The EchoTech Easy3D is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasound images for computerized 3D image processing. Easy3D is an add-on accessory to existing diagnostic ultrasound systems. Easy3D employs freehand scanning without the use of a coordinate and position sensor, therefore, the extension of the data set in the scanning direction is unknown. The images are not intended for use in diagnosis or quantitative measurements. The Easy3D is intended as a general purpose digital 3D ultrasound image processing tool for use in obstetrics for qualitative evaluation of deformities and determination of the need for further fetal ultrasound studies.

The EchoTech 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images. It is intended to acquire, and retrieve digital ultrasound images for computerized 3D image processing. Easy3D is an add-on accessory to existing diagnostic ultrasound systems. Easy3D employs freehand scanning with the use of a coordinate and position sensor and, optionally, with heart cycle (R-Peak) triggering, which enables cardiovascular imaging.

The EchoTech EasyArchive system is indicated to acquire, digitize, archive, and retrieve single or sequences of 2D ultrasound images. EasyArchive is an add-on accessory to existing diagnostic ultrasound systems. EasyArchive is intended as a general purpose digital ultrasound image processing and archiving tool for use in radiology, neurology, gastroenterology, surgery, orthopedics, cardiology, oncology, obstetrics and gynecology.

The EchoTech Quanticon system is indicated in the acquisition of either heart cycle (R-Peak) triggered or nontriggered sequences of 2D ultrasound images for use in the evaluation of contrast agent-based ultrasound exams. In the sequence of images multiple Regions Of Interest (ROI) can be selected. Inside these chosen regions the average gray value or the number of color pixels is calculated over time. Quanticon is intended an add-on accessory to existing diagnostic ultrasound systems. Quanticon is intended as a general digital ultrasound processing and archiving tool for use in cardiology, radiology, and neurology,

The EchoTech EasyStress system is indicated for the acquisition of heart cycle (R-Peak) triggered sequences of 2D ultrasound images for use in performing, scoring, measuring, and archiving stress echo studies. The EasyStress system utilizes the ASE Standard for Wall Motion Scoring to quantify wall motion abnormalities of the heart. EasyStress is an add-on accessory to existing diagnostic ultrasound systems. EasyStress is a digital ultrasound image processing and archiving tool for use in cardiology.

Device Description

The following products produced by Echotech 3D Imaging Systems are included in this 510(k) premarket notification:

Easy3D Family .
3D FreeScan .
EasyArchive .
Quanticon .
EasyStress .

All of the subject products are accessories to diagnostic ultrasound imaging systems. The products are high performance computer systems based on Intel motherboard and WindowsNT standards. The systems incorporate commercially available image digitizer circuit boards for acquisition, storage, annotation, reporting, and retrieval of ultrasound image data. They also incorporate proprietary image processing software developed by EchoTech 3D Imaging Systems.

The EchoTech Easy3D Family system is a high performance computer system based on Intel motherboard and WindowsNT standards. It incorporates a commercially availabel image digitizer circuit board for acquisition, storage and retrieval of ultrasound image data. The device is an add-on accessory for any existing diagnostic imaging ultrasound system.

The system acquires either heart cycle (R-Peak) triggered or nontriggered sequences of 2D ulrasound images (B/W and Color) The 2D ulrasound images are acquired through video output port of the host ultrasound system as the ultrasound transducer is moved across the patient scan site. The resulting set of digitized 2D images is then converted into a 3D data volume under the assumption that a predefined scan movement was followed. In this step redundant gray values are eleminated, gaps are filled by a trilinear interpolation and the images are sorted depending on the time delay to the R-Peak. The acquisition process might be R-Peak triggered by the heart cycle. This is done by importing an Audio or TTL signal from the Physio module of the ultrasound system.

The EchoTech 3D FreeScan system is a high performance computer system based on Intel motherboard and WindowsNT standards. It incorporates a commercially availabel image digitizer circuit board for the acquisition, storage and retrieval of digital dynamic 3D ultrasound image data sets. The device is an add-on accessory for any existing diagnostic imaging ultrasound system.

The device records ultrasound transducer spatial position in six degrees of freedom during use. Coordinate tracking is achieved with a miniature magnetic field sensor within a transmitted pulsed magnetic field. This is done by attaching a plastic holding plate to the probe of the host ultrasound system, to which the receiver of an electromagnetic sensor device is attached.

2D ulrasound images are acquired triggerd sequentially in a series of steps as the ultrasound transducer is moved across the patient scan site. The resulting set of digitized 2D images is then converted into a 3D data volume. The acquisition process is R-Peak triggered by the heart cycle. This is done by importing an Audio or TTL signal from the Phvsio module of the ultrasound system.

The commercially available coordinate sensor device consists of an IBM compatible PC board, a tranmitter and a receiver. The transmitter generates a spherical magnetic field and the receiver can be moved anywhere within 1m of the transmitter to generate a set of 3 translational and 3 angulation values.

The 3D FreeScan system digitizes R-Peak triggerd the ulrasound images from the video output port of the host ultrasound system through a video cable. The images are stored in the computer memory. In a postprocessing step the oblique images are transformed into a Cartesian coordinate system. In this step redundant gray values are eleminated, gaps are filled by a trilinear interpolation and the images are sorted depending on the time delay to the R-Peak.

The EchoTech EasyArchive system is a high performance computer system based on Intel motherboard and WindowsNT standards. It incorporates a commercially availabel image digitizer circuit board for acquisition, storage and retrieval of ultrasound image data. The device is an add-on accessory for any existing diagnostic imaging ultrasound system.

The system acquires single 2D ultrasound images or sequences of 2D ulrasound images. The EasyArchive system digitizes the ulrasound images from the video output port of the host ultrasound system through a video cable. The images or sequneces are stored in the computer memory. The data can be stored along with patient adminstrative data in a data base on the EasyArchive harddisk or on removeable media for later display and retrieval.

The EchoTech QuantiCon system is a high performance computer system based on Intel motherboard and WindowsNT standards. It incorporates a commercially availabel image digitizer circuit board for acquisition, storage and retrieval of ultrasound image data. The device is an add-on accessory for any existing diagnostic imaging ultrasound svstem.

The system acquires either heart cycle (R-Peak) triggered or nontriggered sequences of 2D ulrasound images. In the sequence of images multiple Regions Of Interest (ROI) can be selected. Inside these regions the average gray value or the number of color pixel is calculated over time.

The QuantiCon system digitizes the ulrasound images from the video output port of the host ultrasound system through a video cable. The trigger signal for the acquisition process is taken from the ultrasound system either as an Audio beep or as a TTL signal. The images are stored in the computer memory. In a postprocessing step the images are lossless compressed (runlength compression). The postprocessed data can be stored along with patient adminstrative data in a data base on the QuantiCon harddisk or on removeable media for later display and retrieval.

The EchoTech EasyStress system is a high performance computer system based on Intel motherboard and WindowsNT standards. It incorporates a commercially availabel image digitizer circuit board for acquisition, storage and retrieval of ultrasound image data. The device is an add-on accessory for any existing diagnostic imaging ultrasound system.

The system acquires heart cycle (R-Peak) triggered sequences of 2D ulrasound images. Corressponding to the guidelines of the American Society of Echocardiographie ASE 16 sequences can be acquired. (4 stress phases and for each stress phase four standard views of the heart). The sequences can be synchronized replayed either sorted after stress phase or standard views. In the replay mode wall mation scoring WMS can be carried out following the guidelines of the ASE. The EasyStress system digitizes the ulrasound images from the video output port of the host ultrasound system through a video cable. The trigger signal for the acquisition process is taken from the ultrasound system either as an Audio beep or as a TTL signal. The images are stored in the computer memory. In a postprocessing step the images are lossless compressed (runlength compression). The postprocessed data can be stored along with patient adminstrative data in a data base on the EasyStress harddisk or on removeable media for later display and retrieval.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study conducted for the EchoTech 3D Imaging Systems K013088 submission:

Summary of Acceptance Criteria and Device Performance for K013088

It's important to note right away that the provided text is a 510(k) summary from 2002. At that time, the level of detail regarding acceptance criteria and performance studies in 510(k) summaries was often much less granular than what is typically expected for AI/ML-driven devices today. The document focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance metrics against specific acceptance criteria.

The acceptance criteria are implicitly met by demonstrating that the device functions as intended and is safe and effective when compared to predicate devices. The "Table of Acceptance Criteria and Reported Device Performance" below will reflect this interpretive approach given the limited explicit detail.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Predicate Equivalence)	Reported Device Performance
Functional Equivalence:
- Acquisition of 2D ultrasound images	Device acquires 2D ultrasound images.
- 3D reconstruction of ultrasound images	Device performs 3D reconstruction.
- Image analysis capabilities (ROI selection, gray value/color pixel calculation, WMS)	Device supports ROI selection, calculates average gray value/number of color pixels, and supports WMS according to ASE guidelines.
- Image storage and retrieval	Device stores and retrieves digital ultrasound images.
- Compatibility with existing diagnostic ultrasound systems (as an add-on)	Device functions as an add-on accessory to existing diagnostic ultrasound systems.
- Use of video output for image digitization	Device digitizes images from host ultrasound system's video output.
- Coordination tracking (for 3D FreeScan)	3D FreeScan records ultrasound transducer spatial position using a magnetic field sensor.
- R-Peak triggering (where applicable)	Devices incorporate R-Peak triggering via Audio or TTL signals for heart cycle synchronization.
- Lossless compression (where applicable)	Devices perform lossless compression (runlength compression).
Safety & Efficacy:
- Software functionality and reliability	Software testing and validation performed at module and system level. Test results support design intent.
- Compliance with internal company procedures	Testing followed internal company procedures.
- Conformance to system performance specifications	Actual device performance conforms to system performance specifications.

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

Sample Size for Test Set: The document explicitly states: "Testing was performed according to internal company procedures. Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted." It also mentions "Additional system testing was done by a third party standards test house." However, no specific sample sizes (e.g., number of cases, images, or patients) for the test set are provided.
Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. Given the nature of a 510(k) submission from 2002, such details were often not a required component in the summary. The focus was on demonstrating the functionality and safety of the software system itself.

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

The document does not specify the number of experts used to establish ground truth for the test set.
It also does not detail the qualifications of any experts (e.g., "radiologist with 10 years of experience"). This type of detail is typical for clinically validated AI algorithms, but not for software systems focused on image acquisition, processing, and archiving, especially from this era. The primary "ground truth" seems to be the expected functional output of the software (e.g., does it correctly acquire, store, and process images as designed).

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1). As mentioned above, the testing appears to be functional and system-level validation against specifications rather than a clinical performance study requiring expert consensus beyond verifying software output.

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

No MRMC comparative effectiveness study was mentioned or indicated. The device described is an "add-on accessory" for image acquisition, processing, storage, and retrieval. It's not an AI diagnostic aid intended to improve human reader performance or a standalone diagnostic algorithm. Therefore, an MRMC study and a human-in-the-loop effect size improvement would not be applicable or expected for this type of device based on the provided information.

6. Standalone Performance Study

A standalone performance evaluation was implicitly done in the sense that the software and system functionalities were tested to ensure they met their design specifications. "Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Additional system testing was done by a third party standards test house." This indicates that the algorithm/system was tested independently for its intended functions (acquisition, storage, processing, 3D reconstruction, calculation of ROIs, WMS, etc.), even if specific standalone metrics (like sensitivity/specificity for a diagnostic task) are not provided. Given the device's function as an image processing tool rather than a diagnostic one, its standalone performance would relate to its ability to correctly process and present images.

7. Type of Ground Truth Used

The ground truth used appears to be primarily related to engineering and functional specifications, and potentially logical correctness of image processing (e.g., a 3D reconstruction visually matches the input, ROI calculations are mathematically correct).
There is no mention of ground truth established by expert consensus on clinical findings, pathology results, or patient outcomes data, as the device's indications for use are focused on image processing and archiving rather than providing a new diagnosis or clinical interpretation. For example, for the Easy3D system, it states "The images are not intended for use in diagnosis or quantitative measurements." and "intended as a general purpose digital 3D ultrasound image processing tool for use in obstetrics for qualitative evaluation of deformities and determination of the need for further fetal ultrasound studies." This implies the "ground truth" is whether the system correctly processes images for qualitative review, not whether it correctly identifies deformities itself.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This is expected as the device predates widespread use of AI/ML or deep learning, which would typically involve distinct training sets. The software's functionality would have been developed using conventional programming and algorithms, not by training on a large dataset.

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

As there's no mention of a training set, there's also no information on how ground truth for a training set was established. The software development would have relied on established principles of image processing and system design, rather than data-driven machine learning models.

Summary

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K013088

510(k) Summary EchoTech 3D Imaging Systems

APR 0 4 2002

Easy3D Family 3D FreeScan EasyArchive Quanticon EasyStress

Submitter (Consultant) Name and Address

Morningstar Consulting Group, Inc. P. O. Box 219 Indian Hills, CO 80454

Submitter (Consultant) Contact Person

Kevin Morningstar, Senior Consultant (303) 697-8198 phone: (303) 697-7907 fax:

Sponsor Name and Address

EchoTech 3D Imaging Systems Inc 555 Burbank St. Unit A Broomfield, CO 80020

Sponsor Contact Person

Mr. Anthony Harris Manager of Operations phone 303-438-8455 fax 303-438-8530

Manufacturer Name and Address

EchoTech 3D Imaging Systems GmbH Zeppelinstr. 4 D-85399 Hallbergmoos Germany

Manufacturer Contact Person

Peter Wiczek, Product Line Manager phone: 011 49 811 5556 0 011 49 811 5556 20 fax:

Common, Classification & Proprietary Names

Common Name: Classification Name: Proprietary Name:

Digital ultrasound image analysis system Picture Archiving and Communications System (PACS) Easy3D, 3D FreeScan, EasyArchive, Quanticon, and EasyStress

0-1

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Classification
Class:	ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
Panel:	Radiology
CFR Section:	21 CFR 892.2050
Product Code:	LLZ (image processing system)

Predicate Devices

Comments of the control of the control of the consisted to concerner of the consisted on the consisted on the consisted on the consistedEchoTech 3D FreeScan	K980308	May 6, 1998
Tom-Tec Echo-Scan	K963807	December 18, 1996

Device Description

The following products produced by Echotech 3D Imaging Systems are included in this 510(k) premarket notification:

Easy3D Family .
3D FreeScan .
EasyArchive .
Quanticon .
EasyStress .

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images are lossless compressed (runlength compression). The postprocessed data can be stored along with patient adminstrative data in a data base on the QuantiCon harddisk or on removeable media for later display and retrieval.

Intended Use

The EchoTech Easy3D system is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasound images for computerized 3D image processing. Easy3D is an add-on accessory to existing diagnostic ultrasound svstems. Easy3D employs freehand scanning without the use of a coordinate and position sensor, therefore, the extension of the data set in the scanning direction is unknown. The images are not intended for use in diagnosis or quantitative measurements. The Easy3D is intended as a general purpose digital 3D ultrasound image processing tool for use in obstetrics for qualitative evaluation of deformities and determination of the need for further fetal ultrasound studies.

The EchoTech 3D FreeScan system is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasound images for computerized 3D image processing. Easy3D is an add-on accessory to existing diagnostic ultrasound systems. Easy3D employs freehand scanning with the use of a coordinate and position sensor and, optionally, with heart cycle (R-Peak) triggering, which enables cardiovascular imaging.

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radiology, neurology, gastroenterology, urology, surgery, orthopedics, cardiology, oncology, obstetrics and gynecology.

The EchoTech EasyStress system is indicated for the acquisition of heart cycle (R-Peak) triagered sequences of 2D ultrasound images for use in performing, scoring, measuring, reporting, and archiving stress echo studies. The EasyStress system utilizes the ASE Standard for Wall Motion Scoring to quantify wall motion abnormalities of the heart. EasyStress is an add-on accessory to existing diagnostic ultrasound systems. EasyStress is a digital ultrasound image processing and archiving tool for use in cardiology.

Verification and Validation Procedures

Testing was performed according to internal company procedures. Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Additional system testing was done by a third party standards test house.

Test results support the conclusion that actual device performance satisfies the design intent. Actual device performance as tested internally and by third parties conforms to the system performance specifications.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR o 4 2002

EchoTech 3D Imaging Systems, Inc. % Mr. Kevin Morningstar President & Senior Consultant Morningstar Consulting Group, Inc. P.O. Box 219 INDIAN HILLS CO 80454

Re: K013088

Trade/Device Name: EchoTech Easy 3D, 3D FreeScan, EasyArchive, Quanticon, EasyStress Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Number: 21 CFR 892.2050 Regulatory Name: Picture archiving and communications system Regulatory Class: II

Product Code: 90 IYO and LLZ Dated: March 4, 2002 Received: March 6, 2002

Dear Mr. Morningstar:

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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) 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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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name EchoTech Easy3D System

Indications for Use:

(Per 21 CFR 801.109)

The EchoTech Easy3D is indicated for acquisition of related sets of 2D ultrasound images and 3D reconstruction of ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasound images for computerized 3D image processing. Easy3D is an add-on accessory to existing diagnostic ultrasound systems. Easy3D employs freehand scanning without the use of a coordinate and position sensor, therefore, the extension of the data set in the scanning direction is unknown. The images are not intended for use in diagnosis or guantitative measurements. The Easy3D is intended as a general purpose digital 3D ultrasound image processing tool for use in obstetrics for qualitative evaluation of deformities and determination of the need for further fetal ultrasound studies.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K013088

Prescription Use	OR	Over-The-Counter Use
------------------	----	----------------------

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. 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 biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging 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.