2.0
	or magnetic resonanceimage (MRI). The importprocess can retrieve filesfrom a CD ROM, a localfolder or the PACS. Inparallel, there is adatabase of digitalrepresentations relatedto prosthetic materialssupplied by theirproducing companies.PeekMed allows healthprofessional to digitallyperform the surgicalplanning without addingany additional steps tothat process. Thissoftware system requiresno imaging studyacquisition specification(no protocol). Experiencein usage and a clinicalassessment arenecessary for a properuse of the software.	judgments and experienceare required to properlyuse the software.
Subspecialties	PeekMed allows thesurgeon to perform thepre-surgical planningefficiently in thefollowing subspecialties:- Hip- Knee- Spine- Upper Limb- Foot and Ankle	TraumaCad provides easy-to-use solutions forvarious orthopedicsubspecialties:- Hip- Knee- Pediatric- Trauma- Deformity- Analysis	Orthopedic subspecialtiessupported by PeekMedare also covered inTraumaCad. Themajorities of theprocedures supported byPeekMed are alsosupported by TraumaCad.The procedures that arenot common to bothdevices have been tested
Manufacturer	510(K) Submitter	Predicate	Significant Differences
	Peek Health, S.A.	Orthocrat, Ltd
Device TradeName	PeekMed	TraumaCad version 2.0
	- Trauma	- Spine- Foot and Ankle- Upper LimbThe followingmeasurements can bemade using TraumaCadmeasurements tools:-Hip: Hip DeformityAnalysis, PolyethyleneWear Wizard, Leg LengthDiscrepancy Tool,Acetabular Index, VCAAngle of Lequesne, CupVersion, Center ofRotation, Stem Version	and validated throughPeekMed development. Itdoes not raise differentquestions of safety oreffectiveness.
	For each subspecialty,there are severalprocedures:-Hip: Hip DysplasiaCorrection, Limb LengthDiscrepancy, Center ofRotation – Ranawatmethod, AcetabularAngle, Total HipArthroplasty-Knee: Leg DeformityCorrection, AP KneeResection, AP Full Legresection, High TibialOsteotomy, ACL TunnelReconstruction, MedialPatellofemoral Ligament-Spine: Single CobbAngle, Thoracic KyphosisAngle, Lumbar LordosisAngle, Sagittal VerticalAxis, Pelvic Angles,Coronal Balance, Sacro-femoral Angle, SagittalBalance, Smith-PetersenOsteotomy, PedicleSubtraction Osteotomy	-Knee: Limb AlignmentAnalysis, Center LineFinder, Simple Line, HighTibial Osteotomy, TibialCutting, Joint Line-Spine: VertebraeLabeling, Cobb Angle,Double Cobb Angle, TripleCobb Angle, Pelvic RadiusAngle, Sacral Obliquity, ,Coronal Balance, SagittalBalance,Spondylolysthesis,Thoracic Kyphosis Angle,Thoracic Trunk Shift, T1Tilt Angle, LumbarLordosis, Spine Slip Angle
Manufacturer	510(K) Submitter	Predicate	Significant Differences
	Peek Health, S.A.	Orthocrat, Ltd
Device Trade	PeekMed	TraumaCad version 2.0
Name
	-Upper Limb: TotalShoulder Replacement,	Upper Limb: Center LineFinder, Simple Line, JointLine
	Clavicular Angle,Shoulder Resurfacing	-Foot and ankle: FootOsteotomies Wizard,
	-Foot and Ankle: TalarTilt, Hallux Valgus,Moreau-Costa-BertaniInternal Angle, Moreau-Costa-Bertani ExternalAngle, Maestro Formula	Hallux Valgus Angle,Hallux ValgusInterphalangeus Angle,Intermetatarsal Angle,Distal Metatarsal ArticularAngle (DMAA), ProximalMetatarsal Articular Angle(PMAA), Talar Tilt
	-Trauma: DiaphysealShaft Fracture Angle,Metaphyseal ShaftFracture Angle, Roof Arc	-Trauma: Limb AlignmentAnalysis, DiaphysealFracture Angulation,Metaphyseal FractureAngulation, Center LineFinder, Simple Line, RoofArc, Joint Line
		-Pediatric: Hip DeformityAnalysis, Limb AlignmentAnalysis, AcetabularIndex, Reimer's Index, VCAAngle of Lequesne
Patient Population	Adults and pediatrics	Adults and pediatrics	N/A
End users	Surgeons	Surgeons	N/A
Computer	Personal Computer orWorkstation	Personal Computer orWorkstation	N/A
Manufacturer	510(K) Submitter	Predicate	Significant Differences
	Peek Health, S.A.	Orthocrat, Ltd
Device TradeName	PeekMed	TraumaCad version 2.0
Operating System	Windows or OS X	Windows	PeekMed can run throughWindows or OSX and hasbeen tested and validatedfor the both systems.
Device availability	It can be set to start froma workstation orstandalone for planningprocedures	It can be set to start froma workstation orstandalone for planningprocedures	N/A
Images source	Receives medical imagesfrom various sources(including PACS)	Receives medical imagesfrom various sources(including PACS)	N/A
Data processing	The software processesdata in order to providean overlap anddimensioning of digitalrepresentations of theprosthetic material	The software processesdata in order to providean overlap anddimensioning of digitalrepresentations of theprosthetic material	N/A
Manufacturer	510(K) Submitter	Predicate	Significant Differences
	Peek Health, S.A.	Orthocrat, Ltd
Device TradeName	PeekMed	TraumaCad version 2.0
Digital overlap ofprosthetic material	Allows the overlap ofmodels and theintersection of themodels	Allows the overlap ofmodels	The additional featurefrom PeekMed of allowingthe intersection of themodels has been testedand validated and doesnot raise differentquestions of safety oreffectiveness.
Interactive modelpositioning	Yes	Yes	N/A
Interactive modeldimensioning	Yes	Yes	N/A
Model rotation	Yes	Yes	N/A
Support for digitalprostheticmaterials providedby themanufacturers	Yes	Yes	N/A
Automaticcalibration	Yes	Yes	N/A
Pre-surgicalplanning	Yes	Yes	N/A
Contact with thepatient	No	No	N/A
Control of lifesupporting devices	No	No	N/A
Humanintervention forimageinterpretation	Yes	Yes	N/A
Manufacturer	510(K) Submitter	Predicate	Significant Differences
	Peek Health, S.A.	Orthocrat, Ltd
Device TradeName	PeekMed	TraumaCad version 2.0
Ability to addadditional moduleswhen available	Yes	Yes	N/A

Table 5A – Comparison of Characteristics

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9. Non-Clinical Performance Data

Results from internal verification and validation testing performed in accordance with Peek Health' design control processes confirm that PeekMed product specifications have been met. Acceptance criteria were achieved for all tests. Supporting documentation is included in this 510(k) Premarket Notification and supports the claims of substantial equivalence to the predicate device.

Verification testing consisted of specific software functionalities testing and system level testing. Acceptance criteria, defined in the product requirements, were met for each verification test and are described in JIRA. A risk analysis in accordance with ISO 14971 was completed as part of the software design and development effort.

Validation activities for the subject device consisted of:

Validation tests performed internally prior to the release to the market by qualified personnel ● (personnel with background in anatomy and biomedical field), in an environment simulating the real end-user environment. This validation follows a pre-defined test script document, according to the tests defined in the Confluence sheets. To reassure that the lengths and angles measured with the internal functions of 'ruler' and 'angle' of the PeekMed software effectively and repeatedly match the real dimensions, validation consists the measuring of images of three implantable medical devices (prosthesis), CE marked and with strictly defined dimensions. Validation phase ensures that all product requirements have been fulfilled, meets the end-users needs, and ensure the safety and proper performance of the device.
. As a complementary validation, external validation is performed through a continuous follow-up from the Marketing and Sales team, follow-up on events registered in the platform mixpanel and user/customer surveys. Also, satisfaction questionnaires were made to assess the usability of the PeekMed software when comparing with others in the market, and also to make sure that the device operates as intended during the design stage.

10. Statement of Substantial Equivalence

PeekMed, as designed and developed by Peek Health, S.A., is determined to be substantially equivalent to the predicate device. Differences between the two devices do not raise new questions about the safety and effectiveness of PeekMed.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).