The Medisign® MM3000 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Medisign® MM3000 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Medisign® MM3000 meter contains some speaking functions but is not intended for use by the visually impaired.

The Medisign® MM3000 Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Medisign® MM3000 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Medisign® MM3000Test Strips are for use with the Medisign® MM3000 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The Medisign® Glucose Control Solutions are intended for use with the Medisign® MM3000 meter and Medisign® MM3000 Test Strips as a quality control check to verify the meter and test strip are working together properly, and that the test is performing correctly.

The Medisign Link Diabetes Management Software is personal computer(PC) based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for effective controlling and managing blood glucose.

The Medisign® MM3000 Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) fresh capillary whole blood from fingertip, palm, or forearm. The Medisign® Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. The Medisign® MM3000 Multi meter contains some speaking functions but is not intended for use by the visually impaired.

The Medisign® MM3000 Multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Medisign® MM3000 Multi Blood Glucose Test Strips are for use with the Medisign® MM3000 Multi Blood Glucose Meter to quantitatively measure glucose (sugar) fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The Medisign® MM3000 Glucose Control Solutions are intended for use with the Medisign® MM3000 meter and Medisign® MM3000 Test Strips as a quality control check to verify the meter and test strip are working together properly, and that the test is performing correctly.

Device Description

Medisign Blood Glucose Monitoring System measures the glucose in the whole blood sample by using a small electrical current produced by chemical reaction between glucose in the blood and glucose oxidase (GOD) on the test strip. This current is proportionally converted to the amount of glucose in the blood sample to display as the blood glucose result. Glucose measurements are reported as plasma equivalents. Blood glucose results from test strips that are plasma-equivalent are approximately 11% higher than those obtained with whole-blood referenced test strips.

Medisign MM3000 Blood Glucose Monitoring System is basically provided with a blood glucose meter, blood glucose test strips, a lancing device, sterile lancets, and a carrying bag including user manual, quick reference manual and log book. Some kits do not include blood glucose test strips. Blood glucose test strips, blood glucose control solutions (1, 2, 3 levels), diabetes management software, and data transporting cable are sold separately.

Medisign MM3000 Multi Blood Glucose Monitoring System is basically provided with a blood glucose meter, blood glucose test strips, and a carrying bag including user manual, quick reference manual and log book. Some kits do not include blood glucose test strips. Disposable lancing device, blood glucose test strips, blood glucose control solutions (1,2,3 levels), diabetes management software, and data transporting cable are sold separately.

Each box of test strips contains one vial of 10 test strips, one vial of 25 test strips, one vial of 50 test strips, or two vials of 25 test strips. Also, each box may contain 25 test strips packed with single aluminum foiled pack or 50 test strips packed with single aluminum foiled pack. Each test strip contains the following reagent compositions: glucose oxidase (A. Niger) -2.5 units, redox mediator - 32.3ug and buffer & non-reactant - 50.5uq.

Each box of control solutions (1, 2, 3 levels) contains one vial of aqueous control solution (4ml each): Level 1 contains 0.03% concentrations of glucose (approximately 40 mg/dL) and Level 2 contains 0.11% concentrations of glucose (approximately 85 mg/dL) and Level 3 contains 0.23% concentrations of glucose (approximately 260 mg/dL).

AI/ML Overview

Here's the information about the acceptance criteria and study for the Medisign MM3000 Blood Glucose Monitoring System, extracted and organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state numerical acceptance criteria for the Medisign MM3000 Blood Glucose Monitoring System performance (e.g., accuracy percentages or error ranges). Instead, it states that "all tests have been proved satisfactory according to the predetermined acceptance criteria." It also does not present a table of specific reported device performance metrics in relation to these criteria. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data against predefined quantitative targets.

However, based on general expectations for blood glucose monitoring systems, acceptance criteria typically revolve around accuracy relative to a laboratory reference method. The measuring range is reported as 20 - 600 mg/dL.

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

The document mentions that a "system performance test including human factor study was conducted." However, it does not specify the sample size used for this test set nor the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications. For blood glucose monitoring systems, ground truth is typically established by comparative measurements using a laboratory reference method.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method. In the context of blood glucose monitoring systems, "adjudication" usually refers to how discrepancies between the device and the reference method are handled or how multiple readers for a test are reconciled. Since this is an in-vitro diagnostic device measuring a quantitative value, adjudication in the sense of expert consensus on qualitative interpretation is not typically applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This question is not applicable to the Medisign MM3000 Blood Glucose Monitoring System. This device is an in-vitro diagnostic device for quantitative blood glucose measurement, not an AI-assisted diagnostic imaging or interpretation system that would involve human "readers" or an MRMC study design.

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

The device is a standalone system for measuring blood glucose. Its performance is evaluated as the algorithm/system without human intervention in the measurement process itself, beyond the user applying the sample. The document states a "system performance test" was conducted, implying standalone performance evaluation.

7. The Type of Ground Truth Used:

While not explicitly stated in detail, the ground truth for blood glucose monitoring systems is invariably established through comparison with a laboratory reference method. The phrase "Blood glucose results from test strips that are plasma-equivalent are approximately 11% higher than those obtained with whole-blood referenced test strips" implies that plasma-equivalent values (likely derived from a laboratory reference) are the standard against which the device's measurements are calibrated and compared.

8. The Sample Size for the Training Set:

The document does not provide information on the sample size for a training set. Blood glucose meters do not typically undergo a "training" phase in the same way machine learning algorithms do. Their performance is based on the chemical and electrical properties of the test strips and meter, which are developed and validated.

9. How the Ground Truth for the Training Set was Established:

As mentioned above, the concept of a "training set" and associated ground truth establishment is not directly applicable to this type of medical device in the same way it would be for an AI/machine learning system. The device's fundamental performance is based on its electrochemical methodology and calibration, not on learning from a dataset.

Summary

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K133260

JUN 2 7 2014

510(k) Summary

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

1. Type of 510(k): Traditional 510(k)
1. Prepared Date:

May 2, 2014

3. Submission Sponsor:

Tianjin Empecs Medical Device Co., Ltd.

4. Address:

No.35 and 37, Yingcheng street, Hangu, Binhai New Area, Tianjin, 300480 China

5. Contact:

Eric.Chae, Regulatory Affairs Manager Phone: +82-70-7124-0474 Fax: +82-31-776-4496

1. Registration Number: 9616530

7. Measurement:

Whole blood glucose

8. Type of Test:

Quantitative, utilizing Glucose Oxidase technology

9. Device Name:

Medisign MM3000 Blood Glucose Monitoring System Medisign MM3000 Multi Blood Glucose Monitoring System

510k Summary

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10. Common Classification Name:

Blood Glucose Test System

11. Classification:

Product Code	Classification	Regulation Section	Panel
NBW - System, Test, BloodGlucose, Over The Counter	Class II	21 CFR 862.1345	75-Chemistry
CGA - Glucose Oxidase,Glucose	Class II	21 CFR 862.1345	75-Chemistry
JJX - Quality ControlMaterial	Class I	21 CFR 862.1660	75-Chemistry
JQP - Calculator/dataprocessing module forclinical use.	Class I	21 CFR 862.2100	75-Chemistry

12. Predicate Device Information:

Device Name:	Medisign MM1100 Blood Glucose Monitoring System,Medisign MM1100 Multi Blood Glucose Monitoring System
510(k) Number:	K111456

13. Intended Use

Medisign* MM3000 Blood Glucose Monitoring System

The Medisign® MM3000Test Strips are for use with the Medisign® MM3000 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the

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fingertips, forearm or palm.

Medisign® MM3000 Multi Blood Glucose Monitoring System

The Medisign Link Diabetes Management Software is personal computer(PC) based software intended for use in home and professional settings to help people with diabetes and their

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healthcare professionals in the review, analysis and evaluation of glucose test results for effective controlling and managing blood glucose.

14. Device Description

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15. Device Modifications

The modified Medisign MM3000Blood Glucose Monitoring System and Medisign MM3000 Multi Blood Glucose Monitoring System have the following that are identically same as the predicate device:

= Intended use
□Operation principle
· []Fundamental scientific technology
= □Raw materials
= [Operation environment
= □Measuring range

The modifications from the predicate device are as follows:

■Meter shape
· [] Type of a battery
= □Change to the memory capacity
Change to the expiration date of the test strip 트
I Change to assigned Glucose Control Solutions level title(from A,B to 2,3)
Addition of an Glucose Control Solution low level (level title: Level 1) .
■Addition of an alarm function
□ Addition of the hypoglycemic indicator
= [ Addition of average results for 7,28 days
= □Addition of a lancing device to the meter set for single user
= []Addition of a voice function feature
Addition of a single test strip package ■
□Exclude a check strip as the optional components (Control Solutions are enough to cover the check strip function of the control test)

16. Comparison to the Predicate Device

Similarities
Features	Predicate Device(K111456)	Candidate Device	SEDecision
Intended Use	Refer to the Intended UseSection	Same	SE
Enzyme	Glucose Oxidase (AspergillusNiger)	Same	SE

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Test Principle	Electrochemical reaction	Same	SE
Test Sample	Capillary whole blood	Same	SE
Electrode Material	Carbon	Same	SE
Coding of Test Strip	Auto coding	Same	SE
Calibration	Plasma equivalent	Same	SE
OperatingTemperature	50 - 104°F	Same	SE
Operating Humidity	10 - 90%RH	Same	SE
Hematocrit Range	30 - 55%	Same	SE
Alternate Site TestingSite	Palm, Forearm	Same	SE
Measuring Time	5 seconds	Same	SE
Sample Volume	Minimum 0.5 micro liter	Same	SE
Measuring Range	20 - 600 mg/dL	Same	SE
Pre/Post-mealflagging	Yes	Same	SE
Battery Life	Approximatelymorethan1,000 tests	Same	SE
Test Strip Ejector	Available	Same	SE
Differences
Battery	Two(2) 3.0V Lithiumbatteries(CR2032)	Two(2) 1.5V Alkalinebatteries(LR03, AAA)	-
Memory Capacity	300 results with date, timeand flag	500 results with date, timeand flag	-
Test Strip ExpirationDate	18 months(3 months after first opening)	24 months(3 months after first opening)	-
Glucose ControlSolution Level Title	Level ALevel B	Level 1Level 2Level 3	-
Alarm Function	N/A	Three(3) different intervalsettings available	-
Hypoglycemicindicator	N/A	Available	-
Averaging Results	14 days	7,14 and 28 days	-

510k Summary

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Lancing Device forsingle user	N/A	Included to the single usersystem(for Over the count useonly)	-
Voice Function	N/A	Available	-
Test Strip Packaging	Desiccant vial	• Desiccant vial or• Waterproof aluminum foilpack for single test strippacking	-
Check Strip	Optional Component	N/A	-

17. Performance Evaluation of Modified Device

The modified device has the same intended use, fundamental scientific technology and performance characteristics as the predicate device. Therefore, the performance, safety and effectiveness have not been changed from the predicate device. However, to confirm these changes have not brought any unexpected functional failure or adverse effect, a system performance test including human factor study was conducted. The test procedures were all the same as those applied to the predicate device submission. As a result, all tests have been proved satisfactory according to the predetermined acceptance criteria. Refer to section #13 for the procedures and results.

18. Summary of Design Control Activities

13.1 Risk analysis

The Risk assessment was conducted and The risk analysis method used to assess the impact of the modification was a Failure Modes and Effects Analysis(FMEA). Detected risks were assessed and controlled as low as possible.

13.2 Disinfection Study

Disinfectant CaviWipes® with the EPA registration number of 46781-8 has been validated demonstrating complete inactivation of the live virus inoculated on the materials of the meter and the reusable lancing device. The result showed that the disinfectant in preventing the spread of blood born pathogens, particularly hepatitis B virus(HBV).

A robustness performance test for a reusable lancing device also demonstrated that with 200 precleanings and 200 disinfection cycles, which is equivalent to 1 times use per a week for 3 years for the lay user at home. As a result, there was no deterioration on the performance or external materials of the lancing device.

A robustness performance test for the meter demonstrated that with 1,100 pre-cleanings and 1,100 disinfection cycles, which is equivalent to 10 times use per day for 3 years in a professional

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setting. The number of the cycle also includes those for the lay user at home. As a result, there was no deterioration on the performance or external materials of the meter.

13.3 Verification Activities for Modified Features

Verification activities were successfully executed to validate the modification and all test results fell within the acceptance criteria.(see attachment section #24)

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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing-like shapes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Scrvice

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

TIANJIN EMPECS MEDICAL DEVICE CO., LTD. C/O PRISCILLA CHUNG 2651 E CHAPMAN AVE STE 100 FULLERTON CA 92831

June 27, 2014

Re: K133260

Trade/Device Name: Medisign MM3000 Blood Glucose Monitoring System, Medisign MM3000 Multi Blood Glucose Monitoring System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX, JQP Dated: May 20, 2014 Received: May 20, 2014

Dear Ms. Priscilla Chung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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-Ms. Chung

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -S

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133260

Device Name

Medisign MM3000 Blood Glucose Monitoring System

Indications for Use (Describe)

The Medisign® MM3000 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forcarm or palm. The Medisign® MM3000 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The Medisign® MM3000 meter contains some speaking functions but is not intended for use by the visually impaired.

The Medisign® MM3000 Blood Glucose Monitoring System is intended for self-lesting outside the body (in vitro diagnosic use) by people with diabetes at home as an aid to monitor the effectivencs of diabeles control. The Medisign® MM3000 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Medisian® Glucose Control Solutions are intended for use with the Medisign® MM3000 Test Strips as a quality control check to verify the meter and test strip are working together properly, and that the test is performing correctly.

The Medisign Link Diabetes Management Software is personal computer(PC) based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, and evaluation of glucose test results for effective controlling and managing blood glucose.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/10/Picture/17 description: The image contains the text "Staycee Deck -SFDA". The text is stacked vertically, with "Staycee Deck" on the top line and "-SFDA" on the bottom line. The text is in a bold, sans-serif font. The image is black and white.

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

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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."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (it known) K133260

Device Name

Medisign MM3000 Multi Blood Glucose Monitoring System

Indications for Use (Describe)

The Medisign® MM3000 Multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) fresh capillary whole blood from fingertip, palm, or forearm. The Mecisign® MM30001 Multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. The Medisign® MM3000 Multi meter contains some speaking functions but is not intended for use by the visually impaired.

The Medisign® MM3000 Multi Blood Glucose Test Strips are for use with the Medisign® MM3000 Multi Bloud Glucose Meter to quantitatively measure glucose (sugar) fresh capillary whole blood samples drawn from the lingertips, forearm or palm.

The Medisign® MM3000 Glucose Control Solutions are intended for use with the Medisign® MM3000 meter and Medisign® MM3000 Test Strips as a quality control check to verily the meter and test strip are working together properly, and that the test is performing correctly.

The Medisian Link Diabetes Management Software is personal computer(PC) based software intended for use in home and professional settings to help people with diabeles and their healthcare professionals in the review, and evaluation of glucose test results for effective controlling and managing blood glucose.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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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.

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."

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.